Lucy Hicks

Teenage girls are experiencing record high levels of sexual violence, and nearly three in five girls report feeling persistently sad or hopeless, according to a new report by the Centers for Disease Control and Prevention.
 

Nearly 70% of teens who identified as lesbian, bisexual, gay, or questioning (LGBQ+) report experiencing feelings of persistent sadness and hopeless, and nearly one in four (22%) LGBQ+ had attempted suicide in 2021, according to the report.

“High school should be a time for trailblazing, not trauma. These data show our kids need far more support to cope, hope, and thrive,” said Debra Houry, MD, MPH, the CDC’s acting principal deputy director, in a press release about the findings.

The new analysis looked at data from 2011 to 2021 from the CDC’s Youth Risk and Behavior Survey (YRBS), a semiannual analysis of the health behaviors of students in grades 9-12. The 2021 survey is the first YRBS conducted since the COVID-19 pandemic began and included 17,232 respondents.

Although the researchers saw signs of improvement in risky sexual behaviors and substance abuse, as well as fewer experiences of bullying, the analysis found youth mental health worsened over the past 10 years. This trend was particularly troubling for teenage girls: 57% said they felt persistently sad or hopeless in 2021, a 60% increase from a decade ago. By comparison, 29% of teenage boys reported feeling persistently sad or hopeless, compared with 21% in 2011.

Nearly one-third of girls (30%) reported seriously considering suicide, up from 19% in 2011. In teenage boys, serious thoughts of suicide increased from 13% to 14% from 2011 to 2021. The percentage of teenage girls who had attempted suicide in 2021 was 13%, nearly twice that of teenage boys (7%).

More than half of students with a same-sex partner (58%) reported seriously considering suicide, and 45% of LGBQ+ teens reported the same thoughts. One third of students with a same-sex partner reported attempting suicide in the past year.

The report did not have trend data on LGBQ+ students because of changes in survey methods. The 2021 survey did not have a question accessing gender identity, but this will be incorporated into future surveys, according to the researchers.

Hispanic and multiracial students were more likely to experience persistent feelings of sadness or hopelessness, compared with their peers, with 46% and 49%, respectively, reporting these feelings. From 2011-2021, the percentage of students reporting feelings of hopelessness increased in each racial and ethnic group. The percentage of Black, Hispanic, and White teens who seriously considered suicide also increased over the decade. (A different report released by the CDC on Feb. 10 found that the rate of suicide among Blacks in the United States aged 10-24 jumped 36.6% between 2018 and 2021, the largest increase for any racial or ethnic group.)

The survey also found an alarming spike in sexual violence toward teenage girls. Nearly one in five females (18%) experienced sexual violence in the past year, a 20% increase from 2017. More than 1 in 10 teen girls (14%) said they had been forced to have sex, according to the researchers.

Rates of sexual violence was even higher in LGBQ+ teens. Nearly two in five teens with a partner of the same sex (39%) experienced sexual violence, and 37% reported being sexually assaulted. More than one in five LGBQ+ teens (22%) had experienced sexual violence, and 20% said they had been forced to have sex, the report found.

Among racial and ethnic groups, American Indian and Alaskan Native and multiracial students were more likely to experience sexual violence. The percentage of White students reporting sexual violence increased from 2017 to 2021, but that trend was not observed in other racial and ethnic groups.

Delaney Ruston, MD, an internal medicine specialist in Seattle and creator of “Screenagers,” a 2016 documentary about how technology affects youth, said excessive exposure to social media can compound feelings of depression in teens – particularly, but not only, girls. “They can scroll and consume media for hours, and rather than do activities and have interactions that would help heal from depression symptoms, they stay stuck,” Ruston said in an interview. “As a primary care physician working with teens, this is an extremely common problem I see in my clinic.”

One approach that can help, Dr. Ruston added, is behavioral activation. “This is a strategy where you get them, usually with the support of other people, to do small activities that help to reset brain reward pathways so they start to experience doses of well-being and hope that eventually reverses the depression. Being stuck on screens prevents these healing actions from happening.”

The report also emphasized the importance of school-based services to support students and combat these troubling trends in worsening mental health. “Schools are the gateway to needed services for many young people,” the report stated. “Schools can provide health, behavioral, and mental health services directly or establish referral systems to connect to community sources of care.”

“Young people are experiencing a level of distress that calls on us to act with urgency and compassion,” Kathleen Ethier, PhD, director of the CDC’s division of adolescent and school health, added in a statement. “With the right programs and services in place, schools have the unique ability to help our youth flourish.”

A version of this article first appeared on Medscape.com.

Teenage girls are experiencing record high levels of sexual violence, and nearly three in five girls report feeling persistently sad or hopeless, according to a new report by the Centers for Disease Control and Prevention.
 

Nearly 70% of teens who identified as lesbian, bisexual, gay, or questioning (LGBQ+) report experiencing feelings of persistent sadness and hopeless, and nearly one in four (22%) LGBQ+ had attempted suicide in 2021, according to the report.

“High school should be a time for trailblazing, not trauma. These data show our kids need far more support to cope, hope, and thrive,” said Debra Houry, MD, MPH, the CDC’s acting principal deputy director, in a press release about the findings.

The new analysis looked at data from 2011 to 2021 from the CDC’s Youth Risk and Behavior Survey (YRBS), a semiannual analysis of the health behaviors of students in grades 9-12. The 2021 survey is the first YRBS conducted since the COVID-19 pandemic began and included 17,232 respondents.

Although the researchers saw signs of improvement in risky sexual behaviors and substance abuse, as well as fewer experiences of bullying, the analysis found youth mental health worsened over the past 10 years. This trend was particularly troubling for teenage girls: 57% said they felt persistently sad or hopeless in 2021, a 60% increase from a decade ago. By comparison, 29% of teenage boys reported feeling persistently sad or hopeless, compared with 21% in 2011.

Nearly one-third of girls (30%) reported seriously considering suicide, up from 19% in 2011. In teenage boys, serious thoughts of suicide increased from 13% to 14% from 2011 to 2021. The percentage of teenage girls who had attempted suicide in 2021 was 13%, nearly twice that of teenage boys (7%).

More than half of students with a same-sex partner (58%) reported seriously considering suicide, and 45% of LGBQ+ teens reported the same thoughts. One third of students with a same-sex partner reported attempting suicide in the past year.

The report did not have trend data on LGBQ+ students because of changes in survey methods. The 2021 survey did not have a question accessing gender identity, but this will be incorporated into future surveys, according to the researchers.

Hispanic and multiracial students were more likely to experience persistent feelings of sadness or hopelessness, compared with their peers, with 46% and 49%, respectively, reporting these feelings. From 2011-2021, the percentage of students reporting feelings of hopelessness increased in each racial and ethnic group. The percentage of Black, Hispanic, and White teens who seriously considered suicide also increased over the decade. (A different report released by the CDC on Feb. 10 found that the rate of suicide among Blacks in the United States aged 10-24 jumped 36.6% between 2018 and 2021, the largest increase for any racial or ethnic group.)

The survey also found an alarming spike in sexual violence toward teenage girls. Nearly one in five females (18%) experienced sexual violence in the past year, a 20% increase from 2017. More than 1 in 10 teen girls (14%) said they had been forced to have sex, according to the researchers.

Rates of sexual violence was even higher in LGBQ+ teens. Nearly two in five teens with a partner of the same sex (39%) experienced sexual violence, and 37% reported being sexually assaulted. More than one in five LGBQ+ teens (22%) had experienced sexual violence, and 20% said they had been forced to have sex, the report found.

Among racial and ethnic groups, American Indian and Alaskan Native and multiracial students were more likely to experience sexual violence. The percentage of White students reporting sexual violence increased from 2017 to 2021, but that trend was not observed in other racial and ethnic groups.

Delaney Ruston, MD, an internal medicine specialist in Seattle and creator of “Screenagers,” a 2016 documentary about how technology affects youth, said excessive exposure to social media can compound feelings of depression in teens – particularly, but not only, girls. “They can scroll and consume media for hours, and rather than do activities and have interactions that would help heal from depression symptoms, they stay stuck,” Ruston said in an interview. “As a primary care physician working with teens, this is an extremely common problem I see in my clinic.”

One approach that can help, Dr. Ruston added, is behavioral activation. “This is a strategy where you get them, usually with the support of other people, to do small activities that help to reset brain reward pathways so they start to experience doses of well-being and hope that eventually reverses the depression. Being stuck on screens prevents these healing actions from happening.”

The report also emphasized the importance of school-based services to support students and combat these troubling trends in worsening mental health. “Schools are the gateway to needed services for many young people,” the report stated. “Schools can provide health, behavioral, and mental health services directly or establish referral systems to connect to community sources of care.”

“Young people are experiencing a level of distress that calls on us to act with urgency and compassion,” Kathleen Ethier, PhD, director of the CDC’s division of adolescent and school health, added in a statement. “With the right programs and services in place, schools have the unique ability to help our youth flourish.”

A version of this article first appeared on Medscape.com.

Teenage girls are experiencing record high levels of sexual violence, and nearly three in five girls report feeling persistently sad or hopeless, according to a new report by the Centers for Disease Control and Prevention.
 

Nearly 70% of teens who identified as lesbian, bisexual, gay, or questioning (LGBQ+) report experiencing feelings of persistent sadness and hopeless, and nearly one in four (22%) LGBQ+ had attempted suicide in 2021, according to the report.

“High school should be a time for trailblazing, not trauma. These data show our kids need far more support to cope, hope, and thrive,” said Debra Houry, MD, MPH, the CDC’s acting principal deputy director, in a press release about the findings.

The new analysis looked at data from 2011 to 2021 from the CDC’s Youth Risk and Behavior Survey (YRBS), a semiannual analysis of the health behaviors of students in grades 9-12. The 2021 survey is the first YRBS conducted since the COVID-19 pandemic began and included 17,232 respondents.

Although the researchers saw signs of improvement in risky sexual behaviors and substance abuse, as well as fewer experiences of bullying, the analysis found youth mental health worsened over the past 10 years. This trend was particularly troubling for teenage girls: 57% said they felt persistently sad or hopeless in 2021, a 60% increase from a decade ago. By comparison, 29% of teenage boys reported feeling persistently sad or hopeless, compared with 21% in 2011.

Nearly one-third of girls (30%) reported seriously considering suicide, up from 19% in 2011. In teenage boys, serious thoughts of suicide increased from 13% to 14% from 2011 to 2021. The percentage of teenage girls who had attempted suicide in 2021 was 13%, nearly twice that of teenage boys (7%).

More than half of students with a same-sex partner (58%) reported seriously considering suicide, and 45% of LGBQ+ teens reported the same thoughts. One third of students with a same-sex partner reported attempting suicide in the past year.

The report did not have trend data on LGBQ+ students because of changes in survey methods. The 2021 survey did not have a question accessing gender identity, but this will be incorporated into future surveys, according to the researchers.

Hispanic and multiracial students were more likely to experience persistent feelings of sadness or hopelessness, compared with their peers, with 46% and 49%, respectively, reporting these feelings. From 2011-2021, the percentage of students reporting feelings of hopelessness increased in each racial and ethnic group. The percentage of Black, Hispanic, and White teens who seriously considered suicide also increased over the decade. (A different report released by the CDC on Feb. 10 found that the rate of suicide among Blacks in the United States aged 10-24 jumped 36.6% between 2018 and 2021, the largest increase for any racial or ethnic group.)

The survey also found an alarming spike in sexual violence toward teenage girls. Nearly one in five females (18%) experienced sexual violence in the past year, a 20% increase from 2017. More than 1 in 10 teen girls (14%) said they had been forced to have sex, according to the researchers.

Rates of sexual violence was even higher in LGBQ+ teens. Nearly two in five teens with a partner of the same sex (39%) experienced sexual violence, and 37% reported being sexually assaulted. More than one in five LGBQ+ teens (22%) had experienced sexual violence, and 20% said they had been forced to have sex, the report found.

Among racial and ethnic groups, American Indian and Alaskan Native and multiracial students were more likely to experience sexual violence. The percentage of White students reporting sexual violence increased from 2017 to 2021, but that trend was not observed in other racial and ethnic groups.

Delaney Ruston, MD, an internal medicine specialist in Seattle and creator of “Screenagers,” a 2016 documentary about how technology affects youth, said excessive exposure to social media can compound feelings of depression in teens – particularly, but not only, girls. “They can scroll and consume media for hours, and rather than do activities and have interactions that would help heal from depression symptoms, they stay stuck,” Ruston said in an interview. “As a primary care physician working with teens, this is an extremely common problem I see in my clinic.”

One approach that can help, Dr. Ruston added, is behavioral activation. “This is a strategy where you get them, usually with the support of other people, to do small activities that help to reset brain reward pathways so they start to experience doses of well-being and hope that eventually reverses the depression. Being stuck on screens prevents these healing actions from happening.”

The report also emphasized the importance of school-based services to support students and combat these troubling trends in worsening mental health. “Schools are the gateway to needed services for many young people,” the report stated. “Schools can provide health, behavioral, and mental health services directly or establish referral systems to connect to community sources of care.”

“Young people are experiencing a level of distress that calls on us to act with urgency and compassion,” Kathleen Ethier, PhD, director of the CDC’s division of adolescent and school health, added in a statement. “With the right programs and services in place, schools have the unique ability to help our youth flourish.”

A version of this article first appeared on Medscape.com.

Both public and private health plans score poorly when it comes to providing access to autoimmune medication, according to a report commissioned by the Autoimmune Association and Let My Doctors Decide, a national partnership of health care professionals. The analysis, published Jan. 26, found that 75% of insurers in the United States have policies that can limit coverage for Food and Drug Administration–approved medications for Crohn’s disease, lupus nephritis, multiple sclerosis, psoriasis, psoriatic arthritis, rheumatoid arthritis, and ulcerative colitis.

“Choice among health plans is a hallmark of the American health insurance system, yet this analysis shows that people living with autoimmune conditions have few, if any, coverage choices that do not involve significant to severe access restrictions,” the authors wrote.

The study looked at three common utilization management policies by health plans that can limit coverage of certain medications: step therapy, formulary/tier placement, and prior authorization. To compare health plans, researchers weighted these policies using a point system. Each medication indicated for each condition was given a score of 0-4 based on access restrictions in a health plan. If a plan used step therapy, it received one point, and requiring prior authorization added an additional point. They also added points based on where a drug appeared on a plan’s formulary. A lower total score meant fewer access barriers. The numbers were then added, and each health plan received a grade of A, B, C, or F based on their average score. The datasets and analysis were provided and performed by the data analytics firm MMIT.

Nearly 9 in 10 Medicare plans received a C or worse for coverage of medication received via mail order or the pharmacy. In commercial plans, the majority of plans scored Cs or Fs for six of the seven conditions, excluding lupus nephritis, where 67% of all commercial health plans scored a B for access to these medications.

Physician-administered medications tended to receive poorer coverage than drugs received via pharmacy. Across all conditions, 65% of Medicare Advantage plans scored an F for physician-administered medication access. For both psoriasis and multiple sclerosis, at least 80% of Medicare plans earned failing scores because of these restrictions. Coverage was poorer on both commercial and health exchange plans, where across all conditions, 83% achieved failing scores. Two exceptions were the Southern and Northern California PPO plans by the Kaiser Foundation Health Plan. Out of the largest 25 health plans in the United States, these two plans earned As in coverage for physician-administered medications across all seven autoimmune conditions.

The report shows “a growing disconnect between science and health insurance benefit designs that were developed in the 1960s and 1970s,” Kenneth Thorpe, PhD, of Emory University, Atlanta, said in an interview. Insurers originally designed these benefits to prevent excessive utilization in a population of mostly acutely ill patients, he said, whereas now, 90% of healthcare spending is linked to chronic conditions. For these patients, research shows that incentivizing patients to adhere to medications results in fewer hospitalizations and, therefore, more cost savings, Thorpe noted. These plans also do not consider that there is no average patient, he said, and healthcare providers should be able to match each patient to the best treatment option for them rather than trying out other less expensive medications first. “To the extent that physicians can have the flexibility to provide medications and treatments to patients that are going to have the best clinical response, that’s better outcomes at lower cost,” Dr. Thorpe said. While research shows heterogeneity in patient outcomes with different medication, “benefit designs from the past just don’t recognize that.”

Neither America’s Health Insurance Plans nor Pharmaceutical Care Management Association responded to a request for comment.

Quardricos Driskell, executive director of Let My Doctors Decide and vice president of government relations and public policy at the Autoimmune Association, hopes the study will spur action by policy makers and health plans to improve access to medications for the people who need them. Another larger point of the report is to “uphold the sanctity of protecting the doctor and patient relationship,” he said in an interview, adding “that decisions fundamentally need to be made not by insurance plans or middleman pharmacy benefit managers, but by the provider and patient.”

Mr. Driskell and Dr. Thorpe reported no relevant financial relationships. 

A version of this article first appeared on Medscape.com.

Both public and private health plans score poorly when it comes to providing access to autoimmune medication, according to a report commissioned by the Autoimmune Association and Let My Doctors Decide, a national partnership of health care professionals. The analysis, published Jan. 26, found that 75% of insurers in the United States have policies that can limit coverage for Food and Drug Administration–approved medications for Crohn’s disease, lupus nephritis, multiple sclerosis, psoriasis, psoriatic arthritis, rheumatoid arthritis, and ulcerative colitis.

“Choice among health plans is a hallmark of the American health insurance system, yet this analysis shows that people living with autoimmune conditions have few, if any, coverage choices that do not involve significant to severe access restrictions,” the authors wrote.

The study looked at three common utilization management policies by health plans that can limit coverage of certain medications: step therapy, formulary/tier placement, and prior authorization. To compare health plans, researchers weighted these policies using a point system. Each medication indicated for each condition was given a score of 0-4 based on access restrictions in a health plan. If a plan used step therapy, it received one point, and requiring prior authorization added an additional point. They also added points based on where a drug appeared on a plan’s formulary. A lower total score meant fewer access barriers. The numbers were then added, and each health plan received a grade of A, B, C, or F based on their average score. The datasets and analysis were provided and performed by the data analytics firm MMIT.

Nearly 9 in 10 Medicare plans received a C or worse for coverage of medication received via mail order or the pharmacy. In commercial plans, the majority of plans scored Cs or Fs for six of the seven conditions, excluding lupus nephritis, where 67% of all commercial health plans scored a B for access to these medications.

Physician-administered medications tended to receive poorer coverage than drugs received via pharmacy. Across all conditions, 65% of Medicare Advantage plans scored an F for physician-administered medication access. For both psoriasis and multiple sclerosis, at least 80% of Medicare plans earned failing scores because of these restrictions. Coverage was poorer on both commercial and health exchange plans, where across all conditions, 83% achieved failing scores. Two exceptions were the Southern and Northern California PPO plans by the Kaiser Foundation Health Plan. Out of the largest 25 health plans in the United States, these two plans earned As in coverage for physician-administered medications across all seven autoimmune conditions.

The report shows “a growing disconnect between science and health insurance benefit designs that were developed in the 1960s and 1970s,” Kenneth Thorpe, PhD, of Emory University, Atlanta, said in an interview. Insurers originally designed these benefits to prevent excessive utilization in a population of mostly acutely ill patients, he said, whereas now, 90% of healthcare spending is linked to chronic conditions. For these patients, research shows that incentivizing patients to adhere to medications results in fewer hospitalizations and, therefore, more cost savings, Thorpe noted. These plans also do not consider that there is no average patient, he said, and healthcare providers should be able to match each patient to the best treatment option for them rather than trying out other less expensive medications first. “To the extent that physicians can have the flexibility to provide medications and treatments to patients that are going to have the best clinical response, that’s better outcomes at lower cost,” Dr. Thorpe said. While research shows heterogeneity in patient outcomes with different medication, “benefit designs from the past just don’t recognize that.”

Neither America’s Health Insurance Plans nor Pharmaceutical Care Management Association responded to a request for comment.

Quardricos Driskell, executive director of Let My Doctors Decide and vice president of government relations and public policy at the Autoimmune Association, hopes the study will spur action by policy makers and health plans to improve access to medications for the people who need them. Another larger point of the report is to “uphold the sanctity of protecting the doctor and patient relationship,” he said in an interview, adding “that decisions fundamentally need to be made not by insurance plans or middleman pharmacy benefit managers, but by the provider and patient.”

Mr. Driskell and Dr. Thorpe reported no relevant financial relationships. 

A version of this article first appeared on Medscape.com.

Both public and private health plans score poorly when it comes to providing access to autoimmune medication, according to a report commissioned by the Autoimmune Association and Let My Doctors Decide, a national partnership of health care professionals. The analysis, published Jan. 26, found that 75% of insurers in the United States have policies that can limit coverage for Food and Drug Administration–approved medications for Crohn’s disease, lupus nephritis, multiple sclerosis, psoriasis, psoriatic arthritis, rheumatoid arthritis, and ulcerative colitis.

“Choice among health plans is a hallmark of the American health insurance system, yet this analysis shows that people living with autoimmune conditions have few, if any, coverage choices that do not involve significant to severe access restrictions,” the authors wrote.

The study looked at three common utilization management policies by health plans that can limit coverage of certain medications: step therapy, formulary/tier placement, and prior authorization. To compare health plans, researchers weighted these policies using a point system. Each medication indicated for each condition was given a score of 0-4 based on access restrictions in a health plan. If a plan used step therapy, it received one point, and requiring prior authorization added an additional point. They also added points based on where a drug appeared on a plan’s formulary. A lower total score meant fewer access barriers. The numbers were then added, and each health plan received a grade of A, B, C, or F based on their average score. The datasets and analysis were provided and performed by the data analytics firm MMIT.

Nearly 9 in 10 Medicare plans received a C or worse for coverage of medication received via mail order or the pharmacy. In commercial plans, the majority of plans scored Cs or Fs for six of the seven conditions, excluding lupus nephritis, where 67% of all commercial health plans scored a B for access to these medications.

Physician-administered medications tended to receive poorer coverage than drugs received via pharmacy. Across all conditions, 65% of Medicare Advantage plans scored an F for physician-administered medication access. For both psoriasis and multiple sclerosis, at least 80% of Medicare plans earned failing scores because of these restrictions. Coverage was poorer on both commercial and health exchange plans, where across all conditions, 83% achieved failing scores. Two exceptions were the Southern and Northern California PPO plans by the Kaiser Foundation Health Plan. Out of the largest 25 health plans in the United States, these two plans earned As in coverage for physician-administered medications across all seven autoimmune conditions.

The report shows “a growing disconnect between science and health insurance benefit designs that were developed in the 1960s and 1970s,” Kenneth Thorpe, PhD, of Emory University, Atlanta, said in an interview. Insurers originally designed these benefits to prevent excessive utilization in a population of mostly acutely ill patients, he said, whereas now, 90% of healthcare spending is linked to chronic conditions. For these patients, research shows that incentivizing patients to adhere to medications results in fewer hospitalizations and, therefore, more cost savings, Thorpe noted. These plans also do not consider that there is no average patient, he said, and healthcare providers should be able to match each patient to the best treatment option for them rather than trying out other less expensive medications first. “To the extent that physicians can have the flexibility to provide medications and treatments to patients that are going to have the best clinical response, that’s better outcomes at lower cost,” Dr. Thorpe said. While research shows heterogeneity in patient outcomes with different medication, “benefit designs from the past just don’t recognize that.”

Neither America’s Health Insurance Plans nor Pharmaceutical Care Management Association responded to a request for comment.

Quardricos Driskell, executive director of Let My Doctors Decide and vice president of government relations and public policy at the Autoimmune Association, hopes the study will spur action by policy makers and health plans to improve access to medications for the people who need them. Another larger point of the report is to “uphold the sanctity of protecting the doctor and patient relationship,” he said in an interview, adding “that decisions fundamentally need to be made not by insurance plans or middleman pharmacy benefit managers, but by the provider and patient.”

Mr. Driskell and Dr. Thorpe reported no relevant financial relationships. 

A version of this article first appeared on Medscape.com.

The first biosimilar for Humira, adalimumab-atto (Amjevita), is now available in the United States, according to an announcement on Jan. 31 by the manufacturer, Amgen. At least seven other U.S. Food and Drug Administration–approved Humira biosimilars are expected to become available later in 2023.

Amjevita was approved by the FDA in September 2016 for multiple inflammatory diseases, including rheumatoid arthritis, psoriatic arthritis, ankylosing spondylitis, Crohn’s disease, ulcerative colitis, and plaque psoriasis. The delayed launch was part of a global settlement with Humira’s manufacturer, AbbVie.

Humira (adalimumab) has been available since 2002 and is consistently one of the top-selling drugs in the United States. A single 40-mg Amjevita pen device will be available at two prices: a list price (wholesale acquisition cost) of $1,557.59, 55% below the current Humira list price, and a list price of $3,288.24, 5% below the current Humira list price, according to Amgen.

“Amgen’s goal is to provide broad access for patients by offering two options to health plans and pharmacy benefit managers,” the company said in the press release.

Patients are less likely to benefit from the more significant discount, said Marta Wosinska, PhD, a health care economist at the Brookings Institute in Washington, DC. It's expected that insurance companies will use the higher list price for Amjevita, she said, as this higher price will also likely have higher rebates. Rebates are payments to health insurance payers provided by drug manufacturers to promote use of an expensive drug. Some pharmacy benefit managers have already said that they plan to charge patients the same amount for Humira as its biosimilars, Dr. Wosinska said.

"For an existing patient, there's really no incentive for them to switch," she said in an interview.

So far only one insurance company, Kaiser Permanente, has plans to switch patients over to biosimilars, according to the health policy podcast Tradeoffs, and the insurer will stop covering Humira by the end of this year.

A version of this article first appeared on Medscape.com.

*This story was updated 2/1/2023.

The first biosimilar for Humira, adalimumab-atto (Amjevita), is now available in the United States, according to an announcement on Jan. 31 by the manufacturer, Amgen. At least seven other U.S. Food and Drug Administration–approved Humira biosimilars are expected to become available later in 2023.

Amjevita was approved by the FDA in September 2016 for multiple inflammatory diseases, including rheumatoid arthritis, psoriatic arthritis, ankylosing spondylitis, Crohn’s disease, ulcerative colitis, and plaque psoriasis. The delayed launch was part of a global settlement with Humira’s manufacturer, AbbVie.

Humira (adalimumab) has been available since 2002 and is consistently one of the top-selling drugs in the United States. A single 40-mg Amjevita pen device will be available at two prices: a list price (wholesale acquisition cost) of $1,557.59, 55% below the current Humira list price, and a list price of $3,288.24, 5% below the current Humira list price, according to Amgen.

“Amgen’s goal is to provide broad access for patients by offering two options to health plans and pharmacy benefit managers,” the company said in the press release.

Patients are less likely to benefit from the more significant discount, said Marta Wosinska, PhD, a health care economist at the Brookings Institute in Washington, DC. It's expected that insurance companies will use the higher list price for Amjevita, she said, as this higher price will also likely have higher rebates. Rebates are payments to health insurance payers provided by drug manufacturers to promote use of an expensive drug. Some pharmacy benefit managers have already said that they plan to charge patients the same amount for Humira as its biosimilars, Dr. Wosinska said.

"For an existing patient, there's really no incentive for them to switch," she said in an interview.

So far only one insurance company, Kaiser Permanente, has plans to switch patients over to biosimilars, according to the health policy podcast Tradeoffs, and the insurer will stop covering Humira by the end of this year.

A version of this article first appeared on Medscape.com.

*This story was updated 2/1/2023.

The first biosimilar for Humira, adalimumab-atto (Amjevita), is now available in the United States, according to an announcement on Jan. 31 by the manufacturer, Amgen. At least seven other U.S. Food and Drug Administration–approved Humira biosimilars are expected to become available later in 2023.

Amjevita was approved by the FDA in September 2016 for multiple inflammatory diseases, including rheumatoid arthritis, psoriatic arthritis, ankylosing spondylitis, Crohn’s disease, ulcerative colitis, and plaque psoriasis. The delayed launch was part of a global settlement with Humira’s manufacturer, AbbVie.

Humira (adalimumab) has been available since 2002 and is consistently one of the top-selling drugs in the United States. A single 40-mg Amjevita pen device will be available at two prices: a list price (wholesale acquisition cost) of $1,557.59, 55% below the current Humira list price, and a list price of $3,288.24, 5% below the current Humira list price, according to Amgen.

“Amgen’s goal is to provide broad access for patients by offering two options to health plans and pharmacy benefit managers,” the company said in the press release.

Patients are less likely to benefit from the more significant discount, said Marta Wosinska, PhD, a health care economist at the Brookings Institute in Washington, DC. It's expected that insurance companies will use the higher list price for Amjevita, she said, as this higher price will also likely have higher rebates. Rebates are payments to health insurance payers provided by drug manufacturers to promote use of an expensive drug. Some pharmacy benefit managers have already said that they plan to charge patients the same amount for Humira as its biosimilars, Dr. Wosinska said.

"For an existing patient, there's really no incentive for them to switch," she said in an interview.

So far only one insurance company, Kaiser Permanente, has plans to switch patients over to biosimilars, according to the health policy podcast Tradeoffs, and the insurer will stop covering Humira by the end of this year.

A version of this article first appeared on Medscape.com.

*This story was updated 2/1/2023.

For a patient who needs a liver, living donation offers an alternative to staying on a list of more than 10,000 people waiting for a transplant. But what happens when your donor is not a match? To expand the number of living liver donations in the United States, the United Network for Organ Sharing (UNOS) has launched the first national paired liver donation pilot program.

“It’s an exciting time to be caring for patients who need liver transplants,” Benjamin Samstein, MD, chief of liver transplantation at New York–Presbyterian/Weill Cornell Medical Center, New York, said in an interview. He is the principal investigator for the UNOS pilot program. “I do believe it is within our grasp to make sure that nobody dies while waiting for an organ,” he said.

The initiative involves 15 U.S. transplant centers. So far, one recipient-donor pair has enrolled in the program. The pilot program has three main goals: Increase access to living donor transplants; increase access to transplants earlier, when recipients are in better health; and work out how to create and sustain a national program.
 

What is paired donation?

In 2020, 1,095 people died while waiting for a liver transplant, according to a report from the Organ Procurement and Transplant Network (OPTN) – a public-private partnership that includes more than 250 transplant centers and 50 organ procurement organizations across the country.

Most liver transplants involve deceased donors. One way to improve access to lifesaving transplants is through living donation, by which a healthy individual donates part of his or her liver. Someone can participate in nondirected or “altruistic” donation, in which someone donates a liver to someone they don’t know, or they can donate to a specific individual (usually a blood relative or a spouse).

With living liver donation, someone may receive a liver earlier, before getting sick enough to be given priority on the wait-list for deceased donation. Because the recipients are in better health, they may have an easier time recovering from the surgery, Ruthanne Leishman, who manages paired donation programs at UNOS, said in an interview.

In some cases, an individual will want to donate an organ to a specific person, but testing reveals that the two would not be a good match. Paired donation allows incompatible donors and recipients to find matches with other incompatible pairs. Each donor matches with the other pairs’ recipient, so the organs are essentially swapped or exchanged between the two pairs.

“People who want to donate get excited about the fact that they are not just helping their loved one but they’re also helping somebody else,” Ms. Leishman said.

Paired kidney donation programs have been running since 2002, but paired liver donation is relatively new. Since the first U.S. living-donor liver transplant in 1989, the procedure has become safer and is a viable alternative to deceased liver donation. A growing number of living donor programs are popping up at transplant centers across the country.

Still, living-donor liver donation makes up a small percentage of the liver transplants that are performed every year. In 2022, 603 living-donor liver transplants were performed in the United States, compared to 8,925 liver transplants from deceased donors, according to OPTN data. Dr. Samstein estimates a couple dozen paired liver exchanges may have been performed in the United States over the past few years within individual hospital systems. A goal of this pilot program, along with increasing access to liver transplants, is to see whether paired liver donation works on a national level, Ms. Leishman said.
 

Challenges to building a national program

There are several notable differences between living donor kidney transplants and living donor liver transplants. For example, living donor liver transplant is a more complicated surgery and poses greater risk to the donor. According to the OPTN 2020 Annual Report, from 2015 to 2019, the rehospitalization rate for living liver donors was twice that of living kidney donors up to 6 weeks after transplant (4.7% vs. 2.4%). One year post transplant, the cumulative rehospitalization rate was 11.0% for living liver donors and 4.8% for living kidney donors.

The risk of dying because of living donation is also higher for liver donors compared to kidney donors. The National Kidney Association states that the odds of dying during kidney donation are about 3 in 100,000, while estimates for risk of death for living liver donors range from 1 in 500 to 1 in 1,000. But some of these estimates are from 10 or more years ago, and outcomes have likely improved, said Whitney Jackson, MD, medical director of living donor liver transplant at UCHealth University of Colorado Hospital, Aurora. Her program is participating in the UNOS pilot.

More recent data from OPTN provides some idea of risk: Of 3,967 liver donors who donated between March 1, 2008, to Sept. 30, 2022, three deaths were reported within 30 days of transplant. However, the causes of death were not specified and therefore may be unrelated to the surgery. By comparison, of 74,555 kidney donors during that date range, 10 deaths were reported at 30 days post surgery.

In addition to a more complex surgery, surgeons also have a smaller time window in which to transplant a liver than than they do to transplant a kidney. A kidney can remain viable in cold storage for 24-36 hours, and it can be transported via commercial airlines cross country. Livers have to be transplanted within 8-12 hours, according to the OPTN website. For living donation, the graft needs to be transplanted within about 4 hours, Dr. Samstein noted; this poses a logistical challenge for a national organ paired donation program.

“We worked around that with the idea that we would move the donor rather than the organ,” he said. The program will require a donor (and a support person) to travel to the recipient’s transplant center where the surgery will be performed. While 3 of the 15 pilot paired donation transplant centers are in New York City, the other programs are scattered across the country, meaning a donor may have to fly to a different city to undergo surgery.

Including the preoperative evaluation, meeting the surgical team, the surgery itself, and follow-up, the donor could stay for about a month. The program offers up to $10,000 of financial assistance for travel expenses (for both the donor and support person), as well as lost wages and dependent care (for the donor only). Health insurance coverage will also be provided by the pilot program, in partnership with the American Foundation for Donation and Transplant.

The program requires that transplant candidates (the recipients) be at least 12 years old, be on the waiting list for deceased liver donation at one of the pilot’s transplant centers, and have a Model for End-Stage Liver Disease (MELD) score of 25 or less. All potential donors must be 18 years or older and must undergo a medical and psychosocial evaluation. Nondirected donors can register with the program, and they will be paired with a candidate on the liver transplant waiting list at the same transplant center.

The 1-year pilot program is set to begin when the program conducts its first match run – an algorithm will help match pairs who are enrolled in the program. About five to seven enrolled pairs would be ideal for the first match run, a UNOS spokesperson said. It is possible that the 1-year pilot program could run without performing any paired transplants, but that’s unlikely if multiple pairs are enrolled in the system, the spokesperson said. At the time of this story’s publication, the one enrolled pair are a mother and daughter who are registered at the UCHealth Transplant Center in Colorado.
 

Is a national liver paired donor program feasible?

While the UNOS pilot program offers financial assistance for expenses related to liver donation, some transplant surgeons are skeptical about the potential travel component of the pilot program.

The pilot program requires that the donor bring one support person if there is a need to travel for the surgery, but undergoing major abdominal surgery from a transplant team they are not familiar with may be stressful, said Peter Abt, MD, a transplant surgeon at the Hospital of the University of Pennsylvania and the Children’s Hospital of Philadelphia. “That’s a big ask,” he said, “and I’m not sure many potential donors would be up to that.”

John Roberts, MD, a transplant surgeon at the University of California, San Francisco, agreed that the travel component may put additional stress on the donor, but “if it’s the only way for the recipient to get a transplant, then the donor might be motivated,” he added.

Dr. Jackson remains optimistic. “Our experience so far has been that, yes, some people have been hesitant for things like traveling, but a lot of people who seem to be genuinely dedicated to the idea of living donation have been very enthusiastic,” she noted.

Dr. Leishman agreed that the travel aspect appears to one of the greatest barriers to participants entering the program but noted that a goal of the pilot program is to understand better what works - and what doesn’t – when considering a liver paired donation program on a national scale. “[Our] steering committee has put together a really nice framework that they think will work, but they know it’s not perfect. We’re going to have to tweak it along the way,” she said.

More information on the paired liver donation pilot program can be found on the UNOS website.

The sources interviewed for this article reported no financial conflicts of interest.

A version of this article first appeared on Medscape.com.

This article was updated 2/15/23.

For a patient who needs a liver, living donation offers an alternative to staying on a list of more than 10,000 people waiting for a transplant. But what happens when your donor is not a match? To expand the number of living liver donations in the United States, the United Network for Organ Sharing (UNOS) has launched the first national paired liver donation pilot program.

“It’s an exciting time to be caring for patients who need liver transplants,” Benjamin Samstein, MD, chief of liver transplantation at New York–Presbyterian/Weill Cornell Medical Center, New York, said in an interview. He is the principal investigator for the UNOS pilot program. “I do believe it is within our grasp to make sure that nobody dies while waiting for an organ,” he said.

The initiative involves 15 U.S. transplant centers. So far, one recipient-donor pair has enrolled in the program. The pilot program has three main goals: Increase access to living donor transplants; increase access to transplants earlier, when recipients are in better health; and work out how to create and sustain a national program.
 

What is paired donation?

In 2020, 1,095 people died while waiting for a liver transplant, according to a report from the Organ Procurement and Transplant Network (OPTN) – a public-private partnership that includes more than 250 transplant centers and 50 organ procurement organizations across the country.

Most liver transplants involve deceased donors. One way to improve access to lifesaving transplants is through living donation, by which a healthy individual donates part of his or her liver. Someone can participate in nondirected or “altruistic” donation, in which someone donates a liver to someone they don’t know, or they can donate to a specific individual (usually a blood relative or a spouse).

With living liver donation, someone may receive a liver earlier, before getting sick enough to be given priority on the wait-list for deceased donation. Because the recipients are in better health, they may have an easier time recovering from the surgery, Ruthanne Leishman, who manages paired donation programs at UNOS, said in an interview.

In some cases, an individual will want to donate an organ to a specific person, but testing reveals that the two would not be a good match. Paired donation allows incompatible donors and recipients to find matches with other incompatible pairs. Each donor matches with the other pairs’ recipient, so the organs are essentially swapped or exchanged between the two pairs.

“People who want to donate get excited about the fact that they are not just helping their loved one but they’re also helping somebody else,” Ms. Leishman said.

Paired kidney donation programs have been running since 2002, but paired liver donation is relatively new. Since the first U.S. living-donor liver transplant in 1989, the procedure has become safer and is a viable alternative to deceased liver donation. A growing number of living donor programs are popping up at transplant centers across the country.

Still, living-donor liver donation makes up a small percentage of the liver transplants that are performed every year. In 2022, 603 living-donor liver transplants were performed in the United States, compared to 8,925 liver transplants from deceased donors, according to OPTN data. Dr. Samstein estimates a couple dozen paired liver exchanges may have been performed in the United States over the past few years within individual hospital systems. A goal of this pilot program, along with increasing access to liver transplants, is to see whether paired liver donation works on a national level, Ms. Leishman said.
 

Challenges to building a national program

There are several notable differences between living donor kidney transplants and living donor liver transplants. For example, living donor liver transplant is a more complicated surgery and poses greater risk to the donor. According to the OPTN 2020 Annual Report, from 2015 to 2019, the rehospitalization rate for living liver donors was twice that of living kidney donors up to 6 weeks after transplant (4.7% vs. 2.4%). One year post transplant, the cumulative rehospitalization rate was 11.0% for living liver donors and 4.8% for living kidney donors.

The risk of dying because of living donation is also higher for liver donors compared to kidney donors. The National Kidney Association states that the odds of dying during kidney donation are about 3 in 100,000, while estimates for risk of death for living liver donors range from 1 in 500 to 1 in 1,000. But some of these estimates are from 10 or more years ago, and outcomes have likely improved, said Whitney Jackson, MD, medical director of living donor liver transplant at UCHealth University of Colorado Hospital, Aurora. Her program is participating in the UNOS pilot.

More recent data from OPTN provides some idea of risk: Of 3,967 liver donors who donated between March 1, 2008, to Sept. 30, 2022, three deaths were reported within 30 days of transplant. However, the causes of death were not specified and therefore may be unrelated to the surgery. By comparison, of 74,555 kidney donors during that date range, 10 deaths were reported at 30 days post surgery.

In addition to a more complex surgery, surgeons also have a smaller time window in which to transplant a liver than than they do to transplant a kidney. A kidney can remain viable in cold storage for 24-36 hours, and it can be transported via commercial airlines cross country. Livers have to be transplanted within 8-12 hours, according to the OPTN website. For living donation, the graft needs to be transplanted within about 4 hours, Dr. Samstein noted; this poses a logistical challenge for a national organ paired donation program.

“We worked around that with the idea that we would move the donor rather than the organ,” he said. The program will require a donor (and a support person) to travel to the recipient’s transplant center where the surgery will be performed. While 3 of the 15 pilot paired donation transplant centers are in New York City, the other programs are scattered across the country, meaning a donor may have to fly to a different city to undergo surgery.

Including the preoperative evaluation, meeting the surgical team, the surgery itself, and follow-up, the donor could stay for about a month. The program offers up to $10,000 of financial assistance for travel expenses (for both the donor and support person), as well as lost wages and dependent care (for the donor only). Health insurance coverage will also be provided by the pilot program, in partnership with the American Foundation for Donation and Transplant.

The program requires that transplant candidates (the recipients) be at least 12 years old, be on the waiting list for deceased liver donation at one of the pilot’s transplant centers, and have a Model for End-Stage Liver Disease (MELD) score of 25 or less. All potential donors must be 18 years or older and must undergo a medical and psychosocial evaluation. Nondirected donors can register with the program, and they will be paired with a candidate on the liver transplant waiting list at the same transplant center.

The 1-year pilot program is set to begin when the program conducts its first match run – an algorithm will help match pairs who are enrolled in the program. About five to seven enrolled pairs would be ideal for the first match run, a UNOS spokesperson said. It is possible that the 1-year pilot program could run without performing any paired transplants, but that’s unlikely if multiple pairs are enrolled in the system, the spokesperson said. At the time of this story’s publication, the one enrolled pair are a mother and daughter who are registered at the UCHealth Transplant Center in Colorado.
 

Is a national liver paired donor program feasible?

While the UNOS pilot program offers financial assistance for expenses related to liver donation, some transplant surgeons are skeptical about the potential travel component of the pilot program.

The pilot program requires that the donor bring one support person if there is a need to travel for the surgery, but undergoing major abdominal surgery from a transplant team they are not familiar with may be stressful, said Peter Abt, MD, a transplant surgeon at the Hospital of the University of Pennsylvania and the Children’s Hospital of Philadelphia. “That’s a big ask,” he said, “and I’m not sure many potential donors would be up to that.”

John Roberts, MD, a transplant surgeon at the University of California, San Francisco, agreed that the travel component may put additional stress on the donor, but “if it’s the only way for the recipient to get a transplant, then the donor might be motivated,” he added.

Dr. Jackson remains optimistic. “Our experience so far has been that, yes, some people have been hesitant for things like traveling, but a lot of people who seem to be genuinely dedicated to the idea of living donation have been very enthusiastic,” she noted.

Dr. Leishman agreed that the travel aspect appears to one of the greatest barriers to participants entering the program but noted that a goal of the pilot program is to understand better what works - and what doesn’t – when considering a liver paired donation program on a national scale. “[Our] steering committee has put together a really nice framework that they think will work, but they know it’s not perfect. We’re going to have to tweak it along the way,” she said.

More information on the paired liver donation pilot program can be found on the UNOS website.

The sources interviewed for this article reported no financial conflicts of interest.

A version of this article first appeared on Medscape.com.

This article was updated 2/15/23.

For a patient who needs a liver, living donation offers an alternative to staying on a list of more than 10,000 people waiting for a transplant. But what happens when your donor is not a match? To expand the number of living liver donations in the United States, the United Network for Organ Sharing (UNOS) has launched the first national paired liver donation pilot program.

“It’s an exciting time to be caring for patients who need liver transplants,” Benjamin Samstein, MD, chief of liver transplantation at New York–Presbyterian/Weill Cornell Medical Center, New York, said in an interview. He is the principal investigator for the UNOS pilot program. “I do believe it is within our grasp to make sure that nobody dies while waiting for an organ,” he said.

The initiative involves 15 U.S. transplant centers. So far, one recipient-donor pair has enrolled in the program. The pilot program has three main goals: Increase access to living donor transplants; increase access to transplants earlier, when recipients are in better health; and work out how to create and sustain a national program.
 

What is paired donation?

In 2020, 1,095 people died while waiting for a liver transplant, according to a report from the Organ Procurement and Transplant Network (OPTN) – a public-private partnership that includes more than 250 transplant centers and 50 organ procurement organizations across the country.

Most liver transplants involve deceased donors. One way to improve access to lifesaving transplants is through living donation, by which a healthy individual donates part of his or her liver. Someone can participate in nondirected or “altruistic” donation, in which someone donates a liver to someone they don’t know, or they can donate to a specific individual (usually a blood relative or a spouse).

With living liver donation, someone may receive a liver earlier, before getting sick enough to be given priority on the wait-list for deceased donation. Because the recipients are in better health, they may have an easier time recovering from the surgery, Ruthanne Leishman, who manages paired donation programs at UNOS, said in an interview.

In some cases, an individual will want to donate an organ to a specific person, but testing reveals that the two would not be a good match. Paired donation allows incompatible donors and recipients to find matches with other incompatible pairs. Each donor matches with the other pairs’ recipient, so the organs are essentially swapped or exchanged between the two pairs.

“People who want to donate get excited about the fact that they are not just helping their loved one but they’re also helping somebody else,” Ms. Leishman said.

Paired kidney donation programs have been running since 2002, but paired liver donation is relatively new. Since the first U.S. living-donor liver transplant in 1989, the procedure has become safer and is a viable alternative to deceased liver donation. A growing number of living donor programs are popping up at transplant centers across the country.

Still, living-donor liver donation makes up a small percentage of the liver transplants that are performed every year. In 2022, 603 living-donor liver transplants were performed in the United States, compared to 8,925 liver transplants from deceased donors, according to OPTN data. Dr. Samstein estimates a couple dozen paired liver exchanges may have been performed in the United States over the past few years within individual hospital systems. A goal of this pilot program, along with increasing access to liver transplants, is to see whether paired liver donation works on a national level, Ms. Leishman said.
 

Challenges to building a national program

There are several notable differences between living donor kidney transplants and living donor liver transplants. For example, living donor liver transplant is a more complicated surgery and poses greater risk to the donor. According to the OPTN 2020 Annual Report, from 2015 to 2019, the rehospitalization rate for living liver donors was twice that of living kidney donors up to 6 weeks after transplant (4.7% vs. 2.4%). One year post transplant, the cumulative rehospitalization rate was 11.0% for living liver donors and 4.8% for living kidney donors.

The risk of dying because of living donation is also higher for liver donors compared to kidney donors. The National Kidney Association states that the odds of dying during kidney donation are about 3 in 100,000, while estimates for risk of death for living liver donors range from 1 in 500 to 1 in 1,000. But some of these estimates are from 10 or more years ago, and outcomes have likely improved, said Whitney Jackson, MD, medical director of living donor liver transplant at UCHealth University of Colorado Hospital, Aurora. Her program is participating in the UNOS pilot.

More recent data from OPTN provides some idea of risk: Of 3,967 liver donors who donated between March 1, 2008, to Sept. 30, 2022, three deaths were reported within 30 days of transplant. However, the causes of death were not specified and therefore may be unrelated to the surgery. By comparison, of 74,555 kidney donors during that date range, 10 deaths were reported at 30 days post surgery.

In addition to a more complex surgery, surgeons also have a smaller time window in which to transplant a liver than than they do to transplant a kidney. A kidney can remain viable in cold storage for 24-36 hours, and it can be transported via commercial airlines cross country. Livers have to be transplanted within 8-12 hours, according to the OPTN website. For living donation, the graft needs to be transplanted within about 4 hours, Dr. Samstein noted; this poses a logistical challenge for a national organ paired donation program.

“We worked around that with the idea that we would move the donor rather than the organ,” he said. The program will require a donor (and a support person) to travel to the recipient’s transplant center where the surgery will be performed. While 3 of the 15 pilot paired donation transplant centers are in New York City, the other programs are scattered across the country, meaning a donor may have to fly to a different city to undergo surgery.

Including the preoperative evaluation, meeting the surgical team, the surgery itself, and follow-up, the donor could stay for about a month. The program offers up to $10,000 of financial assistance for travel expenses (for both the donor and support person), as well as lost wages and dependent care (for the donor only). Health insurance coverage will also be provided by the pilot program, in partnership with the American Foundation for Donation and Transplant.

The program requires that transplant candidates (the recipients) be at least 12 years old, be on the waiting list for deceased liver donation at one of the pilot’s transplant centers, and have a Model for End-Stage Liver Disease (MELD) score of 25 or less. All potential donors must be 18 years or older and must undergo a medical and psychosocial evaluation. Nondirected donors can register with the program, and they will be paired with a candidate on the liver transplant waiting list at the same transplant center.

The 1-year pilot program is set to begin when the program conducts its first match run – an algorithm will help match pairs who are enrolled in the program. About five to seven enrolled pairs would be ideal for the first match run, a UNOS spokesperson said. It is possible that the 1-year pilot program could run without performing any paired transplants, but that’s unlikely if multiple pairs are enrolled in the system, the spokesperson said. At the time of this story’s publication, the one enrolled pair are a mother and daughter who are registered at the UCHealth Transplant Center in Colorado.
 

Is a national liver paired donor program feasible?

While the UNOS pilot program offers financial assistance for expenses related to liver donation, some transplant surgeons are skeptical about the potential travel component of the pilot program.

The pilot program requires that the donor bring one support person if there is a need to travel for the surgery, but undergoing major abdominal surgery from a transplant team they are not familiar with may be stressful, said Peter Abt, MD, a transplant surgeon at the Hospital of the University of Pennsylvania and the Children’s Hospital of Philadelphia. “That’s a big ask,” he said, “and I’m not sure many potential donors would be up to that.”

John Roberts, MD, a transplant surgeon at the University of California, San Francisco, agreed that the travel component may put additional stress on the donor, but “if it’s the only way for the recipient to get a transplant, then the donor might be motivated,” he added.

Dr. Jackson remains optimistic. “Our experience so far has been that, yes, some people have been hesitant for things like traveling, but a lot of people who seem to be genuinely dedicated to the idea of living donation have been very enthusiastic,” she noted.

Dr. Leishman agreed that the travel aspect appears to one of the greatest barriers to participants entering the program but noted that a goal of the pilot program is to understand better what works - and what doesn’t – when considering a liver paired donation program on a national scale. “[Our] steering committee has put together a really nice framework that they think will work, but they know it’s not perfect. We’re going to have to tweak it along the way,” she said.

More information on the paired liver donation pilot program can be found on the UNOS website.

The sources interviewed for this article reported no financial conflicts of interest.

A version of this article first appeared on Medscape.com.

This article was updated 2/15/23.

The U.S. Food and Drug Administration has approved the medication lenacapavir (Sunlenca) for adults living with multidrug resistant HIV-1 infection. After the initial doses are completed – given both orally and via subcutaneous injection – the drug is administered by injection every 6 months.
 

“Following today’s decision from the FDA, lenacapavir helps to fill a critical unmet need for people with complex prior treatment histories and offers physicians a long-awaited twice-yearly option for these patients who otherwise have limited therapy choices,” said site principal investigator Sorana Segal-Maurer, MD, a professor of clinical medicine at Weill Cornell Medicine, New York, in a statement.

HIV drug regimens generally consist of two or three HIV medicines combined in a daily pill. In 2021, the FDA approved the first injectable complete drug regimen for HIV-1, Cabenuva, which can be administered monthly or every other month. Lenacapavir is administered only twice annually, but it is also combined with other antiretrovirals. The injections and oral tablets of lenacapavir are estimated to cost $42,250 in the first year of treatment and then $39,000 annually in the subsequent years, Reuters reported.

Lenacapavir is the first of a new class of drug called capsid inhibitors to be FDA-approved for treating HIV-1. The drug blocks the HIV-1 virus’s protein shell and interferes with essential steps of the virus’s evolution. The approval, announced today, was based on a multicenter clinical trial of 72 patients with multidrug resistant HIV-1 infection. After a year of the medication, 30 (83%) of the 36 patients randomly assigned to take lenacapavir, in combination with other HIV medications, had undetectable viral loads.

“Today’s approval ushers in a new class of antiretroviral drugs that may help patients with HIV who have run out of treatment options,” said Debra Birnkrant, MD, director of the division of antivirals in the FDA’s Center for Drug Evaluation and Research, in a press release. “The availability of new classes of antiretroviral medications may possibly help these patients live longer, healthier lives.”

A version of this article first appeared on Medscape.com.

The U.S. Food and Drug Administration has approved the medication lenacapavir (Sunlenca) for adults living with multidrug resistant HIV-1 infection. After the initial doses are completed – given both orally and via subcutaneous injection – the drug is administered by injection every 6 months.
 

“Following today’s decision from the FDA, lenacapavir helps to fill a critical unmet need for people with complex prior treatment histories and offers physicians a long-awaited twice-yearly option for these patients who otherwise have limited therapy choices,” said site principal investigator Sorana Segal-Maurer, MD, a professor of clinical medicine at Weill Cornell Medicine, New York, in a statement.

HIV drug regimens generally consist of two or three HIV medicines combined in a daily pill. In 2021, the FDA approved the first injectable complete drug regimen for HIV-1, Cabenuva, which can be administered monthly or every other month. Lenacapavir is administered only twice annually, but it is also combined with other antiretrovirals. The injections and oral tablets of lenacapavir are estimated to cost $42,250 in the first year of treatment and then $39,000 annually in the subsequent years, Reuters reported.

Lenacapavir is the first of a new class of drug called capsid inhibitors to be FDA-approved for treating HIV-1. The drug blocks the HIV-1 virus’s protein shell and interferes with essential steps of the virus’s evolution. The approval, announced today, was based on a multicenter clinical trial of 72 patients with multidrug resistant HIV-1 infection. After a year of the medication, 30 (83%) of the 36 patients randomly assigned to take lenacapavir, in combination with other HIV medications, had undetectable viral loads.

“Today’s approval ushers in a new class of antiretroviral drugs that may help patients with HIV who have run out of treatment options,” said Debra Birnkrant, MD, director of the division of antivirals in the FDA’s Center for Drug Evaluation and Research, in a press release. “The availability of new classes of antiretroviral medications may possibly help these patients live longer, healthier lives.”

A version of this article first appeared on Medscape.com.

The U.S. Food and Drug Administration has approved the medication lenacapavir (Sunlenca) for adults living with multidrug resistant HIV-1 infection. After the initial doses are completed – given both orally and via subcutaneous injection – the drug is administered by injection every 6 months.
 

“Following today’s decision from the FDA, lenacapavir helps to fill a critical unmet need for people with complex prior treatment histories and offers physicians a long-awaited twice-yearly option for these patients who otherwise have limited therapy choices,” said site principal investigator Sorana Segal-Maurer, MD, a professor of clinical medicine at Weill Cornell Medicine, New York, in a statement.

HIV drug regimens generally consist of two or three HIV medicines combined in a daily pill. In 2021, the FDA approved the first injectable complete drug regimen for HIV-1, Cabenuva, which can be administered monthly or every other month. Lenacapavir is administered only twice annually, but it is also combined with other antiretrovirals. The injections and oral tablets of lenacapavir are estimated to cost $42,250 in the first year of treatment and then $39,000 annually in the subsequent years, Reuters reported.

Lenacapavir is the first of a new class of drug called capsid inhibitors to be FDA-approved for treating HIV-1. The drug blocks the HIV-1 virus’s protein shell and interferes with essential steps of the virus’s evolution. The approval, announced today, was based on a multicenter clinical trial of 72 patients with multidrug resistant HIV-1 infection. After a year of the medication, 30 (83%) of the 36 patients randomly assigned to take lenacapavir, in combination with other HIV medications, had undetectable viral loads.

“Today’s approval ushers in a new class of antiretroviral drugs that may help patients with HIV who have run out of treatment options,” said Debra Birnkrant, MD, director of the division of antivirals in the FDA’s Center for Drug Evaluation and Research, in a press release. “The availability of new classes of antiretroviral medications may possibly help these patients live longer, healthier lives.”

A version of this article first appeared on Medscape.com.

Just 56% of infectious disease fellowship programs filled their 2023 slots, according to new data released by the National Resident Matching Program. Infectious disease (ID) fellowships had seen a jump in applications in the previous 2 years, but these new numbers may suggest a backward slide in a specialty that for many years has struggled to recruit residents.

This latest match rate in ID fellowships is lower than those of the previous 5 years. There are unfilled positions across the country, including in health care hot spots. In Boston, all three slots at Boston Medical Center ID fellowship program are currently empty.

“For our program, going unfilled is a pretty rare event,” said Daniel Bourque, MD, an assistant professor of infectious disease at Boston University and director of the program. “For a program in the city of Boston that’s at a large tertiary care center, that definitely was a big surprise.”

Many other ID fellowships have joined BMC in posting about their vacancies on social media, looking for residents who may not have matched in other fellowships and for physicians who initially decided not to pursue additional training but are now reconsidering.

“If you are interested in a career in this exciting field, in the amazing city of Seattle, with incredible and friendly colleagues, please contact us,” the University of Washington’s ID fellowship program tweeted. Tulane University, Creighton University, the University of Connecticut, Washington University in St. Louis, and the University of Colorado also advertised their unfilled positions.

Other ID doctors commiserated with the disappointing match year. “I made a new riddle after yesterday’s match results: In the hospital, everyone needs me. Yet, no one wants to be me. What am I? An ID doctor,” tweeted Nathan Nolan, MD, MPH, an infectious disease specialist at the Veterans Health Administration in St. Louis.
 

Infectious disease positions continue to grow

One contributor to this downturn could be the growing number of infectious disease programs offered, whereas the number of applicants has generally remained stable. In 2018, there were 394 slots at 151 infectious disease fellowship programs offered. For the 2023 match year, there were 441 slots at 175 programs.

At the same time, there has not been a notable rise in applicants. From match years 2018 to 2020, about 320 applicants applied for ID fellowship positions each year. There was a rise in in interest in first 2 years of the pandemic, with 404 and 387 applicants in the 2021 and 2022 match years, respectively. The most recent round suggests a return to prepandemic numbers, with 330 residents applying to ID programs.

“I think it’s fair to question whether, as a field, we should be increasing training programs and spots at this point, and if it’s better to focus on ways to increase interest and demand,” said Daniel Diekema, MD, an ID physician at Maine Medical Center in Portland. “Otherwise, we’re just going to look worse and worse every year,” he added, and the work that goes into creating these training opportunities will not have a return on investment.
 

More training, less pay

The fellowship recruitment issues combined with an already short supply of infectious disease specialists can be traced back to comparatively worse pay compared with other subspecialties, experts say. Infectious disease was the fifth lowest paid specialty in the 2022 Medscape Physician Compensation Report – ranking above only primary care specialties and diabetes and endocrinology.

Pursuing this subspeciality in medicine may not translate to higher pay, Dr. Diekema noted. For example, a physician who completes an internal medicine residency and then a 2- to 3-year infectious disease fellowship can make less than a physician who pursues hospital medicine directly after completing the same residency.

“You’re in a situation where you’re doing additional training to reduce your income earning potential, and that’s a very hard sales pitch to make,” he said. It’s become more difficult as student loan debts continue to increase, he added.

Because infectious disease is a cognitive specialty and does not perform procedures, it is at a disadvantage in a typical fee-for-service pay model. ID physicians also advise on hospital policies for testing and personal protective equipment, which is not always compensated, said Wendy Armstrong, MD, a professor of infectious diseases at Emory University, Atlanta.
 

A reflection of pandemic burnout?

Experts also wonder if the past 2 years of the pandemic and the notable burnout in ID and other in-demand specialties may have dissuaded applicants from pursuing the ID career path.

“This residency class is the class that started their training in June or July of 2020 and represent that residency class that has trained throughout the pandemic,” Dr. Bourque said. “Does [this low match rate] reflect a negative outlook on the field of ID because of COVID? Is it a reflection of trainee burnout in the setting of the pandemic?”

Dr. Diekema wonders if increased public scrutiny and politicization of the field may have discouraged residents. “The vilification of public health and [of] infectious disease experts like Dr. Fauci by significant portions of our society can be demoralizing,” he said. “People might say, ‘Why would I want to put myself through that?’ ”

But Dr. Armstrong doubts this is the case. “I’ve never had a resident tell me that was on their radar screen,” she said, noting that while there had been recent improvements in applicants, lower match numbers for ID fellowships have been a long-standing issue.
 

Rethinking reimbursement

Experts agree that pay issues need to be addressed to make ID a more attractive specialty. Moving away from traditional payment plans to value-based models using quality measurements specific to infectious disease could be one way to quantify the value of ID specialists in care systems.

The Infectious Diseases Society of America recently met with the panel that sets compensation rates for Medicare to discuss ways to increase compensation for ID, said IDSA president Carlos del Rio, MD. He is also a professor of medicine at Emory University.

ID specialists need to be able to put a dollar value to their policy work that’s not related to patient reimbursement, Dr. del Rio said. IDSA’s ongoing compensation initiative advocates for value-based care and provides salary negotiation tools for ID specialists, he added.

“Salaries shouldn’t simply be defined by what reimbursement is, and that’s true for other specialties,” such as hospital medicine and palliative care at many institutions, Dr. Armstrong said. “Infectious disease needs to be held at the same level of respect and value.”

But despite issues within the specialties, ID physicians remain passionate about their field.

“It is the most fascinating specialty I can ever imagine,” Dr. Armstrong said. Dr. Bourque agreed, noting the dynamic nature of specialty, with the emergence of new diseases like COVID-19 and reemergence of diseases like mpox (formerly called monkeypox), Zika, Ebola, and chikungunya in the past decade.

“There’s nothing about the field of infectious diseases that, in my mind, isn’t fascinating or rewarding enough to bring people in,” added Dr. Diekema. “The factors that are keeping people out are primarily economic factors and aspects of our health care system that need attention.”

A version of this article first appeared on Medscape.com.

Just 56% of infectious disease fellowship programs filled their 2023 slots, according to new data released by the National Resident Matching Program. Infectious disease (ID) fellowships had seen a jump in applications in the previous 2 years, but these new numbers may suggest a backward slide in a specialty that for many years has struggled to recruit residents.

This latest match rate in ID fellowships is lower than those of the previous 5 years. There are unfilled positions across the country, including in health care hot spots. In Boston, all three slots at Boston Medical Center ID fellowship program are currently empty.

“For our program, going unfilled is a pretty rare event,” said Daniel Bourque, MD, an assistant professor of infectious disease at Boston University and director of the program. “For a program in the city of Boston that’s at a large tertiary care center, that definitely was a big surprise.”

Many other ID fellowships have joined BMC in posting about their vacancies on social media, looking for residents who may not have matched in other fellowships and for physicians who initially decided not to pursue additional training but are now reconsidering.

“If you are interested in a career in this exciting field, in the amazing city of Seattle, with incredible and friendly colleagues, please contact us,” the University of Washington’s ID fellowship program tweeted. Tulane University, Creighton University, the University of Connecticut, Washington University in St. Louis, and the University of Colorado also advertised their unfilled positions.

Other ID doctors commiserated with the disappointing match year. “I made a new riddle after yesterday’s match results: In the hospital, everyone needs me. Yet, no one wants to be me. What am I? An ID doctor,” tweeted Nathan Nolan, MD, MPH, an infectious disease specialist at the Veterans Health Administration in St. Louis.
 

Infectious disease positions continue to grow

One contributor to this downturn could be the growing number of infectious disease programs offered, whereas the number of applicants has generally remained stable. In 2018, there were 394 slots at 151 infectious disease fellowship programs offered. For the 2023 match year, there were 441 slots at 175 programs.

At the same time, there has not been a notable rise in applicants. From match years 2018 to 2020, about 320 applicants applied for ID fellowship positions each year. There was a rise in in interest in first 2 years of the pandemic, with 404 and 387 applicants in the 2021 and 2022 match years, respectively. The most recent round suggests a return to prepandemic numbers, with 330 residents applying to ID programs.

“I think it’s fair to question whether, as a field, we should be increasing training programs and spots at this point, and if it’s better to focus on ways to increase interest and demand,” said Daniel Diekema, MD, an ID physician at Maine Medical Center in Portland. “Otherwise, we’re just going to look worse and worse every year,” he added, and the work that goes into creating these training opportunities will not have a return on investment.
 

More training, less pay

The fellowship recruitment issues combined with an already short supply of infectious disease specialists can be traced back to comparatively worse pay compared with other subspecialties, experts say. Infectious disease was the fifth lowest paid specialty in the 2022 Medscape Physician Compensation Report – ranking above only primary care specialties and diabetes and endocrinology.

Pursuing this subspeciality in medicine may not translate to higher pay, Dr. Diekema noted. For example, a physician who completes an internal medicine residency and then a 2- to 3-year infectious disease fellowship can make less than a physician who pursues hospital medicine directly after completing the same residency.

“You’re in a situation where you’re doing additional training to reduce your income earning potential, and that’s a very hard sales pitch to make,” he said. It’s become more difficult as student loan debts continue to increase, he added.

Because infectious disease is a cognitive specialty and does not perform procedures, it is at a disadvantage in a typical fee-for-service pay model. ID physicians also advise on hospital policies for testing and personal protective equipment, which is not always compensated, said Wendy Armstrong, MD, a professor of infectious diseases at Emory University, Atlanta.
 

A reflection of pandemic burnout?

Experts also wonder if the past 2 years of the pandemic and the notable burnout in ID and other in-demand specialties may have dissuaded applicants from pursuing the ID career path.

“This residency class is the class that started their training in June or July of 2020 and represent that residency class that has trained throughout the pandemic,” Dr. Bourque said. “Does [this low match rate] reflect a negative outlook on the field of ID because of COVID? Is it a reflection of trainee burnout in the setting of the pandemic?”

Dr. Diekema wonders if increased public scrutiny and politicization of the field may have discouraged residents. “The vilification of public health and [of] infectious disease experts like Dr. Fauci by significant portions of our society can be demoralizing,” he said. “People might say, ‘Why would I want to put myself through that?’ ”

But Dr. Armstrong doubts this is the case. “I’ve never had a resident tell me that was on their radar screen,” she said, noting that while there had been recent improvements in applicants, lower match numbers for ID fellowships have been a long-standing issue.
 

Rethinking reimbursement

Experts agree that pay issues need to be addressed to make ID a more attractive specialty. Moving away from traditional payment plans to value-based models using quality measurements specific to infectious disease could be one way to quantify the value of ID specialists in care systems.

The Infectious Diseases Society of America recently met with the panel that sets compensation rates for Medicare to discuss ways to increase compensation for ID, said IDSA president Carlos del Rio, MD. He is also a professor of medicine at Emory University.

ID specialists need to be able to put a dollar value to their policy work that’s not related to patient reimbursement, Dr. del Rio said. IDSA’s ongoing compensation initiative advocates for value-based care and provides salary negotiation tools for ID specialists, he added.

“Salaries shouldn’t simply be defined by what reimbursement is, and that’s true for other specialties,” such as hospital medicine and palliative care at many institutions, Dr. Armstrong said. “Infectious disease needs to be held at the same level of respect and value.”

But despite issues within the specialties, ID physicians remain passionate about their field.

“It is the most fascinating specialty I can ever imagine,” Dr. Armstrong said. Dr. Bourque agreed, noting the dynamic nature of specialty, with the emergence of new diseases like COVID-19 and reemergence of diseases like mpox (formerly called monkeypox), Zika, Ebola, and chikungunya in the past decade.

“There’s nothing about the field of infectious diseases that, in my mind, isn’t fascinating or rewarding enough to bring people in,” added Dr. Diekema. “The factors that are keeping people out are primarily economic factors and aspects of our health care system that need attention.”

A version of this article first appeared on Medscape.com.

Just 56% of infectious disease fellowship programs filled their 2023 slots, according to new data released by the National Resident Matching Program. Infectious disease (ID) fellowships had seen a jump in applications in the previous 2 years, but these new numbers may suggest a backward slide in a specialty that for many years has struggled to recruit residents.

This latest match rate in ID fellowships is lower than those of the previous 5 years. There are unfilled positions across the country, including in health care hot spots. In Boston, all three slots at Boston Medical Center ID fellowship program are currently empty.

“For our program, going unfilled is a pretty rare event,” said Daniel Bourque, MD, an assistant professor of infectious disease at Boston University and director of the program. “For a program in the city of Boston that’s at a large tertiary care center, that definitely was a big surprise.”

Many other ID fellowships have joined BMC in posting about their vacancies on social media, looking for residents who may not have matched in other fellowships and for physicians who initially decided not to pursue additional training but are now reconsidering.

“If you are interested in a career in this exciting field, in the amazing city of Seattle, with incredible and friendly colleagues, please contact us,” the University of Washington’s ID fellowship program tweeted. Tulane University, Creighton University, the University of Connecticut, Washington University in St. Louis, and the University of Colorado also advertised their unfilled positions.

Other ID doctors commiserated with the disappointing match year. “I made a new riddle after yesterday’s match results: In the hospital, everyone needs me. Yet, no one wants to be me. What am I? An ID doctor,” tweeted Nathan Nolan, MD, MPH, an infectious disease specialist at the Veterans Health Administration in St. Louis.
 

Infectious disease positions continue to grow

One contributor to this downturn could be the growing number of infectious disease programs offered, whereas the number of applicants has generally remained stable. In 2018, there were 394 slots at 151 infectious disease fellowship programs offered. For the 2023 match year, there were 441 slots at 175 programs.

At the same time, there has not been a notable rise in applicants. From match years 2018 to 2020, about 320 applicants applied for ID fellowship positions each year. There was a rise in in interest in first 2 years of the pandemic, with 404 and 387 applicants in the 2021 and 2022 match years, respectively. The most recent round suggests a return to prepandemic numbers, with 330 residents applying to ID programs.

“I think it’s fair to question whether, as a field, we should be increasing training programs and spots at this point, and if it’s better to focus on ways to increase interest and demand,” said Daniel Diekema, MD, an ID physician at Maine Medical Center in Portland. “Otherwise, we’re just going to look worse and worse every year,” he added, and the work that goes into creating these training opportunities will not have a return on investment.
 

More training, less pay

The fellowship recruitment issues combined with an already short supply of infectious disease specialists can be traced back to comparatively worse pay compared with other subspecialties, experts say. Infectious disease was the fifth lowest paid specialty in the 2022 Medscape Physician Compensation Report – ranking above only primary care specialties and diabetes and endocrinology.

Pursuing this subspeciality in medicine may not translate to higher pay, Dr. Diekema noted. For example, a physician who completes an internal medicine residency and then a 2- to 3-year infectious disease fellowship can make less than a physician who pursues hospital medicine directly after completing the same residency.

“You’re in a situation where you’re doing additional training to reduce your income earning potential, and that’s a very hard sales pitch to make,” he said. It’s become more difficult as student loan debts continue to increase, he added.

Because infectious disease is a cognitive specialty and does not perform procedures, it is at a disadvantage in a typical fee-for-service pay model. ID physicians also advise on hospital policies for testing and personal protective equipment, which is not always compensated, said Wendy Armstrong, MD, a professor of infectious diseases at Emory University, Atlanta.
 

A reflection of pandemic burnout?

Experts also wonder if the past 2 years of the pandemic and the notable burnout in ID and other in-demand specialties may have dissuaded applicants from pursuing the ID career path.

“This residency class is the class that started their training in June or July of 2020 and represent that residency class that has trained throughout the pandemic,” Dr. Bourque said. “Does [this low match rate] reflect a negative outlook on the field of ID because of COVID? Is it a reflection of trainee burnout in the setting of the pandemic?”

Dr. Diekema wonders if increased public scrutiny and politicization of the field may have discouraged residents. “The vilification of public health and [of] infectious disease experts like Dr. Fauci by significant portions of our society can be demoralizing,” he said. “People might say, ‘Why would I want to put myself through that?’ ”

But Dr. Armstrong doubts this is the case. “I’ve never had a resident tell me that was on their radar screen,” she said, noting that while there had been recent improvements in applicants, lower match numbers for ID fellowships have been a long-standing issue.
 

Rethinking reimbursement

Experts agree that pay issues need to be addressed to make ID a more attractive specialty. Moving away from traditional payment plans to value-based models using quality measurements specific to infectious disease could be one way to quantify the value of ID specialists in care systems.

The Infectious Diseases Society of America recently met with the panel that sets compensation rates for Medicare to discuss ways to increase compensation for ID, said IDSA president Carlos del Rio, MD. He is also a professor of medicine at Emory University.

ID specialists need to be able to put a dollar value to their policy work that’s not related to patient reimbursement, Dr. del Rio said. IDSA’s ongoing compensation initiative advocates for value-based care and provides salary negotiation tools for ID specialists, he added.

“Salaries shouldn’t simply be defined by what reimbursement is, and that’s true for other specialties,” such as hospital medicine and palliative care at many institutions, Dr. Armstrong said. “Infectious disease needs to be held at the same level of respect and value.”

But despite issues within the specialties, ID physicians remain passionate about their field.

“It is the most fascinating specialty I can ever imagine,” Dr. Armstrong said. Dr. Bourque agreed, noting the dynamic nature of specialty, with the emergence of new diseases like COVID-19 and reemergence of diseases like mpox (formerly called monkeypox), Zika, Ebola, and chikungunya in the past decade.

“There’s nothing about the field of infectious diseases that, in my mind, isn’t fascinating or rewarding enough to bring people in,” added Dr. Diekema. “The factors that are keeping people out are primarily economic factors and aspects of our health care system that need attention.”

A version of this article first appeared on Medscape.com.

For patients with severe arthritis, joint replacement is considered when more conservative treatments have failed. Because patients with obesity have a higher risk of complications during and after surgery, some surgeons, hospitals, and insurance companies have adopted body mass index cutoffs as a basis for deciding whether to offer patients these elective surgeries. But some experts argue that these cutoffs are arbitrary, exclude patients who can still benefit from the surgery, and can increase disparities in care.

“By enforcing cutoffs in general, you’re losing the ability for each surgeon to determine who they want to operate on,” said Daniel Wiznia, MD, assistant professor of orthopedic surgery at Yale University, New Haven, Conn. He is on the leadership committee of the Movement Is Life Caucus, a nonprofit group focused on eliminating disparities in musculoskeletal health. “For every surgeon, it’s up to them to decide if they feel comfortable doing the surgery,” he noted in an interview. “My guidance for that would be, don’t just say no because of the number – look at the patient’s entire medical profile.”

According to the Centers for Disease Control and Prevention, nearly 42% of adults in the United States have a BMI over 30, and 9.2% of adults have a BMI over 40. This excess weight puts additional stress on joints: When a person is walking, experts estimate that the force on the knees can be two to three times someone’s body weight. Over time, this pressure can wear down the cartilage on joints.

As a result, people who are overweight or obese are more likely to develop osteoarthritis and to need joint replacements. According to a Canadian study, patients with a BMI of 30-35 are 3.4 times as likely to require a hip replacement and are 8.5 times as likely to require a knee replacement compared to individuals with a BMI in the “healthy weight” range. With a BMI above 40, individuals were 8.5 times more likely to need a hip replacement and were 32.7 times as likely to need a knee replacement.
 

More complications, greater expense

While there are no universally recommended BMI cutoffs for joint replacement surgery, it is not uncommon for institutions to require that patients have a BMI below a certain value (usually 35-40) to proceed with surgery. A 2013 survey of physicians from the American Association of Hip and Knee Surgeons found that 52% of surgeons required a BMI below 40 to qualify for surgery.

One of the main reasons for these cutoffs is the elevated risk of complications during and after surgery. Research suggests that obesity is associated with higher rates of wound dehiscence, prosthetic joint infection (PJI), and revision total joint arthroplasty. One 2016 study suggests that patients with a BMI of 35-39.9 are twice as likely to experience PJI compared to patients with a BMI below 35. For patients with a BMI of 40 or higher, PJI is four times as likely.

Another study found that patients whose BMI is 35-40 and who undergo total joint arthroplasty have a 6.4-fold greater risk of deep incision infection. For those with a BMI over 40, that rises to a 12.9-fold increased risk compared to patients with a BMI of 18.5-25. Patients with obesity tend to have other comorbidities that can increase the risk of complications during surgery, such as type 2 diabetes, coronary artery disease, and chronic kidney disease.

Because of the increased risk of complications, health care costs tend to be higher for patients with obesity. The growing popularity of bundled health payments can discourage operating on patients who are more likely to experience complications, such as patients with high BMIs, noted Dr. Wiznia.

Research suggests that minorities and people with lower socioeconomic status are disproportionately affected by these cutoffs. According to the CDC, among non-Hispanic Black Americans and Hispanic Americans, rates of obesity are higher than among their White counterparts, and these patients are less likely to undergo joint replacement. Strictly enforcing this eligibility criterion can worsen those disparities. A study involving 21,294 adults over age 50 from the National Health and Nutrition Examination Survey (NHANES) found that requiring a BMI of under 35 for total joint arthroplasty resulted in Black patients being 39% less likely to be eligible for surgery than White patients. And individuals with an annual household income under $45,000 were 19% less likely to qualify for surgery than those with a household income above $45,000.
 

BMI no better than other risk factors

Although high BMI is independently associated with a higher risk of complications, the increased risk of complications conferred by a BMI at or above 40 is similar to or lower than those of other comorbidities that surgeons generally accept, said Nicholas Giori, MD, PhD, professor of orthopedic surgery at Stanford (Calif.) University, and chief of orthopedic surgery at the VA Palo Alto Health Care System. These other comorbidities include age older than 75, hypertension that requires medication, and insulin-controlled diabetes. “The independent risk of just having the diagnosis of insulin-dependent diabetes is actually comparable to the independent risk of having obesity by itself,” he told this news organization, “and all of us operate on [patients with] diabetes.”

Also, there is no BMI at which the risk of complications suddenly increases, according to the American Academy of Orthopaedic Surgeons. “It’s a rising complication rate as you go into higher BMIs,” Dr. Giori said. “If you operate on someone with a BMI of 39 vs. 41, you’re not going to find that much of a difference [in risk].” But if a medical system enforced a hard BMI cutoff of 40, one patient would qualify for surgery while the other would be barred.
 

Weight not as “modifiable” as previously thought

Weight is often considered a “modifiable factor” for a person considering undergoing total joint arthroplasty, but research suggests that the issue is more complicated. “Obesity is tricky, because some people are successful [in weight loss],” said Dr. Giori. Those tend to be the more memorable stories. “But a large majority have a really hard time losing substantial weight – enough to make a difference in risk,” he continued.

A study conducted in North Carolina found that restricting patients with a BMI over 40 from having elective total joint arthroplasty procedures until their weight was optimized did not result in successful weight loss. Only 20% of patients who originally presented with a BMI above this limit eventually underwent surgery after 2 years, and fewer than half of these patients had achieved a BMI of less than 40 at the time of their surgery. A third of all patients in the study did not return to the orthopedic office after their first visit.

“To hold a hard cutoff when it’s very, very hard to modify ... is essentially telling people that they are not going to ever have surgery,” Dr. Giori said; “I think that can be unfair to some patients.”

Bariatric surgery is often suggested for patients with obesity who have not experienced successful weight loss with diet and lifestyle changes alone, but bariatric surgery comes with its own complications. Research on outcomes from total joint arthroplasty among patients with who have lost weight with bariatric surgery has yielded mixed results. “I rarely push anyone hard to go that route but present it as an option for certain patients,” said Benjamin M. Stronach, MD, an orthopedic surgeon at the University of Arkansas for Medical Sciences, in Little Rock. He usually brings up bariatric surgery with patients with a BMI in the high 40s or higher to gauge their interest. If patients are already considering weight loss surgery, his office provides referrals.

But even bariatric surgery does not result in successful long-term weight loss for every patient, Dr. Stronach said. He’s seeing more and more patients who come for consultations after having undergone bariatric surgery 10 to 15 years ago. These patients lost a significant amount of weight, but then gained the weight back. He noted that bariatric surgery can be very successful for some patients who adhere to their postbariatric regimen. “We typically see fairly impressive results in the short term,” he said.
 

Patients with obesity benefit from joint replacement

Although patients with obesity are at higher risk for complications from joint replacement surgery, research suggests that these patients can still benefit greatly from these surgeries and that these surgeries remain cost-effective. Some studies have found that patients with obesity tend to have worse outcomes after surgery than patients who are not obese, but often, patients with high BMIs are starting from a lower point, with greater joint pain and limited mobility, Dr. Giori said. But the improvements – that is, net change in measured outcomes – can be greater for obese patients.

“Several studies have shown equal or greater improvements in validated outcome scores, function, and satisfaction compared with nonobese patients after surgery,” authors wrote in a recent review article in which they discuss how to optimize joint replacement surgery for patients with obesity. The article, published in the November 2022 issue of the Journal of the American Academy of Orthopaedic Surgeon (JAAOS), is part of a collection of review articles by the Movement Is Life Caucus.

Encourage weight loss, but look beyond the number

Rather than adhering to strict BMI cutoffs, some experts urge surgeons to consider the patient as a whole and to evaluate each individual’s overall health and potential risk. Dr. Giori generally considers high BMI as just another comorbidity when assessing a patient’s overall risk. “For a person who only has a high BMI but is otherwise healthy, I see no reason not to go ahead and schedule that person for surgery, because reducing the patient’s BMI will not substantially reduce the patient’s complication risk, and a delay in surgery may adversely affect the patient’s quality of life and ability to earn a living,” he said.

“If someone is between a BMI of 40 and 45, we are definitely going to have a discussion about weight,” Dr. Stronach said. He generally counsels against surgery for any patient with a BMI at 45 or above. He wants patients to have a BMI below 40 before surgery but considers individual cases for exceptions. “We will still move forward at times with someone with a BMI of 41, as an example, who is otherwise healthy,” he said. Similarly, if a patient has lost a significant amount of weight (e.g., the patient’s BMI was reduced from 50 to 41), the patient is actively engaged in improving their health, and surgeons believe the patient has significantly reduced their risk, “a lot of time, we’re not going to draw a line in the sand right at [a BMI of] 40,” he said.

While using a BMI of under 35 or 40 as a guideline when starting to work with patients is reasonable, working toward a weight loss of 5%-10% of total body weight is another goal to consider, authors advise in the JAAOS obesity review article. Research suggests that even a 5% reduction in overall body weight can reduce surgical complications and can improve a patient’s glucose and lipid levels and cardiac profile. Referrals to dietitians and weight loss programs, as well as behavioral counseling, can also be useful in initiating weight loss and keeping patients engaged in the process, the authors wrote.
 

Consider a patient’s comorbidities

Many patients with obesity have comorbidities, such as type 2 diabetes and hypertension, that can also be optimized for surgery so as to lower a patient’s overall risk profile. For patients with diabetes, achieving an A1c of 8% or lower can be a reasonable goal and can reduce risk. “We’ve found that an HbA1c level of 8% or less is something that virtually all diabetics (though not everybody) can reach, and it’s something that can be reached in a reasonable amount of time,” Dr. Giori said. Preoperative use of beta-blockers, continued use of ACE inhibitors or angiotensin receptor blockers, and behavioral modifications can improve a patient’s cardiac health before surgery.

Malnutrition can be a correctable problem for patients, regardless of BMI. In the Movement Is Life collection of optimization articles, experts recommend that orthopedists screen for malnutrition with blood tests for albumin, vitamin D, transferrin, and total lymphocyte count. Patients with malnutrition should be screened for food insecurity, experts advise, and surgical candidates with deficiencies can be given supplements of omega-3 fatty acids, arginine, and protein shakes.

Surgeon comfort and shared decision-making

Dr. Wiznia emphasized that the patient and surgeon need to discuss the risks of surgery, concerns about potential complications, and how a complication could affect the patient’s life moving forward. “Ultimately, the surgeon needs to make the decision [of whether or not to proceed [with surgery] with the patient,” he said, “but not every surgeon is going to feel comfortable operating on these patients, and not every medical institution is going to have the equipment and the investments to support surgeons doing it.”

Dr. Giori agreed that surgeons should proceed only with surgical cases they feel comfortable with. Certain surgeons may decide not to operate on individuals with higher BMIs because of the potential complications and can refer these patients to more specialized care centers. Operating on larger patients is more difficult and requires surgical skills and expertise that the surgeon may not have, he noted. “What I do object to is a system-wide BMI cutoff – for example, if an insurance company won’t pay for you to have a joint replacement, regardless of where you go or who your surgeon is,” Dr. Giori added. “I think that’s wrong, because it’s not patient centered and it’s basically excluding people from having a life-altering operation.”

Dr. Giori and Dr. Wiznia report no relevant financial relationships. Dr. Stronach is a consultant for DJ Orthopaedics, Johnson & Johnson, and MiCare Path.

A version of this article first appeared on Medscape.com.

For patients with severe arthritis, joint replacement is considered when more conservative treatments have failed. Because patients with obesity have a higher risk of complications during and after surgery, some surgeons, hospitals, and insurance companies have adopted body mass index cutoffs as a basis for deciding whether to offer patients these elective surgeries. But some experts argue that these cutoffs are arbitrary, exclude patients who can still benefit from the surgery, and can increase disparities in care.

“By enforcing cutoffs in general, you’re losing the ability for each surgeon to determine who they want to operate on,” said Daniel Wiznia, MD, assistant professor of orthopedic surgery at Yale University, New Haven, Conn. He is on the leadership committee of the Movement Is Life Caucus, a nonprofit group focused on eliminating disparities in musculoskeletal health. “For every surgeon, it’s up to them to decide if they feel comfortable doing the surgery,” he noted in an interview. “My guidance for that would be, don’t just say no because of the number – look at the patient’s entire medical profile.”

According to the Centers for Disease Control and Prevention, nearly 42% of adults in the United States have a BMI over 30, and 9.2% of adults have a BMI over 40. This excess weight puts additional stress on joints: When a person is walking, experts estimate that the force on the knees can be two to three times someone’s body weight. Over time, this pressure can wear down the cartilage on joints.

As a result, people who are overweight or obese are more likely to develop osteoarthritis and to need joint replacements. According to a Canadian study, patients with a BMI of 30-35 are 3.4 times as likely to require a hip replacement and are 8.5 times as likely to require a knee replacement compared to individuals with a BMI in the “healthy weight” range. With a BMI above 40, individuals were 8.5 times more likely to need a hip replacement and were 32.7 times as likely to need a knee replacement.
 

More complications, greater expense

While there are no universally recommended BMI cutoffs for joint replacement surgery, it is not uncommon for institutions to require that patients have a BMI below a certain value (usually 35-40) to proceed with surgery. A 2013 survey of physicians from the American Association of Hip and Knee Surgeons found that 52% of surgeons required a BMI below 40 to qualify for surgery.

One of the main reasons for these cutoffs is the elevated risk of complications during and after surgery. Research suggests that obesity is associated with higher rates of wound dehiscence, prosthetic joint infection (PJI), and revision total joint arthroplasty. One 2016 study suggests that patients with a BMI of 35-39.9 are twice as likely to experience PJI compared to patients with a BMI below 35. For patients with a BMI of 40 or higher, PJI is four times as likely.

Another study found that patients whose BMI is 35-40 and who undergo total joint arthroplasty have a 6.4-fold greater risk of deep incision infection. For those with a BMI over 40, that rises to a 12.9-fold increased risk compared to patients with a BMI of 18.5-25. Patients with obesity tend to have other comorbidities that can increase the risk of complications during surgery, such as type 2 diabetes, coronary artery disease, and chronic kidney disease.

Because of the increased risk of complications, health care costs tend to be higher for patients with obesity. The growing popularity of bundled health payments can discourage operating on patients who are more likely to experience complications, such as patients with high BMIs, noted Dr. Wiznia.

Research suggests that minorities and people with lower socioeconomic status are disproportionately affected by these cutoffs. According to the CDC, among non-Hispanic Black Americans and Hispanic Americans, rates of obesity are higher than among their White counterparts, and these patients are less likely to undergo joint replacement. Strictly enforcing this eligibility criterion can worsen those disparities. A study involving 21,294 adults over age 50 from the National Health and Nutrition Examination Survey (NHANES) found that requiring a BMI of under 35 for total joint arthroplasty resulted in Black patients being 39% less likely to be eligible for surgery than White patients. And individuals with an annual household income under $45,000 were 19% less likely to qualify for surgery than those with a household income above $45,000.
 

BMI no better than other risk factors

Although high BMI is independently associated with a higher risk of complications, the increased risk of complications conferred by a BMI at or above 40 is similar to or lower than those of other comorbidities that surgeons generally accept, said Nicholas Giori, MD, PhD, professor of orthopedic surgery at Stanford (Calif.) University, and chief of orthopedic surgery at the VA Palo Alto Health Care System. These other comorbidities include age older than 75, hypertension that requires medication, and insulin-controlled diabetes. “The independent risk of just having the diagnosis of insulin-dependent diabetes is actually comparable to the independent risk of having obesity by itself,” he told this news organization, “and all of us operate on [patients with] diabetes.”

Also, there is no BMI at which the risk of complications suddenly increases, according to the American Academy of Orthopaedic Surgeons. “It’s a rising complication rate as you go into higher BMIs,” Dr. Giori said. “If you operate on someone with a BMI of 39 vs. 41, you’re not going to find that much of a difference [in risk].” But if a medical system enforced a hard BMI cutoff of 40, one patient would qualify for surgery while the other would be barred.
 

Weight not as “modifiable” as previously thought

Weight is often considered a “modifiable factor” for a person considering undergoing total joint arthroplasty, but research suggests that the issue is more complicated. “Obesity is tricky, because some people are successful [in weight loss],” said Dr. Giori. Those tend to be the more memorable stories. “But a large majority have a really hard time losing substantial weight – enough to make a difference in risk,” he continued.

A study conducted in North Carolina found that restricting patients with a BMI over 40 from having elective total joint arthroplasty procedures until their weight was optimized did not result in successful weight loss. Only 20% of patients who originally presented with a BMI above this limit eventually underwent surgery after 2 years, and fewer than half of these patients had achieved a BMI of less than 40 at the time of their surgery. A third of all patients in the study did not return to the orthopedic office after their first visit.

“To hold a hard cutoff when it’s very, very hard to modify ... is essentially telling people that they are not going to ever have surgery,” Dr. Giori said; “I think that can be unfair to some patients.”

Bariatric surgery is often suggested for patients with obesity who have not experienced successful weight loss with diet and lifestyle changes alone, but bariatric surgery comes with its own complications. Research on outcomes from total joint arthroplasty among patients with who have lost weight with bariatric surgery has yielded mixed results. “I rarely push anyone hard to go that route but present it as an option for certain patients,” said Benjamin M. Stronach, MD, an orthopedic surgeon at the University of Arkansas for Medical Sciences, in Little Rock. He usually brings up bariatric surgery with patients with a BMI in the high 40s or higher to gauge their interest. If patients are already considering weight loss surgery, his office provides referrals.

But even bariatric surgery does not result in successful long-term weight loss for every patient, Dr. Stronach said. He’s seeing more and more patients who come for consultations after having undergone bariatric surgery 10 to 15 years ago. These patients lost a significant amount of weight, but then gained the weight back. He noted that bariatric surgery can be very successful for some patients who adhere to their postbariatric regimen. “We typically see fairly impressive results in the short term,” he said.
 

Patients with obesity benefit from joint replacement

Although patients with obesity are at higher risk for complications from joint replacement surgery, research suggests that these patients can still benefit greatly from these surgeries and that these surgeries remain cost-effective. Some studies have found that patients with obesity tend to have worse outcomes after surgery than patients who are not obese, but often, patients with high BMIs are starting from a lower point, with greater joint pain and limited mobility, Dr. Giori said. But the improvements – that is, net change in measured outcomes – can be greater for obese patients.

“Several studies have shown equal or greater improvements in validated outcome scores, function, and satisfaction compared with nonobese patients after surgery,” authors wrote in a recent review article in which they discuss how to optimize joint replacement surgery for patients with obesity. The article, published in the November 2022 issue of the Journal of the American Academy of Orthopaedic Surgeon (JAAOS), is part of a collection of review articles by the Movement Is Life Caucus.

Encourage weight loss, but look beyond the number

Rather than adhering to strict BMI cutoffs, some experts urge surgeons to consider the patient as a whole and to evaluate each individual’s overall health and potential risk. Dr. Giori generally considers high BMI as just another comorbidity when assessing a patient’s overall risk. “For a person who only has a high BMI but is otherwise healthy, I see no reason not to go ahead and schedule that person for surgery, because reducing the patient’s BMI will not substantially reduce the patient’s complication risk, and a delay in surgery may adversely affect the patient’s quality of life and ability to earn a living,” he said.

“If someone is between a BMI of 40 and 45, we are definitely going to have a discussion about weight,” Dr. Stronach said. He generally counsels against surgery for any patient with a BMI at 45 or above. He wants patients to have a BMI below 40 before surgery but considers individual cases for exceptions. “We will still move forward at times with someone with a BMI of 41, as an example, who is otherwise healthy,” he said. Similarly, if a patient has lost a significant amount of weight (e.g., the patient’s BMI was reduced from 50 to 41), the patient is actively engaged in improving their health, and surgeons believe the patient has significantly reduced their risk, “a lot of time, we’re not going to draw a line in the sand right at [a BMI of] 40,” he said.

While using a BMI of under 35 or 40 as a guideline when starting to work with patients is reasonable, working toward a weight loss of 5%-10% of total body weight is another goal to consider, authors advise in the JAAOS obesity review article. Research suggests that even a 5% reduction in overall body weight can reduce surgical complications and can improve a patient’s glucose and lipid levels and cardiac profile. Referrals to dietitians and weight loss programs, as well as behavioral counseling, can also be useful in initiating weight loss and keeping patients engaged in the process, the authors wrote.
 

Consider a patient’s comorbidities

Many patients with obesity have comorbidities, such as type 2 diabetes and hypertension, that can also be optimized for surgery so as to lower a patient’s overall risk profile. For patients with diabetes, achieving an A1c of 8% or lower can be a reasonable goal and can reduce risk. “We’ve found that an HbA1c level of 8% or less is something that virtually all diabetics (though not everybody) can reach, and it’s something that can be reached in a reasonable amount of time,” Dr. Giori said. Preoperative use of beta-blockers, continued use of ACE inhibitors or angiotensin receptor blockers, and behavioral modifications can improve a patient’s cardiac health before surgery.

Malnutrition can be a correctable problem for patients, regardless of BMI. In the Movement Is Life collection of optimization articles, experts recommend that orthopedists screen for malnutrition with blood tests for albumin, vitamin D, transferrin, and total lymphocyte count. Patients with malnutrition should be screened for food insecurity, experts advise, and surgical candidates with deficiencies can be given supplements of omega-3 fatty acids, arginine, and protein shakes.

Surgeon comfort and shared decision-making

Dr. Wiznia emphasized that the patient and surgeon need to discuss the risks of surgery, concerns about potential complications, and how a complication could affect the patient’s life moving forward. “Ultimately, the surgeon needs to make the decision [of whether or not to proceed [with surgery] with the patient,” he said, “but not every surgeon is going to feel comfortable operating on these patients, and not every medical institution is going to have the equipment and the investments to support surgeons doing it.”

Dr. Giori agreed that surgeons should proceed only with surgical cases they feel comfortable with. Certain surgeons may decide not to operate on individuals with higher BMIs because of the potential complications and can refer these patients to more specialized care centers. Operating on larger patients is more difficult and requires surgical skills and expertise that the surgeon may not have, he noted. “What I do object to is a system-wide BMI cutoff – for example, if an insurance company won’t pay for you to have a joint replacement, regardless of where you go or who your surgeon is,” Dr. Giori added. “I think that’s wrong, because it’s not patient centered and it’s basically excluding people from having a life-altering operation.”

Dr. Giori and Dr. Wiznia report no relevant financial relationships. Dr. Stronach is a consultant for DJ Orthopaedics, Johnson & Johnson, and MiCare Path.

A version of this article first appeared on Medscape.com.

For patients with severe arthritis, joint replacement is considered when more conservative treatments have failed. Because patients with obesity have a higher risk of complications during and after surgery, some surgeons, hospitals, and insurance companies have adopted body mass index cutoffs as a basis for deciding whether to offer patients these elective surgeries. But some experts argue that these cutoffs are arbitrary, exclude patients who can still benefit from the surgery, and can increase disparities in care.

“By enforcing cutoffs in general, you’re losing the ability for each surgeon to determine who they want to operate on,” said Daniel Wiznia, MD, assistant professor of orthopedic surgery at Yale University, New Haven, Conn. He is on the leadership committee of the Movement Is Life Caucus, a nonprofit group focused on eliminating disparities in musculoskeletal health. “For every surgeon, it’s up to them to decide if they feel comfortable doing the surgery,” he noted in an interview. “My guidance for that would be, don’t just say no because of the number – look at the patient’s entire medical profile.”

According to the Centers for Disease Control and Prevention, nearly 42% of adults in the United States have a BMI over 30, and 9.2% of adults have a BMI over 40. This excess weight puts additional stress on joints: When a person is walking, experts estimate that the force on the knees can be two to three times someone’s body weight. Over time, this pressure can wear down the cartilage on joints.

As a result, people who are overweight or obese are more likely to develop osteoarthritis and to need joint replacements. According to a Canadian study, patients with a BMI of 30-35 are 3.4 times as likely to require a hip replacement and are 8.5 times as likely to require a knee replacement compared to individuals with a BMI in the “healthy weight” range. With a BMI above 40, individuals were 8.5 times more likely to need a hip replacement and were 32.7 times as likely to need a knee replacement.
 

More complications, greater expense

While there are no universally recommended BMI cutoffs for joint replacement surgery, it is not uncommon for institutions to require that patients have a BMI below a certain value (usually 35-40) to proceed with surgery. A 2013 survey of physicians from the American Association of Hip and Knee Surgeons found that 52% of surgeons required a BMI below 40 to qualify for surgery.

One of the main reasons for these cutoffs is the elevated risk of complications during and after surgery. Research suggests that obesity is associated with higher rates of wound dehiscence, prosthetic joint infection (PJI), and revision total joint arthroplasty. One 2016 study suggests that patients with a BMI of 35-39.9 are twice as likely to experience PJI compared to patients with a BMI below 35. For patients with a BMI of 40 or higher, PJI is four times as likely.

Another study found that patients whose BMI is 35-40 and who undergo total joint arthroplasty have a 6.4-fold greater risk of deep incision infection. For those with a BMI over 40, that rises to a 12.9-fold increased risk compared to patients with a BMI of 18.5-25. Patients with obesity tend to have other comorbidities that can increase the risk of complications during surgery, such as type 2 diabetes, coronary artery disease, and chronic kidney disease.

Because of the increased risk of complications, health care costs tend to be higher for patients with obesity. The growing popularity of bundled health payments can discourage operating on patients who are more likely to experience complications, such as patients with high BMIs, noted Dr. Wiznia.

Research suggests that minorities and people with lower socioeconomic status are disproportionately affected by these cutoffs. According to the CDC, among non-Hispanic Black Americans and Hispanic Americans, rates of obesity are higher than among their White counterparts, and these patients are less likely to undergo joint replacement. Strictly enforcing this eligibility criterion can worsen those disparities. A study involving 21,294 adults over age 50 from the National Health and Nutrition Examination Survey (NHANES) found that requiring a BMI of under 35 for total joint arthroplasty resulted in Black patients being 39% less likely to be eligible for surgery than White patients. And individuals with an annual household income under $45,000 were 19% less likely to qualify for surgery than those with a household income above $45,000.
 

BMI no better than other risk factors

Although high BMI is independently associated with a higher risk of complications, the increased risk of complications conferred by a BMI at or above 40 is similar to or lower than those of other comorbidities that surgeons generally accept, said Nicholas Giori, MD, PhD, professor of orthopedic surgery at Stanford (Calif.) University, and chief of orthopedic surgery at the VA Palo Alto Health Care System. These other comorbidities include age older than 75, hypertension that requires medication, and insulin-controlled diabetes. “The independent risk of just having the diagnosis of insulin-dependent diabetes is actually comparable to the independent risk of having obesity by itself,” he told this news organization, “and all of us operate on [patients with] diabetes.”

Also, there is no BMI at which the risk of complications suddenly increases, according to the American Academy of Orthopaedic Surgeons. “It’s a rising complication rate as you go into higher BMIs,” Dr. Giori said. “If you operate on someone with a BMI of 39 vs. 41, you’re not going to find that much of a difference [in risk].” But if a medical system enforced a hard BMI cutoff of 40, one patient would qualify for surgery while the other would be barred.
 

Weight not as “modifiable” as previously thought

Weight is often considered a “modifiable factor” for a person considering undergoing total joint arthroplasty, but research suggests that the issue is more complicated. “Obesity is tricky, because some people are successful [in weight loss],” said Dr. Giori. Those tend to be the more memorable stories. “But a large majority have a really hard time losing substantial weight – enough to make a difference in risk,” he continued.

A study conducted in North Carolina found that restricting patients with a BMI over 40 from having elective total joint arthroplasty procedures until their weight was optimized did not result in successful weight loss. Only 20% of patients who originally presented with a BMI above this limit eventually underwent surgery after 2 years, and fewer than half of these patients had achieved a BMI of less than 40 at the time of their surgery. A third of all patients in the study did not return to the orthopedic office after their first visit.

“To hold a hard cutoff when it’s very, very hard to modify ... is essentially telling people that they are not going to ever have surgery,” Dr. Giori said; “I think that can be unfair to some patients.”

Bariatric surgery is often suggested for patients with obesity who have not experienced successful weight loss with diet and lifestyle changes alone, but bariatric surgery comes with its own complications. Research on outcomes from total joint arthroplasty among patients with who have lost weight with bariatric surgery has yielded mixed results. “I rarely push anyone hard to go that route but present it as an option for certain patients,” said Benjamin M. Stronach, MD, an orthopedic surgeon at the University of Arkansas for Medical Sciences, in Little Rock. He usually brings up bariatric surgery with patients with a BMI in the high 40s or higher to gauge their interest. If patients are already considering weight loss surgery, his office provides referrals.

But even bariatric surgery does not result in successful long-term weight loss for every patient, Dr. Stronach said. He’s seeing more and more patients who come for consultations after having undergone bariatric surgery 10 to 15 years ago. These patients lost a significant amount of weight, but then gained the weight back. He noted that bariatric surgery can be very successful for some patients who adhere to their postbariatric regimen. “We typically see fairly impressive results in the short term,” he said.
 

Patients with obesity benefit from joint replacement

Although patients with obesity are at higher risk for complications from joint replacement surgery, research suggests that these patients can still benefit greatly from these surgeries and that these surgeries remain cost-effective. Some studies have found that patients with obesity tend to have worse outcomes after surgery than patients who are not obese, but often, patients with high BMIs are starting from a lower point, with greater joint pain and limited mobility, Dr. Giori said. But the improvements – that is, net change in measured outcomes – can be greater for obese patients.

“Several studies have shown equal or greater improvements in validated outcome scores, function, and satisfaction compared with nonobese patients after surgery,” authors wrote in a recent review article in which they discuss how to optimize joint replacement surgery for patients with obesity. The article, published in the November 2022 issue of the Journal of the American Academy of Orthopaedic Surgeon (JAAOS), is part of a collection of review articles by the Movement Is Life Caucus.

Encourage weight loss, but look beyond the number

Rather than adhering to strict BMI cutoffs, some experts urge surgeons to consider the patient as a whole and to evaluate each individual’s overall health and potential risk. Dr. Giori generally considers high BMI as just another comorbidity when assessing a patient’s overall risk. “For a person who only has a high BMI but is otherwise healthy, I see no reason not to go ahead and schedule that person for surgery, because reducing the patient’s BMI will not substantially reduce the patient’s complication risk, and a delay in surgery may adversely affect the patient’s quality of life and ability to earn a living,” he said.

“If someone is between a BMI of 40 and 45, we are definitely going to have a discussion about weight,” Dr. Stronach said. He generally counsels against surgery for any patient with a BMI at 45 or above. He wants patients to have a BMI below 40 before surgery but considers individual cases for exceptions. “We will still move forward at times with someone with a BMI of 41, as an example, who is otherwise healthy,” he said. Similarly, if a patient has lost a significant amount of weight (e.g., the patient’s BMI was reduced from 50 to 41), the patient is actively engaged in improving their health, and surgeons believe the patient has significantly reduced their risk, “a lot of time, we’re not going to draw a line in the sand right at [a BMI of] 40,” he said.

While using a BMI of under 35 or 40 as a guideline when starting to work with patients is reasonable, working toward a weight loss of 5%-10% of total body weight is another goal to consider, authors advise in the JAAOS obesity review article. Research suggests that even a 5% reduction in overall body weight can reduce surgical complications and can improve a patient’s glucose and lipid levels and cardiac profile. Referrals to dietitians and weight loss programs, as well as behavioral counseling, can also be useful in initiating weight loss and keeping patients engaged in the process, the authors wrote.
 

Consider a patient’s comorbidities

Many patients with obesity have comorbidities, such as type 2 diabetes and hypertension, that can also be optimized for surgery so as to lower a patient’s overall risk profile. For patients with diabetes, achieving an A1c of 8% or lower can be a reasonable goal and can reduce risk. “We’ve found that an HbA1c level of 8% or less is something that virtually all diabetics (though not everybody) can reach, and it’s something that can be reached in a reasonable amount of time,” Dr. Giori said. Preoperative use of beta-blockers, continued use of ACE inhibitors or angiotensin receptor blockers, and behavioral modifications can improve a patient’s cardiac health before surgery.

Malnutrition can be a correctable problem for patients, regardless of BMI. In the Movement Is Life collection of optimization articles, experts recommend that orthopedists screen for malnutrition with blood tests for albumin, vitamin D, transferrin, and total lymphocyte count. Patients with malnutrition should be screened for food insecurity, experts advise, and surgical candidates with deficiencies can be given supplements of omega-3 fatty acids, arginine, and protein shakes.

Surgeon comfort and shared decision-making

Dr. Wiznia emphasized that the patient and surgeon need to discuss the risks of surgery, concerns about potential complications, and how a complication could affect the patient’s life moving forward. “Ultimately, the surgeon needs to make the decision [of whether or not to proceed [with surgery] with the patient,” he said, “but not every surgeon is going to feel comfortable operating on these patients, and not every medical institution is going to have the equipment and the investments to support surgeons doing it.”

Dr. Giori agreed that surgeons should proceed only with surgical cases they feel comfortable with. Certain surgeons may decide not to operate on individuals with higher BMIs because of the potential complications and can refer these patients to more specialized care centers. Operating on larger patients is more difficult and requires surgical skills and expertise that the surgeon may not have, he noted. “What I do object to is a system-wide BMI cutoff – for example, if an insurance company won’t pay for you to have a joint replacement, regardless of where you go or who your surgeon is,” Dr. Giori added. “I think that’s wrong, because it’s not patient centered and it’s basically excluding people from having a life-altering operation.”

Dr. Giori and Dr. Wiznia report no relevant financial relationships. Dr. Stronach is a consultant for DJ Orthopaedics, Johnson & Johnson, and MiCare Path.

A version of this article first appeared on Medscape.com.

The Centers for Disease Control and Prevention is warning of an early surge in respiratory disease caused by multiple viruses. As influenza viruses, respiratory syncytial virus (RSV), SARS-CoV-2, and rhinovirus/enterovirus simultaneously circulate, the agency cautioned that this confluence of viral activity could strain the health care system, according to a CDC Health Network Alert advisory issued Nov. 4.

“This early increase in disease incidence highlights the importance of optimizing respiratory virus prevention and treatment measures, including prompt vaccination and antiviral treatment,” the alert stated.

The CDC reports that RSV activity is increasing nationally, but in some areas – such as the South and Mountain West – cases appear to be trending downward.

Influenza cases continue to climb, with the virus activity being the highest in the South, Mid-Atlantic, and the south-central West Coast, according to CDC data. “In fact, we’re seeing the highest influenza hospitalization rates going back a decade,” said José Romero, MD, director of the CDC’s National Center for Immunization and Respiratory Diseases, during a press briefing. The agency estimates that there have been 1.6 million illnesses, 13,000 hospitalizations, and 730 deaths from the flu so far this season. As of Nov. 4, there have been two pediatric deaths.

COVID-19 cases appear to have plateaued in the past three weeks, Dr. Romero said; however, the CDC expects that there will be “high-level circulation of SARS-CoV-2 this fall and winter,” the health alert stated.

The CDC advised that all eligible individuals aged 6-months or older should be vaccinated against COVID-19 and influenza. To protect against RSV-hospitalization, high-risk children should receive the monoclonal antibody drug palivizumab (Synagis). High-risk children include infants born before 29 weeks, children younger than age 2 with chronic lung disease or hemodynamically significant congenital heart disease, and children with suppressed immune systems or neuromuscular disorders.

Any patient with confirmed or suspected flu who is hospitalized, at higher risk for influenza complications, or who has a severe or progressive illness should be treated as early as possible with antivirals, such as oral oseltamivir (Tamiflu).

Patients with confirmed SARS-CoV-2 infection with increased risk of complications should also be treated with antivirals, such as nirmatrelvir and ritonavir (Paxlovid) or remdesivir (Veklury).

Patients should also be reminded to wash their hands frequently, cover coughs and sneezes, stay home when sick, and avoid close contact with people who are sick, the CDC advised.

“There’s no doubt that we will face some challenges this winter,” said Dawn O’Connell, HHS Assistant Secretary for Preparedness and Response, “but it’s important to remember that RSV and flu are not new, and we have safe and effective vaccines for COVID-19 and the flu.”

A version of this article first appeared on Medscape.com.

The Centers for Disease Control and Prevention is warning of an early surge in respiratory disease caused by multiple viruses. As influenza viruses, respiratory syncytial virus (RSV), SARS-CoV-2, and rhinovirus/enterovirus simultaneously circulate, the agency cautioned that this confluence of viral activity could strain the health care system, according to a CDC Health Network Alert advisory issued Nov. 4.

“This early increase in disease incidence highlights the importance of optimizing respiratory virus prevention and treatment measures, including prompt vaccination and antiviral treatment,” the alert stated.

The CDC reports that RSV activity is increasing nationally, but in some areas – such as the South and Mountain West – cases appear to be trending downward.

Influenza cases continue to climb, with the virus activity being the highest in the South, Mid-Atlantic, and the south-central West Coast, according to CDC data. “In fact, we’re seeing the highest influenza hospitalization rates going back a decade,” said José Romero, MD, director of the CDC’s National Center for Immunization and Respiratory Diseases, during a press briefing. The agency estimates that there have been 1.6 million illnesses, 13,000 hospitalizations, and 730 deaths from the flu so far this season. As of Nov. 4, there have been two pediatric deaths.

COVID-19 cases appear to have plateaued in the past three weeks, Dr. Romero said; however, the CDC expects that there will be “high-level circulation of SARS-CoV-2 this fall and winter,” the health alert stated.

The CDC advised that all eligible individuals aged 6-months or older should be vaccinated against COVID-19 and influenza. To protect against RSV-hospitalization, high-risk children should receive the monoclonal antibody drug palivizumab (Synagis). High-risk children include infants born before 29 weeks, children younger than age 2 with chronic lung disease or hemodynamically significant congenital heart disease, and children with suppressed immune systems or neuromuscular disorders.

Any patient with confirmed or suspected flu who is hospitalized, at higher risk for influenza complications, or who has a severe or progressive illness should be treated as early as possible with antivirals, such as oral oseltamivir (Tamiflu).

Patients with confirmed SARS-CoV-2 infection with increased risk of complications should also be treated with antivirals, such as nirmatrelvir and ritonavir (Paxlovid) or remdesivir (Veklury).

Patients should also be reminded to wash their hands frequently, cover coughs and sneezes, stay home when sick, and avoid close contact with people who are sick, the CDC advised.

“There’s no doubt that we will face some challenges this winter,” said Dawn O’Connell, HHS Assistant Secretary for Preparedness and Response, “but it’s important to remember that RSV and flu are not new, and we have safe and effective vaccines for COVID-19 and the flu.”

A version of this article first appeared on Medscape.com.

The Centers for Disease Control and Prevention is warning of an early surge in respiratory disease caused by multiple viruses. As influenza viruses, respiratory syncytial virus (RSV), SARS-CoV-2, and rhinovirus/enterovirus simultaneously circulate, the agency cautioned that this confluence of viral activity could strain the health care system, according to a CDC Health Network Alert advisory issued Nov. 4.

“This early increase in disease incidence highlights the importance of optimizing respiratory virus prevention and treatment measures, including prompt vaccination and antiviral treatment,” the alert stated.

The CDC reports that RSV activity is increasing nationally, but in some areas – such as the South and Mountain West – cases appear to be trending downward.

Influenza cases continue to climb, with the virus activity being the highest in the South, Mid-Atlantic, and the south-central West Coast, according to CDC data. “In fact, we’re seeing the highest influenza hospitalization rates going back a decade,” said José Romero, MD, director of the CDC’s National Center for Immunization and Respiratory Diseases, during a press briefing. The agency estimates that there have been 1.6 million illnesses, 13,000 hospitalizations, and 730 deaths from the flu so far this season. As of Nov. 4, there have been two pediatric deaths.

COVID-19 cases appear to have plateaued in the past three weeks, Dr. Romero said; however, the CDC expects that there will be “high-level circulation of SARS-CoV-2 this fall and winter,” the health alert stated.

The CDC advised that all eligible individuals aged 6-months or older should be vaccinated against COVID-19 and influenza. To protect against RSV-hospitalization, high-risk children should receive the monoclonal antibody drug palivizumab (Synagis). High-risk children include infants born before 29 weeks, children younger than age 2 with chronic lung disease or hemodynamically significant congenital heart disease, and children with suppressed immune systems or neuromuscular disorders.

Any patient with confirmed or suspected flu who is hospitalized, at higher risk for influenza complications, or who has a severe or progressive illness should be treated as early as possible with antivirals, such as oral oseltamivir (Tamiflu).

Patients with confirmed SARS-CoV-2 infection with increased risk of complications should also be treated with antivirals, such as nirmatrelvir and ritonavir (Paxlovid) or remdesivir (Veklury).

Patients should also be reminded to wash their hands frequently, cover coughs and sneezes, stay home when sick, and avoid close contact with people who are sick, the CDC advised.

“There’s no doubt that we will face some challenges this winter,” said Dawn O’Connell, HHS Assistant Secretary for Preparedness and Response, “but it’s important to remember that RSV and flu are not new, and we have safe and effective vaccines for COVID-19 and the flu.”

A version of this article first appeared on Medscape.com.

Black Americans are 80% more likely to be hospitalized for the flu, compared with White Americans, according to new federal data.

Black, Hispanic, and American Indian/Alaska Native (AI/AN) adults in the United States also have had lower influenza vaccination rates, compared with their White counterparts, since 2010, researchers at the Centers for Disease Control and Prevention (CDC) revealed in a report.

The inequalities are the result of barriers to care, distrust of the medical system, and misinformation, the report said.

“We have many of the tools we need to address inequities and flu vaccination coverage and outcomes,” said CDC Acting Principal Deputy Director Debra Houry, MD, MPH, in a press call; “however, we must acknowledge that inequities in access to care continue to exist. To improve vaccine uptake, we must address the root causes of these ongoing disparities.”

The CDC has already reported early increases in flu activity in the United States, with the highest activity in the southeastern and south-central parts of the country. Experts also warn of a potentially more severe influenza season than in the previous 2 years. CDC officials emphasized that vaccination is the best protection against severe illness, hospitalization, and death from the flu. “Everyone should get vaccinated against flu today and encourage others and their community to get a flu vaccine for the best protection against flu this fall and winter,” Dr. Houry said.

In the recent report on disparities by community published October 18 in CDC Vital Signs, researchers looked at hospitalization rates from 2009 to 2022 and vaccination rates from 2010 to 2022 based on race and ethnicity using two national databases, the Influenza-Associated Hospitalization Surveillance Network and the Behavioral Risk Factor Surveillance System. All individuals included in the analysis were aged 18 years or older, and the 2020-2021 flu season was excluded from the analysis because of insufficient data.

Compared with those for White adults, hospitalization rates were 80% higher for Black adults, 30% higher for Hispanic adults, and 20% higher for AI/AN adults. While flu vaccination rates were similar in White and Asian adults (about 54%), coverage was lower in Black (42%), Hispanic (38%), AI/AN (41%), and other/multiracial (43%) adults. This disparity persisted even among individuals who had medical insurance, a personal health care provider, and a routine checkup within the last year.

“This report adds to the body of evidence that shows people from certain racial and ethnic minority groups have more severe outcomes at higher rates than White adults,” Carla Black, PhD, MPH, an epidemiologist at the CDC’s Immunization Services Division, said during the press call. While flu vaccines may not always prevent infection, people who do get sick after being vaccinated tend to have better outcomes, she added. The report noted that building trust, increasing access to vaccination services, and combating misinformation are important steps to increasing vaccine coverage in minority groups. 

While social distancing measures such as masking have made it difficult for the flu to spread, the relaxation of these safety measures could also lead to higher case counts. “We’ve had two mild flu seasons, and this means we might be ripe for a severe season,” Dr. Black said. “People haven’t had natural disease in 2 years, so there’s less natural immunity out there. People are going back to work. People are traveling again. All of these factors could contribute to us having a more severe flu season.”

A version of this article first appeared on Medscape.com.

Black Americans are 80% more likely to be hospitalized for the flu, compared with White Americans, according to new federal data.

Black, Hispanic, and American Indian/Alaska Native (AI/AN) adults in the United States also have had lower influenza vaccination rates, compared with their White counterparts, since 2010, researchers at the Centers for Disease Control and Prevention (CDC) revealed in a report.

The inequalities are the result of barriers to care, distrust of the medical system, and misinformation, the report said.

“We have many of the tools we need to address inequities and flu vaccination coverage and outcomes,” said CDC Acting Principal Deputy Director Debra Houry, MD, MPH, in a press call; “however, we must acknowledge that inequities in access to care continue to exist. To improve vaccine uptake, we must address the root causes of these ongoing disparities.”

The CDC has already reported early increases in flu activity in the United States, with the highest activity in the southeastern and south-central parts of the country. Experts also warn of a potentially more severe influenza season than in the previous 2 years. CDC officials emphasized that vaccination is the best protection against severe illness, hospitalization, and death from the flu. “Everyone should get vaccinated against flu today and encourage others and their community to get a flu vaccine for the best protection against flu this fall and winter,” Dr. Houry said.

In the recent report on disparities by community published October 18 in CDC Vital Signs, researchers looked at hospitalization rates from 2009 to 2022 and vaccination rates from 2010 to 2022 based on race and ethnicity using two national databases, the Influenza-Associated Hospitalization Surveillance Network and the Behavioral Risk Factor Surveillance System. All individuals included in the analysis were aged 18 years or older, and the 2020-2021 flu season was excluded from the analysis because of insufficient data.

Compared with those for White adults, hospitalization rates were 80% higher for Black adults, 30% higher for Hispanic adults, and 20% higher for AI/AN adults. While flu vaccination rates were similar in White and Asian adults (about 54%), coverage was lower in Black (42%), Hispanic (38%), AI/AN (41%), and other/multiracial (43%) adults. This disparity persisted even among individuals who had medical insurance, a personal health care provider, and a routine checkup within the last year.

“This report adds to the body of evidence that shows people from certain racial and ethnic minority groups have more severe outcomes at higher rates than White adults,” Carla Black, PhD, MPH, an epidemiologist at the CDC’s Immunization Services Division, said during the press call. While flu vaccines may not always prevent infection, people who do get sick after being vaccinated tend to have better outcomes, she added. The report noted that building trust, increasing access to vaccination services, and combating misinformation are important steps to increasing vaccine coverage in minority groups. 

While social distancing measures such as masking have made it difficult for the flu to spread, the relaxation of these safety measures could also lead to higher case counts. “We’ve had two mild flu seasons, and this means we might be ripe for a severe season,” Dr. Black said. “People haven’t had natural disease in 2 years, so there’s less natural immunity out there. People are going back to work. People are traveling again. All of these factors could contribute to us having a more severe flu season.”

A version of this article first appeared on Medscape.com.

Black Americans are 80% more likely to be hospitalized for the flu, compared with White Americans, according to new federal data.

Black, Hispanic, and American Indian/Alaska Native (AI/AN) adults in the United States also have had lower influenza vaccination rates, compared with their White counterparts, since 2010, researchers at the Centers for Disease Control and Prevention (CDC) revealed in a report.

The inequalities are the result of barriers to care, distrust of the medical system, and misinformation, the report said.

“We have many of the tools we need to address inequities and flu vaccination coverage and outcomes,” said CDC Acting Principal Deputy Director Debra Houry, MD, MPH, in a press call; “however, we must acknowledge that inequities in access to care continue to exist. To improve vaccine uptake, we must address the root causes of these ongoing disparities.”

The CDC has already reported early increases in flu activity in the United States, with the highest activity in the southeastern and south-central parts of the country. Experts also warn of a potentially more severe influenza season than in the previous 2 years. CDC officials emphasized that vaccination is the best protection against severe illness, hospitalization, and death from the flu. “Everyone should get vaccinated against flu today and encourage others and their community to get a flu vaccine for the best protection against flu this fall and winter,” Dr. Houry said.

In the recent report on disparities by community published October 18 in CDC Vital Signs, researchers looked at hospitalization rates from 2009 to 2022 and vaccination rates from 2010 to 2022 based on race and ethnicity using two national databases, the Influenza-Associated Hospitalization Surveillance Network and the Behavioral Risk Factor Surveillance System. All individuals included in the analysis were aged 18 years or older, and the 2020-2021 flu season was excluded from the analysis because of insufficient data.

Compared with those for White adults, hospitalization rates were 80% higher for Black adults, 30% higher for Hispanic adults, and 20% higher for AI/AN adults. While flu vaccination rates were similar in White and Asian adults (about 54%), coverage was lower in Black (42%), Hispanic (38%), AI/AN (41%), and other/multiracial (43%) adults. This disparity persisted even among individuals who had medical insurance, a personal health care provider, and a routine checkup within the last year.

“This report adds to the body of evidence that shows people from certain racial and ethnic minority groups have more severe outcomes at higher rates than White adults,” Carla Black, PhD, MPH, an epidemiologist at the CDC’s Immunization Services Division, said during the press call. While flu vaccines may not always prevent infection, people who do get sick after being vaccinated tend to have better outcomes, she added. The report noted that building trust, increasing access to vaccination services, and combating misinformation are important steps to increasing vaccine coverage in minority groups. 

While social distancing measures such as masking have made it difficult for the flu to spread, the relaxation of these safety measures could also lead to higher case counts. “We’ve had two mild flu seasons, and this means we might be ripe for a severe season,” Dr. Black said. “People haven’t had natural disease in 2 years, so there’s less natural immunity out there. People are going back to work. People are traveling again. All of these factors could contribute to us having a more severe flu season.”

A version of this article first appeared on Medscape.com.

The Food and Drug Administration has approved the HIV-1 medication ibalizumab-uiyk (Trogarzo, Theratechnologies) for administration by intravenous push.

Ibalizumab-uiyk, a long-acting monoclonal antibody, was first approved by the FDA in 2018 for the treatment of adults with multidrug-resistant HIV-1. It is used in combination with other antiretroviral drugs.

Prior to this approval, the drug was administered intravenously as a single 2,000-mg loading dose, followed by an 800-mg maintenance dose every 2 weeks by a trained medical professional. The intravenous infusion is given over 15-30 minutes, according to the Trogarzo website. Now, the maintenance dose can be administered by intravenous push, a method where the undiluted medication is delivered intravenously by injection, in just 30 seconds.

“The evolution of Trogarzo administration from intravenous infusion to intravenous push means less preparation and treatment time in clinics for patients and their health care providers, possibly allowing for more clinics to administer this treatment,” said Christian Marsolais, PhD, the chief medical officer of Theratechnologies, in an Oct. 3 press release.

The FDA approval of the intravenous push method was based on a clinical study which found that ibalizumab administered via intravenous push had similar safety and pharmacokinetic profiles as the intravenous infusion method. So far, 350 individuals have received ibalizumab as a part of the clinical development program, including 19 people who received the medication via intravenous push. The medication is also being studied for administration via intramuscular injection, the press release said.

The most common side effects of ibalizumab include diarrhea, dizziness, nausea, and rash. Severe adverse events have been reported in two patients: one who developed immune reconstitution inflammatory syndrome and another who reported a severe rash.

While multidrug-resistant HIV that would require ibalizumab is not very common – one study found it occurred in fewer than 2% of people with HIV in Western Europe – it is a “very difficult problem because we need to treat these patients to try to achieve virologic suppression,” Monica Gandhi, MD, MPH, associate chief of the division of HIV, infectious diseases, and global medicine at the University of California, San Francisco, noted in an email. While providers generally try to use nonintravenous medications when possible, ibalizumab is an important medication for people with multidrug-resistant HIV and limited treatment options.

“One barrier to administration was the need for IV infusion over 15-30 minutes,” Dr. Gandhi added. “The ability to give this medication as an IV push is an important breakthrough, as we could give this medication more readily for the relatively low number of individuals who will need it.”

A version of this article first appeared on Medscape.com.

The Food and Drug Administration has approved the HIV-1 medication ibalizumab-uiyk (Trogarzo, Theratechnologies) for administration by intravenous push.

Ibalizumab-uiyk, a long-acting monoclonal antibody, was first approved by the FDA in 2018 for the treatment of adults with multidrug-resistant HIV-1. It is used in combination with other antiretroviral drugs.

Prior to this approval, the drug was administered intravenously as a single 2,000-mg loading dose, followed by an 800-mg maintenance dose every 2 weeks by a trained medical professional. The intravenous infusion is given over 15-30 minutes, according to the Trogarzo website. Now, the maintenance dose can be administered by intravenous push, a method where the undiluted medication is delivered intravenously by injection, in just 30 seconds.

“The evolution of Trogarzo administration from intravenous infusion to intravenous push means less preparation and treatment time in clinics for patients and their health care providers, possibly allowing for more clinics to administer this treatment,” said Christian Marsolais, PhD, the chief medical officer of Theratechnologies, in an Oct. 3 press release.

The FDA approval of the intravenous push method was based on a clinical study which found that ibalizumab administered via intravenous push had similar safety and pharmacokinetic profiles as the intravenous infusion method. So far, 350 individuals have received ibalizumab as a part of the clinical development program, including 19 people who received the medication via intravenous push. The medication is also being studied for administration via intramuscular injection, the press release said.

The most common side effects of ibalizumab include diarrhea, dizziness, nausea, and rash. Severe adverse events have been reported in two patients: one who developed immune reconstitution inflammatory syndrome and another who reported a severe rash.

While multidrug-resistant HIV that would require ibalizumab is not very common – one study found it occurred in fewer than 2% of people with HIV in Western Europe – it is a “very difficult problem because we need to treat these patients to try to achieve virologic suppression,” Monica Gandhi, MD, MPH, associate chief of the division of HIV, infectious diseases, and global medicine at the University of California, San Francisco, noted in an email. While providers generally try to use nonintravenous medications when possible, ibalizumab is an important medication for people with multidrug-resistant HIV and limited treatment options.

“One barrier to administration was the need for IV infusion over 15-30 minutes,” Dr. Gandhi added. “The ability to give this medication as an IV push is an important breakthrough, as we could give this medication more readily for the relatively low number of individuals who will need it.”

A version of this article first appeared on Medscape.com.

The Food and Drug Administration has approved the HIV-1 medication ibalizumab-uiyk (Trogarzo, Theratechnologies) for administration by intravenous push.

Ibalizumab-uiyk, a long-acting monoclonal antibody, was first approved by the FDA in 2018 for the treatment of adults with multidrug-resistant HIV-1. It is used in combination with other antiretroviral drugs.

Prior to this approval, the drug was administered intravenously as a single 2,000-mg loading dose, followed by an 800-mg maintenance dose every 2 weeks by a trained medical professional. The intravenous infusion is given over 15-30 minutes, according to the Trogarzo website. Now, the maintenance dose can be administered by intravenous push, a method where the undiluted medication is delivered intravenously by injection, in just 30 seconds.

“The evolution of Trogarzo administration from intravenous infusion to intravenous push means less preparation and treatment time in clinics for patients and their health care providers, possibly allowing for more clinics to administer this treatment,” said Christian Marsolais, PhD, the chief medical officer of Theratechnologies, in an Oct. 3 press release.

The FDA approval of the intravenous push method was based on a clinical study which found that ibalizumab administered via intravenous push had similar safety and pharmacokinetic profiles as the intravenous infusion method. So far, 350 individuals have received ibalizumab as a part of the clinical development program, including 19 people who received the medication via intravenous push. The medication is also being studied for administration via intramuscular injection, the press release said.

The most common side effects of ibalizumab include diarrhea, dizziness, nausea, and rash. Severe adverse events have been reported in two patients: one who developed immune reconstitution inflammatory syndrome and another who reported a severe rash.

While multidrug-resistant HIV that would require ibalizumab is not very common – one study found it occurred in fewer than 2% of people with HIV in Western Europe – it is a “very difficult problem because we need to treat these patients to try to achieve virologic suppression,” Monica Gandhi, MD, MPH, associate chief of the division of HIV, infectious diseases, and global medicine at the University of California, San Francisco, noted in an email. While providers generally try to use nonintravenous medications when possible, ibalizumab is an important medication for people with multidrug-resistant HIV and limited treatment options.

“One barrier to administration was the need for IV infusion over 15-30 minutes,” Dr. Gandhi added. “The ability to give this medication as an IV push is an important breakthrough, as we could give this medication more readily for the relatively low number of individuals who will need it.”

A version of this article first appeared on Medscape.com.