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Physician burnout common, not readily recognized
CHICAGO – Physician burnout is common, and occurs across specialties including gastroenterology, according to a discussion held at the annual Digestive Disease Week.
A number of studies and surveys have reported on physician burnout, including a large 2015 report from the Mayo Clinic, which found that 54% of the physicians surveyed had at least one symptom of burnout (Mayo Clin Proc. 2015 Dec;90[12]:1600-13).
Still, physicians often fail to recognize burnout symptoms in themselves. At the meeting, Laurie A. Keefer Levine, PhD, a GI health psychologist and the director of psychobehavioral research at the Icahn School of Medicine at Mount Sinai, New York, recounted the story of a medical student who jumped from her apartment building and killed herself.
One of the main questions that came out of this discussion was why burnout isn’t more readily recognized. “It had to do with our strength as medical professionals,” she explained. “One common strength is that the pressure is self generated, and we put a lot of pressure on ourselves to excel.”
Health care providers are passionate about their work and it is difficult to give up opportunities that are important to them. “We can delay gratification a really long time until research results come out, or wait a long time for that promotion,” Dr. Keefer said, “But burnout is a very slow and insidious process. A lot of the time we don’t recognize it, and we think ‘just as long as we publish that paper,’ everything will get better.”
Also as time goes on, and physicians become more secure in their work and take on more responsibility, and that becomes another avenue for burnout. But importantly, she emphasized, burnout can be confused with stress, and many people mistake encroaching burnout for stress.
There are pronounced differences between stress and burnout even though they can be co-occurring. The difference, Dr. Keefer explained, is that stress is a problem of too much – work, pressure, and so on, and it is an “overreaction” of the nervous system in that “we’ve got to get it done.”
There is damage associated with chronic stress, but burnout is very different. Instead, burnout is a problem of “not enough.”
“We do not have enough to mount necessary responses to deal with the stressors that we have,” she said. “We are disengaged, our emotions are blunted. We feel helpless or hopeless and lose our motivation. And don’t care about the things we were once passionate about. We don’t have it in us any longer to contribute.”
Physicians use any number of coping strategies, rather than recognizing the problem. The unhealthiest coping strategy is venting. “We all do it, and it feels great, and it is meant to make us feel better,” said Dr. Keefer. “But if continues to happen over and over again, I would encourage you to think it through – that you are engaging in a coping strategy and may be missing burnout.”
It is imperative that medical providers recognize burnout early on, and not wait until it is too late, when there may be major consequences, she said.
Arthur DeCross, MD, professor of medicine at the University of Rochester (N.Y.), discussed some of the subgroups of gastroenterologists who may be at the highest risk of burnout.
Gender plays a strong role, and female gastroenterologists were more likely to identify themselves as being burned out, compared to their male peers. “They may be at risk in the lower domain for a sense of personal accomplishment,” said Dr. DeCross.
“There are respect issues that may come into play, as the literature shows,” he said. “For example, women are more likely to be addressed by their first name by patients and their peers. Also, even at meetings such as this one, how many times is a female presenter simply introduced by her first name?”
There are implicit respect issues here, said Dr. DeCross. “How many times do we hear something like, ‘and now the lovely Millie will present her findings on …?’ ”
He noted that he didn’t think that this lack of respect is intentional, but that it is happening. In addition, there is an issue of wages, and reported data show that women gastroenterologists earn 15% less than their male peers, he noted.
Women are more likely to have competing elements of family and career that put them on the slower track to promotion, he added.
The duration of one’s career also figured into the equation. Burnout was more noticeable early in the career process, suggesting that physicians with young families may be facing more conflicts and stress, and this is an issue that needs to be further explored, he noted.
“Early in the career, there is also the stress of proving oneself,” said Dr. DeCross.
Another contributor to burnout is when physicians spend an increasing amount of time on weekends and holidays doing work-related activities, along with an increase in internal regulatory burdens in the workplace.
Digestive Disease Week® is jointly sponsored by the American Association for the Study of Liver Diseases (AASLD), the American Gastroenterological Association (AGA) Institute, the American Society for Gastrointestinal Endoscopy (ASGE), and the Society for Surgery of the Alimentary Tract (SSAT).
CHICAGO – Physician burnout is common, and occurs across specialties including gastroenterology, according to a discussion held at the annual Digestive Disease Week.
A number of studies and surveys have reported on physician burnout, including a large 2015 report from the Mayo Clinic, which found that 54% of the physicians surveyed had at least one symptom of burnout (Mayo Clin Proc. 2015 Dec;90[12]:1600-13).
Still, physicians often fail to recognize burnout symptoms in themselves. At the meeting, Laurie A. Keefer Levine, PhD, a GI health psychologist and the director of psychobehavioral research at the Icahn School of Medicine at Mount Sinai, New York, recounted the story of a medical student who jumped from her apartment building and killed herself.
One of the main questions that came out of this discussion was why burnout isn’t more readily recognized. “It had to do with our strength as medical professionals,” she explained. “One common strength is that the pressure is self generated, and we put a lot of pressure on ourselves to excel.”
Health care providers are passionate about their work and it is difficult to give up opportunities that are important to them. “We can delay gratification a really long time until research results come out, or wait a long time for that promotion,” Dr. Keefer said, “But burnout is a very slow and insidious process. A lot of the time we don’t recognize it, and we think ‘just as long as we publish that paper,’ everything will get better.”
Also as time goes on, and physicians become more secure in their work and take on more responsibility, and that becomes another avenue for burnout. But importantly, she emphasized, burnout can be confused with stress, and many people mistake encroaching burnout for stress.
There are pronounced differences between stress and burnout even though they can be co-occurring. The difference, Dr. Keefer explained, is that stress is a problem of too much – work, pressure, and so on, and it is an “overreaction” of the nervous system in that “we’ve got to get it done.”
There is damage associated with chronic stress, but burnout is very different. Instead, burnout is a problem of “not enough.”
“We do not have enough to mount necessary responses to deal with the stressors that we have,” she said. “We are disengaged, our emotions are blunted. We feel helpless or hopeless and lose our motivation. And don’t care about the things we were once passionate about. We don’t have it in us any longer to contribute.”
Physicians use any number of coping strategies, rather than recognizing the problem. The unhealthiest coping strategy is venting. “We all do it, and it feels great, and it is meant to make us feel better,” said Dr. Keefer. “But if continues to happen over and over again, I would encourage you to think it through – that you are engaging in a coping strategy and may be missing burnout.”
It is imperative that medical providers recognize burnout early on, and not wait until it is too late, when there may be major consequences, she said.
Arthur DeCross, MD, professor of medicine at the University of Rochester (N.Y.), discussed some of the subgroups of gastroenterologists who may be at the highest risk of burnout.
Gender plays a strong role, and female gastroenterologists were more likely to identify themselves as being burned out, compared to their male peers. “They may be at risk in the lower domain for a sense of personal accomplishment,” said Dr. DeCross.
“There are respect issues that may come into play, as the literature shows,” he said. “For example, women are more likely to be addressed by their first name by patients and their peers. Also, even at meetings such as this one, how many times is a female presenter simply introduced by her first name?”
There are implicit respect issues here, said Dr. DeCross. “How many times do we hear something like, ‘and now the lovely Millie will present her findings on …?’ ”
He noted that he didn’t think that this lack of respect is intentional, but that it is happening. In addition, there is an issue of wages, and reported data show that women gastroenterologists earn 15% less than their male peers, he noted.
Women are more likely to have competing elements of family and career that put them on the slower track to promotion, he added.
The duration of one’s career also figured into the equation. Burnout was more noticeable early in the career process, suggesting that physicians with young families may be facing more conflicts and stress, and this is an issue that needs to be further explored, he noted.
“Early in the career, there is also the stress of proving oneself,” said Dr. DeCross.
Another contributor to burnout is when physicians spend an increasing amount of time on weekends and holidays doing work-related activities, along with an increase in internal regulatory burdens in the workplace.
Digestive Disease Week® is jointly sponsored by the American Association for the Study of Liver Diseases (AASLD), the American Gastroenterological Association (AGA) Institute, the American Society for Gastrointestinal Endoscopy (ASGE), and the Society for Surgery of the Alimentary Tract (SSAT).
CHICAGO – Physician burnout is common, and occurs across specialties including gastroenterology, according to a discussion held at the annual Digestive Disease Week.
A number of studies and surveys have reported on physician burnout, including a large 2015 report from the Mayo Clinic, which found that 54% of the physicians surveyed had at least one symptom of burnout (Mayo Clin Proc. 2015 Dec;90[12]:1600-13).
Still, physicians often fail to recognize burnout symptoms in themselves. At the meeting, Laurie A. Keefer Levine, PhD, a GI health psychologist and the director of psychobehavioral research at the Icahn School of Medicine at Mount Sinai, New York, recounted the story of a medical student who jumped from her apartment building and killed herself.
One of the main questions that came out of this discussion was why burnout isn’t more readily recognized. “It had to do with our strength as medical professionals,” she explained. “One common strength is that the pressure is self generated, and we put a lot of pressure on ourselves to excel.”
Health care providers are passionate about their work and it is difficult to give up opportunities that are important to them. “We can delay gratification a really long time until research results come out, or wait a long time for that promotion,” Dr. Keefer said, “But burnout is a very slow and insidious process. A lot of the time we don’t recognize it, and we think ‘just as long as we publish that paper,’ everything will get better.”
Also as time goes on, and physicians become more secure in their work and take on more responsibility, and that becomes another avenue for burnout. But importantly, she emphasized, burnout can be confused with stress, and many people mistake encroaching burnout for stress.
There are pronounced differences between stress and burnout even though they can be co-occurring. The difference, Dr. Keefer explained, is that stress is a problem of too much – work, pressure, and so on, and it is an “overreaction” of the nervous system in that “we’ve got to get it done.”
There is damage associated with chronic stress, but burnout is very different. Instead, burnout is a problem of “not enough.”
“We do not have enough to mount necessary responses to deal with the stressors that we have,” she said. “We are disengaged, our emotions are blunted. We feel helpless or hopeless and lose our motivation. And don’t care about the things we were once passionate about. We don’t have it in us any longer to contribute.”
Physicians use any number of coping strategies, rather than recognizing the problem. The unhealthiest coping strategy is venting. “We all do it, and it feels great, and it is meant to make us feel better,” said Dr. Keefer. “But if continues to happen over and over again, I would encourage you to think it through – that you are engaging in a coping strategy and may be missing burnout.”
It is imperative that medical providers recognize burnout early on, and not wait until it is too late, when there may be major consequences, she said.
Arthur DeCross, MD, professor of medicine at the University of Rochester (N.Y.), discussed some of the subgroups of gastroenterologists who may be at the highest risk of burnout.
Gender plays a strong role, and female gastroenterologists were more likely to identify themselves as being burned out, compared to their male peers. “They may be at risk in the lower domain for a sense of personal accomplishment,” said Dr. DeCross.
“There are respect issues that may come into play, as the literature shows,” he said. “For example, women are more likely to be addressed by their first name by patients and their peers. Also, even at meetings such as this one, how many times is a female presenter simply introduced by her first name?”
There are implicit respect issues here, said Dr. DeCross. “How many times do we hear something like, ‘and now the lovely Millie will present her findings on …?’ ”
He noted that he didn’t think that this lack of respect is intentional, but that it is happening. In addition, there is an issue of wages, and reported data show that women gastroenterologists earn 15% less than their male peers, he noted.
Women are more likely to have competing elements of family and career that put them on the slower track to promotion, he added.
The duration of one’s career also figured into the equation. Burnout was more noticeable early in the career process, suggesting that physicians with young families may be facing more conflicts and stress, and this is an issue that needs to be further explored, he noted.
“Early in the career, there is also the stress of proving oneself,” said Dr. DeCross.
Another contributor to burnout is when physicians spend an increasing amount of time on weekends and holidays doing work-related activities, along with an increase in internal regulatory burdens in the workplace.
Digestive Disease Week® is jointly sponsored by the American Association for the Study of Liver Diseases (AASLD), the American Gastroenterological Association (AGA) Institute, the American Society for Gastrointestinal Endoscopy (ASGE), and the Society for Surgery of the Alimentary Tract (SSAT).
AT DDW
Physician burnout common, not readily recognized by sufferers
CHICAGO – Physician burnout is common, and occurs across specialties including gastroenterology, according to a discussion held at the annual Digestive Disease Week®.
A number of studies and surveys have reported on physician burnout, including a large 2015 report from the Mayo Clinic, which found that 54% of the physicians surveyed had at least one symptom of burnout (Mayo Clin Proc. 2015 Dec;90[12]:1600-13).
“While she is not the first medical student to kill herself, this was an opportunity for the medical students to sit down and talk with the faculty,” said Dr. Keefer Levine, noting that specifically it focused on how this young woman’s distress had been missed, what was going on with students, and what is missing in medical education.
One of the main questions that came out of this discussion was why burnout isn’t more readily recognized. “It had to do with our strength as medical professionals,” she explained. “One common strength is that the pressure is self-generated, and we put a lot of pressure on ourselves to excel.”
Health care providers are passionate about their work, and it is difficult to give up opportunities that are important to them. “We can delay gratification a really long time until research results come out, or wait a long time for that promotion,” Dr. Keefer Levine said, “But burnout is a very slow and insidious process. A lot of the time we don’t recognize it, and we think ‘just as long as we publish that paper,’ everything will get better.”
Also as time goes on, and physicians become more secure in their work and take on more responsibility, that becomes another avenue for burnout. But importantly, she emphasized, burnout can be confused with stress, and many people mistake encroaching burnout for stress.
There are pronounced differences between stress and burnout even though they can be co-occurring. The difference, Dr. Keefer Levine explained, is that stress is a problem of too much – work, pressure, and so on, and it is an “overreaction” of the nervous system in that “we’ve got to get it done.”
There is damage associated with chronic stress, but burnout is very different. Instead, burnout is a problem of “not enough.”
“We do not have enough to mount necessary responses to deal with the stressors that we have,” she said. “We are disengaged, our emotions are blunted. We feel helpless or hopeless and lose our motivation. And don’t care about the things we were once passionate about. We don’t have it in us any longer to contribute.”
Physicians use any number of coping strategies, rather than recognizing the problem. The unhealthiest coping strategy is venting. “We all do it, and it feels great, and it is meant to make us feel better,” said Dr. Keefer Levine. “But if continues to happen over and over again, I would encourage you to think it through – that you are engaging in a coping strategy and may be missing burnout.”
It is imperative that medical providers recognize burnout early on, and not wait until it is too late, when there may be major consequences, she said.
Arthur DeCross, MD, AGAF, professor of medicine at the University of Rochester (N.Y.), discussed some of the subgroups of gastroenterologists who may be at the highest risk of burnout.
Gender plays a strong role, and female gastroenterologists were more likely to identify themselves as being burned out, compared to their male peers. “They may be at risk in the lower domain for a sense of personal accomplishment,” said Dr. DeCross.
“There are respect issues that may come into play, as the literature shows,” he said. “For example, women are more likely to be addressed by their first name by patients and their peers. Also, even at meetings such as this one, how many times is a female presenter simply introduced by her first name?”
There are implicit respect issues here, said Dr. DeCross. “How many times do we hear something like, ‘and now the lovely Millie will present her findings on ...?’ ”
He noted that he didn’t think that this lack of respect is intentional, but that it is happening. In addition, there is an issue of wages, and reported data show that women gastroenterologists earn 15% less than their male peers, he noted.
Women are more likely to have competing elements of family and career that put them on the slower track to promotion, he added.
The duration of one’s career also figured into the equation. Burnout was more noticeable early in the career process, suggesting that physicians with young families may be facing more conflicts and stress, and this is an issue that needs to be further explored, he noted.
“Early in the career, there is also the stress of proving oneself,” said Dr. DeCross.
Another contributor to burnout is when physicians spend an increasing amount of time on weekends and holidays doing work-related activities, along with an increase in internal regulatory burdens in the workplace.
Dr. DeCross sat down with DDW TV to talk about the results of the survey, which you can watch at http://www.gastro.org/news_items/physician-burnout-amongst-gastroenterologists. Join your colleagues to discuss this important topic in the AGA Community at http://ow.Ly/aYyh30diuq3.
Digestive Disease Week® is jointly sponsored by the American Association for the Study of Liver Diseases (AASLD), the American Gastroenterological Association (AGA) Institute, the American Society for Gastrointestinal Endoscopy (ASGE), and the Society for Surgery of the Alimentary Tract (SSAT).
CHICAGO – Physician burnout is common, and occurs across specialties including gastroenterology, according to a discussion held at the annual Digestive Disease Week®.
A number of studies and surveys have reported on physician burnout, including a large 2015 report from the Mayo Clinic, which found that 54% of the physicians surveyed had at least one symptom of burnout (Mayo Clin Proc. 2015 Dec;90[12]:1600-13).
“While she is not the first medical student to kill herself, this was an opportunity for the medical students to sit down and talk with the faculty,” said Dr. Keefer Levine, noting that specifically it focused on how this young woman’s distress had been missed, what was going on with students, and what is missing in medical education.
One of the main questions that came out of this discussion was why burnout isn’t more readily recognized. “It had to do with our strength as medical professionals,” she explained. “One common strength is that the pressure is self-generated, and we put a lot of pressure on ourselves to excel.”
Health care providers are passionate about their work, and it is difficult to give up opportunities that are important to them. “We can delay gratification a really long time until research results come out, or wait a long time for that promotion,” Dr. Keefer Levine said, “But burnout is a very slow and insidious process. A lot of the time we don’t recognize it, and we think ‘just as long as we publish that paper,’ everything will get better.”
Also as time goes on, and physicians become more secure in their work and take on more responsibility, that becomes another avenue for burnout. But importantly, she emphasized, burnout can be confused with stress, and many people mistake encroaching burnout for stress.
There are pronounced differences between stress and burnout even though they can be co-occurring. The difference, Dr. Keefer Levine explained, is that stress is a problem of too much – work, pressure, and so on, and it is an “overreaction” of the nervous system in that “we’ve got to get it done.”
There is damage associated with chronic stress, but burnout is very different. Instead, burnout is a problem of “not enough.”
“We do not have enough to mount necessary responses to deal with the stressors that we have,” she said. “We are disengaged, our emotions are blunted. We feel helpless or hopeless and lose our motivation. And don’t care about the things we were once passionate about. We don’t have it in us any longer to contribute.”
Physicians use any number of coping strategies, rather than recognizing the problem. The unhealthiest coping strategy is venting. “We all do it, and it feels great, and it is meant to make us feel better,” said Dr. Keefer Levine. “But if continues to happen over and over again, I would encourage you to think it through – that you are engaging in a coping strategy and may be missing burnout.”
It is imperative that medical providers recognize burnout early on, and not wait until it is too late, when there may be major consequences, she said.
Arthur DeCross, MD, AGAF, professor of medicine at the University of Rochester (N.Y.), discussed some of the subgroups of gastroenterologists who may be at the highest risk of burnout.
Gender plays a strong role, and female gastroenterologists were more likely to identify themselves as being burned out, compared to their male peers. “They may be at risk in the lower domain for a sense of personal accomplishment,” said Dr. DeCross.
“There are respect issues that may come into play, as the literature shows,” he said. “For example, women are more likely to be addressed by their first name by patients and their peers. Also, even at meetings such as this one, how many times is a female presenter simply introduced by her first name?”
There are implicit respect issues here, said Dr. DeCross. “How many times do we hear something like, ‘and now the lovely Millie will present her findings on ...?’ ”
He noted that he didn’t think that this lack of respect is intentional, but that it is happening. In addition, there is an issue of wages, and reported data show that women gastroenterologists earn 15% less than their male peers, he noted.
Women are more likely to have competing elements of family and career that put them on the slower track to promotion, he added.
The duration of one’s career also figured into the equation. Burnout was more noticeable early in the career process, suggesting that physicians with young families may be facing more conflicts and stress, and this is an issue that needs to be further explored, he noted.
“Early in the career, there is also the stress of proving oneself,” said Dr. DeCross.
Another contributor to burnout is when physicians spend an increasing amount of time on weekends and holidays doing work-related activities, along with an increase in internal regulatory burdens in the workplace.
Dr. DeCross sat down with DDW TV to talk about the results of the survey, which you can watch at http://www.gastro.org/news_items/physician-burnout-amongst-gastroenterologists. Join your colleagues to discuss this important topic in the AGA Community at http://ow.Ly/aYyh30diuq3.
Digestive Disease Week® is jointly sponsored by the American Association for the Study of Liver Diseases (AASLD), the American Gastroenterological Association (AGA) Institute, the American Society for Gastrointestinal Endoscopy (ASGE), and the Society for Surgery of the Alimentary Tract (SSAT).
CHICAGO – Physician burnout is common, and occurs across specialties including gastroenterology, according to a discussion held at the annual Digestive Disease Week®.
A number of studies and surveys have reported on physician burnout, including a large 2015 report from the Mayo Clinic, which found that 54% of the physicians surveyed had at least one symptom of burnout (Mayo Clin Proc. 2015 Dec;90[12]:1600-13).
“While she is not the first medical student to kill herself, this was an opportunity for the medical students to sit down and talk with the faculty,” said Dr. Keefer Levine, noting that specifically it focused on how this young woman’s distress had been missed, what was going on with students, and what is missing in medical education.
One of the main questions that came out of this discussion was why burnout isn’t more readily recognized. “It had to do with our strength as medical professionals,” she explained. “One common strength is that the pressure is self-generated, and we put a lot of pressure on ourselves to excel.”
Health care providers are passionate about their work, and it is difficult to give up opportunities that are important to them. “We can delay gratification a really long time until research results come out, or wait a long time for that promotion,” Dr. Keefer Levine said, “But burnout is a very slow and insidious process. A lot of the time we don’t recognize it, and we think ‘just as long as we publish that paper,’ everything will get better.”
Also as time goes on, and physicians become more secure in their work and take on more responsibility, that becomes another avenue for burnout. But importantly, she emphasized, burnout can be confused with stress, and many people mistake encroaching burnout for stress.
There are pronounced differences between stress and burnout even though they can be co-occurring. The difference, Dr. Keefer Levine explained, is that stress is a problem of too much – work, pressure, and so on, and it is an “overreaction” of the nervous system in that “we’ve got to get it done.”
There is damage associated with chronic stress, but burnout is very different. Instead, burnout is a problem of “not enough.”
“We do not have enough to mount necessary responses to deal with the stressors that we have,” she said. “We are disengaged, our emotions are blunted. We feel helpless or hopeless and lose our motivation. And don’t care about the things we were once passionate about. We don’t have it in us any longer to contribute.”
Physicians use any number of coping strategies, rather than recognizing the problem. The unhealthiest coping strategy is venting. “We all do it, and it feels great, and it is meant to make us feel better,” said Dr. Keefer Levine. “But if continues to happen over and over again, I would encourage you to think it through – that you are engaging in a coping strategy and may be missing burnout.”
It is imperative that medical providers recognize burnout early on, and not wait until it is too late, when there may be major consequences, she said.
Arthur DeCross, MD, AGAF, professor of medicine at the University of Rochester (N.Y.), discussed some of the subgroups of gastroenterologists who may be at the highest risk of burnout.
Gender plays a strong role, and female gastroenterologists were more likely to identify themselves as being burned out, compared to their male peers. “They may be at risk in the lower domain for a sense of personal accomplishment,” said Dr. DeCross.
“There are respect issues that may come into play, as the literature shows,” he said. “For example, women are more likely to be addressed by their first name by patients and their peers. Also, even at meetings such as this one, how many times is a female presenter simply introduced by her first name?”
There are implicit respect issues here, said Dr. DeCross. “How many times do we hear something like, ‘and now the lovely Millie will present her findings on ...?’ ”
He noted that he didn’t think that this lack of respect is intentional, but that it is happening. In addition, there is an issue of wages, and reported data show that women gastroenterologists earn 15% less than their male peers, he noted.
Women are more likely to have competing elements of family and career that put them on the slower track to promotion, he added.
The duration of one’s career also figured into the equation. Burnout was more noticeable early in the career process, suggesting that physicians with young families may be facing more conflicts and stress, and this is an issue that needs to be further explored, he noted.
“Early in the career, there is also the stress of proving oneself,” said Dr. DeCross.
Another contributor to burnout is when physicians spend an increasing amount of time on weekends and holidays doing work-related activities, along with an increase in internal regulatory burdens in the workplace.
Dr. DeCross sat down with DDW TV to talk about the results of the survey, which you can watch at http://www.gastro.org/news_items/physician-burnout-amongst-gastroenterologists. Join your colleagues to discuss this important topic in the AGA Community at http://ow.Ly/aYyh30diuq3.
Digestive Disease Week® is jointly sponsored by the American Association for the Study of Liver Diseases (AASLD), the American Gastroenterological Association (AGA) Institute, the American Society for Gastrointestinal Endoscopy (ASGE), and the Society for Surgery of the Alimentary Tract (SSAT).
AT DDW
Waiving screening copayments could cut colorectal cancer deaths
CHICAGO – Out-of-pocket costs may present a barrier to colorectal screening, and removing those costs could reduce colorectal cancer deaths, according to new data presented at the annual Digestive Disease Week®.
These data imply that removing copayments could result in a 16% decrease in colorectal cancer–related deaths among Medicare beneficiaries, explained lead author Elisabeth Peterse, PhD, of the department of public health, Erasmus Medical Center, Rotterdam, the Netherlands.
The research also demonstrated that waiving copayments is cost effective, she added.
Despite the effectiveness of colorectal cancer screening, only 58% of eligible individuals adhere to current screening recommendations, Dr. Peterse noted. Financial barriers may play a role in the lack of adherence, as studies have found that removing out-of-pocket costs is one of the most effective interventions for increasing screening.
“But despite the fact that the Affordable Care Act has been successful in partially eliminating cost sharing for colorectal screening, Medicare beneficiaries may still face unexpected out-of-pocket liabilities,” said Dr. Peterse.
Out-of-pocket costs can be complicated, given that they can depend largely on how a procedure is coded. A screening colonoscopy or fecal immunochemical test (FIT) is completely covered if it is coded as a screening test, but follow-up colonoscopies come with 20% copayments.
A screening colonoscopy with polypectomy and a follow-up colonoscopy that is done after a positive fecal immunochemical test are coded as diagnostic rather than screening, so the patient has out-of-pocket costs, she explained.
To explore how waiving the cost of screening could impact colorectal cancer–related mortality and cost effectiveness, the researchers conducted an analysis using a microsimulation model for a cohort composed of 65-year-old individuals.
In the simulation, they estimated colorectal cancer–related mortality, quality-adjusted life-years, and total cost of screening and treatment using the current Medicare copayment schedule. These were then compared with outcomes for alternative situations.
The study was conducted in two parts, explained Dr. Peterse. In the first part, the researchers looked at five scenarios: one in which the 20% copayment was intact. In the second, the copayment was waived without having any impact on adherence. In the third, the investigators looked at a 5% increase in adherence but only at diagnostic follow-up.
In the fourth and fifth scenarios, the investigators looked at 5% and 10% increases in adherence, in both first screening and diagnostic follow-up, she added.
In the study’s second part, the researchers also estimated the threshold increase in participation at which copayment removal would be cost effective, using a $50,000 willingness-to-pay threshold.
They found that without screening, the expected mortality would be 25 colorectal deaths per 1,000 people in a population of 65-year-old individuals. With screening, the number was reduced to 12.8 deaths per 1,000 65-year-olds for colonoscopy, and 14.9 deaths per 1,000 for FIT screening. The total associated costs for screening and treatment for the two modalities were $3.02 million and $2.87 million.
If waiving the copayments had no impact in increasing screening levels, the cost of screening was estimated to increase to $3.1 million (2.8% increase) for colonoscopy and $2.9 million (1.6% increase) for FIT.
But if copayments were removed and there were a 5% increase in adherence, colorectal cancer deaths were estimated to decline to 11.7 (–8.3%) and 13.9 (–6.3%) per 1,000 for colonoscopy and FIT, respectively. That would result in cost-effectiveness ratios of $19,288 and $7,894 for no copayment versus having a copayment. Increasing adherence to 10% would result in an even lower ratio, noted Dr. Peterse.
The threshold increase for participating in screening programs – the point where removing a copayment becomes cost effective – was a 1.8% increase in colonoscopy screening and a 0.8% increase for FIT.
The conclusion is that waiving copayments is cost effective, Dr. Peterse said.
Dr. Peterse added that a limitation to the analysis is that the study authors don’t know to what extent patients are even aware of the copayments. “So, we don’t know if it is a barrier, and we didn’t take other insurance scenarios into account,” she said.
Dr. Peterse declared no relevant disclosures.
AGA Resource
Screening colonoscopy is the most cost-effective test for prevention of colorectal cancer. Patients should be incentivized, through the elimination of cost sharing, to use colonoscopy as a colorectal cancer screening mechanism. Additionally, the preventive screening benefit has contributed to the decline in colorectal cancer rates in our country, and AGA believes that this benefit should be preserved in any health care reform legislation. Read more at http://www.gastro.org/take-action/top-issues/patient-cost-sharing-for-screening-colonoscopy.
CHICAGO – Out-of-pocket costs may present a barrier to colorectal screening, and removing those costs could reduce colorectal cancer deaths, according to new data presented at the annual Digestive Disease Week®.
These data imply that removing copayments could result in a 16% decrease in colorectal cancer–related deaths among Medicare beneficiaries, explained lead author Elisabeth Peterse, PhD, of the department of public health, Erasmus Medical Center, Rotterdam, the Netherlands.
The research also demonstrated that waiving copayments is cost effective, she added.
Despite the effectiveness of colorectal cancer screening, only 58% of eligible individuals adhere to current screening recommendations, Dr. Peterse noted. Financial barriers may play a role in the lack of adherence, as studies have found that removing out-of-pocket costs is one of the most effective interventions for increasing screening.
“But despite the fact that the Affordable Care Act has been successful in partially eliminating cost sharing for colorectal screening, Medicare beneficiaries may still face unexpected out-of-pocket liabilities,” said Dr. Peterse.
Out-of-pocket costs can be complicated, given that they can depend largely on how a procedure is coded. A screening colonoscopy or fecal immunochemical test (FIT) is completely covered if it is coded as a screening test, but follow-up colonoscopies come with 20% copayments.
A screening colonoscopy with polypectomy and a follow-up colonoscopy that is done after a positive fecal immunochemical test are coded as diagnostic rather than screening, so the patient has out-of-pocket costs, she explained.
To explore how waiving the cost of screening could impact colorectal cancer–related mortality and cost effectiveness, the researchers conducted an analysis using a microsimulation model for a cohort composed of 65-year-old individuals.
In the simulation, they estimated colorectal cancer–related mortality, quality-adjusted life-years, and total cost of screening and treatment using the current Medicare copayment schedule. These were then compared with outcomes for alternative situations.
The study was conducted in two parts, explained Dr. Peterse. In the first part, the researchers looked at five scenarios: one in which the 20% copayment was intact. In the second, the copayment was waived without having any impact on adherence. In the third, the investigators looked at a 5% increase in adherence but only at diagnostic follow-up.
In the fourth and fifth scenarios, the investigators looked at 5% and 10% increases in adherence, in both first screening and diagnostic follow-up, she added.
In the study’s second part, the researchers also estimated the threshold increase in participation at which copayment removal would be cost effective, using a $50,000 willingness-to-pay threshold.
They found that without screening, the expected mortality would be 25 colorectal deaths per 1,000 people in a population of 65-year-old individuals. With screening, the number was reduced to 12.8 deaths per 1,000 65-year-olds for colonoscopy, and 14.9 deaths per 1,000 for FIT screening. The total associated costs for screening and treatment for the two modalities were $3.02 million and $2.87 million.
If waiving the copayments had no impact in increasing screening levels, the cost of screening was estimated to increase to $3.1 million (2.8% increase) for colonoscopy and $2.9 million (1.6% increase) for FIT.
But if copayments were removed and there were a 5% increase in adherence, colorectal cancer deaths were estimated to decline to 11.7 (–8.3%) and 13.9 (–6.3%) per 1,000 for colonoscopy and FIT, respectively. That would result in cost-effectiveness ratios of $19,288 and $7,894 for no copayment versus having a copayment. Increasing adherence to 10% would result in an even lower ratio, noted Dr. Peterse.
The threshold increase for participating in screening programs – the point where removing a copayment becomes cost effective – was a 1.8% increase in colonoscopy screening and a 0.8% increase for FIT.
The conclusion is that waiving copayments is cost effective, Dr. Peterse said.
Dr. Peterse added that a limitation to the analysis is that the study authors don’t know to what extent patients are even aware of the copayments. “So, we don’t know if it is a barrier, and we didn’t take other insurance scenarios into account,” she said.
Dr. Peterse declared no relevant disclosures.
AGA Resource
Screening colonoscopy is the most cost-effective test for prevention of colorectal cancer. Patients should be incentivized, through the elimination of cost sharing, to use colonoscopy as a colorectal cancer screening mechanism. Additionally, the preventive screening benefit has contributed to the decline in colorectal cancer rates in our country, and AGA believes that this benefit should be preserved in any health care reform legislation. Read more at http://www.gastro.org/take-action/top-issues/patient-cost-sharing-for-screening-colonoscopy.
CHICAGO – Out-of-pocket costs may present a barrier to colorectal screening, and removing those costs could reduce colorectal cancer deaths, according to new data presented at the annual Digestive Disease Week®.
These data imply that removing copayments could result in a 16% decrease in colorectal cancer–related deaths among Medicare beneficiaries, explained lead author Elisabeth Peterse, PhD, of the department of public health, Erasmus Medical Center, Rotterdam, the Netherlands.
The research also demonstrated that waiving copayments is cost effective, she added.
Despite the effectiveness of colorectal cancer screening, only 58% of eligible individuals adhere to current screening recommendations, Dr. Peterse noted. Financial barriers may play a role in the lack of adherence, as studies have found that removing out-of-pocket costs is one of the most effective interventions for increasing screening.
“But despite the fact that the Affordable Care Act has been successful in partially eliminating cost sharing for colorectal screening, Medicare beneficiaries may still face unexpected out-of-pocket liabilities,” said Dr. Peterse.
Out-of-pocket costs can be complicated, given that they can depend largely on how a procedure is coded. A screening colonoscopy or fecal immunochemical test (FIT) is completely covered if it is coded as a screening test, but follow-up colonoscopies come with 20% copayments.
A screening colonoscopy with polypectomy and a follow-up colonoscopy that is done after a positive fecal immunochemical test are coded as diagnostic rather than screening, so the patient has out-of-pocket costs, she explained.
To explore how waiving the cost of screening could impact colorectal cancer–related mortality and cost effectiveness, the researchers conducted an analysis using a microsimulation model for a cohort composed of 65-year-old individuals.
In the simulation, they estimated colorectal cancer–related mortality, quality-adjusted life-years, and total cost of screening and treatment using the current Medicare copayment schedule. These were then compared with outcomes for alternative situations.
The study was conducted in two parts, explained Dr. Peterse. In the first part, the researchers looked at five scenarios: one in which the 20% copayment was intact. In the second, the copayment was waived without having any impact on adherence. In the third, the investigators looked at a 5% increase in adherence but only at diagnostic follow-up.
In the fourth and fifth scenarios, the investigators looked at 5% and 10% increases in adherence, in both first screening and diagnostic follow-up, she added.
In the study’s second part, the researchers also estimated the threshold increase in participation at which copayment removal would be cost effective, using a $50,000 willingness-to-pay threshold.
They found that without screening, the expected mortality would be 25 colorectal deaths per 1,000 people in a population of 65-year-old individuals. With screening, the number was reduced to 12.8 deaths per 1,000 65-year-olds for colonoscopy, and 14.9 deaths per 1,000 for FIT screening. The total associated costs for screening and treatment for the two modalities were $3.02 million and $2.87 million.
If waiving the copayments had no impact in increasing screening levels, the cost of screening was estimated to increase to $3.1 million (2.8% increase) for colonoscopy and $2.9 million (1.6% increase) for FIT.
But if copayments were removed and there were a 5% increase in adherence, colorectal cancer deaths were estimated to decline to 11.7 (–8.3%) and 13.9 (–6.3%) per 1,000 for colonoscopy and FIT, respectively. That would result in cost-effectiveness ratios of $19,288 and $7,894 for no copayment versus having a copayment. Increasing adherence to 10% would result in an even lower ratio, noted Dr. Peterse.
The threshold increase for participating in screening programs – the point where removing a copayment becomes cost effective – was a 1.8% increase in colonoscopy screening and a 0.8% increase for FIT.
The conclusion is that waiving copayments is cost effective, Dr. Peterse said.
Dr. Peterse added that a limitation to the analysis is that the study authors don’t know to what extent patients are even aware of the copayments. “So, we don’t know if it is a barrier, and we didn’t take other insurance scenarios into account,” she said.
Dr. Peterse declared no relevant disclosures.
AGA Resource
Screening colonoscopy is the most cost-effective test for prevention of colorectal cancer. Patients should be incentivized, through the elimination of cost sharing, to use colonoscopy as a colorectal cancer screening mechanism. Additionally, the preventive screening benefit has contributed to the decline in colorectal cancer rates in our country, and AGA believes that this benefit should be preserved in any health care reform legislation. Read more at http://www.gastro.org/take-action/top-issues/patient-cost-sharing-for-screening-colonoscopy.
AT DDW
Exhaustive leveling needed for diagnosis of colon adenomas
CHICAGO – A substantial number of adenomas may be missed by pathologists, but changes in the standard methodology can significantly decrease that amount, according to findings presented at Digestive Disease Week®.
A nondiagnostic result is common in histologic specimens obtained from the colon and occurs in about 9% of biopsies. However, a protocol known as “exhaustive leveling of histologically nondiagnostic specimens” can significantly increase the detection of adenomas.
“In our study, we were answering the question, Are pathologists missing adenomas?” said Lauren Suzanne Cole, MD, of the University of Arizona, Phoenix.
During a standard pathology analysis, 50% of the polyp isn’t analyzed at all, and the remaining half is cut into three different levels that are approximately 2 microns each. “Ultimately, less than 1% is actually reviewed by the pathologist,” she said.
GI physicians may perceive that the pathology review is definitive, Dr. Cole explained. “They believe that the section is viewed in its entirety, when, in reality, 50% of the tissue block is cut and less than 1% is viewed to come up with a diagnosis.”
The term nondiagnostic biopsy generally indicates that a specific diagnosis cannot be made. In their literature review, Dr. Cole and her team looked at eight published studies and found that a nondiagnostic biopsy was a very common result, ranging from 9% to 16%. In addition, the literature also showed that there was a significant conversion rate in nondiagnostic biopsies, from 4% to 20%, when additional leveling was performed.
In the current study, they investigated whether the detection of adenomas is improved when pathologists examine representative levels taken from the entire tissue block of specimens that have been diagnosed as nondiagnostic.
They conducted a retrospective review of pathology results that had been performed by a large GI practice (from November 2012 to November 2016) after implementing a so-called “polyp protocol,” which included an analysis of tissue sections from the entire tissue block (exhaustive leveling) of polyps initially deemed histologically nondiagnostic.
A total of 120,115 polyps had been removed during the study period, and, of this group, 10,768 (9%) were initially found to be nondiagnostic and were selected for exhaustive leveling. After exhaustive leveling, more than one-third (37%; n = 3,964) of the diagnoses converted to adenoma.
When the detection rate for adenomas for exhaustive leveling was compared with that for standard leveling, there was a statistically significant 3.3% increase (P less than .0001) from baseline.
“Our conclusion is that adenomas are missed,” said Dr. Cole. “This is partially because pathologists are not typically evaluating an entire specimen.”
These results support the need for implementing standardized protocols for exhaustive leveling as a means of increasing the adenoma detection rate, she noted. “Our research emphasizes the need for further studies assessing pathology specimen processing and analysis.”
Digestive Disease Week® is jointly sponsored by the American Association for the Study of Liver Diseases (AASLD), the American Gastroenterological Association (AGA) Institute, the American Society for Gastrointestinal Endoscopy (ASGE), and the Society for Surgery of the Alimentary Tract (SSAT).
Dr. Cole declared no relevant disclosures.
CHICAGO – A substantial number of adenomas may be missed by pathologists, but changes in the standard methodology can significantly decrease that amount, according to findings presented at Digestive Disease Week®.
A nondiagnostic result is common in histologic specimens obtained from the colon and occurs in about 9% of biopsies. However, a protocol known as “exhaustive leveling of histologically nondiagnostic specimens” can significantly increase the detection of adenomas.
“In our study, we were answering the question, Are pathologists missing adenomas?” said Lauren Suzanne Cole, MD, of the University of Arizona, Phoenix.
During a standard pathology analysis, 50% of the polyp isn’t analyzed at all, and the remaining half is cut into three different levels that are approximately 2 microns each. “Ultimately, less than 1% is actually reviewed by the pathologist,” she said.
GI physicians may perceive that the pathology review is definitive, Dr. Cole explained. “They believe that the section is viewed in its entirety, when, in reality, 50% of the tissue block is cut and less than 1% is viewed to come up with a diagnosis.”
The term nondiagnostic biopsy generally indicates that a specific diagnosis cannot be made. In their literature review, Dr. Cole and her team looked at eight published studies and found that a nondiagnostic biopsy was a very common result, ranging from 9% to 16%. In addition, the literature also showed that there was a significant conversion rate in nondiagnostic biopsies, from 4% to 20%, when additional leveling was performed.
In the current study, they investigated whether the detection of adenomas is improved when pathologists examine representative levels taken from the entire tissue block of specimens that have been diagnosed as nondiagnostic.
They conducted a retrospective review of pathology results that had been performed by a large GI practice (from November 2012 to November 2016) after implementing a so-called “polyp protocol,” which included an analysis of tissue sections from the entire tissue block (exhaustive leveling) of polyps initially deemed histologically nondiagnostic.
A total of 120,115 polyps had been removed during the study period, and, of this group, 10,768 (9%) were initially found to be nondiagnostic and were selected for exhaustive leveling. After exhaustive leveling, more than one-third (37%; n = 3,964) of the diagnoses converted to adenoma.
When the detection rate for adenomas for exhaustive leveling was compared with that for standard leveling, there was a statistically significant 3.3% increase (P less than .0001) from baseline.
“Our conclusion is that adenomas are missed,” said Dr. Cole. “This is partially because pathologists are not typically evaluating an entire specimen.”
These results support the need for implementing standardized protocols for exhaustive leveling as a means of increasing the adenoma detection rate, she noted. “Our research emphasizes the need for further studies assessing pathology specimen processing and analysis.”
Digestive Disease Week® is jointly sponsored by the American Association for the Study of Liver Diseases (AASLD), the American Gastroenterological Association (AGA) Institute, the American Society for Gastrointestinal Endoscopy (ASGE), and the Society for Surgery of the Alimentary Tract (SSAT).
Dr. Cole declared no relevant disclosures.
CHICAGO – A substantial number of adenomas may be missed by pathologists, but changes in the standard methodology can significantly decrease that amount, according to findings presented at Digestive Disease Week®.
A nondiagnostic result is common in histologic specimens obtained from the colon and occurs in about 9% of biopsies. However, a protocol known as “exhaustive leveling of histologically nondiagnostic specimens” can significantly increase the detection of adenomas.
“In our study, we were answering the question, Are pathologists missing adenomas?” said Lauren Suzanne Cole, MD, of the University of Arizona, Phoenix.
During a standard pathology analysis, 50% of the polyp isn’t analyzed at all, and the remaining half is cut into three different levels that are approximately 2 microns each. “Ultimately, less than 1% is actually reviewed by the pathologist,” she said.
GI physicians may perceive that the pathology review is definitive, Dr. Cole explained. “They believe that the section is viewed in its entirety, when, in reality, 50% of the tissue block is cut and less than 1% is viewed to come up with a diagnosis.”
The term nondiagnostic biopsy generally indicates that a specific diagnosis cannot be made. In their literature review, Dr. Cole and her team looked at eight published studies and found that a nondiagnostic biopsy was a very common result, ranging from 9% to 16%. In addition, the literature also showed that there was a significant conversion rate in nondiagnostic biopsies, from 4% to 20%, when additional leveling was performed.
In the current study, they investigated whether the detection of adenomas is improved when pathologists examine representative levels taken from the entire tissue block of specimens that have been diagnosed as nondiagnostic.
They conducted a retrospective review of pathology results that had been performed by a large GI practice (from November 2012 to November 2016) after implementing a so-called “polyp protocol,” which included an analysis of tissue sections from the entire tissue block (exhaustive leveling) of polyps initially deemed histologically nondiagnostic.
A total of 120,115 polyps had been removed during the study period, and, of this group, 10,768 (9%) were initially found to be nondiagnostic and were selected for exhaustive leveling. After exhaustive leveling, more than one-third (37%; n = 3,964) of the diagnoses converted to adenoma.
When the detection rate for adenomas for exhaustive leveling was compared with that for standard leveling, there was a statistically significant 3.3% increase (P less than .0001) from baseline.
“Our conclusion is that adenomas are missed,” said Dr. Cole. “This is partially because pathologists are not typically evaluating an entire specimen.”
These results support the need for implementing standardized protocols for exhaustive leveling as a means of increasing the adenoma detection rate, she noted. “Our research emphasizes the need for further studies assessing pathology specimen processing and analysis.”
Digestive Disease Week® is jointly sponsored by the American Association for the Study of Liver Diseases (AASLD), the American Gastroenterological Association (AGA) Institute, the American Society for Gastrointestinal Endoscopy (ASGE), and the Society for Surgery of the Alimentary Tract (SSAT).
Dr. Cole declared no relevant disclosures.
AT DDW
Key clinical point: Current methods of pathology miss between 9% and 16% of adenomas because a specific diagnosis cannot be made.
Major finding: Using exhaustive leveling allowed for a conversion of more than one-third (37%; n = 3,964) of nondiagnostic results to adenoma.
Data source: A retrospective review of the pathology findings of a large GI practice after implementation of exhaustive leveling.
Disclosures: Dr. Cole declared no relevant disclosures.
IL-23 antibody risankizumab can effect, maintain remission in Crohn’s
CHICAGO – Subcutaneous risankizumab maintained clinical remission for half a year in 76% of Crohn’s disease patients who responded to it during an induction study.
The interleukin-23 antibody (ABBV-066; AbbVie) also maintained endoscopic remission in 52% of patients who entered the open-label maintenance phase of the 52-week study, Brian Feagan, MD, said at the annual Digestive Disease Week®.
The three-phase study enrolled 121 patients with moderate to severe Crohn’s disease. The first 12 weeks consisted of intravenous induction therapy; patients were randomized to monthly infusions of risankizumab 200 mg or 600 mg or placebo. The endpoint was deep clinical remission. Patients who achieved remission exited the study. Results of this study were published in April (Lancet.2017;389[10080]:1699-09).
Phase II included only the patients who did not achieve deep clinical remission. They all received open label 600 mg risankizumab infusions every 4 weeks from weeks 14-26. The endpoints were clinical and endoscopic remission.
Phase III, on which Dr. Feagan reported, included the patients who achieved remission in phase II. These patients continued with subcutaneous risankizumab 180 mg every 8 weeks, from week 26-52.
Patients were an average of about 38 years old, with mean disease duration of 16 years. Their median Crohn’s Disease Activity Index (CDAI) score was around 300; their mean Crohn’s Disease Endoscopic Index score was 12. About a quarter had already taken at least one tumor necrosis factor–alpha inhibitor; half of those had taken at least two of those drugs.
At the end of the first induction period, 25 taking the study drug and 6 taking placebo achieved clinical remission (31% vs. 15%). Those taking 600 mg did better than those taking 200 mg (37% vs. 9%).
Patients who didn’t achieve deep clinical remission (a CDAI of less than 150 plus endoscopic remission) entered into the open-label reinduction phase; all received monthly 600-mg infusions from weeks 14 to 26. Of these, 62 achieved clinical remission and entered the open-label maintenance phase.
By week 52, the majority of patients were still in clinical remission, although this varied by the original treatment group: 76% of those first randomized to 600 mg, 59% of those randomized to 200 mg, and 79% of those randomized to placebo. Endoscopic remission was maintained in 52% of the 600-mg group, 23% of the 200-mg group, and 32% of the placebo group.
Deep remission occurred in a subset of patients: 43% of the 600-mg group, 13.6% of the 200-mg group, and 31.6% of the placebo group.
Dr. Feagan also said C-reactive protein levels remained suppressed in the maintenance period. Patients who entered that period had experienced a mean drop of about 9 mg/L in CRP. By week 52, this had risen slightly, but the median decrease was still around 8 mg/L from baseline measures.
There were 11 drug-related adverse events; these were severe in five patients, causing two to withdraw. There were 22 infections during the study, one of which was serious, but no cases of tuberculosis, cancer, or fungal or opportunistic infections.
“We did not see any new or unexpected safety signals,” Dr. Feagan said. “The drug was well tolerated and appears safe.”
This study showed a superior response for the 600-mg induction dose, but Dr. Feagan said the company may explore higher doses before making a final determination. Last November, the Food and Drug Administration granted Orphan Drug Designation to risankizumab for the investigational treatment of Crohn’s disease in pediatric patients. The company is also investigating it in psoriasis; it recently outperformed ustekinumab in a small phase II study of patients with moderate to severe psoriasis.
The study was funded by Boehringer Ingelheim. Dr. Feagan reported financial relationships with AbbVie and Boehringer Ingelheim.
msullivan@frontlinemedcom.com
On Twitter @alz_gal
CHICAGO – Subcutaneous risankizumab maintained clinical remission for half a year in 76% of Crohn’s disease patients who responded to it during an induction study.
The interleukin-23 antibody (ABBV-066; AbbVie) also maintained endoscopic remission in 52% of patients who entered the open-label maintenance phase of the 52-week study, Brian Feagan, MD, said at the annual Digestive Disease Week®.
The three-phase study enrolled 121 patients with moderate to severe Crohn’s disease. The first 12 weeks consisted of intravenous induction therapy; patients were randomized to monthly infusions of risankizumab 200 mg or 600 mg or placebo. The endpoint was deep clinical remission. Patients who achieved remission exited the study. Results of this study were published in April (Lancet.2017;389[10080]:1699-09).
Phase II included only the patients who did not achieve deep clinical remission. They all received open label 600 mg risankizumab infusions every 4 weeks from weeks 14-26. The endpoints were clinical and endoscopic remission.
Phase III, on which Dr. Feagan reported, included the patients who achieved remission in phase II. These patients continued with subcutaneous risankizumab 180 mg every 8 weeks, from week 26-52.
Patients were an average of about 38 years old, with mean disease duration of 16 years. Their median Crohn’s Disease Activity Index (CDAI) score was around 300; their mean Crohn’s Disease Endoscopic Index score was 12. About a quarter had already taken at least one tumor necrosis factor–alpha inhibitor; half of those had taken at least two of those drugs.
At the end of the first induction period, 25 taking the study drug and 6 taking placebo achieved clinical remission (31% vs. 15%). Those taking 600 mg did better than those taking 200 mg (37% vs. 9%).
Patients who didn’t achieve deep clinical remission (a CDAI of less than 150 plus endoscopic remission) entered into the open-label reinduction phase; all received monthly 600-mg infusions from weeks 14 to 26. Of these, 62 achieved clinical remission and entered the open-label maintenance phase.
By week 52, the majority of patients were still in clinical remission, although this varied by the original treatment group: 76% of those first randomized to 600 mg, 59% of those randomized to 200 mg, and 79% of those randomized to placebo. Endoscopic remission was maintained in 52% of the 600-mg group, 23% of the 200-mg group, and 32% of the placebo group.
Deep remission occurred in a subset of patients: 43% of the 600-mg group, 13.6% of the 200-mg group, and 31.6% of the placebo group.
Dr. Feagan also said C-reactive protein levels remained suppressed in the maintenance period. Patients who entered that period had experienced a mean drop of about 9 mg/L in CRP. By week 52, this had risen slightly, but the median decrease was still around 8 mg/L from baseline measures.
There were 11 drug-related adverse events; these were severe in five patients, causing two to withdraw. There were 22 infections during the study, one of which was serious, but no cases of tuberculosis, cancer, or fungal or opportunistic infections.
“We did not see any new or unexpected safety signals,” Dr. Feagan said. “The drug was well tolerated and appears safe.”
This study showed a superior response for the 600-mg induction dose, but Dr. Feagan said the company may explore higher doses before making a final determination. Last November, the Food and Drug Administration granted Orphan Drug Designation to risankizumab for the investigational treatment of Crohn’s disease in pediatric patients. The company is also investigating it in psoriasis; it recently outperformed ustekinumab in a small phase II study of patients with moderate to severe psoriasis.
The study was funded by Boehringer Ingelheim. Dr. Feagan reported financial relationships with AbbVie and Boehringer Ingelheim.
msullivan@frontlinemedcom.com
On Twitter @alz_gal
CHICAGO – Subcutaneous risankizumab maintained clinical remission for half a year in 76% of Crohn’s disease patients who responded to it during an induction study.
The interleukin-23 antibody (ABBV-066; AbbVie) also maintained endoscopic remission in 52% of patients who entered the open-label maintenance phase of the 52-week study, Brian Feagan, MD, said at the annual Digestive Disease Week®.
The three-phase study enrolled 121 patients with moderate to severe Crohn’s disease. The first 12 weeks consisted of intravenous induction therapy; patients were randomized to monthly infusions of risankizumab 200 mg or 600 mg or placebo. The endpoint was deep clinical remission. Patients who achieved remission exited the study. Results of this study were published in April (Lancet.2017;389[10080]:1699-09).
Phase II included only the patients who did not achieve deep clinical remission. They all received open label 600 mg risankizumab infusions every 4 weeks from weeks 14-26. The endpoints were clinical and endoscopic remission.
Phase III, on which Dr. Feagan reported, included the patients who achieved remission in phase II. These patients continued with subcutaneous risankizumab 180 mg every 8 weeks, from week 26-52.
Patients were an average of about 38 years old, with mean disease duration of 16 years. Their median Crohn’s Disease Activity Index (CDAI) score was around 300; their mean Crohn’s Disease Endoscopic Index score was 12. About a quarter had already taken at least one tumor necrosis factor–alpha inhibitor; half of those had taken at least two of those drugs.
At the end of the first induction period, 25 taking the study drug and 6 taking placebo achieved clinical remission (31% vs. 15%). Those taking 600 mg did better than those taking 200 mg (37% vs. 9%).
Patients who didn’t achieve deep clinical remission (a CDAI of less than 150 plus endoscopic remission) entered into the open-label reinduction phase; all received monthly 600-mg infusions from weeks 14 to 26. Of these, 62 achieved clinical remission and entered the open-label maintenance phase.
By week 52, the majority of patients were still in clinical remission, although this varied by the original treatment group: 76% of those first randomized to 600 mg, 59% of those randomized to 200 mg, and 79% of those randomized to placebo. Endoscopic remission was maintained in 52% of the 600-mg group, 23% of the 200-mg group, and 32% of the placebo group.
Deep remission occurred in a subset of patients: 43% of the 600-mg group, 13.6% of the 200-mg group, and 31.6% of the placebo group.
Dr. Feagan also said C-reactive protein levels remained suppressed in the maintenance period. Patients who entered that period had experienced a mean drop of about 9 mg/L in CRP. By week 52, this had risen slightly, but the median decrease was still around 8 mg/L from baseline measures.
There were 11 drug-related adverse events; these were severe in five patients, causing two to withdraw. There were 22 infections during the study, one of which was serious, but no cases of tuberculosis, cancer, or fungal or opportunistic infections.
“We did not see any new or unexpected safety signals,” Dr. Feagan said. “The drug was well tolerated and appears safe.”
This study showed a superior response for the 600-mg induction dose, but Dr. Feagan said the company may explore higher doses before making a final determination. Last November, the Food and Drug Administration granted Orphan Drug Designation to risankizumab for the investigational treatment of Crohn’s disease in pediatric patients. The company is also investigating it in psoriasis; it recently outperformed ustekinumab in a small phase II study of patients with moderate to severe psoriasis.
The study was funded by Boehringer Ingelheim. Dr. Feagan reported financial relationships with AbbVie and Boehringer Ingelheim.
msullivan@frontlinemedcom.com
On Twitter @alz_gal
AT DDW
Key clinical point:
Major finding: By week 52, clinical remission was maintained in 76% of those first randomized to 600 mg, 59% of those randomized to 200 mg, and 79% of those randomized to placebo.
Disclosures: Dr. Feagan reported financial relationships with Boehringer Ingelheim and AbbVie.
When fecal transplants for C. diff. fail, try, try again
CHICAGO – The best remedy for a failed fecal microbiota transplant for recurrent Clostridium difficile infection is most likely a second – or even a third or fourth attempt, according to Monika Fischer, MD.
Fecal microbiota transplants (FMTs) cure the large majority of those with recurrent C. difficile. But for those who don’t respond or who have an early recurrence, repeating the procedure will almost always effect cure, she said at the annual Digestive Disease Week.
“My recommendation would be to repeat FMT once you make sure the diagnosis actually is recurrent C. difficile,” said Dr. Fischer of Indiana University, Indianapolis. “There are sufficient data showing that the success rate after two FMTs significantly increases independent of the delivery route. But the effectiveness rate is highest when FMT is delivered via colonoscopy, so I recommend the second FMT be delivered that way.”
Recurrent failures can also be a sign that something else is amiss clinically, she said. So before proceeding with multiple procedures, some detective work may be in order. It’s best to start with confirmatory testing for the organism, she said.
“We have seen that about 25% of patients referred for FMT don’t actually have C. difficile at all,” Dr. Fischer said. “Be thinking about an alternative diagnosis when the stool tests negative, but the patient is still symptomatic, or if, before the FMT, there was less than a 50% improvement with vancomycin or fidaxomicin therapy.”
“When evaluating a patient for FMT failure, it should be confirmed by stool testing, preferably by toxin testing. Recent studies suggest that PCR [polymerase chain reaction]–positive but toxin-negative patients may be colonized with C. difficile but that an alternative pathology is driving the symptoms. Toxin-negative patients’ outcome is similar with or without treatment, and it is very rare that toxin-negative patients develop CDI [C. difficile infection]–related complications.”
For these patients, the problem could be any of the conditions that cause chronic diarrhea: inflammatory bowel disease, irritable bowel syndrome, celiac disease, microscopic colitis, bile salt malabsorption, chronic pancreatitis, or some other kind of infection. If C. difficile is the confirmed etiology, repeated FMTs are the way to go, Dr. Fischer said.
However, it may be worth mixing up the delivery method. The ever-expanding data on FMT continue to show that colonoscopy delivery has the lowest failure rate – about 10%. Enema is the least successful, with a 40% failure rate. In between those are nasoduodenal tube delivery, which is associated with a 20% failure rate, and oral capsules, with a failure rate varying from 12% to 30%. Fresh stool is also more effective than frozen, which, in turn, is more effective than the lyophilized preparation, Dr. Fischer said.
“Options are to repeat FMT via colonoscopy, but for patients who have had several failures, consider using the upper and lower route at the same time, and give fresh stool, especially if the first transplants used frozen.”
Although the efficacy of FMT doesn’t appear to depend on donor characteristics, patient characteristics do seem to play a role. Dr. Fischer and her colleagues have created an assessment tool to predict who may be at risk for failure. The model was developed in a 300-patient FMT cohort at two centers and validated in a third academic center FMT population. Of 24 clinical variables, three were incorporated into the failure risk model: severe disease (odds ratio, 6), inpatient status (OR, 3.8), and the number of prior C. difficile–related hospitalizations (OR, 1.4 for each one). For severe disease, patients got 5 points on the scale; for inpatient status, 4 points; and for each prior hospitalization, 1 point.
“Patients in the low-risk category [0] had up to 5% chance of failing. Patients with intermediate risk [1-2] had a 15% chance of failing, and patients in the high-risk category [3 or more points] had higher than 35% chance of not responding to single FMT,” Dr. Fischer said.
She also examined this tool in an extended cohort of nearly 500 patients at four additional sites; about 5% had failed more than two FMTs. “We identified two additional risk factors for failing multiple transplants,” Dr. Fischer said. “These were immunocompromised state, which increased the risk by 4 times, and male gender, which increased the risk by 2.5 times.”
She offered some options for the rare patient who has failed repeat FMTs and doesn’t want to try again. “There are some alternative or adjunctive therapies to repeat FMTs that may be considered, in lieu of repeating FMT for the third or fourth time or even following the first FMT failure, if dictated by patient preference. We sometimes offer these for elderly or frail patients or those with a limited life expectancy. These therapy options are from small, nonrandomized trials in multiply recurrent C. difficile infections but have not been vetted in the FMT nonresponder population.”
These include a vancomycin taper, or a vancomycin taper followed by fidaxomicin. Another option, albeit with limited applicability, is suppressive low-dose vancomycin 125 mg given every day, every other day, or every third day, indefinitely. “This can be especially good for elderly, frail patients with limited life expectancy, needing ongoing antibiotic therapy for urinary tract infections,” she said.
Finally, an 8-week vancomycin taper with daily kefir ingestion has been helpful for some patients. Although probiotics have never been proven helpful in C. difficile infections or FMT success, kefir is a different sort of supplement, she said.
“Kefir is different from yogurt. It contains bacteriocins like nisin, a protein with antibacterial properties produced by Lactococcus lactis.”
msullivan@frontlinemedcom.com
On Twitter @alz_gal
CHICAGO – The best remedy for a failed fecal microbiota transplant for recurrent Clostridium difficile infection is most likely a second – or even a third or fourth attempt, according to Monika Fischer, MD.
Fecal microbiota transplants (FMTs) cure the large majority of those with recurrent C. difficile. But for those who don’t respond or who have an early recurrence, repeating the procedure will almost always effect cure, she said at the annual Digestive Disease Week.
“My recommendation would be to repeat FMT once you make sure the diagnosis actually is recurrent C. difficile,” said Dr. Fischer of Indiana University, Indianapolis. “There are sufficient data showing that the success rate after two FMTs significantly increases independent of the delivery route. But the effectiveness rate is highest when FMT is delivered via colonoscopy, so I recommend the second FMT be delivered that way.”
Recurrent failures can also be a sign that something else is amiss clinically, she said. So before proceeding with multiple procedures, some detective work may be in order. It’s best to start with confirmatory testing for the organism, she said.
“We have seen that about 25% of patients referred for FMT don’t actually have C. difficile at all,” Dr. Fischer said. “Be thinking about an alternative diagnosis when the stool tests negative, but the patient is still symptomatic, or if, before the FMT, there was less than a 50% improvement with vancomycin or fidaxomicin therapy.”
“When evaluating a patient for FMT failure, it should be confirmed by stool testing, preferably by toxin testing. Recent studies suggest that PCR [polymerase chain reaction]–positive but toxin-negative patients may be colonized with C. difficile but that an alternative pathology is driving the symptoms. Toxin-negative patients’ outcome is similar with or without treatment, and it is very rare that toxin-negative patients develop CDI [C. difficile infection]–related complications.”
For these patients, the problem could be any of the conditions that cause chronic diarrhea: inflammatory bowel disease, irritable bowel syndrome, celiac disease, microscopic colitis, bile salt malabsorption, chronic pancreatitis, or some other kind of infection. If C. difficile is the confirmed etiology, repeated FMTs are the way to go, Dr. Fischer said.
However, it may be worth mixing up the delivery method. The ever-expanding data on FMT continue to show that colonoscopy delivery has the lowest failure rate – about 10%. Enema is the least successful, with a 40% failure rate. In between those are nasoduodenal tube delivery, which is associated with a 20% failure rate, and oral capsules, with a failure rate varying from 12% to 30%. Fresh stool is also more effective than frozen, which, in turn, is more effective than the lyophilized preparation, Dr. Fischer said.
“Options are to repeat FMT via colonoscopy, but for patients who have had several failures, consider using the upper and lower route at the same time, and give fresh stool, especially if the first transplants used frozen.”
Although the efficacy of FMT doesn’t appear to depend on donor characteristics, patient characteristics do seem to play a role. Dr. Fischer and her colleagues have created an assessment tool to predict who may be at risk for failure. The model was developed in a 300-patient FMT cohort at two centers and validated in a third academic center FMT population. Of 24 clinical variables, three were incorporated into the failure risk model: severe disease (odds ratio, 6), inpatient status (OR, 3.8), and the number of prior C. difficile–related hospitalizations (OR, 1.4 for each one). For severe disease, patients got 5 points on the scale; for inpatient status, 4 points; and for each prior hospitalization, 1 point.
“Patients in the low-risk category [0] had up to 5% chance of failing. Patients with intermediate risk [1-2] had a 15% chance of failing, and patients in the high-risk category [3 or more points] had higher than 35% chance of not responding to single FMT,” Dr. Fischer said.
She also examined this tool in an extended cohort of nearly 500 patients at four additional sites; about 5% had failed more than two FMTs. “We identified two additional risk factors for failing multiple transplants,” Dr. Fischer said. “These were immunocompromised state, which increased the risk by 4 times, and male gender, which increased the risk by 2.5 times.”
She offered some options for the rare patient who has failed repeat FMTs and doesn’t want to try again. “There are some alternative or adjunctive therapies to repeat FMTs that may be considered, in lieu of repeating FMT for the third or fourth time or even following the first FMT failure, if dictated by patient preference. We sometimes offer these for elderly or frail patients or those with a limited life expectancy. These therapy options are from small, nonrandomized trials in multiply recurrent C. difficile infections but have not been vetted in the FMT nonresponder population.”
These include a vancomycin taper, or a vancomycin taper followed by fidaxomicin. Another option, albeit with limited applicability, is suppressive low-dose vancomycin 125 mg given every day, every other day, or every third day, indefinitely. “This can be especially good for elderly, frail patients with limited life expectancy, needing ongoing antibiotic therapy for urinary tract infections,” she said.
Finally, an 8-week vancomycin taper with daily kefir ingestion has been helpful for some patients. Although probiotics have never been proven helpful in C. difficile infections or FMT success, kefir is a different sort of supplement, she said.
“Kefir is different from yogurt. It contains bacteriocins like nisin, a protein with antibacterial properties produced by Lactococcus lactis.”
msullivan@frontlinemedcom.com
On Twitter @alz_gal
CHICAGO – The best remedy for a failed fecal microbiota transplant for recurrent Clostridium difficile infection is most likely a second – or even a third or fourth attempt, according to Monika Fischer, MD.
Fecal microbiota transplants (FMTs) cure the large majority of those with recurrent C. difficile. But for those who don’t respond or who have an early recurrence, repeating the procedure will almost always effect cure, she said at the annual Digestive Disease Week.
“My recommendation would be to repeat FMT once you make sure the diagnosis actually is recurrent C. difficile,” said Dr. Fischer of Indiana University, Indianapolis. “There are sufficient data showing that the success rate after two FMTs significantly increases independent of the delivery route. But the effectiveness rate is highest when FMT is delivered via colonoscopy, so I recommend the second FMT be delivered that way.”
Recurrent failures can also be a sign that something else is amiss clinically, she said. So before proceeding with multiple procedures, some detective work may be in order. It’s best to start with confirmatory testing for the organism, she said.
“We have seen that about 25% of patients referred for FMT don’t actually have C. difficile at all,” Dr. Fischer said. “Be thinking about an alternative diagnosis when the stool tests negative, but the patient is still symptomatic, or if, before the FMT, there was less than a 50% improvement with vancomycin or fidaxomicin therapy.”
“When evaluating a patient for FMT failure, it should be confirmed by stool testing, preferably by toxin testing. Recent studies suggest that PCR [polymerase chain reaction]–positive but toxin-negative patients may be colonized with C. difficile but that an alternative pathology is driving the symptoms. Toxin-negative patients’ outcome is similar with or without treatment, and it is very rare that toxin-negative patients develop CDI [C. difficile infection]–related complications.”
For these patients, the problem could be any of the conditions that cause chronic diarrhea: inflammatory bowel disease, irritable bowel syndrome, celiac disease, microscopic colitis, bile salt malabsorption, chronic pancreatitis, or some other kind of infection. If C. difficile is the confirmed etiology, repeated FMTs are the way to go, Dr. Fischer said.
However, it may be worth mixing up the delivery method. The ever-expanding data on FMT continue to show that colonoscopy delivery has the lowest failure rate – about 10%. Enema is the least successful, with a 40% failure rate. In between those are nasoduodenal tube delivery, which is associated with a 20% failure rate, and oral capsules, with a failure rate varying from 12% to 30%. Fresh stool is also more effective than frozen, which, in turn, is more effective than the lyophilized preparation, Dr. Fischer said.
“Options are to repeat FMT via colonoscopy, but for patients who have had several failures, consider using the upper and lower route at the same time, and give fresh stool, especially if the first transplants used frozen.”
Although the efficacy of FMT doesn’t appear to depend on donor characteristics, patient characteristics do seem to play a role. Dr. Fischer and her colleagues have created an assessment tool to predict who may be at risk for failure. The model was developed in a 300-patient FMT cohort at two centers and validated in a third academic center FMT population. Of 24 clinical variables, three were incorporated into the failure risk model: severe disease (odds ratio, 6), inpatient status (OR, 3.8), and the number of prior C. difficile–related hospitalizations (OR, 1.4 for each one). For severe disease, patients got 5 points on the scale; for inpatient status, 4 points; and for each prior hospitalization, 1 point.
“Patients in the low-risk category [0] had up to 5% chance of failing. Patients with intermediate risk [1-2] had a 15% chance of failing, and patients in the high-risk category [3 or more points] had higher than 35% chance of not responding to single FMT,” Dr. Fischer said.
She also examined this tool in an extended cohort of nearly 500 patients at four additional sites; about 5% had failed more than two FMTs. “We identified two additional risk factors for failing multiple transplants,” Dr. Fischer said. “These were immunocompromised state, which increased the risk by 4 times, and male gender, which increased the risk by 2.5 times.”
She offered some options for the rare patient who has failed repeat FMTs and doesn’t want to try again. “There are some alternative or adjunctive therapies to repeat FMTs that may be considered, in lieu of repeating FMT for the third or fourth time or even following the first FMT failure, if dictated by patient preference. We sometimes offer these for elderly or frail patients or those with a limited life expectancy. These therapy options are from small, nonrandomized trials in multiply recurrent C. difficile infections but have not been vetted in the FMT nonresponder population.”
These include a vancomycin taper, or a vancomycin taper followed by fidaxomicin. Another option, albeit with limited applicability, is suppressive low-dose vancomycin 125 mg given every day, every other day, or every third day, indefinitely. “This can be especially good for elderly, frail patients with limited life expectancy, needing ongoing antibiotic therapy for urinary tract infections,” she said.
Finally, an 8-week vancomycin taper with daily kefir ingestion has been helpful for some patients. Although probiotics have never been proven helpful in C. difficile infections or FMT success, kefir is a different sort of supplement, she said.
“Kefir is different from yogurt. It contains bacteriocins like nisin, a protein with antibacterial properties produced by Lactococcus lactis.”
msullivan@frontlinemedcom.com
On Twitter @alz_gal
AT DDW 2017
Primary care involvement improves chance of meeting recommended surveillance intervals
CHICAGO – Only a small portion of patients with nondysplastic Barrett’s esophagus received appropriately timed endoscopic surveillance, a large database study showed.
But rather than being neglected, patients were more likely to be overassessed, with follow-up endoscopy performed more frequently than the recommended 3- to 5-year intervals, Anna Tavakkoli, MD, reported at the annual Digestive Disease Week.
“Very few patients entered our surveillance program with appropriate surveillance intervals,” said Dr. Tavakkoli, a gastroenterology fellow at the University of Michigan, Ann Arbor.
“We don’t have a formal program at the University of Michigan that drives coordination of care, but we do have great communication here between our primary care providers and our specialists. Our electronic medical records system makes quick messaging between providers easy, and primary care is very good about incorporating diagnoses into patients’ problem lists.”
Malignant transformation of nondysplastic Barrett’s is uncommon, with rates of no more than 4% per year. This understanding led three major societies – the American Gastroenterology Association, the American Society of Gastrointestinal Endoscopy, and the American College of Gastroenterology – to amend their surveillance recommendations in 2011 and 2012. All three societies now recommend a surveillance endoscopy every 3-5 years after the initial diagnosis of nondysplastic Barrett’s esophagus. In fact, the AGA has incorporated this suggestion into its five “Choosing Wisely” recommendations aimed at decreasing overutilization of testing and procedures.
Dr. Tavakkoli’s study examined surveillance timing in a cohort of 1,602 patients with nondysplastic Barrett’s who entered the University of Michigan Barrett’s Esophagus Registry from 1994 to 2016. All of these patents had at least three endoscopies or at least 5 years of follow-up data since their last endoscopy. The primary outcome was identification of trends in the appropriateness of surveillance of patients with nondysplastic Barrett’s esophagus at the University of Michigan. In her analysis, oversurveillance was defined as less than 3 years between the second and third endoscopy; undersurveillance was defined as more than 5 years between them. Dr. Tavakkoli and her colleagues also looked at patients who were lost to follow-up, defined as never receiving a second endoscopy after their initial diagnosis of nondysplastic Barrett’s esophagus and patients who were never surveilled, defined as never receiving their third endoscopy. All patients were compared with those who underwent appropriate surveillance, defined as 3-5 years between their second and third procedure.
The majority of patients were male, and the mean age was 59 years; 30% had long-segment Barrett’s, and 41% had a primary care provider in the university health care system. Most (90%) had their second endoscopy before 2012, when two of the three major societies issued their updated surveillance recommendations.
Of the entire cohort, 40% were lost to follow-up; 17% were never surveilled, and 3% were undersurveilled. Almost a third (31%) were oversurveilled, while just 8% had the appropriate surveillance, Dr. Tavakkoli said.
She then looked at several demographic and clinical factors associated with surveillance in each group, including sex, age, race, and income, comorbidities, length of Barrett’s, family history of esophageal cancer, and whether the patient had a University of Michigan primary care provider.
Having long-segment Barrett’s was associated with a 2.5-times increased risk of receiving a third endoscopy earlier than 3 years, which may be driven by studies that have shown that the risk of malignant transformation increases with Barrett’s length, she said.
The presence of a primary care physician significantly reduced the risk of inappropriate follow-up in every group, except patients who were undersurveilled, she said. The presence of a primary care physician at the University of Michigan decreased the risk of oversurveillance by 56%.
The positive influence of an in-system primary care physician was an important finding in this study, Dr Tavakkoli said. “The oncology data have shown us that poor coordination of care between oncologists and primary care providers contributes to avoidable patient morbidity and mortality, fragmented care, and increased costs. In 2005, the Institute of Medicine published a report emphasizing that coordination between specialists and primary care providers is one of the four key components to cancer survivorship care. There have been a number of GI studies looking at how primary care’s involvement in colorectal screening improves the rates of patients who undergo screening, but among Barrett’s patients, there have not been data showing that having a primary care physician at the center where endoscopic surveillance is done improves utilization patterns.”
Dr. Tavakkoli had no financial disclosures.
msullivan@frontlinemedcom.com
On Twitter @alz_gal
CHICAGO – Only a small portion of patients with nondysplastic Barrett’s esophagus received appropriately timed endoscopic surveillance, a large database study showed.
But rather than being neglected, patients were more likely to be overassessed, with follow-up endoscopy performed more frequently than the recommended 3- to 5-year intervals, Anna Tavakkoli, MD, reported at the annual Digestive Disease Week.
“Very few patients entered our surveillance program with appropriate surveillance intervals,” said Dr. Tavakkoli, a gastroenterology fellow at the University of Michigan, Ann Arbor.
“We don’t have a formal program at the University of Michigan that drives coordination of care, but we do have great communication here between our primary care providers and our specialists. Our electronic medical records system makes quick messaging between providers easy, and primary care is very good about incorporating diagnoses into patients’ problem lists.”
Malignant transformation of nondysplastic Barrett’s is uncommon, with rates of no more than 4% per year. This understanding led three major societies – the American Gastroenterology Association, the American Society of Gastrointestinal Endoscopy, and the American College of Gastroenterology – to amend their surveillance recommendations in 2011 and 2012. All three societies now recommend a surveillance endoscopy every 3-5 years after the initial diagnosis of nondysplastic Barrett’s esophagus. In fact, the AGA has incorporated this suggestion into its five “Choosing Wisely” recommendations aimed at decreasing overutilization of testing and procedures.
Dr. Tavakkoli’s study examined surveillance timing in a cohort of 1,602 patients with nondysplastic Barrett’s who entered the University of Michigan Barrett’s Esophagus Registry from 1994 to 2016. All of these patents had at least three endoscopies or at least 5 years of follow-up data since their last endoscopy. The primary outcome was identification of trends in the appropriateness of surveillance of patients with nondysplastic Barrett’s esophagus at the University of Michigan. In her analysis, oversurveillance was defined as less than 3 years between the second and third endoscopy; undersurveillance was defined as more than 5 years between them. Dr. Tavakkoli and her colleagues also looked at patients who were lost to follow-up, defined as never receiving a second endoscopy after their initial diagnosis of nondysplastic Barrett’s esophagus and patients who were never surveilled, defined as never receiving their third endoscopy. All patients were compared with those who underwent appropriate surveillance, defined as 3-5 years between their second and third procedure.
The majority of patients were male, and the mean age was 59 years; 30% had long-segment Barrett’s, and 41% had a primary care provider in the university health care system. Most (90%) had their second endoscopy before 2012, when two of the three major societies issued their updated surveillance recommendations.
Of the entire cohort, 40% were lost to follow-up; 17% were never surveilled, and 3% were undersurveilled. Almost a third (31%) were oversurveilled, while just 8% had the appropriate surveillance, Dr. Tavakkoli said.
She then looked at several demographic and clinical factors associated with surveillance in each group, including sex, age, race, and income, comorbidities, length of Barrett’s, family history of esophageal cancer, and whether the patient had a University of Michigan primary care provider.
Having long-segment Barrett’s was associated with a 2.5-times increased risk of receiving a third endoscopy earlier than 3 years, which may be driven by studies that have shown that the risk of malignant transformation increases with Barrett’s length, she said.
The presence of a primary care physician significantly reduced the risk of inappropriate follow-up in every group, except patients who were undersurveilled, she said. The presence of a primary care physician at the University of Michigan decreased the risk of oversurveillance by 56%.
The positive influence of an in-system primary care physician was an important finding in this study, Dr Tavakkoli said. “The oncology data have shown us that poor coordination of care between oncologists and primary care providers contributes to avoidable patient morbidity and mortality, fragmented care, and increased costs. In 2005, the Institute of Medicine published a report emphasizing that coordination between specialists and primary care providers is one of the four key components to cancer survivorship care. There have been a number of GI studies looking at how primary care’s involvement in colorectal screening improves the rates of patients who undergo screening, but among Barrett’s patients, there have not been data showing that having a primary care physician at the center where endoscopic surveillance is done improves utilization patterns.”
Dr. Tavakkoli had no financial disclosures.
msullivan@frontlinemedcom.com
On Twitter @alz_gal
CHICAGO – Only a small portion of patients with nondysplastic Barrett’s esophagus received appropriately timed endoscopic surveillance, a large database study showed.
But rather than being neglected, patients were more likely to be overassessed, with follow-up endoscopy performed more frequently than the recommended 3- to 5-year intervals, Anna Tavakkoli, MD, reported at the annual Digestive Disease Week.
“Very few patients entered our surveillance program with appropriate surveillance intervals,” said Dr. Tavakkoli, a gastroenterology fellow at the University of Michigan, Ann Arbor.
“We don’t have a formal program at the University of Michigan that drives coordination of care, but we do have great communication here between our primary care providers and our specialists. Our electronic medical records system makes quick messaging between providers easy, and primary care is very good about incorporating diagnoses into patients’ problem lists.”
Malignant transformation of nondysplastic Barrett’s is uncommon, with rates of no more than 4% per year. This understanding led three major societies – the American Gastroenterology Association, the American Society of Gastrointestinal Endoscopy, and the American College of Gastroenterology – to amend their surveillance recommendations in 2011 and 2012. All three societies now recommend a surveillance endoscopy every 3-5 years after the initial diagnosis of nondysplastic Barrett’s esophagus. In fact, the AGA has incorporated this suggestion into its five “Choosing Wisely” recommendations aimed at decreasing overutilization of testing and procedures.
Dr. Tavakkoli’s study examined surveillance timing in a cohort of 1,602 patients with nondysplastic Barrett’s who entered the University of Michigan Barrett’s Esophagus Registry from 1994 to 2016. All of these patents had at least three endoscopies or at least 5 years of follow-up data since their last endoscopy. The primary outcome was identification of trends in the appropriateness of surveillance of patients with nondysplastic Barrett’s esophagus at the University of Michigan. In her analysis, oversurveillance was defined as less than 3 years between the second and third endoscopy; undersurveillance was defined as more than 5 years between them. Dr. Tavakkoli and her colleagues also looked at patients who were lost to follow-up, defined as never receiving a second endoscopy after their initial diagnosis of nondysplastic Barrett’s esophagus and patients who were never surveilled, defined as never receiving their third endoscopy. All patients were compared with those who underwent appropriate surveillance, defined as 3-5 years between their second and third procedure.
The majority of patients were male, and the mean age was 59 years; 30% had long-segment Barrett’s, and 41% had a primary care provider in the university health care system. Most (90%) had their second endoscopy before 2012, when two of the three major societies issued their updated surveillance recommendations.
Of the entire cohort, 40% were lost to follow-up; 17% were never surveilled, and 3% were undersurveilled. Almost a third (31%) were oversurveilled, while just 8% had the appropriate surveillance, Dr. Tavakkoli said.
She then looked at several demographic and clinical factors associated with surveillance in each group, including sex, age, race, and income, comorbidities, length of Barrett’s, family history of esophageal cancer, and whether the patient had a University of Michigan primary care provider.
Having long-segment Barrett’s was associated with a 2.5-times increased risk of receiving a third endoscopy earlier than 3 years, which may be driven by studies that have shown that the risk of malignant transformation increases with Barrett’s length, she said.
The presence of a primary care physician significantly reduced the risk of inappropriate follow-up in every group, except patients who were undersurveilled, she said. The presence of a primary care physician at the University of Michigan decreased the risk of oversurveillance by 56%.
The positive influence of an in-system primary care physician was an important finding in this study, Dr Tavakkoli said. “The oncology data have shown us that poor coordination of care between oncologists and primary care providers contributes to avoidable patient morbidity and mortality, fragmented care, and increased costs. In 2005, the Institute of Medicine published a report emphasizing that coordination between specialists and primary care providers is one of the four key components to cancer survivorship care. There have been a number of GI studies looking at how primary care’s involvement in colorectal screening improves the rates of patients who undergo screening, but among Barrett’s patients, there have not been data showing that having a primary care physician at the center where endoscopic surveillance is done improves utilization patterns.”
Dr. Tavakkoli had no financial disclosures.
msullivan@frontlinemedcom.com
On Twitter @alz_gal
AT DDW
Key clinical point:
Major finding: Only 8% of patients had the recommended interval of 3-5 years between surveillance endoscopies.
Data source: A retrospective database cohort of 1,602 patients.
Disclosures: Dr. Tavakkoli had no relevant financial disclosures.
Gastrointestinal healing in treated celiac patients can vary
CHICAGO – A gluten-free diet is the cornerstone of treatment for celiac disease, but healing of the gut may take longer in some patients than in others.
New findings presented at the annual Digestive Disease Week suggest that, even though patients treated with a gluten-free diet generally experience clinical improvement during the first few weeks or months of making dietary changes, serologic and especially histologic normalization may take longer – and it is not always certain that it will occur.
As many as 45% of patients exhibit substantial differences in the degree of intestinal injury in separate biopsies. Thus, caution is needed when interpreting the results of individual biopsies when assessing healing in patients who are on gluten-free diets, explained Dr. Choung. Evaluating multiple biopsies “may give a more accurate picture of the mucosal healing,” he noted.
The degree of intestinal damage varies considerably in individuals with celiac disease, and this variability can affect accurate assessments of both recovery and residual injury in patients who continue to have persistent symptoms despite adherence to a gluten-free diet.
The goal of the current study was to evaluate uniformity versus patchiness of mucosal damage in a large cohort of patients with celiac disease who were being treated but who still experienced symptoms.
The study included 1,352 patients with celiac disease who had been on a gluten-free diet for at least 1 year and who had undergone four biopsies from the distal duodenum. Each biopsy was processed separately, and, in each one, the villous height (Vh) and crypt depth (Cd) were measured in up to three different, well-oriented crypts.
The mucosal patchiness of villous atrophy was then defined as a variation in Vh:Cd ratio between biopsies from the same patient that was greater than two standard deviations of the Vh:Cd variations of the study population (mean of Vh:Cd, 2.13; standard deviation, 0.67).
Of the 1,125 patients who had at least five crypts that were measured from all four biopsies, 45% met the criteria for histological patchiness of mucosal healing in the small intestine. The authors found that several factors, including a younger age at diagnosis, female gender, and a higher average Vh:Cd ratio, were positively associated with mucosal patchiness.
However, there were no significant associations observed between mucosal patchiness and the duration of a gluten-free diet or of any gastrointestinal symptoms.
When the analysis was restricted to the population with a Vh:Cd no greater than 2, Dr. Choung and his colleagues found that human leukocyte antigen typing and tissue transglutaminase–immunoglobulin A did not predict mucosal patchiness. However, patients who were positive for deamidated gliadin peptide–IgA or deamidated gliadin peptide–IgG were less likely to exhibit patchiness but had more uniform intestinal injury (odds ratio, 0.4 and 0.4, respectively).
Digestive Disease Week is jointly sponsored by the American Association for the Study of Liver Diseases (AASLD), the American Gastroenterological Association (AGA) Institute, the American Society for Gastrointestinal Endoscopy (ASGE) and the Society for Surgery of the Alimentary Tract (SSAT). Dr. Choung declared no relevant disclosures.
CHICAGO – A gluten-free diet is the cornerstone of treatment for celiac disease, but healing of the gut may take longer in some patients than in others.
New findings presented at the annual Digestive Disease Week suggest that, even though patients treated with a gluten-free diet generally experience clinical improvement during the first few weeks or months of making dietary changes, serologic and especially histologic normalization may take longer – and it is not always certain that it will occur.
As many as 45% of patients exhibit substantial differences in the degree of intestinal injury in separate biopsies. Thus, caution is needed when interpreting the results of individual biopsies when assessing healing in patients who are on gluten-free diets, explained Dr. Choung. Evaluating multiple biopsies “may give a more accurate picture of the mucosal healing,” he noted.
The degree of intestinal damage varies considerably in individuals with celiac disease, and this variability can affect accurate assessments of both recovery and residual injury in patients who continue to have persistent symptoms despite adherence to a gluten-free diet.
The goal of the current study was to evaluate uniformity versus patchiness of mucosal damage in a large cohort of patients with celiac disease who were being treated but who still experienced symptoms.
The study included 1,352 patients with celiac disease who had been on a gluten-free diet for at least 1 year and who had undergone four biopsies from the distal duodenum. Each biopsy was processed separately, and, in each one, the villous height (Vh) and crypt depth (Cd) were measured in up to three different, well-oriented crypts.
The mucosal patchiness of villous atrophy was then defined as a variation in Vh:Cd ratio between biopsies from the same patient that was greater than two standard deviations of the Vh:Cd variations of the study population (mean of Vh:Cd, 2.13; standard deviation, 0.67).
Of the 1,125 patients who had at least five crypts that were measured from all four biopsies, 45% met the criteria for histological patchiness of mucosal healing in the small intestine. The authors found that several factors, including a younger age at diagnosis, female gender, and a higher average Vh:Cd ratio, were positively associated with mucosal patchiness.
However, there were no significant associations observed between mucosal patchiness and the duration of a gluten-free diet or of any gastrointestinal symptoms.
When the analysis was restricted to the population with a Vh:Cd no greater than 2, Dr. Choung and his colleagues found that human leukocyte antigen typing and tissue transglutaminase–immunoglobulin A did not predict mucosal patchiness. However, patients who were positive for deamidated gliadin peptide–IgA or deamidated gliadin peptide–IgG were less likely to exhibit patchiness but had more uniform intestinal injury (odds ratio, 0.4 and 0.4, respectively).
Digestive Disease Week is jointly sponsored by the American Association for the Study of Liver Diseases (AASLD), the American Gastroenterological Association (AGA) Institute, the American Society for Gastrointestinal Endoscopy (ASGE) and the Society for Surgery of the Alimentary Tract (SSAT). Dr. Choung declared no relevant disclosures.
CHICAGO – A gluten-free diet is the cornerstone of treatment for celiac disease, but healing of the gut may take longer in some patients than in others.
New findings presented at the annual Digestive Disease Week suggest that, even though patients treated with a gluten-free diet generally experience clinical improvement during the first few weeks or months of making dietary changes, serologic and especially histologic normalization may take longer – and it is not always certain that it will occur.
As many as 45% of patients exhibit substantial differences in the degree of intestinal injury in separate biopsies. Thus, caution is needed when interpreting the results of individual biopsies when assessing healing in patients who are on gluten-free diets, explained Dr. Choung. Evaluating multiple biopsies “may give a more accurate picture of the mucosal healing,” he noted.
The degree of intestinal damage varies considerably in individuals with celiac disease, and this variability can affect accurate assessments of both recovery and residual injury in patients who continue to have persistent symptoms despite adherence to a gluten-free diet.
The goal of the current study was to evaluate uniformity versus patchiness of mucosal damage in a large cohort of patients with celiac disease who were being treated but who still experienced symptoms.
The study included 1,352 patients with celiac disease who had been on a gluten-free diet for at least 1 year and who had undergone four biopsies from the distal duodenum. Each biopsy was processed separately, and, in each one, the villous height (Vh) and crypt depth (Cd) were measured in up to three different, well-oriented crypts.
The mucosal patchiness of villous atrophy was then defined as a variation in Vh:Cd ratio between biopsies from the same patient that was greater than two standard deviations of the Vh:Cd variations of the study population (mean of Vh:Cd, 2.13; standard deviation, 0.67).
Of the 1,125 patients who had at least five crypts that were measured from all four biopsies, 45% met the criteria for histological patchiness of mucosal healing in the small intestine. The authors found that several factors, including a younger age at diagnosis, female gender, and a higher average Vh:Cd ratio, were positively associated with mucosal patchiness.
However, there were no significant associations observed between mucosal patchiness and the duration of a gluten-free diet or of any gastrointestinal symptoms.
When the analysis was restricted to the population with a Vh:Cd no greater than 2, Dr. Choung and his colleagues found that human leukocyte antigen typing and tissue transglutaminase–immunoglobulin A did not predict mucosal patchiness. However, patients who were positive for deamidated gliadin peptide–IgA or deamidated gliadin peptide–IgG were less likely to exhibit patchiness but had more uniform intestinal injury (odds ratio, 0.4 and 0.4, respectively).
Digestive Disease Week is jointly sponsored by the American Association for the Study of Liver Diseases (AASLD), the American Gastroenterological Association (AGA) Institute, the American Society for Gastrointestinal Endoscopy (ASGE) and the Society for Surgery of the Alimentary Tract (SSAT). Dr. Choung declared no relevant disclosures.
AT DDW
Key clinical point:
Major finding: Patients positive for DGP-IgA or DGP-IgG were less likely to exhibit patchiness but had more uniform intestinal injury (odds ratio, 0.4 and 0.4, respectively).
Data source: 1,352 patients with celiac disease who had been on a gluten-free diet for at least 1 year and who had undergone four biopsies from the distal duodenum.
Disclosures: Dr. Choung declared no relevant disclosures.
Waiving screening copayments could cut colorectal cancer deaths
CHICAGO – Out-of-pocket costs may present a barrier to colorectal screening, and removing those costs could reduce colorectal cancer deaths, according to new data presented at the annual Digestive Disease Week.
These data imply that removing copayments could result in a 16% decrease in colorectal cancer–related deaths among Medicare beneficiaries, explained lead author Elisabeth Peterse, PhD, of the department of public health, Erasmus Medical Center, Rotterdam, the Netherlands.
The research also demonstrated that waiving copayments is cost effective, she added.
Despite the effectiveness of colorectal cancer screening, only 58% of eligible individuals adhere to current screening recommendations, Dr. Peterse noted. Financial barriers may play a role in the lack of adherence, as studies have found that removing out-of-pocket costs is one of the most effective interventions for increasing screening.
“But despite the fact that the Affordable Care Act has been successful in partially eliminating cost sharing for colorectal screening, Medicare beneficiaries may still face unexpected out-of-pocket liabilities,” said Dr. Peterse.
Out-of-pocket costs can be complicated, given that they can depend largely on how a procedure is coded. A screening colonoscopy or fecal immunochemical test (FIT) is completely covered if it is coded as a screening test, but follow-up colonoscopies come with 20% copayments.
A screening colonoscopy with polypectomy and a follow-up colonoscopy that is done after a positive fecal immunochemical test are coded as diagnostic rather than screening, so the patient has out-of-pocket costs, she explained.
To explore how waiving the cost of screening could impact colorectal cancer–related mortality and cost effectiveness, the researchers conducted an analysis using a microsimulation model for a cohort composed of 65-year-old individuals.
In the simulation, they estimated colorectal cancer–related mortality, quality-adjusted life-years, and total cost of screening and treatment using the current Medicare copayment schedule. These were then compared with outcomes for alternative situations.
The study was conducted in two parts, explained Dr. Peterse. In the first part, the researchers looked at five scenarios: one in which the 20% copayment was intact. In the second, the copayment was waived without having any impact on adherence. In the third, the investigators looked at a 5% increase in adherence but only at diagnostic follow-up.
In the fourth and fifth scenarios, the investigators looked at 5% and 10% increases in adherence, in both first screening and diagnostic follow-up, she added.
In the study’s second part, the researchers also estimated the threshold increase in participation at which copayment removal would be cost effective, using a $50,000 willingness-to-pay threshold.
They found that without screening, the expected mortality would be 25 colorectal deaths per 1,000 people in a population of 65-year-old individuals. With screening, the number was reduced to 12.8 deaths per 1,000 65-year-olds for colonoscopy, and 14.9 deaths per 1,000 for FIT screening. The total associated costs for screening and treatment for the two modalities were $3.02 million and $2.87 million.
If waiving the copayments had no impact in increasing screening levels, the cost of screening was estimated to increase to $3.1 million (2.8% increase) for colonoscopy and $2.9 million (1.6% increase) for FIT.
But if copayments were removed and there were a 5% increase in adherence, colorectal cancer deaths were estimated to decline to 11.7 (–8.3%) and 13.9 (–6.3%) per 1,000 for colonoscopy and FIT, respectively. That would result in cost-effectiveness ratios of $19,288 and $7,894 for no copayment versus having a copayment. Increasing adherence to 10% would result in an even lower ratio, noted Dr. Peterse.
The threshold increase for participating in screening programs – the point where removing a copayment becomes cost effective – was a 1.8% increase in colonoscopy screening and a 0.8% increase for FIT.
The conclusion is that waiving copayments is cost effective, Dr. Peterse said.
Dr. Peterse added that a limitation to the analysis is that the study authors don’t know to what extent patients are even aware of the copayments. “So, we don’t know if it is a barrier, and we didn’t take other insurance scenarios into account,” she said.
Dr. Peterse declared no relevant disclosures.
CHICAGO – Out-of-pocket costs may present a barrier to colorectal screening, and removing those costs could reduce colorectal cancer deaths, according to new data presented at the annual Digestive Disease Week.
These data imply that removing copayments could result in a 16% decrease in colorectal cancer–related deaths among Medicare beneficiaries, explained lead author Elisabeth Peterse, PhD, of the department of public health, Erasmus Medical Center, Rotterdam, the Netherlands.
The research also demonstrated that waiving copayments is cost effective, she added.
Despite the effectiveness of colorectal cancer screening, only 58% of eligible individuals adhere to current screening recommendations, Dr. Peterse noted. Financial barriers may play a role in the lack of adherence, as studies have found that removing out-of-pocket costs is one of the most effective interventions for increasing screening.
“But despite the fact that the Affordable Care Act has been successful in partially eliminating cost sharing for colorectal screening, Medicare beneficiaries may still face unexpected out-of-pocket liabilities,” said Dr. Peterse.
Out-of-pocket costs can be complicated, given that they can depend largely on how a procedure is coded. A screening colonoscopy or fecal immunochemical test (FIT) is completely covered if it is coded as a screening test, but follow-up colonoscopies come with 20% copayments.
A screening colonoscopy with polypectomy and a follow-up colonoscopy that is done after a positive fecal immunochemical test are coded as diagnostic rather than screening, so the patient has out-of-pocket costs, she explained.
To explore how waiving the cost of screening could impact colorectal cancer–related mortality and cost effectiveness, the researchers conducted an analysis using a microsimulation model for a cohort composed of 65-year-old individuals.
In the simulation, they estimated colorectal cancer–related mortality, quality-adjusted life-years, and total cost of screening and treatment using the current Medicare copayment schedule. These were then compared with outcomes for alternative situations.
The study was conducted in two parts, explained Dr. Peterse. In the first part, the researchers looked at five scenarios: one in which the 20% copayment was intact. In the second, the copayment was waived without having any impact on adherence. In the third, the investigators looked at a 5% increase in adherence but only at diagnostic follow-up.
In the fourth and fifth scenarios, the investigators looked at 5% and 10% increases in adherence, in both first screening and diagnostic follow-up, she added.
In the study’s second part, the researchers also estimated the threshold increase in participation at which copayment removal would be cost effective, using a $50,000 willingness-to-pay threshold.
They found that without screening, the expected mortality would be 25 colorectal deaths per 1,000 people in a population of 65-year-old individuals. With screening, the number was reduced to 12.8 deaths per 1,000 65-year-olds for colonoscopy, and 14.9 deaths per 1,000 for FIT screening. The total associated costs for screening and treatment for the two modalities were $3.02 million and $2.87 million.
If waiving the copayments had no impact in increasing screening levels, the cost of screening was estimated to increase to $3.1 million (2.8% increase) for colonoscopy and $2.9 million (1.6% increase) for FIT.
But if copayments were removed and there were a 5% increase in adherence, colorectal cancer deaths were estimated to decline to 11.7 (–8.3%) and 13.9 (–6.3%) per 1,000 for colonoscopy and FIT, respectively. That would result in cost-effectiveness ratios of $19,288 and $7,894 for no copayment versus having a copayment. Increasing adherence to 10% would result in an even lower ratio, noted Dr. Peterse.
The threshold increase for participating in screening programs – the point where removing a copayment becomes cost effective – was a 1.8% increase in colonoscopy screening and a 0.8% increase for FIT.
The conclusion is that waiving copayments is cost effective, Dr. Peterse said.
Dr. Peterse added that a limitation to the analysis is that the study authors don’t know to what extent patients are even aware of the copayments. “So, we don’t know if it is a barrier, and we didn’t take other insurance scenarios into account,” she said.
Dr. Peterse declared no relevant disclosures.
CHICAGO – Out-of-pocket costs may present a barrier to colorectal screening, and removing those costs could reduce colorectal cancer deaths, according to new data presented at the annual Digestive Disease Week.
These data imply that removing copayments could result in a 16% decrease in colorectal cancer–related deaths among Medicare beneficiaries, explained lead author Elisabeth Peterse, PhD, of the department of public health, Erasmus Medical Center, Rotterdam, the Netherlands.
The research also demonstrated that waiving copayments is cost effective, she added.
Despite the effectiveness of colorectal cancer screening, only 58% of eligible individuals adhere to current screening recommendations, Dr. Peterse noted. Financial barriers may play a role in the lack of adherence, as studies have found that removing out-of-pocket costs is one of the most effective interventions for increasing screening.
“But despite the fact that the Affordable Care Act has been successful in partially eliminating cost sharing for colorectal screening, Medicare beneficiaries may still face unexpected out-of-pocket liabilities,” said Dr. Peterse.
Out-of-pocket costs can be complicated, given that they can depend largely on how a procedure is coded. A screening colonoscopy or fecal immunochemical test (FIT) is completely covered if it is coded as a screening test, but follow-up colonoscopies come with 20% copayments.
A screening colonoscopy with polypectomy and a follow-up colonoscopy that is done after a positive fecal immunochemical test are coded as diagnostic rather than screening, so the patient has out-of-pocket costs, she explained.
To explore how waiving the cost of screening could impact colorectal cancer–related mortality and cost effectiveness, the researchers conducted an analysis using a microsimulation model for a cohort composed of 65-year-old individuals.
In the simulation, they estimated colorectal cancer–related mortality, quality-adjusted life-years, and total cost of screening and treatment using the current Medicare copayment schedule. These were then compared with outcomes for alternative situations.
The study was conducted in two parts, explained Dr. Peterse. In the first part, the researchers looked at five scenarios: one in which the 20% copayment was intact. In the second, the copayment was waived without having any impact on adherence. In the third, the investigators looked at a 5% increase in adherence but only at diagnostic follow-up.
In the fourth and fifth scenarios, the investigators looked at 5% and 10% increases in adherence, in both first screening and diagnostic follow-up, she added.
In the study’s second part, the researchers also estimated the threshold increase in participation at which copayment removal would be cost effective, using a $50,000 willingness-to-pay threshold.
They found that without screening, the expected mortality would be 25 colorectal deaths per 1,000 people in a population of 65-year-old individuals. With screening, the number was reduced to 12.8 deaths per 1,000 65-year-olds for colonoscopy, and 14.9 deaths per 1,000 for FIT screening. The total associated costs for screening and treatment for the two modalities were $3.02 million and $2.87 million.
If waiving the copayments had no impact in increasing screening levels, the cost of screening was estimated to increase to $3.1 million (2.8% increase) for colonoscopy and $2.9 million (1.6% increase) for FIT.
But if copayments were removed and there were a 5% increase in adherence, colorectal cancer deaths were estimated to decline to 11.7 (–8.3%) and 13.9 (–6.3%) per 1,000 for colonoscopy and FIT, respectively. That would result in cost-effectiveness ratios of $19,288 and $7,894 for no copayment versus having a copayment. Increasing adherence to 10% would result in an even lower ratio, noted Dr. Peterse.
The threshold increase for participating in screening programs – the point where removing a copayment becomes cost effective – was a 1.8% increase in colonoscopy screening and a 0.8% increase for FIT.
The conclusion is that waiving copayments is cost effective, Dr. Peterse said.
Dr. Peterse added that a limitation to the analysis is that the study authors don’t know to what extent patients are even aware of the copayments. “So, we don’t know if it is a barrier, and we didn’t take other insurance scenarios into account,” she said.
Dr. Peterse declared no relevant disclosures.
AT DDW
Key clinical point:
Major finding: Removing copayments for routine screening could reduce deaths from colorectal cancer by up to 16% in Medicare beneficiaries.
Data source: A simulation model that looked at five scenarios to assess how increased adherence to colorectal cancer screening would reduce mortality and cost.
Disclosures: Dr. Peterse declared no relevant disclosures.
Infliximab biosimilar noninferior to originator in IBD – NOR-SWITCH
CHICAGO – The biosimilar infliximab CT-P13 is not inferior to the originator infliximab in terms of efficacy, safety, and immunogenicity in the treatment of inflammatory bowel disease (IBD), a phase IV randomized trial showed.
Patient outcomes were not compromised with the use of the biosimilar, and the cost of treatment was much lower, said lead author Kristin K. Jørgensen, MD, PhD, at Digestive Disease Week®.
“Biologics represent a substantial source of IBD expenditure,” said Dr. Jørgensen of Akershus University Hospital, Lørenskog, Norway. “The medication is expensive, patients are treated on a long-term basis, and the incidence of IBD is increasing.”
Biosimilars are biotherapeutic products that are similar in terms of quality, safety, and efficacy to the already licensed reference biologic product. “Use of biosimilars can potentially dramatically decrease costs and may lead to better patient care,” said Dr. Jørgensen. “The patient gets increased access to biologic therapy, and it is easier to intensify dosing if indicated.”
Tumor necrosis factor–inhibitors are commonly used to treat Crohn’s disease, ulcerative colitis, spondyloarthritis, rheumatoid arthritis, psoriatic arthritis, and chronic plaque psoriasis, and, while they have altered the treatment paradigm, they are expensive products.
The goal of the NOR-SWITCH was to evaluate switching from originator infliximab to CT-P13, in terms of efficacy, safety, and immunogenicity.
Dr. Jørgensen and her colleagues conducted a randomized phase IV trial that enrolled 482 patients who were randomly assigned to either infliximab originator (n = 241) or CT-P13 (n = 241). The primary endpoint was disease worsening during follow-up.
Of the group, 155 patients (32%) had Crohn’s disease, 93 (19%) had ulcerative colitis, 91 (19%) had spondyloarthritis, 77 (16%) had rheumatoid arthritis, 30 (6%) had psoriatic arthritis, and 35 (7%) had chronic plaque psoriasis.
Disease worsening occurred at a similar rate in both groups. In the infliximab originator group, 53 patients (26%) experienced a worsening of their symptoms, compared with 61 patients (30%) in the CT-P13 group. The 95% confidence interval of the adjusted risk difference (−4.4%) was −12.7% to 3.9%, which fell within the prespecified noninferiority margin of 15%.
Therefore, the findings demonstrated that CT-P13 is not inferior to infliximab originator, and the adjusted relative risk of disease worsening for CT-P13 patients was 1.17 (95% CI, 0.82-1.52), compared with the infliximab originator group.
An almost equal number of patients achieved disease remission, 123 patients (61%) in the infliximab originator group and 126 patients (61%) in the CT-P13 group, and the adjusted rate difference was 0.6% (95% CI, –7.5%-8.8%; per-protocol set).
An explorative subgroup analysis that looked at patients with Crohn’s disease and ulcerative colitis showed similar findings between patients treated with either agent.
“Our results support switching from the originator to a biosimilar for nonmedical reasons,” concluded Dr. Jørgensen.
However, she urged caution in generalizing these findings to other biologic agents.
The study was funded by the Norwegian Ministry of Health and Care Services. Dr. Jorgensen reported receiving personal fees from Tillotts, Intercept, and Celltrion. Several coauthors also reported relationships with industry.
Digestive Disease Week® is jointly sponsored by the American Association for the Study of Liver Diseases (AASLD), the American Gastroenterological Association (AGA) Institute, the American Society for Gastrointestinal Endoscopy (ASGE), and the Society for Surgery of the Alimentary Tract (SSAT).
CHICAGO – The biosimilar infliximab CT-P13 is not inferior to the originator infliximab in terms of efficacy, safety, and immunogenicity in the treatment of inflammatory bowel disease (IBD), a phase IV randomized trial showed.
Patient outcomes were not compromised with the use of the biosimilar, and the cost of treatment was much lower, said lead author Kristin K. Jørgensen, MD, PhD, at Digestive Disease Week®.
“Biologics represent a substantial source of IBD expenditure,” said Dr. Jørgensen of Akershus University Hospital, Lørenskog, Norway. “The medication is expensive, patients are treated on a long-term basis, and the incidence of IBD is increasing.”
Biosimilars are biotherapeutic products that are similar in terms of quality, safety, and efficacy to the already licensed reference biologic product. “Use of biosimilars can potentially dramatically decrease costs and may lead to better patient care,” said Dr. Jørgensen. “The patient gets increased access to biologic therapy, and it is easier to intensify dosing if indicated.”
Tumor necrosis factor–inhibitors are commonly used to treat Crohn’s disease, ulcerative colitis, spondyloarthritis, rheumatoid arthritis, psoriatic arthritis, and chronic plaque psoriasis, and, while they have altered the treatment paradigm, they are expensive products.
The goal of the NOR-SWITCH was to evaluate switching from originator infliximab to CT-P13, in terms of efficacy, safety, and immunogenicity.
Dr. Jørgensen and her colleagues conducted a randomized phase IV trial that enrolled 482 patients who were randomly assigned to either infliximab originator (n = 241) or CT-P13 (n = 241). The primary endpoint was disease worsening during follow-up.
Of the group, 155 patients (32%) had Crohn’s disease, 93 (19%) had ulcerative colitis, 91 (19%) had spondyloarthritis, 77 (16%) had rheumatoid arthritis, 30 (6%) had psoriatic arthritis, and 35 (7%) had chronic plaque psoriasis.
Disease worsening occurred at a similar rate in both groups. In the infliximab originator group, 53 patients (26%) experienced a worsening of their symptoms, compared with 61 patients (30%) in the CT-P13 group. The 95% confidence interval of the adjusted risk difference (−4.4%) was −12.7% to 3.9%, which fell within the prespecified noninferiority margin of 15%.
Therefore, the findings demonstrated that CT-P13 is not inferior to infliximab originator, and the adjusted relative risk of disease worsening for CT-P13 patients was 1.17 (95% CI, 0.82-1.52), compared with the infliximab originator group.
An almost equal number of patients achieved disease remission, 123 patients (61%) in the infliximab originator group and 126 patients (61%) in the CT-P13 group, and the adjusted rate difference was 0.6% (95% CI, –7.5%-8.8%; per-protocol set).
An explorative subgroup analysis that looked at patients with Crohn’s disease and ulcerative colitis showed similar findings between patients treated with either agent.
“Our results support switching from the originator to a biosimilar for nonmedical reasons,” concluded Dr. Jørgensen.
However, she urged caution in generalizing these findings to other biologic agents.
The study was funded by the Norwegian Ministry of Health and Care Services. Dr. Jorgensen reported receiving personal fees from Tillotts, Intercept, and Celltrion. Several coauthors also reported relationships with industry.
Digestive Disease Week® is jointly sponsored by the American Association for the Study of Liver Diseases (AASLD), the American Gastroenterological Association (AGA) Institute, the American Society for Gastrointestinal Endoscopy (ASGE), and the Society for Surgery of the Alimentary Tract (SSAT).
CHICAGO – The biosimilar infliximab CT-P13 is not inferior to the originator infliximab in terms of efficacy, safety, and immunogenicity in the treatment of inflammatory bowel disease (IBD), a phase IV randomized trial showed.
Patient outcomes were not compromised with the use of the biosimilar, and the cost of treatment was much lower, said lead author Kristin K. Jørgensen, MD, PhD, at Digestive Disease Week®.
“Biologics represent a substantial source of IBD expenditure,” said Dr. Jørgensen of Akershus University Hospital, Lørenskog, Norway. “The medication is expensive, patients are treated on a long-term basis, and the incidence of IBD is increasing.”
Biosimilars are biotherapeutic products that are similar in terms of quality, safety, and efficacy to the already licensed reference biologic product. “Use of biosimilars can potentially dramatically decrease costs and may lead to better patient care,” said Dr. Jørgensen. “The patient gets increased access to biologic therapy, and it is easier to intensify dosing if indicated.”
Tumor necrosis factor–inhibitors are commonly used to treat Crohn’s disease, ulcerative colitis, spondyloarthritis, rheumatoid arthritis, psoriatic arthritis, and chronic plaque psoriasis, and, while they have altered the treatment paradigm, they are expensive products.
The goal of the NOR-SWITCH was to evaluate switching from originator infliximab to CT-P13, in terms of efficacy, safety, and immunogenicity.
Dr. Jørgensen and her colleagues conducted a randomized phase IV trial that enrolled 482 patients who were randomly assigned to either infliximab originator (n = 241) or CT-P13 (n = 241). The primary endpoint was disease worsening during follow-up.
Of the group, 155 patients (32%) had Crohn’s disease, 93 (19%) had ulcerative colitis, 91 (19%) had spondyloarthritis, 77 (16%) had rheumatoid arthritis, 30 (6%) had psoriatic arthritis, and 35 (7%) had chronic plaque psoriasis.
Disease worsening occurred at a similar rate in both groups. In the infliximab originator group, 53 patients (26%) experienced a worsening of their symptoms, compared with 61 patients (30%) in the CT-P13 group. The 95% confidence interval of the adjusted risk difference (−4.4%) was −12.7% to 3.9%, which fell within the prespecified noninferiority margin of 15%.
Therefore, the findings demonstrated that CT-P13 is not inferior to infliximab originator, and the adjusted relative risk of disease worsening for CT-P13 patients was 1.17 (95% CI, 0.82-1.52), compared with the infliximab originator group.
An almost equal number of patients achieved disease remission, 123 patients (61%) in the infliximab originator group and 126 patients (61%) in the CT-P13 group, and the adjusted rate difference was 0.6% (95% CI, –7.5%-8.8%; per-protocol set).
An explorative subgroup analysis that looked at patients with Crohn’s disease and ulcerative colitis showed similar findings between patients treated with either agent.
“Our results support switching from the originator to a biosimilar for nonmedical reasons,” concluded Dr. Jørgensen.
However, she urged caution in generalizing these findings to other biologic agents.
The study was funded by the Norwegian Ministry of Health and Care Services. Dr. Jorgensen reported receiving personal fees from Tillotts, Intercept, and Celltrion. Several coauthors also reported relationships with industry.
Digestive Disease Week® is jointly sponsored by the American Association for the Study of Liver Diseases (AASLD), the American Gastroenterological Association (AGA) Institute, the American Society for Gastrointestinal Endoscopy (ASGE), and the Society for Surgery of the Alimentary Tract (SSAT).
AT DDW
Key clinical point: An infliximab biosimilar was not inferior to the originator in terms of efficacy, safety, and immunogenicity in the treatment of inflammatory bowel disease (IBD).
Major finding: In the infliximab originator group, 53 patients (26%) experienced disease worsening, vs. 61 patients (30%) in the CT-P13 group, which fell within the prespecified noninferiority margin of 15%.
Data source: A phase IV randomized trial that included 482 patients with inflammatory bowel disease.
Disclosures: The study was funded by the Norwegian Ministry of Health and Care Services. Dr. Jorgensen reported receiving personal fees from Tillotts, Intercept, and Celltrion. Several coauthors also reported relationships with industry.