Brooke McManus

Hospitals participating in the Hospital Quality Incentive Demonstration value-based purchasing project funded by the Centers for Medicare and Medicaid Services raised their overall quality by 17% over 4 years, the agency reported.

The program, launched in 2003 by the CMS and Premier Inc., an alliance of not-for-profit hospitals and health care systems, is designed to test Medicare payment incentives. The goal is to determine if the incentives will improve the safety, quality, and efficiency of inpatient treatment of acute myocardial infarction, coronary artery bypass graft (CABG), heart failure, pneumonia, and hip and knee replacement. The CMS awarded $12 million in year 4 to 225 hospitals. The program determines average composite quality scores for the five areas using more than 30 evidence-based clinical quality measures developed by the Joint Commission and other groups.

In year 4, the mean score had improved most for heart failure patients and pneumonia patients. The heart failure score rose from 64.5% to 92.2%, based on measures that included evaluation of left ventricular systolic function and smoking cessation counseling. The score for pneumonia rose from 69.3% to 92.6%, with measures including appropriate initial antibiotic selection and influenza vaccination.

Hip and knee replacement scores rose from 84.6% to 97.2%, based on measures such as the use of prophylactic antibiotics and the 30-day rerate. For MI patients, the average scores improved from 87.5% to 96.3%, with measures for reporting including administration of aspirin and beta-blockers on arrival, and primary percutaneous coronary intervention within 90 minutes of arrival. According to Premier, the performance improvement saved the lives of an estimated 4,700 MI patients over 4 years.

The average score for CABG patients was up from 84.8% to 98.5%, based on measures that included the use of aspirin at discharge and inpatient mortality.

The shift to paying for health care based on performance rather than volume is often cited as a primary goal of health reform. The reform bills that have surfaced so far this year do not provide much detail on how programs like HQID could be expanded beyond the demonstration phase, although there has been attention to the processes for selecting and validating new quality measures.

Brooke McManus is a reporter for The Gray Sheet. This newspaper and The Gray Sheet are published by Elsevier.

Hospitals participating in the Hospital Quality Incentive Demonstration value-based purchasing project funded by the Centers for Medicare and Medicaid Services raised their overall quality by 17% over 4 years, the agency reported.

The program, launched in 2003 by the CMS and Premier Inc., an alliance of not-for-profit hospitals and health care systems, is designed to test Medicare payment incentives. The goal is to determine if the incentives will improve the safety, quality, and efficiency of inpatient treatment of acute myocardial infarction, coronary artery bypass graft (CABG), heart failure, pneumonia, and hip and knee replacement. The CMS awarded $12 million in year 4 to 225 hospitals. The program determines average composite quality scores for the five areas using more than 30 evidence-based clinical quality measures developed by the Joint Commission and other groups.

In year 4, the mean score had improved most for heart failure patients and pneumonia patients. The heart failure score rose from 64.5% to 92.2%, based on measures that included evaluation of left ventricular systolic function and smoking cessation counseling. The score for pneumonia rose from 69.3% to 92.6%, with measures including appropriate initial antibiotic selection and influenza vaccination.

Hip and knee replacement scores rose from 84.6% to 97.2%, based on measures such as the use of prophylactic antibiotics and the 30-day rerate. For MI patients, the average scores improved from 87.5% to 96.3%, with measures for reporting including administration of aspirin and beta-blockers on arrival, and primary percutaneous coronary intervention within 90 minutes of arrival. According to Premier, the performance improvement saved the lives of an estimated 4,700 MI patients over 4 years.

The average score for CABG patients was up from 84.8% to 98.5%, based on measures that included the use of aspirin at discharge and inpatient mortality.

The shift to paying for health care based on performance rather than volume is often cited as a primary goal of health reform. The reform bills that have surfaced so far this year do not provide much detail on how programs like HQID could be expanded beyond the demonstration phase, although there has been attention to the processes for selecting and validating new quality measures.

Brooke McManus is a reporter for The Gray Sheet. This newspaper and The Gray Sheet are published by Elsevier.

Hospitals participating in the Hospital Quality Incentive Demonstration value-based purchasing project funded by the Centers for Medicare and Medicaid Services raised their overall quality by 17% over 4 years, the agency reported.

The program, launched in 2003 by the CMS and Premier Inc., an alliance of not-for-profit hospitals and health care systems, is designed to test Medicare payment incentives. The goal is to determine if the incentives will improve the safety, quality, and efficiency of inpatient treatment of acute myocardial infarction, coronary artery bypass graft (CABG), heart failure, pneumonia, and hip and knee replacement. The CMS awarded $12 million in year 4 to 225 hospitals. The program determines average composite quality scores for the five areas using more than 30 evidence-based clinical quality measures developed by the Joint Commission and other groups.

In year 4, the mean score had improved most for heart failure patients and pneumonia patients. The heart failure score rose from 64.5% to 92.2%, based on measures that included evaluation of left ventricular systolic function and smoking cessation counseling. The score for pneumonia rose from 69.3% to 92.6%, with measures including appropriate initial antibiotic selection and influenza vaccination.

Hip and knee replacement scores rose from 84.6% to 97.2%, based on measures such as the use of prophylactic antibiotics and the 30-day rerate. For MI patients, the average scores improved from 87.5% to 96.3%, with measures for reporting including administration of aspirin and beta-blockers on arrival, and primary percutaneous coronary intervention within 90 minutes of arrival. According to Premier, the performance improvement saved the lives of an estimated 4,700 MI patients over 4 years.

The average score for CABG patients was up from 84.8% to 98.5%, based on measures that included the use of aspirin at discharge and inpatient mortality.

The shift to paying for health care based on performance rather than volume is often cited as a primary goal of health reform. The reform bills that have surfaced so far this year do not provide much detail on how programs like HQID could be expanded beyond the demonstration phase, although there has been attention to the processes for selecting and validating new quality measures.

Brooke McManus is a reporter for The Gray Sheet. This newspaper and The Gray Sheet are published by Elsevier.

OB.GYN. NEWS and “The Pink Sheet” are published by Elsevier.

The Food and Drug Administration has issued a “not approvable” letter to Luitpold Pharmaceuticals for its ferric carboxymaltose injection (Injectafer), leaving the company to conduct additional clinical trials for the drug as first-line treatment of iron deficiency anemia in women with postpartum and heavy uterine bleeding.

The Daiichi Sankyo Co. subsidiary said in a statement on March 12 that the studies are needed to address safety issues with Injectafer, particularly a mortality signal that led the Drug Safety and Risk Management Advisory Committee to vote against its approval in February.

The panel concluded that studies conducted by Shirley, N.Y.-based Luitpold Pharmaceuticals Inc. showed that Injectafer was efficacious in replenishing iron and improving hemoglobin concentration, but the mortality data raised a red flag—10 deaths of patients who received the drug, 5 of whom had cardiac abnormalities.

A number of committee members advised that if the FDA chose to approve the product, the label should be limited to women for whom oral iron is not effective. Most of those voting in favor of approval said off-label use should be limited, especially in chronic kidney disease patients.

“While we are disappointed about this latest decision, we are committed to the further development of Injectafer and are working on new studies in support of our application and to address the FDA's concerns,” Mary Jane Helenek, Luitpold's president and CEO, said in the company release.

The not approvable letter is the second received by the company related to the mortality signal. Luitpold submitted a statistical assessment of mortality data, study reports for two additional studies, and responses to other FDA questions in September 2007.

The company said its application includes data from 12 multicenter trials including more than 3,000 patients.

OB.GYN. NEWS and “The Pink Sheet” are published by Elsevier.

The Food and Drug Administration has issued a “not approvable” letter to Luitpold Pharmaceuticals for its ferric carboxymaltose injection (Injectafer), leaving the company to conduct additional clinical trials for the drug as first-line treatment of iron deficiency anemia in women with postpartum and heavy uterine bleeding.

The Daiichi Sankyo Co. subsidiary said in a statement on March 12 that the studies are needed to address safety issues with Injectafer, particularly a mortality signal that led the Drug Safety and Risk Management Advisory Committee to vote against its approval in February.

The panel concluded that studies conducted by Shirley, N.Y.-based Luitpold Pharmaceuticals Inc. showed that Injectafer was efficacious in replenishing iron and improving hemoglobin concentration, but the mortality data raised a red flag—10 deaths of patients who received the drug, 5 of whom had cardiac abnormalities.

A number of committee members advised that if the FDA chose to approve the product, the label should be limited to women for whom oral iron is not effective. Most of those voting in favor of approval said off-label use should be limited, especially in chronic kidney disease patients.

“While we are disappointed about this latest decision, we are committed to the further development of Injectafer and are working on new studies in support of our application and to address the FDA's concerns,” Mary Jane Helenek, Luitpold's president and CEO, said in the company release.

The not approvable letter is the second received by the company related to the mortality signal. Luitpold submitted a statistical assessment of mortality data, study reports for two additional studies, and responses to other FDA questions in September 2007.

The company said its application includes data from 12 multicenter trials including more than 3,000 patients.

OB.GYN. NEWS and “The Pink Sheet” are published by Elsevier.

The Food and Drug Administration has issued a “not approvable” letter to Luitpold Pharmaceuticals for its ferric carboxymaltose injection (Injectafer), leaving the company to conduct additional clinical trials for the drug as first-line treatment of iron deficiency anemia in women with postpartum and heavy uterine bleeding.

The Daiichi Sankyo Co. subsidiary said in a statement on March 12 that the studies are needed to address safety issues with Injectafer, particularly a mortality signal that led the Drug Safety and Risk Management Advisory Committee to vote against its approval in February.

The panel concluded that studies conducted by Shirley, N.Y.-based Luitpold Pharmaceuticals Inc. showed that Injectafer was efficacious in replenishing iron and improving hemoglobin concentration, but the mortality data raised a red flag—10 deaths of patients who received the drug, 5 of whom had cardiac abnormalities.

A number of committee members advised that if the FDA chose to approve the product, the label should be limited to women for whom oral iron is not effective. Most of those voting in favor of approval said off-label use should be limited, especially in chronic kidney disease patients.

“While we are disappointed about this latest decision, we are committed to the further development of Injectafer and are working on new studies in support of our application and to address the FDA's concerns,” Mary Jane Helenek, Luitpold's president and CEO, said in the company release.

The not approvable letter is the second received by the company related to the mortality signal. Luitpold submitted a statistical assessment of mortality data, study reports for two additional studies, and responses to other FDA questions in September 2007.

The company said its application includes data from 12 multicenter trials including more than 3,000 patients.

The erectile dysfunction drug Cialis (tadalafil) has been approved by the Food and Drug Administration for once-daily use in 2.5-mg and 5-mg doses, the drug's manufacturer announced.

“This low-dose daily treatment option of Cialis may be most appropriate for men with ED who anticipate more frequent sexual activity,” according to a statement issued by Eli Lilly & Co. “For other men, Cialis taken as needed—the previously approved dosing regimen—may be most appropriate.”

Cialis was approved in 2003 in 5-mg, 10-mg, and 20-mg doses as the first and only phosphodiesterase type 5 inhibitor to provide sustained efficacy for up to 36 hours.

The approval of Cialis once daily is based on results from three phase III randomized, double-blind, placebo-controlled studies, which demonstrated that men with erectile dysfunction who took tadalafil 2.5 mg or 5 mg once daily without regard to their timing of sexual activity experienced improved erectile function, compared with placebo, the statement said.

The most commonly reported adverse events were headache, indigestion, back pain, muscle aches, nasal congestion, flushing, and pain in a limb. These side effects were transient.

FAMILY PRACTICE NEWS and “The Pink Sheet” are published by Elsevier.

The erectile dysfunction drug Cialis (tadalafil) has been approved by the Food and Drug Administration for once-daily use in 2.5-mg and 5-mg doses, the drug's manufacturer announced.

“This low-dose daily treatment option of Cialis may be most appropriate for men with ED who anticipate more frequent sexual activity,” according to a statement issued by Eli Lilly & Co. “For other men, Cialis taken as needed—the previously approved dosing regimen—may be most appropriate.”

Cialis was approved in 2003 in 5-mg, 10-mg, and 20-mg doses as the first and only phosphodiesterase type 5 inhibitor to provide sustained efficacy for up to 36 hours.

The approval of Cialis once daily is based on results from three phase III randomized, double-blind, placebo-controlled studies, which demonstrated that men with erectile dysfunction who took tadalafil 2.5 mg or 5 mg once daily without regard to their timing of sexual activity experienced improved erectile function, compared with placebo, the statement said.

The most commonly reported adverse events were headache, indigestion, back pain, muscle aches, nasal congestion, flushing, and pain in a limb. These side effects were transient.

FAMILY PRACTICE NEWS and “The Pink Sheet” are published by Elsevier.

The erectile dysfunction drug Cialis (tadalafil) has been approved by the Food and Drug Administration for once-daily use in 2.5-mg and 5-mg doses, the drug's manufacturer announced.

“This low-dose daily treatment option of Cialis may be most appropriate for men with ED who anticipate more frequent sexual activity,” according to a statement issued by Eli Lilly & Co. “For other men, Cialis taken as needed—the previously approved dosing regimen—may be most appropriate.”

Cialis was approved in 2003 in 5-mg, 10-mg, and 20-mg doses as the first and only phosphodiesterase type 5 inhibitor to provide sustained efficacy for up to 36 hours.

The approval of Cialis once daily is based on results from three phase III randomized, double-blind, placebo-controlled studies, which demonstrated that men with erectile dysfunction who took tadalafil 2.5 mg or 5 mg once daily without regard to their timing of sexual activity experienced improved erectile function, compared with placebo, the statement said.

The most commonly reported adverse events were headache, indigestion, back pain, muscle aches, nasal congestion, flushing, and pain in a limb. These side effects were transient.

FAMILY PRACTICE NEWS and “The Pink Sheet” are published by Elsevier.

Older type 2 diabetes treatments such as metformin, glipizide, and glimepiride provide the same benefits as newer drugs but at a lower cost, according to Consumer Reports Best Buy Drugs.

“The evidence shows that lower-cost, older medicines work just as well for most people,” Consumer Reports Best Buy Drugs Project Director Gail Shearer said in a statement.

The report is based primarily on an analysis of effectiveness, risks, and estimated costs of 10 diabetes drugs conducted by the Agency for Healthcare Research and Quality.

Metformin, glipizide, and glimepiride are identified as “best buy” drugs by Consumer Reports, which points out those products cost only $10 to $60 a month, less than half the cost of rosiglitazone (Avandia, $131-$262), pioglitazone (Actos, $142-$221), or sitagliptin (Januvia, approximately $200).

While Consumer Reports also lists glipizide and glimepiride as best buys, the report “recommends that most people newly diagnosed with diabetes talk to their doctor about taking metformin first.”

Similarly, an executive summary of the AHRQ report notes that “physicians and patients can feel comfortable using older medications such as metformin and second-generation sulfonylureas, as monotherapy or in combination, before newer diabetes medications such as thiazolidinediones or meglitinides, especially when cost is a factor.”

Metformin was found in the AHRQ analysis to be as effective as other medications but was not associated with weight gain. “Weight increased by 1–5 kg with most of the oral diabetes medications (thiazolidinediones, second-generation sulfonylureas, and repaglinide), but not for metformin and acarbose [Precose], which had no effect on weight in placebo-controlled trials,” according to AHRQ.

The AHRQ report, combined with the promotion of metformin by Consumer Reports, could spell trouble for the already maligned thiazolidinedione drug class.

Rosiglitazone in particular has been under scrutiny since a meta-analysis published in the New England Journal of Medicine found a statistically significant increase in the risk of myocardial infarction and an increase in the risk of death from cardiovascular cases in patients treated with the drug. The AHRQ review was completed prior to the release of the meta-analysis.

The drug's manufacturer, GlaxoSmithKline, also is looking at cardiovascular outcomes in the Rosiglitazone Evaluated for Cardiac Outcomes and Regulation of Glycemia in Diabetes trial. The company has reported that the Food and Drug Administration considers the interim results from RECORD to be promising and suggested that they may contradict the observed safety signal.

According to the AHRQ analysis, “these new studies substantiate our call for more vigorous postmarketing surveillance and long-term comparative assessments of major clinical outcomes.”

Brooke McManus is a staff writer for Elsevier's “The Pink Sheet.”

Older type 2 diabetes treatments such as metformin, glipizide, and glimepiride provide the same benefits as newer drugs but at a lower cost, according to Consumer Reports Best Buy Drugs.

“The evidence shows that lower-cost, older medicines work just as well for most people,” Consumer Reports Best Buy Drugs Project Director Gail Shearer said in a statement.

The report is based primarily on an analysis of effectiveness, risks, and estimated costs of 10 diabetes drugs conducted by the Agency for Healthcare Research and Quality.

Metformin, glipizide, and glimepiride are identified as “best buy” drugs by Consumer Reports, which points out those products cost only $10 to $60 a month, less than half the cost of rosiglitazone (Avandia, $131-$262), pioglitazone (Actos, $142-$221), or sitagliptin (Januvia, approximately $200).

While Consumer Reports also lists glipizide and glimepiride as best buys, the report “recommends that most people newly diagnosed with diabetes talk to their doctor about taking metformin first.”

Similarly, an executive summary of the AHRQ report notes that “physicians and patients can feel comfortable using older medications such as metformin and second-generation sulfonylureas, as monotherapy or in combination, before newer diabetes medications such as thiazolidinediones or meglitinides, especially when cost is a factor.”

Metformin was found in the AHRQ analysis to be as effective as other medications but was not associated with weight gain. “Weight increased by 1–5 kg with most of the oral diabetes medications (thiazolidinediones, second-generation sulfonylureas, and repaglinide), but not for metformin and acarbose [Precose], which had no effect on weight in placebo-controlled trials,” according to AHRQ.

The AHRQ report, combined with the promotion of metformin by Consumer Reports, could spell trouble for the already maligned thiazolidinedione drug class.

Rosiglitazone in particular has been under scrutiny since a meta-analysis published in the New England Journal of Medicine found a statistically significant increase in the risk of myocardial infarction and an increase in the risk of death from cardiovascular cases in patients treated with the drug. The AHRQ review was completed prior to the release of the meta-analysis.

The drug's manufacturer, GlaxoSmithKline, also is looking at cardiovascular outcomes in the Rosiglitazone Evaluated for Cardiac Outcomes and Regulation of Glycemia in Diabetes trial. The company has reported that the Food and Drug Administration considers the interim results from RECORD to be promising and suggested that they may contradict the observed safety signal.

According to the AHRQ analysis, “these new studies substantiate our call for more vigorous postmarketing surveillance and long-term comparative assessments of major clinical outcomes.”

Brooke McManus is a staff writer for Elsevier's “The Pink Sheet.”

Older type 2 diabetes treatments such as metformin, glipizide, and glimepiride provide the same benefits as newer drugs but at a lower cost, according to Consumer Reports Best Buy Drugs.

“The evidence shows that lower-cost, older medicines work just as well for most people,” Consumer Reports Best Buy Drugs Project Director Gail Shearer said in a statement.

The report is based primarily on an analysis of effectiveness, risks, and estimated costs of 10 diabetes drugs conducted by the Agency for Healthcare Research and Quality.

Metformin, glipizide, and glimepiride are identified as “best buy” drugs by Consumer Reports, which points out those products cost only $10 to $60 a month, less than half the cost of rosiglitazone (Avandia, $131-$262), pioglitazone (Actos, $142-$221), or sitagliptin (Januvia, approximately $200).

While Consumer Reports also lists glipizide and glimepiride as best buys, the report “recommends that most people newly diagnosed with diabetes talk to their doctor about taking metformin first.”

Similarly, an executive summary of the AHRQ report notes that “physicians and patients can feel comfortable using older medications such as metformin and second-generation sulfonylureas, as monotherapy or in combination, before newer diabetes medications such as thiazolidinediones or meglitinides, especially when cost is a factor.”

Metformin was found in the AHRQ analysis to be as effective as other medications but was not associated with weight gain. “Weight increased by 1–5 kg with most of the oral diabetes medications (thiazolidinediones, second-generation sulfonylureas, and repaglinide), but not for metformin and acarbose [Precose], which had no effect on weight in placebo-controlled trials,” according to AHRQ.

The AHRQ report, combined with the promotion of metformin by Consumer Reports, could spell trouble for the already maligned thiazolidinedione drug class.

Rosiglitazone in particular has been under scrutiny since a meta-analysis published in the New England Journal of Medicine found a statistically significant increase in the risk of myocardial infarction and an increase in the risk of death from cardiovascular cases in patients treated with the drug. The AHRQ review was completed prior to the release of the meta-analysis.

The drug's manufacturer, GlaxoSmithKline, also is looking at cardiovascular outcomes in the Rosiglitazone Evaluated for Cardiac Outcomes and Regulation of Glycemia in Diabetes trial. The company has reported that the Food and Drug Administration considers the interim results from RECORD to be promising and suggested that they may contradict the observed safety signal.

According to the AHRQ analysis, “these new studies substantiate our call for more vigorous postmarketing surveillance and long-term comparative assessments of major clinical outcomes.”

Brooke McManus is a staff writer for Elsevier's “The Pink Sheet.”