Post by icemandios on Sept 29, 2021 18:46:11 GMT
Major Massachusetts hospitals decide against using Biogen's Aduhelm, with the help of a former FDA adcomm member
Zachary Brennan
Senior Editor
Harvard’s Brigham and Women’s Hospital, Massachusetts General Hospital and other affiliated hospitals with Mass General Brigham, the state’s largest health care provider, have decided to not administer Biogen’s new controversial Alzheimer’s drug Aduhelm, serving up another blow to the drug’s lackluster launch.
Mass General Brigham came to its decision on the local company’s drug after an extensive review of its benefits and risks with the help of experts like Aaron Kesselheim, a Harvard professor and physician who was the third member to resign from the FDA advisory committee after FDA signed off on aducanumab even as the adcomm unanimously called on FDA not to approve it.
Kesselheim told Endpoints News via email, “Their detailed process included compiling a thorough evaluation of the available clinical and economic data, soliciting the opinions of professionals at the various different sites (BWH and MGH as well as other affiliates) with expertise in neurology, psychiatry, internal medicine, and pharmacy (which of course includes national leaders in AD), and then holding a meeting with presentations about the drug and in which the P&T committee members could ask questions of myself and other MGB experts.”
The move to not cover Aduhelm follows similar decisions from the US Department of Veterans Affairs, the Cleveland Clinic, and Mount Sinai Health System in New York, and as multiple federal investigations are looking into Aduhelm’s approval, its $56,000 price tag and the FDA’s cozy relationship with Biogen. HHS’ Inspector General is working on its probe, as is the FDA, which is conducting an internal probe. CMS is also working on a national coverage determination that could set the stage for more coverage.
But Kesselheim said he didn’t think MGB’s decision would change if CMS covers the drug, noting, “whether or not other institutions or payers covered the drug was not to my understanding a major factor in the decision.”
MGB added in a statement, “We understand that this may be difficult news for some of our patients. However, we fully support continued evaluation of this medication and should new data become available we will re-evaluate this decision.”
Zachary Brennan
Senior Editor
Harvard’s Brigham and Women’s Hospital, Massachusetts General Hospital and other affiliated hospitals with Mass General Brigham, the state’s largest health care provider, have decided to not administer Biogen’s new controversial Alzheimer’s drug Aduhelm, serving up another blow to the drug’s lackluster launch.
Mass General Brigham came to its decision on the local company’s drug after an extensive review of its benefits and risks with the help of experts like Aaron Kesselheim, a Harvard professor and physician who was the third member to resign from the FDA advisory committee after FDA signed off on aducanumab even as the adcomm unanimously called on FDA not to approve it.
Kesselheim told Endpoints News via email, “Their detailed process included compiling a thorough evaluation of the available clinical and economic data, soliciting the opinions of professionals at the various different sites (BWH and MGH as well as other affiliates) with expertise in neurology, psychiatry, internal medicine, and pharmacy (which of course includes national leaders in AD), and then holding a meeting with presentations about the drug and in which the P&T committee members could ask questions of myself and other MGB experts.”
The move to not cover Aduhelm follows similar decisions from the US Department of Veterans Affairs, the Cleveland Clinic, and Mount Sinai Health System in New York, and as multiple federal investigations are looking into Aduhelm’s approval, its $56,000 price tag and the FDA’s cozy relationship with Biogen. HHS’ Inspector General is working on its probe, as is the FDA, which is conducting an internal probe. CMS is also working on a national coverage determination that could set the stage for more coverage.
But Kesselheim said he didn’t think MGB’s decision would change if CMS covers the drug, noting, “whether or not other institutions or payers covered the drug was not to my understanding a major factor in the decision.”
MGB added in a statement, “We understand that this may be difficult news for some of our patients. However, we fully support continued evaluation of this medication and should new data become available we will re-evaluate this decision.”
