Post by icemandios on Jan 12, 2022 16:22:22 GMT
Exclusive: Biogen president fears CMS will finalize restrictive coverage decision for Aduhelm, preps plans to flood NCD with comments
Zachary Brennan
Senior Editor
While lamenting yesterday’s proposed national coverage decision for its controversial Alzheimer’s drug, Biogen’s US president Alisha Alaimo pledged to flood CMS with comments over the next 30 days in an attempt to ensure the final version does not reflect Tuesday’s draft, according to an internal email reviewed by Endpoints News.
“We were prepared for the range of scenarios. Unfortunately, this is one of the most restrictive options CMS could have chosen,” Alaimo said in an email to staff on Wednesday. “If this draft becomes final in April, it will significantly limit Medicare reimbursement for Aduhelm and future therapies in this class.”
The draft decision from yesterday, dubbed a “strong rebuke” of FDA’s accelerated approval of Aduhelm last June based on flimsy efficacy data, showed how CMS can deflate a company’s potential mega-blockbuster by only paying for additional clinical trials, with specific restrictions that Biogen and other companies developing anti-amyloid drugs will have to meet.
While praising the reaction from patient groups, which included the Alzheimer’s Association calling the draft decision “shocking discrimination against everyone with Alzheimer’s disease,” Alaimo said Biogen is “activating a comprehensive plan to educate HCPs, patient advocates and other stakeholders,” in order to “encourage submissions to CMS’ 30-day open comment period.”
That could be key for Biogen to drive home the point to CMS that its decision should be altered between the draft and final versions.
Alaimo attempted to stress that history has shown that the final version of an NCD “can significantly change from the draft,” noting that CAR-T therapies also received a more restrictive coverage with evidence development draft NCD in 2019, requiring CMS-approved clinical trials, but “after significant public feedback, the class was granted broader access (coverage with restrictions) by Medicare.”
Experts, however, have said that the CAR-T NCD might not be an apples-to-apples comparison for Biogen, as CAR-T therapies have been proven in clinical trials to be both safe and effective in treating certain forms of cancer, and as the comments for CAR-T were generally much more supportive of coverage than those for amyloid-directed drugs.
Rachel Sachs, a law professor at Washington University in St. Louis, told Endpoints that Biogen’s internal comment “largely doesn’t disagree with the NCD on the merits. It doesn’t say that the NCD was in fact wrong to say that existing trials have not demonstrated meaningful improvements in health outcomes. So it’s hard to see how their comments would be responsive to the substance of the NCD itself.”
Zachary Brennan
Senior Editor
While lamenting yesterday’s proposed national coverage decision for its controversial Alzheimer’s drug, Biogen’s US president Alisha Alaimo pledged to flood CMS with comments over the next 30 days in an attempt to ensure the final version does not reflect Tuesday’s draft, according to an internal email reviewed by Endpoints News.
“We were prepared for the range of scenarios. Unfortunately, this is one of the most restrictive options CMS could have chosen,” Alaimo said in an email to staff on Wednesday. “If this draft becomes final in April, it will significantly limit Medicare reimbursement for Aduhelm and future therapies in this class.”
The draft decision from yesterday, dubbed a “strong rebuke” of FDA’s accelerated approval of Aduhelm last June based on flimsy efficacy data, showed how CMS can deflate a company’s potential mega-blockbuster by only paying for additional clinical trials, with specific restrictions that Biogen and other companies developing anti-amyloid drugs will have to meet.
While praising the reaction from patient groups, which included the Alzheimer’s Association calling the draft decision “shocking discrimination against everyone with Alzheimer’s disease,” Alaimo said Biogen is “activating a comprehensive plan to educate HCPs, patient advocates and other stakeholders,” in order to “encourage submissions to CMS’ 30-day open comment period.”
That could be key for Biogen to drive home the point to CMS that its decision should be altered between the draft and final versions.
Alaimo attempted to stress that history has shown that the final version of an NCD “can significantly change from the draft,” noting that CAR-T therapies also received a more restrictive coverage with evidence development draft NCD in 2019, requiring CMS-approved clinical trials, but “after significant public feedback, the class was granted broader access (coverage with restrictions) by Medicare.”
Experts, however, have said that the CAR-T NCD might not be an apples-to-apples comparison for Biogen, as CAR-T therapies have been proven in clinical trials to be both safe and effective in treating certain forms of cancer, and as the comments for CAR-T were generally much more supportive of coverage than those for amyloid-directed drugs.
Rachel Sachs, a law professor at Washington University in St. Louis, told Endpoints that Biogen’s internal comment “largely doesn’t disagree with the NCD on the merits. It doesn’t say that the NCD was in fact wrong to say that existing trials have not demonstrated meaningful improvements in health outcomes. So it’s hard to see how their comments would be responsive to the substance of the NCD itself.”
