Biogen pushes for broad CMS coverage of Alzheimer's drug — while Eli Lilly looks to escape an NCD
The nine-month quest for CMS to figure out how (or how not) to cover Biogen’s new Alzheimer’s drug Aduhelm, and potentially more amyloid-targeted monoclonal antibodies, kicked off in earnest on Tuesday with an open public hearing of comments from various stakeholders stressing the pros and cons of covering this new, pricey drug with unknown clinical benefits.
Biogen and its affiliates stressed the need for a quick and positive National Coverage Determination from CMS as other physicians and a speaker from ICER called on CMS to not cover the drug or to limit coverage in certain ways as Biogen’s clinical trials didn’t show strong signs of clinical benefit, the $56,000 annual price tag doesn’t match those benefits, and as the trials didn’t address a diverse group of populations, like African Americans or Latinx, who are frequently affected by Alzheimer’s.
While an all-out rejection in coverage from CMS seems unlikely given the history of the centers’ prior NCDs on CAR-T therapies and other treatments and devices, Biogen opened Tuesday’s call with the first two comments from executives reiterating the necessity for widespread and early coverage.
“Therapy should not be limited to academic centers as many underserved and under-represented patients don’t have access to these centers,” Maha Radhakrishnan, CMO at Biogen, said.
An earlier Biogen exec called on the agency to encourage MACs to cover Aduhelm at the local level while the NCD process is ongoing, echoing comments from an anonymous Biogen employee who told Endpoints News last week that he declined to use his relationship with a large academic medical center to encourage local Medicare policymakers to cover Aduhelm as he didn’t think it was ethical.
But it was in the written comments (see below) where a strong force of academics and other Alzheimer’s researchers called on Medicare to do what FDA didn’t do, and reject coverage for Aduhelm
Not all amyloid drugs?
But it was an Eli Lilly doctor who called on CMS to not make any rash decision that prematurely shortchanges the entire class of amyloid-targeted drugs.
Lilly said late last month it’s filing its amyloid-targeted donanemab with the FDA later this year based on Phase II data now that the FDA considers amyloid clearance reasonably likely to lead to cognitive benefit.
Brandy Matthews, a neurologist and senior medical adviser to Lilly, noted the company’s “concern” at the outset of its public comment that a class-based NCD “might be premature at this point” because different monoclonal antibodies are at different stages of development and evidence might become available during or after the NCD.
Each Alzheimer’s drug should be evaluated on its own amyloid plaque reduction, safety profile and clinical benefit, Matthews said. CMS coverage policies to evaluate therapeutics should occur for each one, she said while urging CMS for flexibility that does not limit access to future therapies.
“Limitations on the first approved therapy should not automatically apply to future therapies,” she said.
As Biogen-funded academics signaled how to use Aduhelm on Tuesday, Matthews called on CMS to use the enrollment criteria for each clinical trial as the starting point for coverage.
Flood of negative written comments
Outside of Tuesday’s call, a pile-up of written comments on the national coverage analyses shows just how many think FDA was wrong to approve Aduhelm and that CMS should not provide coverage.
Roger Albin, a professor of neurology at the University of Michigan, wrote, “The data supporting utility of aducanumab for Alzheimer Disease isn’t even weak. The FDA should never have approved this agent. CMS should decline to provide coverage for aducanumab treatment.”
James Lah, director of the Cognitive Neurology Program at Emory University School of Medicine, added, “The FDA made several mistakes in reviewing aducanumab, but perhaps foremost was their failure to request the advisory panel consider the option of Accelerated Approval. Had they done so, I suspect there would have been fruitful discussion to inform the many decisions now left to us as providers and payors to answer.”
“The fact that this drug was FDA approved is a travesty; please do not make it worse. The money that would cover this drug could go to much better use for those patients and caregivers,” wrote Andrea Bial, program director at the Loyola-Hines Geriatric Medicine Fellowship Program.
Brienne Miner, associate professor of geriatrics at Yale University, wrote, “I am deeply troubled by the pressure to use an unproven and potentially dangerous treatment in our patients, many of whom are desperate to try anything that might give them hope. I don’t see how they can really make an informed decision here.”
Samantha Holden, an assistant professor in the Department of Neurology at the University of Colorado, also noted, “As a cognitive neurologist and dementia specialist, I have long waited for an effective disease-modifying therapy for my patients. I have not been convinced that aducanumab is that drug. I am extremely concerned regarding the presented data, conflicting results between ENGAGE and EMERGE, the costs, and potential to increase inequities in neurological care in this country.”
Michael Carome, director of the nonprofit Public Citizen’s Health Research Group, also called on CMS to exclude coverage for Aduhelm, arguing that the drug “cannot possibly be deemed reasonable and necessary” as “based on the currently available scientific evidence, reduction of amyloid-beta plaques in the brain itself is not a clinically meaningful outcome.”
Moving forward, the initial written public comment period ends on August 11, and then CMS will review those comments over 6 months in developing a proposed NCD and memorandum. No later than Jan. 12, 2022, the proposed NCD will be available, and the public will have one more 30-day comment period. A final NCD will be completed no later than April 12, 2022, CMS said Tuesday.
Medicare payment rates and codes are generated outside the NCD process.