Medicare intends to limit coverage for the controversial Alzheimer’s disease drug, aducanumab (Aduhelm, Biogen) through a special program to help assess the effectiveness of the exorbitantly expensive drug, federal officials said on Tuesday.
On December 20, Biogen announced a plan to reduce the drug’s annual cost in the United States by 50% – from $ 56,000 to $ 28,200 – as officials at the Centers for Medicare & Medicaid Services (CMS) decided to Medicare’s drug coverage policy.
In making its proposed coverage decision, CMS announced that it will pay for aducanumab, a monoclonal antibody, as part of its Evidence-Based Coverage (EDC) mechanism. In making its decision, CMS approached aducanumab as the first in a potential new class of monoclonal antibodies for the treatment of Alzheimer’s disease (AD).
Drugs approved by the U.S. Food and Drug Administration (FDA) in this class would only be covered for people on Medicare if they are enrolled in eligible clinical trials, CMS said. The agency will accept public comments on the decision for 30 days.
In a statement, CMS Administrator Chiquita Brooks-LaSure said the agency is “committed to providing the American public with a clear, reliable and evidence-based decision that is only made after an analysis Thorough public commentary on the benefits and risks of Medicare coverage for Patients. “
As reported by Medscape Medical News, the FDA approved aducanumab on June 7 through an expedited approval process. The approval, which sparked a storm of controversy that included the resignation of three members of the FDA’s central and peripheral nervous system drug advisory committee, was granted on the basis of the drug’s ability to reduce plaque. beta-amyloid.
As part of the fast-track approval mechanism, Biogen has yet to provide strong scientific evidence that aducanumab has clinically significant disease modifying effects. However, definitive evidence won’t be available anytime soon. In its approval letter, the FDA set a deadline of 2030 for a final report on this research.
“Unusual but appropriate” step
The Medicare decision marks a shift in the agency’s approach to paying for drugs. On a call with reporters, Tamara Syrek Jensen, JD, director of CMS’s coverage and analysis group, admitted the agency had taken an “unusual but appropriate” step in trying to establish a national policy concerning the payment of a drug.
On the same call, Lee Fleisher, MD, Chief Medical Officer of CMS, addressed the challenges presented by aducanumab, given the urgent need for treatment for AD.
“As a practicing physician, I cannot stress enough the need to understand the risks and benefits of a given treatment in order to better educate patients and their families,” said Fleisher. “We know, based on some evidence, that there may be potential promise with this treatment. That is why it is essential for us to seek further scientific evidence.”
The evidence-based coverage program will allow Medicare to facilitate data collection while protecting patients, Fleisher noted.
“CMS uses its authority provided by Congress to determine whether the drug is considered reasonable and necessary, which means that the benefits of improving cognition outweigh the harms of the Medicare population,” Fleisher said .
Biogen, based in Cambridge, Massachusetts, has urged CMS to reconsider its approach to paying for aducanumab. In a statement, the company said Medicare should cover “the class of therapies directed against amyloid with populations studied in respective clinical trials and guided by expert recommendations for appropriate use.”
“We believe that Alzheimer’s patients should have compatible access to other therapies with the FDA’s expedited approval,” Biogen said in the release.
In the company’s view, the CED approach “will significantly limit patient access to FDA-approved treatment, especially for underserved patients, as evidenced by other CED decisions.”
“DACs can take months or even years to start, and hundreds of patients with Alzheimer’s disease – the majority of whom are Medicare beneficiaries – progress from mild to moderate stages every day, where treatment may no longer be an option, ”said Biogen.
Drugmakers feared CMS would opt for CED even before the draft decision was released.
BIO, the trade group of biotechnology companies, has urged CMS to provide access to aducanumab without undue restrictions.
Drugmakers are already concerned about CMS efforts “to impose new barriers to coverage – and, in particular, coverage with the development of evidence (EDC),” Crystal Kuntz, vice president of policy and development. research at BIO, and Andy Cosgrove, the organization’s director. director of policy and research, noted in a July 2021 commentary on the aducanumab review.
Rather, Medicare should continue to provide access to drugs for FDA-approved indications, with additional flexibility for off-label anti-cancer drug indications, they noted.
“We believe this should continue to be the case, to ensure that vulnerable Medicare beneficiaries have necessary access to life-changing, life-saving drugs,” BIO officials wrote.
However, CMS has also received numerous calls from doctors asking the agency to limit the use of aducanumab to at least until it is proven to produce a significant clinical benefit.
In a press release, Howard Fillit, MD, co-founder and scientific director of the Alzheimer’s Drug Discovery Foundation, applauded the decision, describing it as “the right decision.”
“This decision supports the conduct of additional clinical trials, which are needed to gain further information on the clinical efficacy and safety profile of this drug in real-world populations. This decision has implications for other drugs in this class at an advanced stage of development. If these trials show clearer and more robust clinical efficacy, then it is possible that the FDA will grant full approval to these amyloid monoclonal antibodies, and Medicare would likely provide full payment, ”he added.
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