Last week the Center for Medicare and Medicaid Services (CMS) limited coverage of Aduhelm, Biogen’s Alzheimer’s drug, to administration only within clinical trials. This brilliant strategic move mitigates the damage caused by the FDA’s failure to protect the public from an ineffective drug.
Canada declined to approve Aduhelm, as has the European Union. In the U.S., many prominent payers have already denied coverage for Aduhelm, including all Blue Cross/Blue Shield plans. The Department of Veterans Affairs has declined to put Aduhelm on its formulary. Kaiser Permanente, one of the largest health maintenance organization in the U.S., covers Aduhelm only with special approval.
Other payers have been waiting on the Medicare outcome to finalize their own decisions. Medicare’s National Coverage Determination decision will dramatically impact Aduhelm usage both directly and indirectly, through influence on other payers.
Limiting the damage
The FDA approves drugs based on whether they are effective and safe, while the CMS standard evaluates whether an item or service is “reasonable and necessary for the diagnosis or treatment of an illness or injury.” It is very unusual for CMS’ National Coverage Determination (NCD) program to question coverage of an FDA-approved drug, and it is vanishingly rare for the agency to deny coverage of any therapeutic outright.
Restricting coverage to clinical trials in which Aduhelm’s ephemeral benefits and apparent harms (including brain swelling, brain bleeds, and brain shrinkage) can be further evaluated effectively limits the damage resulting from the FDA's decision.
The specter of paying for Aduhelm accounted for most of a recent 14.5% increase in Medicare premiums for 2022. (For comparison, in 2020 the increase was only 3.5%.) Xavier Becerra, the Secretary of Health and Human Services, asked CMS to revisit the Medicare premium hike after Biogen halved the price of Aduhelm. This NCD result should further reduce the level of increase required.
Taxpayers dodged a bullet here. Not only does Aduhelm cost $28,200 per year (that’s the discounted price), but that doesn’t include the expensive brain scans that must accompany Aduhelm prescribing, nor the cost of treating complications. Some researchers believe that up to 47 million Americans may have “preclinical” Alzheimer’s disease, so the potential size of market for these treatments is very fluid.
Medicare should have never had to make this decision to mitigate FDA’s folly: Aduhelm should not have been approved. When the FDA approves ineffective drugs or drugs for which harms outweigh benefits (Aduhelm fits both categories), it abdicates its responsibility to protect “the public health by assuring the safety, efficacy and security of human and veterinary drugs…”
Search for effective therapies goes on
Forty years of research on Alzheimer’s disease has produced no medicine able to reverse, halt or even slow the progression of this debilitating disease. Aduhelm is no different; clinical trials produced no clinical improvement, a questionable, transient, slowing of decline in one of two studies, and well-documented harms, including brain bleeding and swelling in 41% of patients. Risking harm for no discernible benefit is never a good idea.
The CMS wisely specified its decision to cover all monoclonal antibodies directed against amyloid for the treatment of Alzheimer’s. Following the FDA’s disastrous decision on Aduhelm, additional monoclonal antibody candidates, including donanemab and lecanumab, are wending their way through the approval process. The FDA granted both of these a breakthrough therapy designation in June 2021. All of these drugs target amyloid plaque in the brain, despite the fact that the connection between amyloid and Alzheimer’s is unclear, and most people with amyloid plaque never develop dementia.
Medicare is the largest payer for prescription drugs in the country, covering 30% ($101 billion) in retail drug spending. S o when Medicare pays, all taxpayers pay. We are fortunate that CMS made the responsible decision in this case to promote public health and protect the country from significant financial damage. But how long will it be until the next unnecessary, ineffective or usuriously priced drug is pushed through the regulatory process, adding to the financial burden of U.S. taxpayers?
U.S. law prevents the government, including Medicare, from negotiating drug prices, a practice that foreign counterparts use to manage drug costs. Medicare must be allowed to negotiate with pharmaceutical companies on prices for their medications – a proposed part of the Build Back Better Act. Kudos to CMS, and may the government continue to protect prescribers and patients from corporations that sell false hopes to fuel their profits.
Dave Stanke is a research associate at PharmedOut, a research and education project at Georgetown Georgetown University Medical Center that promotes rational prescribing. Adriane Fugh-Berman MD is a Professor in the Department of Pharmacology and Physiology and the Department of Family Medicine at Georgetown University Medical Center. She also directs PharmedOut.
This article originally appeared on Detroit Free Press: Medicare wisely declines to pay for Alzheimer's drug \ Opinion