As CMS begins its coverage review of Biogen’s controversial Alzheimer’s drug Aduhelm, MA plans and their members await a decision that could bring significant financial consequences for both.
CMS’ initial proposal is expected within six months, with a final decision coming within nine months.1 That decision is also expected to apply to any similar drugs in the future, CMS has said.2
The agency may decide to limit use of the drug, covering it only for patients who meet the FDA criteria for mild symptoms.2 It could also decide to defer to Medicare contractors.2
The decision will be closely watched as Aduhelm has raised considerable controversy for its $56,000 per year cost. With most of the nearly 6 million Americans with Alzheimer’s covered by Medicare, coverage of the drug could raise the program’s annual spending on drugs delivered in hospitals and doctor’s offices by 50%.3 If 1 million Medicare beneficiaries begin using the drug, it would cost Medicare $57 billion annually, which is significantly more than the program spends on all other Part B drugs combined.4
Kaiser Family Foundation has estimated that if just 500,000 of the nearly 2 million Medicare enrollees who currently take an Alzheimer’s treatment covered under Part D begin using Aduhelm, premiums for all beneficiaries would rise by about $97 per year.5 Meanwhile, MA beneficiaries could see co-insurance costs in the thousands,5 and enrollees in both traditional Medicare and MA could also see higher Part B premiums.4
Apart from the drug’s sticker price, it requires monthly visits to an infusion center as well as multiple brain scans throughout treatment to spot side effects.3 The cost of those scans as well as any treatments for serious side effects would also be borne by Medicare.3
Even more concerning is the fact that some doctors and other industry stakeholders say the drug has not been shown to benefit patients or slow progression of dementia.2,3 This month, the Institute for Clinical and Economic Review’s California Technology Assessment Forum voted unanimously that it offers no benefit for Alzheimer’s disease patients.6
While it remains to be seen where CMS will land, the decision could have significant consequences for Medicare program and its beneficiaries, and it could even act as a catalyst for congressional action on drug prices.4
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References
- Roy, T., Humer, C. U.S. starts national Medicare coverage policy review for Biogen’s Aduhelm. Reuters. July 12, 2021. https://www.reuters.com/business/healthcare-pharmaceuticals/us-starts-review-national-medicare-coverage-policy-biogens-aduhelm-2021-07-12/
- Walker, J. Medicare to review coverage for new Alzheimer’s drug Aduhelm. Wall Street Journal. July 12, 2021. https://www.wsj.com/articles/medicare-to-review-coverage-for-new-alzheimers-drug-aduhelm-11626130325
- Katz, J., Kliff, S., Sanger-Katz, M. New drug could cost the government as much as it spends on NASA. New York Times. June 22, 2021. https://www.nytimes.com/2021/06/22/upshot/alzheimers-aduhelm-medicare-cost.html
- Kubanski, J., Neuman, T. FDA’s Approval of Biogen’s New Alzheimer’s Drug Has Huge Cost Implications for Medicare and Beneficiaries. KFF. June, 10, 2021. https://www.kff.org/medicare/issue-brief/fdas-approval-of-biogens-new-alzheimers-drug-has-huge-cost-implications-for-medicare-and-beneficiaries/
- Luhby, T. How everyone on Medicare could end up paying for the pricey new Alzheimer’s drug. CNN. July 10, 2021. https://edition.cnn.com/2021/07/10/politics/aduhelm-alzheimers-drug-medicare/index.html
- Wehrwein, P. Aduhelm pros and cons debated at ICER meeting. Managed Healthcare Executive. July 15, 2021. https://www.managedhealthcareexecutive.com/view/aduhelm-pros-and-cons-debated-at-icer-meeting
