Discussion 10 - Aduhelm

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Johns Hopkins University *

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AS.020.306

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Medicine

Date

Dec 6, 2023

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docx

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Uploaded by AdmiralMetal11936

CMS Coverage Decision for Aduhelm Alzheimer’s Drug Last summer, The US Centers for Medicare & Medicaid Services (CMS) decided to extend coverage based the U.S Food & Drug Administration due to the historic decision to grant accelerated approval for the Alzheimer’s drug, Aduhelm, based on proven clinical benefits from clinical trials. This controversial decision has Aduhelm manufacturer Biogen exclaiming that the coverage restrictions are an “unprecedented decision that effectively denies all Medicare beneficiaries access to Aduhelm” (Arthur, 2022). Currently, over 6 million of America’s older populations suffer from Alzheimer’s Disease and are only projected to significantly increase to 14 million by the year 2060 if things do not change. There is no question that there needs to be more development in Alzheimer’s research, however, the question is whether Medicare should extend funding for these new and expensive drugs if it means an additional cost to Medicare patients. Aduhelm is a new monoclonal antibody drug that targets amyloid-beta plaques, preventing them from accumulating inside the brain (Center for Drug Evaluation and Research, 2021). Past guidelines for providing clinical evidence for reports of effective drugs and biologics have significantly evolved to prioritize safety and clinical efficacy (Center for Drug Evaluation and Research, 1998). In this case, it is based on the link between Aduhelm’s pharmacologic effect paired with its clinical effects diminishing the plaques that lead to Alzheimer’s. Biogen argues that since Aduhelm demonstrated significant success during its clinical trials, it is indicative of future clinical benefit meriting unrestrictive coverage. Traditionally the FDA requires a drug to successfully complete a Phase 4 trial for a drug to be granted approval. Currently, Aduhelm has not completed all 4 trial phases, therefore, there is hesitance on whether it would be premature to expect it to have governmental coverage. One side of the argument shows hesitance for this decision based on limited access to those who cannot afford to pay for drugs such as Aduhelm without Medicare assistance. Medicare patients deserve access to effective treatments and proposals made by the National Coverage Determination (NCD). This is also a sensible decision because Alzheimer’s is a rapidly altering degenerative disease, therefore, those suffering simply do not have the time to wait. Although I do agree that Medicare patients deserve top-shelf treatments, I am too hesitant to fast-track a drug prematurely if it means lowering safety standards. Although Biogen, is on to some truly remarkable groundbreaking work, I understand why CMS would require efficacy reports from Biogen to fact check their claims. As a compromise, CMS not only acknowledge Biogen’s valiant efforts by permitting its accelerated pathway approval but also agreed to extend coverage to approve trials

covered under the National Institutes of Health (NIHN) or the FDA (Arthur, 2022). I believe that their decision is a huge step forward for biotech/pharma companies as well as for us consumers. While still maintaining a level of checks and balances by prioritizing weighing the potential benefit of a new drug versus the potential harm premature unknown long-term outcomes could have on the patient. Due to increased public demand, the full drug cost for Aduhelm was reduced from $56,000 to $28,000 per year with varied costs to the patient based on their insurance policy (The National Council on Aging, 2021). All in all, I do see this as an acknowledgment that changes to coverage policy need to be made to allot for both consumer assurance and flexibility of development. This will hopefully even out the playing field for Medicare patients to have equal access to top-notch effective treatment without any additional cost to them. Resources: Arthur, R. (2022, April 11). CMS limits coverage of Biogen's alzheimer's Drug Aduhelm . biopharma. Retrieved April 13, 2022, from https://www.biopharma- reporter.com/Article/2022/04/11/CMS-limits-coverage-of-Biogen-s-Alzheimer- s-drug-Aduhelm Center for Drug Evaluation and Research. (2021, July 8). Aducanumab (marketed as Aduhelm) information . U.S. Food and Drug Administration. Retrieved April 13, 2022, from https://www.fda.gov/drugs/postmarket-drug-safety-information- patients-and-providers/aducanumab-marketed-aduhelm-information Center for Drug Evaluation and Research. (1997, May). Providing clinical evidence of effectiveness for human drug and Biolog . U.S. Food and Drug Administration. Retrieved May 13, 2022, from https://www.fda.gov/regulatory- information/search-fda-guidance-documents/providing-clinical-evidence- effectiveness-human-drug-and-biological-products What You Need to Know About Aduhelm . The National Council on Aging. (2021, January 12). Retrieved April 13, 2022, from https://www.ncoa.org/article/what- you-need-to-know-about-aduhelm

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