by Giftina Wilson, PharmD Candidate
On June 7, 2021, the FDA approved the controversial Aduhelm® (aducanumab) for treating Alzheimer’s Disease despite inadequate evidence of the drug’s efficacy based on a highly debated posthoc analysis.1
Currently, there is an ongoing discussion on whether Medicare will provide coverage of this new antibody to its beneficiaries.
Aduhelm is a newly approved anti-amyloid monoclonal antibody; as with most biologics, it is costly.
In July 2021, CMS (Centers of Medicare and Medicaid Services) opened a National Coverage Determination Analysis to determine whether Medicare will provide coverage for Aduhelm.
Currently, local level Medicare Administrative Contractors, who represent 12 jurisdictions across the country, are making CMS coverage decisions for Aduhelm coverage.2
To determine whether a national policy is warranted, CMS asked the public to participate and vocalize their thoughts on whether to cover Aduhelm.
The annual price per patient will be around $56,000 which could cost Medicare over $50 billion per year based on CMS estimates.
Adding Aduhelm to the Medicare formulary would place an enormous financial strain on the program.
Aduhelm treatment for a single year is projected to outstrip the combined price of all other approved treatments for Alzheimer’s.
This cost affects CMS spending, and budgets, and may also increase the premium for part B Medicare patients.3
Additionally, the cost of the medication could spill into state budgets, where Medicaid pays premiums for low-income Medicare patients.
Typically, Medicare covers drugs approved by the FDA based on how “necessary” the drugs are for patients, not based on cost.4
Not only is the efficacy of Aduhelm questionable, but the debate over the expense of Aduhelm is an important consideration for payers as well.
Aduhelm requires patients to undergo extensive tests to confirm the presence of underlying protein plaques in the brains of Alzheimer’s patients via PET and MRI scans before beginning therapy.
Patients who choose to take this medication will also be required to undergo periodic MRI tests after administration of the drug to monitor for side effects such as brain swelling and intracranial bleeding that occurred in a significant proportion of patients in the phase 3 trials.
In 2013, CMS chose not to pay for Alzheimer’s PET scans, which cost several thousand dollars per patient, due to the still unclear role that amyloid plaques and other potentially identifiable PET scan findings play in the progression of Alzheimer’s.5
It’s still unclear whether CMS will revert their choice and pay for these brain scans for Aduhelm.
However, upon FDA’s approval, there was no mention on whether patients who want to try the drug need to be tested for amyloid-beta plaques prior to treatment, although it was a requirement for treatment in the phase 3 trials; that decision may lie in the hands of Medicare, private insurance, and doctors who prescribe the drug.
In conclusion, Medicare is in the process of deciding whether to cover Aduhelm and its associated brain exams for Medicare patients.
We know that if Medicare approves coverage of Aduhelm and the tests, then the year spending of Medicare may increase by $29 billion to $50 billion.
This could increase the price of premiums for Medicare patients and increase the cost for taxpayers as well.
PharmD Live does not support adding Aduhelm to the Medicare formulary until more evidence of effectiveness becomes available.
We urge caution in using Aduhelm due to the potential for serious side effects, limited efficacy, and potential cost concerns for payers, in addition to patients who are struggling with an incurable disease.
About the author – Giftina Wilson, Pharm.D candidate, Pharmacist Intern – Ms. Wilson is a fourth-year pharmacy student who is interested in pursuing a residency to become a clinical pharmacist. She also has a passion to assist those in underserved populations. She has held various leadership positions in student organizations including being a campus executive director in APhA, treasurer in SNPhA, and class secretary in the student council. In her free time, she enjoys hiking and reading.
References
- King R. CMS starts process to decide on covering pricey Alzheimer’s drug aducanumab. Fierce Healthcare website. https://www.fiercehealthcare.com/payer/cms-starts-process-to-decide-covering-pricey-alzheimer-s-drug-aducanumab. Published July 12, 2021. Updated July 12, 2021. Accessed August 12, 2021.
- CMS. CMS Opens National Coverage Determination Analysis on Treatment for Alzheimer’s Disease. https://www.cms.gov/newsroom/press-releases/cms-opens-national-coverage-determination-analysis-treatment-alzheimers-disease. Published July 12, 2021. Updated July 12, 2021. Accessed August 12, 2021.
- Bailey V. Medicare Coverage Determination for Alzheimer’s Drug Is Underway. Health Payer Intelligence website. https://healthpayerintelligence.com/news/medicare-coverage-determination-for-alzheimers-drug-is-underway. Published July 14, 2021. Updated July 14, 2021. Accessed August 12, 2021.
- Cubanski J, Neuman T. FDA’s Approval of Biogen’s New Alzheimer’s Drug Has Huge Cost Implications for Medicare and Beneficiaries. KFF website. https://www.kff.org/medicare/issue-brief/fdas-approval-of-biogens-new-alzheimers-drug-has-huge-cost-implications-for-medicare-and-beneficiaries. Published June 10, 2021. Updated June 10, 2021. Accessed August 12, 2021.
- Alltucker K. Aduhelm, the new $56,000 Alzheimer’s drug, is more expensive than you think. Here’s why. USA TODAY website. https://www.usatoday.com/story/news/health/2021/06/22/new-alzheimers-drug-brain-scans-mris-monitoring-boost-aduhelm-cost/7686658002/. Published June 22, 2021. Updated June 22, 2021. Accessed August 12, 2021.
