On January 11, 2022, the Centers for Medicare and Medicaid Services (CMS) proposed that Medicare would offer Aduhelm coverage. Aduhelm is a drug for the treatment of mild Alzheimer’s disease, only as part of a clinical trial approved by CMS or supported by the National Institutes of Health (NIH).
The trial will help to generate the evidence that CMS suggests is currently lacking regarding whether Aduhelm is reasonable and necessary for the treatment of Alzheimer’s disease. This preliminary National Coverage Determination (NCD) comes after months of handwringing over the potential impact of this new high-priced drug on Medicare spending and a substantial Medicare Part B premium increase that took effect in January 2022. CMS proposes to cover Aduhelm and similar FDA-approved anti-amyloid monoclonal antibody treatments under Coverage with Evidence Development (CED) for patients participating in CMS-approved or NIH-supported randomized clinical trials.
There are some strong critics of CMS’ decision after the FDA approved the use of Aduhelm in June 2021, inclusive of the Alzheimer’s Association. Harry Johns, the Alzheimer’s Association CEO, stated in response to the CMS National Coverage Decision, “Today’s draft decision by the Centers for Medicare & Medicaid Services (CMS) is shocking discrimination against everyone with Alzheimer’s disease, especially those who are already disproportionately impacted by this fatal disease, including women, Blacks, and Hispanics. Critically, this draft decision is not about one treatment but about this class of potential future treatments targeting amyloid for the treatment of Alzheimer’s disease. This draft decision appears focused on an individual treatment rather than a class, which is not what CMS set out to do.”
While the CMS decision, which will be finalized in April 2022, proposes the terms of Medicare coverage of these treatments for Alzheimer’s disease, the Aduhelm story is not likely to end here. HHS Secretary Becerra has directed CMS to reassess the monthly 2022 Medicare Part B premium in light of the announcement from Biogen, the drug’s manufacturer, that it was slashing the price of Aduhelm by 50% from $56,000 to $28,200 in response to anemic demand for the new drug.
In November 2021, prior to the release of the preliminary national coverage determination and the drop in the price of Aduhelm, CMS announced a 14.5% hike in the Medicare Part B premium for 2022. The increase in the premium—from $148.50 in 2021 to $170.10 in 2022—was based on a “high-cost” scenario that took into account the potential increase in Medicare Part B spending for Aduhelm, among other factors. CMS attributed about half of the premium increase to the need to boost revenues to cover higher projected Part B spending for this one drug alone.
In addition to Medicare, the Aduhelm coverage decision could have implications for Medicaid. While Medicaid must cover FDA-approved drugs, states may be able to impose medical necessity criteria as well as strict prior authorization requirements based on the Medicare coverage determination limiting utilization. The magnitude of the financial implications for Medicaid could hinge on further coverage guidance from CMS.
What are the next steps for coverage? The proposed coverage determination is open for comment for 30 days. The final decision will be announced by April 11.
Jason Karlawish, MD, and Medicare expert Allison Hoffman, JD, reviewed the proposal and spoke about what this decision could mean for PMC. Watch the recording and read the coverage of the recent PMC Community Discussion on the Centers for Medicare and Medicaid Services (CMS) proposal for Aduhelm coverage by clicking here.