Alzheimer’s Drug Aducanumab Causes Medicare Part B Premium Sticker Shock for All Beneficiaries

In November, Medicare Part B beneficiaries received an unpleasant surprise when the Centers for Medicare and Medicaid Services (CMS) announced that their standard monthly premium for 2022 would jump to $170.10, a 15% spike over the 2021 standard monthly premium level of $148.50 and one of the largest increases ever.[1] Likewise, the annual deductible for all Medicare Part B beneficiaries increased to $233 in 2022, up 15% from the annual deductible of $203 in 2021.

At the time CMS announced these major hits to the wallets of Medicare beneficiaries, agency officials told reporters that about half the increase is due to contingency planning if the Medicare program ultimately has to cover aducanumab (ADUHELM) for treatment of Alzheimer’s disease.

All Part B Medicare beneficiaries thus are being forced to bear significant financial burden as a direct result of the Food and Drug Administration’s (FDA’s) reckless June 2021 decision to approve aducanumab, a drug that has not been proven to provide any clinically meaningful benefit to Alzheimer’s patients but nevertheless carries an indefensible annual price tag that was initially set at $56,000 per year of treatment for just the drug alone and later reduced to $28,000. There will be additional costs to Medicare for clinic visits for administration of the aducanumab, which is given by intravenous injection, and for expensive MRI scans to monitor patients for brain swelling and bleeding known to be caused by the drug.

The FDA approved aducanumab under its accelerated approval pathway despite the nearly unanimous conclusion of an independent panel of experts convened by the agency in November 2020 — and of many other scientists, neurologists and geriatric specialists — that there was inadequate evidence that the drug is effective for slowing cognitive decline in patients with Alzheimer’s disease.[2]

Starting in November 2020, Public Citizen waged an aggressive campaign opposing FDA approval of aducanumab.[3] We argued that approval of the drug would, among other things, raise false hope for millions of Alzheimer’s disease patients and their families and potentially bankrupt the Medicare program because of the drug’s exorbitant price.

CMS is currently considering whether Medicare should cover aducanumab and, if so, whether such coverage should be limited to certain Alzheimer’s disease patients. In August 2021, Public Citizen submitted written comments to CMS urging the agency to exclude aducanumab from coverage under the Medicare program.[4]

To protect the many Medicare beneficiaries who cannot afford the unacceptable 15% jump in Part B premiums and deductibles, CMS must promptly announce that it will exclude aducanumab from coverage under the Medicare program until there is definitive evidence that the drug provides substantial cognitive benefit to Alzheimer’s disease patients.
 

References

[1] Centers for Medicare and Medicaid Services. 2022 Medicare Parts A & B premiums and deductibles/2022 Medicare Part D income-related monthly adjustment amounts. November 12, 2021. https://www.cms.gov/newsroom/fact-sheets/2022-medicare-parts-b-premiums-and-deductibles2022-medicare-part-d-income-related-monthly-adjustment. Accessed December 7, 2021.

[2] Food and Drug Administration. Final summary minutes of the Peripheral and Central Nervous System Drugs Advisory Committee meeting. November 6, 2020. https://www.fda.gov/media/145690/download. Accessed December 7, 2021.

[3] Public Citizen. Aducanumab; Brand name: Aduhelm. https://www.citizen.org/article/aducanumab/. Accessed December 7, 2021.

[4] Public Citizen. Comments regarding the Centers for Medicare and Medicaid Services’ National Coverage Determination analysis for monoclonal antibodies directed against amyloid for the treatment of Alzheimer’s disease (CAG-00460N). August 11, 2021. https://www.citizen.org/wp-content/uploads/2598.pdf. Accessed December 7, 2021.