Aduhelm Preliminary Approval Only for Limited Use in Clinical Trials

The Centers for Medicare & Medicaid Services (CMS) said today (January 11) that it provisionally supports the limited use of Aduhelm, the controversial Alzheimer’s medicine, in clinical trials. The agency’s final decision is expected in April. The drug was approved last June by the U.S. Food & Drug Administration despite widespread concerns about its effectiveness.

Limiting the drug’s use will intensify pressure on CMS to reduce the large increases in the Part B premium for Medicare that it announced last fall. Aduhelm will be charged as a Part B medication because it must be infused in an office setting, unlike Part D drugs, which are self-administered by patients.

On November 12, Medicare cited potential Aduhelm spending as a major factor in its decision to raise the basic monthly Part B premium by $21.60, or nearly 15 percent, to $170.10 from $148.50 in 2021. The other causes were continued health-care price inflation and to make up for the government’s decision to minimize the 2021 premium increase to help people being battered by economic losses related to the pandemic.

As I wrote at the time, “(T)the sting of higher premiums will be reduced by next year’s Social Security cost of living adjustment (COLA) of 5.9 percent — the largest in 40 years. From where I sit, the COLA provided Medicare with the cover it needed to boost what amounts to a rainy-day reserve, not only for Aduhelm expenses but also broadly higher health care costs.”

On December 20, however, Biogen, the maker of Aduhelm, said it would cut its price in half to $28,000, triggering calls for a reduction in the Part B premium. Pressure increased earlier this week when Xavier Becerra, head of the U.S. Department of Health & Human Services, asked CMS to reassess amount of the Part B premium increase.