Medicare limits coverage of new Alzheimer’s treatment

Officials at the U.S. Department of Health and Human Services will restrict Medicare coverage of a new Alzheimer’s treatment to clinical trials, rejecting activists who had demanded full access for early-onset dementia patients.

Thursday’s decision from the department’s Centers for Medicare & Medicaid Services (CMS), affirms an earlier Jan. 11 preliminary ruling.

Citing concerns over possible side effects, including headaches, dizziness, falls and brain bleeds, the ruling confirms that Medicare will provide “enhanced access and coverage” only for those chosen to participate “in CMS-approved studies” of the drug Aduhelm (aducanumab) and all similar future treatments.

The Food and Drug Administration approved Aduhelm in June as the first new treatment for Alzheimer’s since 2003. The drug, from Massachusetts-based Biogen and Japan’s Eisai Company, is the only FDA-approved treatment that uses antibodies to remove plaque from the brain.

Medicare activists said the decision to limit coverage to clinical trials could delay the treatment’s availability by 10 years.

Sue Peschin, president of the Washington, D.C.-based Alliance for Aging Research, said Medicare had chosen to “ration care” by finalizing its decision.

“They are putting the value of the almighty dollar ahead of the value of older adults and people with disabilities,” Ms. Peschin said in an email.

The activist, who met with HHS Secretary Xavier Becerra to share her concerns, said the decision could set “a precedent” for CMS to undermine future FDA approvals of treatments for cancer and rare afflictions like Lou Gehrig’s disease.

Activists have long complained that Medicare delays FDA-approved treatments for the elderly, many of whom would rather risk the side effects than watch their diseases progress beyond the point where new drugs could help.

Jim Taylor, whose wife Geri suffers from Alzheimer’s, hammered that point home during a March 15 rally of more than 100 activists at HHS.

“Yes, it works, but no, you can’t have it,” Mr. Taylor said.

Both the FDA and CMS are part of HHS.

Medicare’s final decision to limit coverage of Aduhelm followed a 30-day public comment period.

In its statement on Thursday, CMS said it considered more than 10,000 comments and more than 250 peer-reviewed research documents before reaching it.

According to the statement, more than 6 million Americans suffer from Alzheimer’s and more than 14 million will have it by 2060, “barring effective interventions.”

For those who take part in the upcoming clinical trials, Medicare will cover Aduhelm and all related services, including PET scans.