Coverage of drug for Alzheimer’s limited by Medicare

WASHINGTON — Medicare said Tuesday it will limit coverage of a $28,000-a-year Alzheimer’s drug whose benefits have been widely questioned, a major development in the nation’s tug-of-war over the fair value of new medicines that offer tantalizing possibilities but come with prohibitive prices.

The initial determination from the Centers for Medicare and Medicaid Services, or CMS, means that patients taking Biogen’s Aduhelm medication will have to be part of clinical trials to assess the drug’s effectiveness in slowing the progression of dementia. Medicare’s national coverage determination would become final this spring, following a public comment period and further evaluation by the agency.

“Alzheimer’s disease is a devastating illness that has touched the lives of millions of American families,” Medicare administrator Chiquita Brooks-lasure said in a statement. “CMS has been and remains committed to providing the American public with a clear, trusted, evidence-based decision that is made only after a thorough analysis of public feedback on the benefits and risks of coverage for Medicare patients.” The requirement for clinical studies applies to the entire class of drugs of which Aduhelm is a pioneer, monoclonal antibodies directed against amyloid.

Aduhelm’s initial launch price of $56,000 a year led to an increase of nearly $22 in Medicare’s monthly “Part B” premium for outpatient care, the largest ever in dollar terms but not percentagewise. Medicare attributed about half of this year’s increase to contingency planning for Aduhelm. Faced with skepticism over its medication, Biogen recently slashed the price to $28,200, but Medicare enrollees were already on the hook for the $170.10 premium. Health and Human Services Secretary Xavier Becerra has directed Medicare to reassess the premium increase.

Medicare does not traditionally take cost into account when evaluating coverage, but rather whether a treatment is “reasonable and necessary” in caring for program enrollees. But the high price of Aduhelm and the fact that most of the 6 million Americans with Alzheimer’s are old enough to be covered by Medicare stretched the limits.

Some insurers have balked at paying for the drug, while several medical centers across the country have been either slow to decide on using it or said they weren’t planning to prescribe it for now.