Medicare limits coverage Aduhelm, the $28,000-a-year Alzheimer's drug from Biogen

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 means that patients taking Biogen's Aduhelm medication will have to be part of research efforts 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.

'YOU REACH FOR ANYTHING': Doctors must decide whether patients should get the new Alzheimer's drug, Aduhelm

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 percentage-wise. 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.

“Biogen came to market with an eye-popping price tag,” said Tricia Neuman, a Medicare expert with the nonpartisan Kaiser Family Foundation. “Even after they slashed their drug’s price in half, it is still more than $28,000, which is not insignificant. At that price, it is clearly an issue for the Medicare program, premiums and out-of-pocket costs.”

Aduhelm has sparked controversy since its approval by the Food and Drug Administration last June, which came against the recommendation of the agency's outside advisers.

The medicine, administered by IV in a doctor’s office, hasn’t been shown to reverse or significantly slow Alzheimer’s. But the FDA said that its ability to reduce clumps of plaque in the brain is likely to slow dementia.

Many experts say there is little evidence to support that claim. And a federal watchdog and congressional investigators are conducting separate probes into how FDA reviewed the medication. Of particular concern are several undocumented meetings between FDA reviewers and company executives in the run-up to the drug’s approval.

This article originally appeared on USA TODAY: Medicare limits coverage of Aduhelm, Alzheimer's drug that costs $28K