The Centers for Medicare and Medicaid Services (CMS), which makes coverage determinations, has so far been unrelenting in its decision to limit coverage of an entire drug class to people participating in clinical trials or CMS-approved comparative studies. 

Even if the drug is fully approved, the agency has said patients will have to be participating in registries, which report outcomes.

The treatments in question are monoclonal antibody infusions that target brain plaque known as amyloid that’s associated with Alzheimer’s.

There have been two of these types of treatments approved thus far, but a third is looming.

Eli Lilly this week announced seemingly positive results from a clinical trial of its similar therapy and said it will seek FDA approval by the end of June.

In recent weeks, bipartisan lawmakers and attorneys general have joined advocacy groups in pressing CMS to change its decision. They argue that by limiting coverage, the treatments will be far too expensive and out of reach for people that would benefit the most.

CMS Administrator Chiquita Brooks-LaSure faced pointed questions and criticisms in a House hearing last week, and a bipartisan group of 25 attorneys general wrote to the agency this week urging “full and unrestricted” Medicare coverage. 

The coverage policy is controversial, but it came after the FDA’s approval of Alzheimer’s drug Aduhelm in June 2021, despite concerns that it did not work as intended.

A congressional investigation later found the FDA’s process was “rife with irregularities.”

CMS restricted coverage to Aduhelm but also decided to place any similar future drugs under the same restrictions. 

For example, the FDA approved a drug called Leqembi on an expedited basis in January. The treatment showed some modest benefit in slowing the progression of early-stage Alzheimer’s.

But the clinical trial for the drug has already concluded, and there are no registries set up.

That means Medicare enrollees with Alzheimer’s can’t access the $26,500 per year treatment unless they pay out of pocket.