Medicare Reveals Coverage Policy for Amyloid mAbs

Every journalist remembers their first interview – mine was with a researcher from the University of California about early Alzheimer’s work around amyloid beta plaques. Since then, I’ve held an interest in the field, but it’s not often I get to write about the topic. Why? Because breakthroughs in Alzheimer’s have been slim pickings, and there’s still no scientific consensus about what causes it – although amyloid beta plaques have remained a prominent theory.

In June 2021, the FDA approved Biogen’s Aduhelm (aducanumab) under its accelerated approval pathway. It was the first new therapy approved for Alzheimer’s since 2003. But can it really be classed as a “breakthrough?” After all, it’s difficult to ignore the controversy that has surrounded Aduhelm and its approval. If you’re out of the loop, feel free to catch up on what’s been going on with Aduhelm. In short, the main controversy stems from the fact that the drug was approved for its ability to reduce amyloid plaque in the brain. But will reduction of the plaques lead to better outcomes for Alzheimer’s patients? That’s the missing link, with some experts arguing there is no evidence.

In light of the unknown, how should Medicare coverage work? The CMS has been debating this topic over the last few months. And, on April 7, the CMS revealed its final coverage policy. The policy was inspired by Aduhelm but will also apply to other mAbs directed against amyloid for treating Alzheimer’s (there are a few coming down pipelines). And the decision? The mAbs will be covered by Medicare – but only if the patient is part of a clinical trial.

Prior to the decision, the CMS held a consultation – receiving around 10,000 comments. And it was a bitter fight. Some comments heavily lobbied for access to the drug, while others were strongly against it. In some cases, experts resigned from scientific advisory boards for groups that were lobbying CMS to cover the drug.

Given how polarizing opinions were in the comment period, it’s no surprise that the final decision has also stirred up strong views. Perhaps the biggest point of contention is whether the CMS is going above its station. In a statement from the Biotechnology Innovation Organization, Michelle McMurray-Health, President and CEO, said, “With this decision, CMS is not just saying it has no confidence in Alzheimer’s drugs approved under the FDA’s Accelerated Approval pathway. It also is undermining confidence in FDA’s traditional drug approval process more broadly.”

Biogen has also commented that the type of coverage restrictions proposed by the CMS have never been applied to FDA-approved medicines in other disease areas.

As noted, other mAbs targeting amyloid are in development. And perhaps the argument will settle as more data emerges. In its statement, Biogen added, “When additional data from this new class of treatments become available, Biogen urges CMS to reconsider today’s decision for all FDA-approved amyloid-beta targeting therapies. For lecanemab, our partner Eisai has initiated FDA filing via the accelerated approval pathway and the readout of the Phase 3 confirmatory Clarity AD clinical trial is expected in the fall.”