Medicare's Alzheimer's announcement

Medicare doubles down on its decision to only cover a new class of Alzheimer’s drugs with participation in a registry—an announcement that continues to create a barrier for patients and undermines the FDA’s accelerated approval process. (551 words, 2 minutes, 45 seconds)

Medicare doubles down on requirement to participate in registries for  access to Alzheimer’s drugs

Centers for Medicare and Medicaid Services (CMS) announced Medicare will cover a new class of Alzheimer’s drugs that have received “traditional approval” only if patients participate in a registry—here’s what we know.

The news: If an Alzheimer’s drug has received “traditional approval” from the U.S. Food and Drug Administration (FDA), Medicare will cover the drug “in appropriate settings that also support the collection of real-world information to study the usefulness of these drugs for people with Medicare,” says CMS.

What drugs we’re talking about: Biogen’s Aduhelm and Eisai’s Leqembi, which both received accelerated approval. Leqembi could receive traditional approval soon.

What this means: Medicare will only cover drugs if they’ve received “traditional” (not accelerated) approval and are administered with participation in a registry.

Why it matters: Requiring a registry “as a condition of coverage is an unnecessary barrier,” says the Alzheimer’s Association. “Registries are important tools to gather much-needed real-world evidence to transform and improve patient care. But, registries should not be a requirement for coverage of an FDA-approved treatment.”

The bottom line: This policy is consistent with CMS' restrictive National Coverage Determination and, rather than increase access, seems to only reinforce the idea that accelerated approval is “less than” traditional approval. BIO will continue to push for patient access to needed therapies.

'When courts challenge the FDA’s authority, they put patients’ lives at risk'

“The entire biotechnology and pharmaceutical industry will be thrown into turmoil if judges can second-guess the scientific expertise of the U.S. Food and Drug Administration,” writes BIO CEO Rachel King in Nature.

"In April 2023, U.S. District Court Judge Matthew Kacsmaryk not only allowed a legal challenge to FDA's approval of mifepristone, but also indicated that it was likely to succeed. The ruling generated immense controversy because the drug can be used to terminate pregnancies. But the implications of the judge's order, which the U.S. Supreme Court has temporarily blocked from taking effect, go far beyond the ongoing debate over reproductive rights," she continues.

Read the whole thing in Nature.

President Biden’s Friday: At 7pm ET, he’ll address the nation about the debt ceiling agreement. Later, he’ll attend the Friday Evening Parade at the Marine Barracks in D.C. Meanwhile, he’s expected to nominate former North Carolina health secretary Mandy Cohen for director of the Centers for Disease Control and Prevention (CDC), reports POLITICO. 

What’s Happening on Capitol Hill: Last night, the Senate passed 63-36 legislation to suspend the debt ceiling until after the 2024 election. The bill now goes to President Biden for signature.