CMS doubles down on troubling decision to limit coverage of Alzheimer’s drugs

CMS reaffirms its decision on coverage of breakthrough Alzheimer’s drugs—here’s what they said. Plus, we popped into USDA’s Agricultural Outlook Forum yesterday where we heard Secretary Vilsack’s views on SAF and what the administration’s thinking about Mexico. (539 words, 2 minutes, 41 seconds)

CMS doubles down on troubling decision to limit coverage of Alzheimer’s drugs

Centers for Medicare and Medicaid Services (CMS) announced the decision yesterday in response to a petition from the Alzheimer’s Association.

ICYMI: Last year, CMS decided Medicare would cover monoclonal antibodies targeting amyloid plaque for the treatment of Alzheimer’s only if they have received traditional approval from the U.S. Food and Drug Administration (FDA); drugs receiving Accelerated Approval would only be covered for patients in clinical trials.

Why it matters: This determination, which came following the Accelerated Approval of the breakthrough drug Aduhelm, was an “enormous setback for Alzheimer’s patients and an unprecedented and dangerous infringement on the FDA’s scientific autonomy and decision making,” according to BIO.

CMS reaffirmed the decision yesterday: “At this time, CMS is not reconsidering the national coverage determination (NCD) for Food and Drug Administration (FDA)-approved monoclonal antibodies directed against amyloid for the treatment of Alzheimer’s disease,” said CMS. “If a monoclonal antibody directed against amyloid for the treatment of Alzheimer’s disease subsequently receives traditional FDA approval, CMS will provide broader coverage using the framework we announced last year.”

The impact: The CMS decision severely restricts patient access to two FDA Accelerated Approvals for breakthrough Alzheimer’s drugs—Aduhelm and LEQEMBI—the first in 20 years. These restrictions could lead to “less investment in certain areas,” as BIO’s Chief Policy Officer John Murphy explained.

More reading: Report shows Accelerated Approval’s value in money and lives

USDA Agricultural Outlook Forum: SAF, carbon markets, and Mexico

Speaking at the U.S. Department of Agriculture’s 99th Agricultural Outlook Forum yesterday, Agriculture Secretary Tom Vilsack promoted efforts to increase farm income with climate-smart agriculture, sustainable aviation fuel, and bio-based products.

What USDA’s doing: The $3 billion Partnership for Climate-Smart Commodities supports 141 projects piloting ways to “de-risk our farmers from embracing climate-smart practices by turning those practices into profits,” said Secretary Vilsack in his keynote.

One key tool: opening carbon markets through the Growing Climate Solutions Act, said Vilsack. The legislation, supported by BIO and passed as part of last year’s omnibus spending package, tasks USDA with opening carbon markets to more farmers and foresters.

The role of bio-based products: Vilsack mentioned USDA support for projects that develop bio-based products, like an asphalt substitute made from soybeans, noting USDA’s BioPreferred program promotes these products. (BIO backs that program and wants it strengthened.)

“The best example I can give you is sustainable aviation fuel,” he said when describing government support for bio-based products made from agricultural feedstock. “This is a whole new industry that hasn’t existed,” with demand for 36 billion gallons.

Any update on Mexico? “While I don’t have any news to share this afternoon,” said Chief Ag Negotiator Doug McKalip during a later session, “we have been looking at this very closely, working very tirelessly, and if it’s not something that can be resolved through the discussions we’re having, certainly there are all options on the table in terms of utilizing…tools in the [U.S.-Mexico-Canada Agreement].”

USDA’s Agricultural Outlook Forum continues today, with sessions on climate-smart practices, tools for climate adaptation, and equity and inclusion.

President Biden’s Friday: Holding a virtual meeting from the White House with G7 Leaders and Ukrainian President Zelensky “to continue coordinating our efforts,” CNN reports.

What’s Happening on Capitol Hill: The House is quiet. The Senate Armed Services Committee has a hearing on the war in Ukraine.