Good Day BIO: CMS restricts coverage of Alzheimer’s drug

CMS released its unprecedented final coverage determination for a breakthrough Alzheimer’s drug—we have the details and why it’s an enormous setback for Alzheimer’s patients and a dangerous infringement on FDA’s autonomy. Plus, we mark the 50th birthday of APHIS. (683 words, 3 minutes, 24 seconds)

CMS restricts coverage of Alzheimer’s drug to patients in clinical trials

Medicare will cover a breakthrough Alzheimer’s drug Aduhelm only for participants in clinical trials, says the final national coverage determination—an “enormous setback for Alzheimer’s patients and an unprecedented and dangerous infringement on the FDA’s scientific autonomy and decision making,” says BIO.

The decision: “Medicare will cover monoclonal antibodies that target amyloid (or plaque) for the treatment of Alzheimer’s disease that receive traditional approval from FDA under coverage with evidence development,” says Centers for Medicare and Medicaid Services (CMS). “[F]or drugs that FDA has not determined to have shown a clinical benefit (or that receive an accelerated FDA approval), Medicare will cover in the case of FDA or National Institutes of Health (NIH) approved trials.”

To put it simply: For drugs with accelerated approval, “we are staying with the original decision, and saying that trials will be covered,” CMS Chief Medical Officer Dr. Lee Fleisher explained on a call yesterday. “If any of the drugs have shown a clinical benefit through the traditional approval pathway, there will be quick coverage.”

It’s unprecedented: “These coverage restrictions, including the distinction between accelerated approval and traditional approval, have never been applied to FDA-approved medicines for other disease areas,” said Biogen, the BIO member who developed Aduhlem.

The implication: “This overreach means an entire class of cures may never make it to market. Worse, it will have a chilling effect on innovation and future cures,” said U.S. Reps. Cathy McMorris Rodgers (R-WA) and Kevin Brady (R-TX).  

“CMS does not have the scientific expertise to do this critical work. While FDA has thousands of experienced scientists and clinicians, CMS has less than 30,” said BIO President and CEO Dr. Michelle McMurry-Heath. “In the end, CMS has actually made its initial proposal far worse and expanded the damage it will cause to many more patient populations and their loved ones.”

The background: Biogen’s Aduhelm is the first FDA-approved drug for Alzheimer’s in 20 years, and the first-ever disease-modifying treatment. Bipartisan Members of Congress as well as industry and patient groups are widely united against this decision.

Happy 50th Birthday, APHIS!

ICYMI, USDA’s Animal and Plant Health Inspection Service (APHIS) has been “safeguarding the health of American agriculture and natural resources” for 50 years now—here’s why we’re celebrating.

Founded on April 2, 1972, APHIS protects the health and welfare of U.S. plants and animals, working on issues like stopping invasive pests and diseases, and overseeing genetically engineered products. 

APHIS is key to pandemic preparedness. “Congress allocated $300 million to APHIS to strengthen our One Health capacity and develop an early warning system for SARS-CoV-2,” says APHIS Administrator Kevin Shea.

One Health is a public health approach that recognizes the links between human, animal, and environmental health—and it’s vital to stopping future disease outbreaks, in humans, animals, and even plants.

BIO works closely with APHIS to get biotech solutions to the market—including on a much-needed update to ag biotech regulations in 2020, which says certain GE plants with traits that could’ve been developed through conventional breeding do not require pre-market review.

Microbes are next—and we’ll be working with APHIS to ensure developers of GE microbes have a predictable and science-based regulatory pathway, too.   

P.S. Reminder: Monday, April 11 is the deadline to apply for the BBC StoryWorks project! We’re working with BBC StoryWorks to spotlight biotechnology solutions that are innovative, impactful and inclusive—demonstrating how biotech can help achieve vital climate targets, improve health, and foster a diverse culture of open science. Learn more about the project and how you can participate. 

More Agriculture and Environment News:

Nature: What the war in Ukraine means for energy, climate, and food
“Russia’s invasion has caused a short-term spike in prices, but could prompt a long-term shift towards sustainability.”

President Biden’s Friday: At 12:15 PM ET, he’ll deliver remarks with Judge Ketanji Brown Jackson, who was confirmed yesterday as the first Black woman to the Supreme Court.  

What’s Happening on Capitol Hill: The Senate confirmed Judge Ketanji Brown Jackson yesterday by 53-47, with Republican Senators Mitt Romney, Susan Collins, and Lisa Murkowski joining Democrats in voting to confirm. (CMS didn’t even have to wait for the Friday news dump.)