CMS decision is ‘back-door government medical rationing’

The Wall Street Journal Editorial Board weighs in on the recent CMS announcement regarding coverage of breakthrough Alzheimer’s drugs, and a new report on the rise in plastic pollution shows the need for biotech solutions. (643 words, 3 minutes, 12 seconds)

CMS Alzheimer’s decision is ‘back-door government medical rationing’

“President Biden says his Administration is leading the fight against Alzheimer’s disease, but at the same time it is restricting access to breakthrough treatments,” said the Wall Street Journal Editorial Board on Friday—and we agree.

ICYMI: Centers for Medicare and Medicaid Services (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.

CMS doubled down on the decision—announcing last week they would not reconsider the coverage decision.

“This is back-door government medical rationing,” says the Wall Street Journal Ed Board. “To justify its restrictions, CMS claimed that no large randomized controlled trial on anti-amyloid treatments had shown a ‘clear (non-conflicting) improved health outcome’ and that it could reconsider its position if one does. Well, now one has, yet CMS refuses to budge.”

There has been widespread opposition to the CMS decision—including from 74 House members (including 38 Democrats) and BIO.

The big picture: “Medicare rationing won’t stop at Alzheimer’s treatments. CMS last month proposed reducing payments for other drugs that win FDA accelerated approval in the future. These would likely include cancer therapies that shrink tumors in early trials, but whose survival benefits require more time to bear out,” concludes the WSJ Ed Board.

More reading: Aduhelm decision will ‘chill’ innovation, say BIO experts

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Flagship Pioneering: Flagship Pioneering Named to Fast Company’s Annual List of the World’s Most Innovative Companies for 2023
“Flagship Pioneering, the bioplatform innovation company, has been named to Fast Company’s prestigious annual list of the World’s Most Innovative Companies for 2023, ranking as the #5 most innovative company in North America…Many of the bioplatform companies Flagship has founded have invented entirely new modalities or therapeutic approaches, bred new plants, or introduced novel agricultural methods for measuring and rewarding carbon capture.”

Only 9% of plastic is recycled – but biotech has solutions

The first-ever Organization for Economic Cooperation and Development (OECD) Global Plastics Outlook says plastic pollution is rising—a sign we must deploy biotech solutions.

The key finding: Global plastic waste doubled from 2000 to 2019, with 50% ending up in landfill, 19% incinerated, and just 9% recycled, says the OECD.

What’s the source? While most pollution comes from macroplastics, “leakage of microplastics (synthetic polymers smaller than 5 mm in diameter) from things like industrial plastic pellets, synthetic textiles, road markings, and tyre wear are also a serious concern,” explains the OECD.

What should we do? “Reducing pollution from plastics will require action, and international co-operation, to reduce plastic production, including through innovation, better product design and developing environmentally friendly alternatives, as well as efforts to improve waste management and increase recycling,” concludes the report.

Biotech is already tackling innovation—developing sustainable, biodegradable bioplastics.

Here are a few BIO member examples:

• Danimer Scientific’s PHA looks and feels like plastic but is made with natural fermentation and biodegrades in soil and marine environments—and it’s already being deployed for candy wrappers.
• Geno (formerly Genomatica) produced a plant-based version of the chemical raw material HMDA, which makes materials ranging from nylon to coatings and adhesives.
• Virent makes biodegradable or compostable “drop-in” plastics from recycled carbon or crop waste.
• LanzaTech is capturing carbon from industrial emissions and fermenting it to make a raw material used by athletic clothing company lululemon.

Listen: Last year, an episode of the I am BIO Podcast explored biotech solutions to the microplastic problem—from microorganisms to art.  

President Biden’s Monday: Speaking at the International Association of Fire Fighters Legislative Conference in D.C.

What’s Happening on Capitol Hill: House Republicans are getting ready to bring their first major agenda item—“a marquee energy package”—to the House floor, with a goal of passage at the end of the month, reports POLITICO. Later this week, former CDC Director Dr. Robert Redfield will testify before a House Oversight Committee hearing on the origins of COVID-19.