Good Day BIO: An exclusive look at the impact of the Aduhelm decision

ICYMI: CMS announced they’ll only cover a breakthrough Alzheimer’s drug for patients in clinical trials. In a new exclusive, we talk to BIO experts about the impact. Also, today’s new episode of the I am BIO Podcast talks to two people who helped a flight powered by 100% SAF take off. (753 words, 3 minutes, 45 seconds)

BIO Exclusive: Aduhelm decision will ‘chill’ innovation

How will the Centers for Medicare & Medicaid Services (CMS) final coverage decision for a breakthrough Alzheimer’s drug affect patients and investment? We spoke to two BIO experts to find out. 

ICYMI: CMS announced they would restrict coverage of an FDA-approved Alzheimer’s drug to patients enrolled in clinical trials—click here to catch up.

This will significantly influence future innovation and investments in novel therapies,BIO experts exclusively told us.

On an institutional level, the main message “is that CMS doesn’t believe the scientific determinations of FDA,” said BIO’s Chief Policy Officer John A. Murphy III. “The market would take that as a signal that future access to certain innovative new products may suffer similar problems,” possibly leading to “less investment in certain areas.”

It’s a “significant departure, a significant change” in the way CMS has always operated, added Crystal Kuntz, BIO VP of Healthcare Policy & Research. “They essentially made a national non-coverage decision.”

And it’s “precedent-setting” for future drugs with accelerated approval, Kuntz warned. “The rest of the market is left without any guidance from CMS as to when it will usurp the FDA’s scientific determinations and will supplant its own. So, it is a demonstrably chilling impact on future innovations,” Murphy said.

So, what now? A complete reversal is unlikely, per Kuntz—but there are many avenues, both politically and patient-driven, to try to prevent anything like this from happening again. Furthermore, CMS should be made to clarify its position, said Murphy—including defining the evidence it is going to require before it decides “to remove this NCD.” 

Read and share our exclusive story at Bio.News.

Watch and share BIO’s Chief Policy Officer John Murphy on the CMS decision

More Health Care News: 

International Business Times (Opinion): How to really close the global vaccine gap
“[T]he problem isn't a lack of vaccines themselves. Rather, a combination of vaccine hesitancy and regulatory, infrastructure, and logistical barriers are to blame for low inoculation rates,” writes BIO President and CEO Dr. Michelle McMurry-Heath. 

The Dallas Morning News (Opinion): U.S. medical progress is in jeopardy
“Attempts to undermine public-private partnerships could erode the financial foundation of R&D,” writes Victoria Ford, President and CEO of the Texas Healthcare and Bioscience Institute.

SAF is safe and can reduce emissions up to 85% – how do we help it take off?

In December, a United Airlines flight from Chicago to Washington DC was the first-ever passenger flight powered by 100% sustainable aviation fuel—demonstrating the potential for aviation to reduce its carbon footprint. In the new episode of the I am BIO Podcast, we hear from two people who helped make it happen and how we help this fuel take off.

First, why it matters: “When it comes to transportation, commercial air travel is one of the fastest growing sources of greenhouse gas emissions,” says BIO’s Dr. Michelle McMurry-Heath. “Since 1990, carbon emissions from commercial air travel have increased by more than 22%. By comparison, the military has decreased its aviation greenhouse gases by 66% during the same period.”

Enter sustainable aviation fuels, which can “reduce emissions up to 85%, with promise through technology to really reduce the emissions beyond, up to 100%,” says United Airlines’ Chief Sustainability Officer Lauren Riley.

Right now, aircraft are only allowed to use up to 50% SAF—but “what we demonstrated on that flight…is that you can safely fly using 100% sustainable aviation fuel in your engine and performs exactly the same as fossil jet fuel,” she explains.

Read: World’s first passenger flight with 100% renewable fuel takes off—thanks to biotech

So, how did they do it? With a product from Virent, the BIO member converting sugars into “fuels and chemicals no different than what you see out of a petroleum refinery today,” explains Virent President and General Counsel Dave Kettner. The flight “proved that you don’t need to change the aircrafts or the fueling industry, because there is the possibility of providing a 100% drop-in sustainable aviation fuel.”

Now, we need policy solutions—like low-carbon fuel standards which stimulate “the kind of supply we need,” says Riley, as well as SAF tax credits to incentivize suppliers to “create the kind of fuels that we need that can truly pull the carbon out of flying.”

Listen: Click here to stream the episode or listen via Apple, Google, Spotify, or wherever you get your podcasts.

President Biden’s Tuesday: The day begins with a video call with allies and partners to discuss Ukraine. Then, visiting the New Hampshire Port Authority at Portsmouth Harbor, where he’ll deliver remarks on the Bipartisan Infrastructure Law at 2:45 PM ET.

What’s Happening on Capitol Hill: Recess.