News : Axios Vitals: New drug limits

Friday, April 8, 2022

Axios Vitals: New drug limits

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Presented By PhRMA

Axios Vitals

By Tina Reed · Apr 08, 2022

Happy Friday, Vitals readers. Today's newsletter is 940 words or a 3½-minute read.

🚨 Situational awareness: Michael Neidorff, the longtime CEO of Centene credited with building the company from a small regional insurer to a powerhouse in government-back insurance, died on Thursday, the Wall Street Journal reported.

👂 Tell us your story: Have you suffered from the symptoms of long COVID? We want to hear your story. Hit reply to this email to contact me.

1 big thing: Aduhelm limits spur questions on Medicare's process

Illustration: Brendan Lynch/Axios

The Biden administration's decision Thursday to offer limited Medicare coverage for Biogen's controversial Alzheimer's drug Aduhelm raises questions about what's ahead for other new and costly drugs.

Driving the news: CMS announced Medicare will cover Aduhelm, but will limit the coverage to patients enrolled in a clinical trial in order to access the drug.

Those patients must also have mild rather than advanced symptoms and show evidence of a build-up of amyloid plaques in the brain, which is one of the hallmarks of the disease.
The class of drugs Aduhelm is part of will be subject to similar conditions unless they're approved through the FDA's traditional drug approval pathway.

What they're saying: "There is potential for promise with this treatment. However, there's not yet enough evidence of clinical benefit to say it is reasonable and necessary for people with Medicare," CMS chief medical officer Lee Fleisher said in a call with reporters.

State of play: The move angered Biogen and advocacy groups, who say the unprecedented requirement would unfairly block access for most patients.

But the restrictions won praise from others in the medical community who said guardrails were appropriate given the major concerns about this drug.

Catch up quick: Aduhelm received "conditional" approval from the FDA in June with the requirement that further trials show the drug slows cognitive decline.

It's been the center of an intense lobbying battle in recent months, as well as congressional debates over the FDA's "accelerated approval" process.

What they're saying: "The big question will be 'Is this really just CMS talking about one class or is CMS going to expand this out and consider this for accelerated approval for other drugs?'" Chris Meekins, a former HHS official who is now an analyst at Raymond James, tells Axios.

"I continue to believe this is a special case and this won't become a broader policy for drugs that receive accelerated approval," he says.

Go deeper.

2. ACA subsidy cliff hits Southern states hardest

Data: Urban Institute Health Insurance Policy Simulation Model 2022; Cartogram: Jacque Schrag/Axios

A disproportionate share of young adults, low-income people, Black Americans and residents of Southern states will lose health coverage if Congress doesn't extend enhanced ACA subsidies, Axios' Caitlin Owens writes about a new analysis from the Robert Wood Johnson Foundation.

Why it matters: The analysis estimates that 3.1 million Americans would become uninsured when the subsidies expire beginning next year, and millions more would face much higher premiums than they currently pay. But those effects wouldn't be felt evenly across the country.

The big picture: Democrats' coronavirus relief package last year made ACA subsidies more generous and expanded who was eligible for them, but only temporarily.

Millions more people have entered the ACA marketplaces as a result. But Democrats' efforts to extend the subsidies have stalled in the Senate, along with the rest of President Biden's domestic agenda.

What we're watching: Insurers calculate premiums months before open enrollment begins in November.

That means that if the tax credits aren't extended in the first half of this year, insurers may not have time to adjust their premiums accordingly.

3. U.S. life expectancy drops ... again

Illustration of a red cross being torn in half.

Illustration: Gabriella Turrisi/Axios

The average U.S. life expectancy has fallen by more than two years in 2020 and 2021, according to a new study, not yet peer-reviewed.

By the numbers: There was a historically high drop in estimated life expectancy in 2020, from about 78.9 years in 2019 to 77 years in 2020, a fall of 1.9 years, the study led by University of Colorado Boulder found.

Life expectancy dropped by another 0.4 of a year in 2021, they found, leading to a net loss of 2.26 years over the two-year period.
In comparison, a collection of 19 peer countries averaged a 0.4 year decrease in life expectancy between 2019 and 2020 and a 0.28 year increase between 2020 and 2021, with a net loss of 0.3 years over the two-year period.

A message from PhRMA

Insured Americans face barriers to care

Nearly half of insured Americans who take prescription medicines encounter barriers that delay or limit their access to medicines.

Learn more about the abusive insurance practices that can stand between patients and the care they need in PhRMA's new report.

4. Black Americans' trust in medicine relatively high, survey says

Black Americans are emerging from the pandemic with relatively high confidence in the U.S. medical establishment, but with lingering concerns that they're underrepresented in health care and STEM jobs, Axios' Adriel Bettelheim writes.

Driving the news: A Pew Research Center survey of 3,456 Black adults found trust in medical scientists is greater than for other groups and institutions, including the military, religious leaders or public school principals.

But many Black Americans still view science and health disciplines as less inclusive than other segments of society like sports and music.

Go deeper: 78% of Black adults said they have either a great deal or a fair amount of confidence in medical scientists to act in the public's best interests.

But Black Americans also are more concerned as a group about the prospect of research misconduct, and highly aware of historical wrongs.

Getting personal: Black Americans' personal experiences with medical care also were mixed, though 61% gave their health care provider excellent or very good marks for care they've received recently.

55% had at least one negative experience with health providers in the past, like having to speak up to get proper care or that the pain they were experiencing was not being taken seriously.
Younger Black women ages 18 to 49 were much likelier to have had at least one negative experience with routine care in the past and prefer to see a Black health provider.

5. Dog of the week

Nola. Photo courtesy of Sarah Langford

Meet Nola, a Boston Terrier named after New Orleans, Louisiana.

With it being baseball's opening week, it seemed appropriate to feature this four-legged fan of the Houston Astros.
She "gives a stink face anytime anyone brings up the trash can scandal," says her human Sarah Lanford.

Want your pup to be featured as a dog of the week? Send me an email with the cutest photo you've got and some details about them, and they could become Vitals' famous.