Wednesday, May 3, 2023

Fentanyl’s deadly, uneven toll

Presented by PhRMA: Delivered daily by 10 a.m., Pulse examines the latest news in health care politics and policy.
May 03, 2023 View in browser
 
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By Krista Mahr and Daniel Payne

Presented by

PhRMA

With Katherine Ellen Foley, Robert King, Alice Miranda Ollstein and Megan R. Wilson 

Driving the day

Folded hands are pictured.

Black Americans have been hit particularly hard by deadly fentanyl overdoses. | Brynn Anderson/AP Photo

A 279 PERCENT SPIKE — The CDC released a report today showing that fentanyl death rates skyrocketed 279 percent between 2016 and 2021, and communities of color have been disproportionately impacted by the rise, Krista reports.

The impact: As fentanyl flooded the U.S., more Black Americans died from fentanyl overdoses than from any other drug in 2021 and at far higher rates than white or Hispanic Americans. The CDC report found that American Indian or Alaska Native individuals had the highest rate of fentanyl overdose deaths of any racial or ethnic group that year.

How we got here: Social isolation, economic stress and being cut off from substance use treatment affected hundreds of thousands of Americans during the pandemic; opioid overdose deaths helped push America’s life expectancy in 2021 to its lowest level since 1996.

But the crisis is most acute in communities with the fewest resources. Decades of discriminatory drug policies, underfunded treatment and racism in the medical field make it exponentially harder for Black patients, in particular, to get help, even as this deadly new substance has infiltrated the illicit drug supply chain, experts said.

“The seesaw was already tipped to the wrong side,” Jerome Adams, who was surgeon general during the Trump administration, said in an interview. “We were barely holding it up prior to the pandemic, and then it just completely tipped — particularly for communities of color.”

What’s being done about it: The Biden administration emphasized improving equity in drug treatment in the National Drug Control Strategy released last year and has ramped up funneling more resources into the mental health crisis laid bare during the pandemic.

It has pledged to crack down on fentanyl trafficking at the U.S.-Mexico border and taken steps to loosen some restrictions that had made it so hard to get treatment as the fentanyl crisis escalates.

“Improving racial equity — including in drug policy — has been a principle of the Biden-Harris Administration since the very beginning, and it’s guided our historic work to remove barriers to evidence-based treatments like methadone and buprenorphine, expand access to life-saving services like naloxone, and prevent drug use before it begins,” Alex Barriger, a spokesperson for the Office of National Drug Control Policy, said in a statement to POLITICO.

“We will continue to work to beat the opioid crisis and ensure everyone who needs treatment for substance use disorder can get it.”

WELCOME TO WEDNESDAY PULSE — Think plant milk is healthier than dairy or that white potatoes are bad for you? Not true, nutritionists say. And here are eight other food myths they wish people would get over. Send your favorite misconceptions, news and tips to dpayne@politico.com.

TODAY ON OUR PULSE CHECK PODCAST, host Megan Messerly talks with Krista Mahr, who breaks down a new CDC report that finds more Black Americans died from fentanyl overdoses than from any other drug in 2021 and at far higher rates than white or Hispanic Americans. Krista explains how the pandemic, health inequities and other factors have contributed to the rise in overdose deaths in Black communities.

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A message from PhRMA:

PBMs control your health care. Pharmacy benefit managers (PBMs) decide if medicines get covered and what you pay, regardless of what your doctor prescribes. They say they want lower prices, yet they often deny or limit coverage of lower-cost generics and biosimilars, instead covering medicines with higher prices so they make more money. This business model allows PBM profits to soar and can lead to higher costs for everyone. What else are they hiding?

 
In Congress

Bill Cassidy. Photo credit: Francis Chung/E&E News

The Senate HELP Committee has delayed its hearing to consider legislation aimed at lowering drug costs after Sen. Bill Cassidy voiced concerns about amendments to the package. | Francis Chung/E&E News

‘ARE WE ALL HAPPY?’ The Senate HELP Committee’s effort to lower drug prices was derailed Tuesday and postponed amid allegations of reneging on agreements made while crafting the package, Megan reports.

The committee’s ranking member, Sen. Bill Cassidy (R-La.), blamed Chair Bernie Sanders (I-Vt.) for upending what had been negotiated and failing to share key documents, including technical assistance from the FDA, with Republicans until right before the hearing.

“At some point, process matters,” Cassidy said, “and I’m sorry to be a skunk in the room.”

Sanders pushed back with Cassidy’s characterization.

Among Cassidy’s major points of contention were a number of allegedly last-minute bipartisan amendments from Sen. Maggie Hassan (D-N.H.) to the RARE Act.

The amendments, which will likely be part of the discussion moving forward, aim to impact access to cheaper generic drugs — including one that would help bring products to the market faster by allowing the FDA to give generic drugmakers information about where its ingredients differ from their brand-name counterparts.

Other members — including Sen. Tim Kaine (D-Va.) — wondered aloud whether it would be best to push the hearing back until top executives at big drugmakers and pharmacy benefit managers — the pharmaceutical middlemen that negotiate drug discounts with drugmakers and design prescription drug benefits for health plans — appear before the panel on May 10. After a prolonged, mostly private debate in which Majority Leader Chuck Schumer was consulted, Sanders agreed to move the date to May 11.

“Are we all happy?” joked Sanders. Despite the disagreements during the hearing, he added, “All of us want to accomplish important goals, so let’s go forward together.”

 

GET READY FOR GLOBAL TECH DAY: Join POLITICO Live as we launch our first Global Tech Day alongside London Tech Week on Thursday, June 15. Register now for continuing updates and to be a part of this momentous and program-packed day! From the blockchain, to AI, and autonomous vehicles, technology is changing how power is exercised around the world, so who will write the rules? REGSITER HERE.

 
 
Abortion

GREENLIGHT FOR GENERIC ABORTION PILL SUIT — A judge in West Virginia has denied the state’s motion to dismiss a lawsuit by the maker of the generic version of the abortion pill mifepristone, allowing the pharmaceutical company’s challenge to state restrictions on the drug to proceed, Alice reports.

GenBioPro’s CEO cheered the decision in a statement, arguing that it proves “there is nothing hypothetical about our company’s affirmations that our medication would be available to a wider market in West Virginia if not for the state’s unlawful abortion ban and restrictions.”

The case is one of two challenging state curbs on the pill as illegally interfering with federal regulations that allow broad access.

WYDEN REIGNITES FEUD OVER ‘GHOST NETWORKS’ — Senate Finance Committee staff released a “secret shopper” study on Wednesday that showed most Medicare Advantage mental health provider directories had misleading or false contact information, Robert reports.

The study was released ahead of a hearing the committee is holding Wednesday on the prevalence of such “ghost networks” in Medicare Advantage.

What was in it: Finance majority staff examined mental health provider directories across 12 different plans in six states. Staff members contacted 120 providers in the directory and found that more than 80 percent of the listings were either inaccurate or unavailable. For instance, 39 listings didn’t have a working number, didn’t return a call or had an incorrect number. Another 22 calls were to providers that weren’t taking new patients.

Sometimes when staff members could get through, they reached a different mental health provider than listed. In one instance, a receptionist at a facility told the staffers that the provider had notified the plan multiple times they weren’t in the service area.

Wyden’s mission: Sen. Ron Wyden (D-Ore.) has railed against “ghost networks” before, arguing that Medicare Advantage plans aren't doing enough to ensure access to mental health services.

CMS has taken some action to address provider directories. The agency finalized a payment rule last month that requires plans to include providers’ cultural and language capabilities in their directories as part of an effort to bolster health equity in the program.

 

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At the Agencies

LILLY TO ASK FOR ALZHEIMER’S DRUG APPROVAL — Drugmaker Eli Lilly said today that topline results of its Phase III study of donanemab, the company’s anti-amyloid Alzheimer’s candidate, showed that 47 percent of patients who received the drug showed no cognitive decline after a year compared with 29 percent of those who took the placebo, Katherine reports.

Donanemab also slowed disease progression by 35 to 40 percent compared with a placebo, according to various measures of cognitive decline. The company said it would work quickly to ask the FDA to approve the drug.

The FDA denied Lilly’s bid for accelerated approval in January because not enough study participants had taken the drug for a full year in the company’s Phase II trial.

What’s next: In addition to asking the FDA for approval, the company plans to present the full results of its Phase III trial at the Alzheimer’s Association International Conference in July.

 

DON’T MISS THE POLITICO ENERGY SUMMIT: A new world energy order is emerging and America’s place in it is at a critical juncture. Join POLITICO on Thursday, May 18 for our first-ever energy summit to explore how the U.S. is positioning itself in a complicated energy future. We’ll explore progress on infrastructure and climate funding dedicated to building a renewable energy economy, Biden’s environmental justice proposals, and so much more. REGISTER HERE.

 
 
What We're Reading

The Wall Street Journal reports why patients are losing access to free medicines amid a drugmaker squabble.

KFF reports on the new programs in rural areas bringing paramedic care into people’s homes.

Bloomberg reports how scientists use lessons from Covid-19 to track bird flu mutations.

 

A message from PhRMA:

Middlemen like PBMs are charging fees tied to the price of medicines, which means they make more money when the price of a medicine goes up. This business model allows PBM profits to soar and can lead to higher costs for patients. It’s time to break the link between PBM fees and medicine prices.

 
 

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