With help from Megan R. Wilson

WALLET WALLOP: THE COST OF CARE — Scientists are heralding Eisai’s Leqembi and Lilly’s donanemab as the dawn of “the decade of Alzheimer’s,” and health wonks have started to suss out what this all may mean for the average older adult’s wallet.

Part B premium hikes? “We have every reason to believe there is going to be a bump as a function of this medication as well as other medications coming to the market that are very expensive,” Cheryl Damberg, a senior economist and director of the RAND Center of Excellence on health system performance, told Prescription Pulse.

Aduhelm, the Alzheimer’s drug from Biogen approved in 2021, initially caused Part B premiums to jump more than $20 in 2022 to about $170. But questions about the drug’s efficacy and limited Medicare coverage led to little uptake, prompting the Biden administration to cut premiums the following year.

But what about 2024? In March, Medicare’s Trustees estimated that Part B monthly premiums would rise from $164.90 to $174.80. After Leqembi’s approval, the Senior Citizens League — one of the largest older adult advocacy groups — estimated the drug would cause premiums to increase by an additional $5, bringing the total monthly cost to about $180.

But Leqembi’s rollout is expected to be slow, making it unclear when Medicare will bear the full effect of the drug that people are expected to take continually. “Geriatricians and neurologists are going to be relatively cautious because of … the potential for brain bleeds [as side effects] and also … the very modest effects,” Damberg said.

Eisai and Biogen estimated that about 10,000 people will be taking the drug by April 2024, but they expect 100,000 people to be on the drug after three years, which could mean the big premium spikes happen in 2025 or 2026.

Damburg and her colleagues have estimated that Medicare could end up spending $2 billion to $5.1 billion annually on Leqembi and the additional associated medical fees. In addition to Leqembi’s $26,000 price tag, the program will cover visits to neurologists, diagnostic PET scans and MRIs to monitor for brain swelling or bleeding — plus any treatments required to mitigate those effects. Coinsurance costs to patients would be more than $6,600 annually.

IT’S FRIDAY. WELCOME TO PRESCRIPTION PULSE. We’re thrilled to welcome our teammate Lauren Gardner back from parental leave!

Send news and tips to Katherine Ellen Foley ([email protected] or @katherineefoley), Lauren Gardner ([email protected] or @Gardner_LM) and David Lim ([email protected] or @davidalim or @david.a.lim).

TODAY ON OUR PULSE CHECK PODCAST, host Alice Miranda Ollstein talks with Kelly Hooper, who delves into what’s behind the spike in overdose deaths involving both cocaine and opioids over the past decade.

TIME FOR ADVISORY COMMITTEES TO EVOLVE — Peter Marks, director of the FDA’s Center for Biologics Evaluation and Research, thinks the agency’s independent expert panels must modernize to remain relevant as more gene and cell therapies emerge.

“It’s very challenging to give someone 100 pages and say, ‘Read this and become an expert on this,’ when they have, like, a week to do so,” he told our Robert King at a POLITICO live event Thursday. “It’s not because our advisers aren’t good, it’s because of the complexity of what we’re dealing with.”

Marks also noted that in the small field of rare diseases, finding panelists who don’t have ties to the industry in some way is a challenge.

However, he did not offer specific solutions to improve advisory committees.

POLITICO’s Ben Leonard has five takeaways from Robert’s talk with Marks and an ensuing panel discussion.

PANDEMIC PREP BILL ADVANCES — The Senate HELP Committee approved bipartisan legislation Thursday to reauthorize the Pandemic and All-Hazards Preparedness Act, which expires Sept. 30. Six Republicans voted with committee Democrats a day after the House Energy and Commerce Committee OK’d a narrower version along party lines.

The Senate panel also adopted an amendment from Sen. John Hickenlooper (D-Colo.) that would create an FDA program focused on reviewing new medical countermeasures for emerging pathogens.

OBESITY DRUG MAKERS RAMP UP LOBBYING — Novo Nordisk, the maker of Wegovy and Ozempic, which can be used for weight loss, hired lobbying and public affairs firm Subject Matter to persuade lawmakers to expand Medicare coverage for obesity drugs, Megan reports.

Last month, the company reported hiring law and lobbying firm Arnold & Porter Kaye Scholer, which employs former Rep. Ron Kind (D-Wis.), who sponsored a bill to expand coverage while in Congress, according to a disclosure form filed Thursday.

In January, Eli Lilly, maker of the drug Mounjaro, which is pending FDA approval for weight loss, hired Todd Strategy Group to work on the issue.

Meanwhile, lawmakers in the House and Senate reintroduced bipartisan legislation Thursday that would allow Medicare Part D to cover care and drugs for obesity.

FTC DOES ABOUT FACE — The Federal Trade Commission unanimously voted Thursday to disavow previous guidance opposing transparency requirements for pharmacy benefit managers as the agency continues to probe the industry.

The move comes as bipartisan legislation moves through Congress to require PBMs — the middlemen that manage prescription drugs for health insurers — to disclose more about how they do business.

The FTC is studying PBMs’ influence on the drug industry as pharmaceutical companies and lawmakers in both parties blame them for skyrocketing drug prices. The PBMs’ lobbying group has warned against any effort to compel disclosure of pricing information they say would harm their ability to negotiate with drugmakers for the best deals for consumers.

Carol Blackford has joined AdvaMed as executive vice president of payment and health care delivery. She was most recently policy director of the hospital and ambulatory policy group at the Centers for Medicare and Medicaid Services.

Covid changed Newt Gingrich’s mind about health research funding, Erin Shumaker reports for POLITICO.

One of Pfizer’s largest sterile injectable manufacturing sites in North Carolina was severely damaged by a tornado, Tyler Patchen reports for Endpoints News. FDA Commissioner Robert Califf tweeted that the agency is in talks with Pfizer and “following the situation closely.”

22nd Century is expanding distribution of its low-nicotine cigarettes in convenience stores in California, Florida, Kansas, Missouri and Texas, Richard Craver writes for the Winston-Salem Journal.