With Carmen Paun

A NEW ALZHEIMER’S THERAPY … AT WHAT COST? Less than a week after the FDA granted full approval to the first Alzheimer’s drug in more than two decades, concerns about its affordability and accessibility are spilling out into the open.

From Alzheimer’s advocacy groups to the chair of the Senate’s most powerful health care committee to independent drug value estimators, serious questions are being raised about how much and how many Alzheimer’s patients will be helped by Leqembi.

The $26,500-a-year drug, made by Eisai and Biogen, will be available to Medicare beneficiaries who enroll in a nationwide registry that will track their progress on the drug over time: That coverage is broader than it was when Leqembi had only accelerated approval from the FDA.

But drug-pricing experts have been quick to point out that the financial burden of the drug to patients and the federal government will be huge — and Bernie Sanders (I-Vt.), chair of the Health, Education, Labor and Pensions Committee, is unhappy and demanding more information from HHS Secretary Xavier Becerra.

Consider these statistics and estimates:

— $5,000: The annual co-pay Medicare beneficiaries will have to pay

— $8,900: The price the respected Institute for Clinical and Economic Review estimates the drug should cost annually given its modest cognitive decline benefits

— 6.7 million: The number of people living with Alzheimer’s in the U.S.

— 10,000: The number of patients Eisai estimates will be taking Leqembi by next April

— 100,000: The number of patients Eisai estimates will be taking the drug after three years

— $2.7 billion: Medicare’s projected spending on Leqembi if 100,000 beneficiaries receive the drug over the next three years, according to the Kaiser Family Foundation — significantly more than the $1.8 billion Medicare spent in 2021 on a bone-density drug that is the third most expensive drug under the program’s Part B prescription coverage

— $17.8 billion: Medicare’s projected spending on Leqembi if just 10 percent of those living with the disease take the drug, which is more than the $15.9 billion Medicare spent in 2021 on the top 10 drugs covered under Part B.

“A prescription drug is not effective if a patient who needs that drug cannot afford it,” Sanders wrote in a letter Monday to Becerra.

Sanders demanded that Becerra answer several of his questions about Leqembi’s estimated cost for older adults and Medicare — and noted that if he does not receive a response by July 21, he’ll instead invite the HHS secretary to testify before the HELP Committee.

IT’S TUESDAY. WELCOME TO PRESCRIPTION PULSE. Hoping everyone stays safe with the severe weather on the East Coast this week.

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

TODAY ON OUR PULSE CHECK PODCAST, host Ben Leonard talks with Megan R. Wilson, who breaks down what lies in store for lawmakers returning from their July recess — with only 11 legislative days before their next. Expect high policy aspirations and partisan gridlock as deadlines approach for must-pass health care legislation.

SESHAMANI WEIGHS IN ON BONA FIDE MARKETING — At a roundtable Monday, CMS Deputy Administrator Meena Seshamani addressed how the agency will implement Medicare drug price negotiations this year, including what criteria the agency might use to determine whether a drug has a generic competition.

If a drug has generic competition, it can be excluded from the list of drugs CMS will select for drug price negotiations later this year and in the future. Seshamani seemed to imply that CMS will want to make determinations for exemptions case by case.

“The various drugs all have nuances to them, the markets are different, the patient populations are different, the combinations of different drugs that may be utilized are different,” Seshamani said.

The topic was part of a discussion on lowering prescription drug prices for older adults hosted by nonprofit Protect Our Care that also featured executives from AARP and the Brookings Schaeffer Initiative.

The criteria discussion was partly sparked by a new article in The New England Journal of Medicine in which academics argued that CMS must more clearly define what counts as so-called bona fide marketing of a generic or biosimilar drug; in short, a term that describes how much market share and over what time period a generic or biologic gains after FDA approval. The metric is important to track, the article’s authors argue, saying that some brand-name drugmakers could try to avoid Medicare negotiations by saying their drugs face generic competition “that is largely illusory.”

The researchers suggested that CMS consider defining a threshold of 50 percent market share after one month of availability for generic drugs in Medicare Part D to “ensure that only drugs with meaningful generic competition are exempt from price negotiation.”

“The various drugs all have nuances to them, the markets are different, the patient populations are different, the combinations of different drugs that may be utilized are different,” Seshamani said.

WHERE HAVE ALL THE AD COMMS GONE? The FDA is reviewing more and more complex drugs than ever before. And yet, in the past decade, the agency has held far fewer public meetings of its independent expert advisers.

In 2021, the number of meetings of FDA outside expert panels for human drugs was less than half of what it was in 2010, a new Harvard study found.

The work, published in JAMA Health Forum, found that over the 11-year span studied, there were 409 advisory committee meetings for drugs.

The meetings are one of the few opportunities the public has to hear deliberations about a product under FDA review before an approval decision is made.

“The role of advisory committees in the current regulatory landscape should be more clearly and publicly defined,” the study authors concluded, echoing a sentiment they and other public health experts have shared before. The authors believe the transparency of ad comm meetings would improve public trust in the FDA.

There’s a difference between when advisers positively and negatively review a candidate, according to an accompanying commentary by Genevieve Kanter, an associate professor of public policy at the USC Sol Price School of Public Policy. When the committee voted in favor of approval, the FDA agreed 97 percent of the time. But when advisers recommended against approval, the FDA followed their advice only 67 percent of the time.

“The FDA appears to have been looking for reasons to approve drugs,” Kanter said, which may erode public trust in the drug approval process.

The FDA wouldn’t comment on the study but said generally that while it views the ad comm discussions to be a useful resource, ultimately, career staff make approval decisions. “The FDA continues to explore ways to improve its advisory committees to ensure the agency gets timely and sound advice from these committees and will communicate any updates when available,” said Michael Felberbaum, an FDA spokesperson.

PLANS FOR COVID VAX COMMERCIALIZATION — Early guidance from the CDC said that, by Aug. 3, the federal government will stop ordering Covid-19 vaccines as part of transitioning the shots to the commercial market.

Providers can still work with the feds for vaccine purchases if needed, but the CDC anticipates that new fall boosters due out later this year will be available through doctors, clinics and insurers as vaccines were pre-Covid.

The agency expects the FDA to make authorization decisions in mid- to late September on new boosters based on the XBB.1.5 variant, followed by recommendations from the CDC.

MORE MENTHOL VAPE AUTHORIZATIONS DENIED — The FDA’s Center for Tobacco Products issued marketing denial orders Monday for myBlu menthol e-cigarettes. MyBlu is a major e-cigarette brand; its parent company, Imperial Brands, is valued at around $20 billion.

The agency said the company did not provide enough evidence that its menthol vapes would benefit adult smokers more than tobacco vapes that have already been authorized.

Tennessee’s ban on gender-affirming care to minors went into effect this past weekend after a decision from the U.S. Court of Appeals for the Sixth Circuit, POLITICO’s Lucy Hodgman reports.

Old lead-covered cables laid by telecom companies are leaching toxic heavy metal into soil and water supplies in some parts of the country, according to an investigation by The Wall Street Journal’s Susan Pulliam, Shalini Ramachandran, John West, Coulter Jones and Thomas Gryta.

The FDA laid out details for its planned transition to electronic transmission from paper export documents for medical devices, which starts in 2024.