Slimming the cost of obesity drugs

Medicare will likely choose the obesity drug semaglutide for price negotiation "within the next few years," according to a new analysis by the Congressional Budget Office. That could curb the cost of legislation requiring Medicare to cover obesity drugs, which would increase the chances of Congress actually passing such a bill.

My new story today lays out several uncertainties that make it difficult to project the cost to Medicare of covering obesity drugs, which the program is currently banned from doing. It's not clear how many more seniors would be eligible for obesity drugs if Medicare were to cover them for obesity because a significant share of obese patients also have conditions for which Medicare already covers the drugs. Medication adherence is another uncertainty, as is the timing of generic competition and the impact of better obesity drugs being approved.

However, the CBO was explicit in saying that it's not aware of research showing that obesity drugs would reduce spending in other parts of the health care system. Read more from me.

EVENTFUL

Today's the day: STAT Breakthrough Summit East

Weight-loss drugs: check. Patients: check. Health care investors: check. AI: check. CRISPER: check. Health equity: check.

STAT's latest conference in New York today has you covered on some of the most important and buzziest topics in health care. Learn about how GLP-1 drugs could curb all our pesky cravings and whether insurers will prevent us from getting drugs we need to keep want at bay. Or go to hear about patient influence over drug development and coverage. Ever hear of pharmacoequity? (I hadn't either.) Well, go to learn about what policymakers can do to provide Black and Latino patients equitable access to medicines.

There's still time to register for virtual attendance to today's event here.

DIAGNOSTICS

Congress to discuss another crack at lab-developed test regulation

The House health committee is holding a hearing today on lab-developed tests and how best to regulate them. Last September, the FDA announced its plan to start actively monitoring the lab-made diagnostics — which came after years of regulatory hot potato between the FDA and Congress. The FDA is getting ready to finalize that rule in the next few weeks, and no one in the lab industry is happy about it.

"I can't find a single stakeholder that thinks this is really the right way to go," Susan Van Meter, president of the American Clinical Laboratory Association told Lizzy Lawrence, STAT's devices reporter.

Van Meter will testify at the hearing, and her chief goal is convincing lawmakers to pick LDT-related legislation back up. Lawmakers came close in 2022 to passing a bill that would have enabled the FDA to actively regulate the tests through a more flexible, less costly framework. But the bill, called the VALID Act, was ultimately rejected by Republicans who sympathized with the labs in academic medical centers and hospitals that opposed the provision.

Patient advocates, meanwhile, are less concerned with the vehicle for regulation and more concerned about the tests being vetted in the first place. President of Friends of Cancer Research Jeff Allen said people should be confident in the accuracy of their test results, regardless of whether the test was developed in a lab or a manufacturing facility. Allen will also testify at the hearing today. He's open to Congress legislating on LDTs, but doesn't think that should mean abandoning the FDA's rule.

"I don't think the solution here is to simply turn a blind eye to regulation and allow for potentially inaccurate tests to be a part of the mix," Allen told Lizzy.

FDA

Chief Justice Roberts, meet 'Suicide Bunny Mother's Milk and Cookies'

The FDA insists it was right to tell the e-cigarete company Triton Distribution it couldn't sell vape juices with flavor names like "Suicide Bunny Mother's Milk and Cookies," "Jimmy The Juice Man Peachy Strawberry," and "Signature Series Mom's Pistachio" — and now it's asking the Supreme Court to back it up, my colleague Nick Florko reports.

The FDA's new petition comes in response to an earlier federal court ruling that forced the agency to re-review Triton's application, and more generally chided the agency's convoluted process for reviewing e-cigarette applications as "the regulatory equivalent of Romeo sending Mercutio on a wild good chase – and then admitting there never was a goose while denying he even suggested the chase."

The FDA says the ruling is especially concerning because that court ruled any e-cigarette company in the country can sue there as long as at least one local gas station sold their products, and agreed to join the lawsuit. As a result, vape companies nationally have been "flocking" to the sympathetic southern judges, the FDA warns in the brief, noting that it has won in legal battles over this same issue in seven other federal appeals courts.

The Supreme Court is under no obligation to take the case, but if it does, it could have monumental implications for the multi-billion dollar e-cigarette market, and millions of Americans who use some form of nicotine product. "What the court decides is going to affect the entire consumer marketplace in the United States for nicotine-containing products," said Cliff Douglas, the head of the Foundation for a Smoke-Free World.

BUDGET

The Becerra budget recap

Becerra returned to the hill Wednesday for a double-header of House hearings on the proposed 2025 budget. Sarah Owermohle sat through it so you didn't have to. As with last week in the Senate, lawmakers asked about the Change Health Care breach and the president's behavioral health plans. Some other highlights:

PBM problems. Asked about regulating PBMs, Becerra told lawmakers that HHS is "somewhat constrained by law" and would need transparency legislation and consumer protections (like those recently booted from the minibus package). He added: "If you talk to community pharmacists, they will say PBMs are the main reason why so many of them are going out of business."

Pandemic ripples. Republicans have been pushing for CDC reform, and on Wednesday brought up public frustrations and "serious lack of faith" in the agency. But some also asked why funding for the strategic national stockpile would remain flat in this budget, when by ASPR's own projections it'd need a significant bump to replenish the store. Becerra replied that the agency is working with the framework Congress gave and "making really hard decisions" — but of course, wouldn't say no to more SNS cash

Adding it up. GOP members were also displeased with the budget math, namely that some initiatives — like $1.4 billion for Biden's personal priority, the Cancer Moonshot, and $1 billion for a CDC adult vaccine program — were moved from discretionary to mandatory funding. That means they wouldn't be up for yearly allocations, but also that while discretionary funding went down this year, the overall proposed budget is still ballooning. Becerra said the move is because "the utility and value [of these programs] is well-known."

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What we're reading

New gene therapy, to be priced at $4.25 million, has already transformed children's lives, STAT
Trump, who regularly claims Biden is mentally unfit for president, avoids mentioning that his father Fred Trump Sr. had Alzheimer's. The Washington Post
Johnson & Johnson sues former employee for allegedly taking thousands of documents to a new job at Pfizer, STAT
Kentucky becomes the fourth state to let pharmacists substitute biosimilars for their brand-name counterparts without doctor permission, Inside Health Policy