A new backdoor way to get Wegovy

wegovy

Steffen Trumpf/picture alliance/Getty Images

As we've reported over and over, Congress has made virtually no progress on allowing Medicare to cover new, buzzy anti-obesity medications. But an FDA decision last week could give more Medicare patients access to the drug anyway, I write in a new story out today.

The FDA's decision to allow Novo Nordisk to market Wegovy's benefits to prevent heart disease means that Medicare plans could decide to cover the drug, which is already covered for diabetes under the name Ozempic, for a wider population.

The coverage expansion likely won't happen overnight, as plans deliberate whether to cover the medication and potentially work to negotiate discounts. But if more patients do get access over time, that could also make legislation to allow Medicare to cover obesity treatments cheaper and more attractive to lawmakers, too. Read more on what we know about what's next, and what the decision could mean for the Medicare program.

influence

BIO and WuXi part ways

BIO announced yesterday that it is separating from WuXi in the face of increasing U.S. government scrutiny of it and other Chinese companies, my colleague John Wilkerson reports.

It's an about-face for a lobbying organization that recently was willing to defend WuXi against attacks, and it's a sign that the U.S. biotechs will have to make do without a company they have come to heavily rely on for developing and making drugs.

BIO CEO John Crowley, who started in that position last week, said BIO is cutting ties with WuXi to "reaffirm the organization's position with regards to national security and the role that the industry plays as a vital strategic asset."

2024 budget

Budget austerity doesn't bring friends

Biden's proposed 2025 budget for the FDA, despite a slight bump, doesn't give the agency nearly enough to modernize its programs and IT, a group lobbying for the agency's authorities is warning Congress.

The health department's $130.7 billion budget proposal for FY 2025 would keep spending pretty flat across a range of agencies and programs, including the FDA, my co-author Sarah Owermohle writes. And while HHS proposes a $168 million increase — a 5% hike — for the FDA, most of that would funnel to salary increases, Steve Grossman, director of the Alliance for a Strong FDA, said in a statement. The Alliance plans to ask Congress for more funds focused on modern IT and data management and programs "that will keep the agency on pace with increasingly-sophisticated technologies and societal needs," he added.

Asked about the relatively small proposed increase, FDA Commissioner Rob Califf told reporters Monday, "Of course, we always like to have more money. But, I guess the short answer is we're glad to have a budget." He also alluded to coming technological challenges: "...If you look at gene editing and artificial intelligence and all the things we've got a tremendous amount of work. "

Stay tuned: HHS Secretary Xavier Becerra testifies on the spending proposal before the Senate Finance committee this morning. It's his first in what is likely to be a run of congressional appearances selling Biden's 2025 budget vision.

capitol hill

Pressing the press on PBMs

Leaders of the Senate Finance Committee will kick off the morning today with a public plea to attach legislation to reform how pharmacy benefit managers operate to Congress' next tranche of government funding bills that has to pass by March 22 to avert a government shutdown.

There have also been sign-on letters circulating in both the House led by Reps. Debbie Dingell (D-Mich.) and Buddy Carter (R-Ga.) and in the Senate led by Sens. Jon Tester (D-Mont.) and James Lankford (R-Okla.) asking for action on PBM reform.

From where we sit today, appealing to the public for help building pressure and circulating letters with eight days before the deadline isn't necessarily an indication of impending action. Several sources following the talks don't expect another health care package to advance this month. And some of the major sticking points over PBM reform have to do with the commercial market, which doesn't have anything to do with Sens. Ron Wyden (D-Ore.) or Mike Crapo (R-Idaho).

That being said, we never say never around here. Keep John in the loop at john.wilkerson@statnews.com.

white house watch

Neera, Neera, on the wall, what's the fairest policy of them all?

Neera Tanden, the White House's Domestic Policy Advisor, knows that President Biden has an awareness problem with voters on his Medicare drug price negotiation program. But when POLITICO's Eugene Daniels asked her what the White House is doing to bring more awareness to the issue at the publication's Health Care Summit on Wednesday, she flipped the question around.

"Perhaps we could get more coverage for our health care accomplishments," she said. (For the record, we are out here writing as much as we can, Neera!)

But once she moved past that jab, she said that the awareness gap was one of the reasons that President Biden targeted the pharmaceutical industry in his State of the Union address. She also said that voters are more likely to focus on the stakes of an election during an election year, and contrasted Biden's health care stance with former President Trump's statements criticizing the Affordable Care Act. Tanden also dodged questions about the timing of a forthcoming menthol cigarette ban, just saying that it was a big and complicated rule.

FDA Principal Deputy Commissioner Namandjé Bumpus also appeared. She dodged a question about her aspirations to lead the agency: "I'm a civil servant, so I'm here to serve in any capacity," she said.

And former Trump adviser Kellyanne Conway mentioned health care issues voters care about as including coverage, access, reliability, affordability, transparency, the cost of prescription drugs, the cost of long-term care for loved ones, surprise billing, and coverage for drugs like obesity treatments and insulin.

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