| | | |   | Happy Thursday, D.C. Diagnosis readers! We’ve got a jam-packed issue today that I’m excited to share. Before that, mark your calendars for an opportunity to hang out with the STAT team and meet fellow readers at our D.C. happy hour next Friday, Oct. 7. There will be free drinks, light bites, and wonky conversations! In the meantime, pass your tips to rachel.cohrs@statnews.com. | | | Drug pricing’s bureaucracy begins to take shape Medicare has a herculean task ahead of setting up an infrastructure to take on an entirely new function for the program — regulating how much it pays for certain medications, and penalizing drug makers that hike prices faster than inflation. With new responsibility comes new bureaucracy, new documents obtained by STAT show.
Earlier this month, HHS Secretary Xavier Becerra outlined in documents sent to lawmakers that Medicare is planning to establish a Medicare Drug Rebate and Negotiations Group with six divisions and dozens of new positions to carry out the new tasks. Congress gave the agency $3 billion in administrative funding to stand up new processes.
I have the full org chart and more details in my new story out this morning. | The next frontier of the drug pricing fight  Sen. Thom Tillis (R-N.C.) (Alex Wong/Getty Images) Now that Democrats have gotten Medicare negotiation over the finish line, industry and advocacy groups are already salivating over the next big fight: pharmaceutical patent reform.
Generic and biosimilar manufacturers have long wanted patent reform. Patients for Affordable Drugs just added the issue to its priority list. And now there’s a new advocacy group emerging to vehemently oppose reform efforts: the Council for Innovation Promotion.
The “pro-intellectual property coalition,” led by a former head of IP policy at the U.S. Chamber of Commerce, launched last night, featuring longtime pharma industry allies and Senate Judiciary Committee members Sens. Chris Coons (D-Del.) and Thom Tillis (R-N.C.). PhRMA President and CEO Steve Ubl attended the event as well, and got a handshake from Coons. Both lawmakers assured assembled industry leaders and experts that they would fight for strong IP protections.
“One of us [is] going to be holding the gavel next year on the IP subcommittee. I've got my own preferences, but either way, it'll work just fine. Because we've demonstrated no matter who holds the gavel, we're here to do the same thing,” Tillis said.
A whole lot of drug pricing policy passed in Democrats’ reform package this summer, but there are still a number of stalled bipartisan pharmaceutical patent reform bills in the Senate that are relatively low-hanging fruit. The bills would address patent gaming practices like product hopping and evergreening, crack down on sham petitions filed with the FDA, and limit pay-for-delay deals.
The U.S. Patent and Trade Office also last week announced a collaboration with the FDA to “protect against the patenting of incremental, obvious changes to existing drugs that do not qualify for patents.” Watch this space for the future. | Did President Biden shoot himself in the foot on Medicare premiums? Just hours after President Biden trumpeted lower Medicare premiums this week, Biogen and Eisai released promising new data from another potential blockbuster Alzheimer’s treatment — setting up another round of controversy for Medicare, and possible new cost headaches, too.
Medicare developed historically restrictive payment rules around an entire category of Alzheimer’s treatments based on data from Biogen’s controversial drug Aduhelm, which didn’t show evidence of patient benefit before the FDA gave it an accelerated approval. But this new drug from Biogen and Eisai slowed the rate of cognitive decline by 27% in a clinical trial, the companies said Tuesday, raising questions about access for Medicare patients if a drug is truly proven to work. The companies are hoping to get accelerated approval for the drug from the FDA in January, and full approval as soon as next summer.
As Medicare’s policy stands right now, Eisai and Biogen would still have to create a relatively rigorous data collection system for lecanemab even if it gets a full, traditional approval from the FDA. There’s no precedent for these kinds of restrictions for traditionally approved drugs, and either patient groups or the manufacturers could challenge the requirements, said Sean Tunis, an industry consultant and senior fellow at the Center for the Evaluation of Value and Risk in Health at Tufts Medical Center.
“I would be very surprised if the requirements stay the same, in the context of a drug with traditional approval and demonstrated benefit. It would be too wildly divergent from what has ever happened before,” Tunis said.
If all those dominoes fall: the FDA approves the drug, Medicare loosens its coverage restrictions and patients can get the drug using the program (and these are very big ifs at this stage), it would likely create new costs for the Medicare program — and jack premiums up. There’s no indication yet of what Eisai and Biogen would choose to charge for the drug, but that looming price question is one of many that I outline with my colleagues Adam Feuerstein and Damian Garde in a new story this morning. | The White House repeats its failed Covid funding strategy… again For the past six months, the White House has been stuck in a cycle of asking Republicans for emergency Covid funding ahead of some big vote, and still coming away empty-handed. There’s usually a letter from the White House budget office, then some squabbling by Republicans about accounting issues, and then nothing passes.
The Biden administration’s flip-flopping over the urgency of new funds has soured relationships with even moderate Republicans, many of whom think having private insurance plans and citizens start to pay for Covid-19 treatments and vaccines is a good thing. President Biden’s declaration that the pandemic is over has also made requesting new funds harder, a Democratic congressional aide said.
It’s unclear whether the White House has any inclination to change its strategy, but there are a couple alternative paths forward.
A regular appropriating cycle is gearing up, and it’s possible that they’ll have more luck wrapping Covid money into regular funding for HHS instead of framing it as an emergency, a Republican Senate aide said.
Or the White House could start negotiating in earnest with Republicans who have shown some willingness to entertain support for a second iteration of Operation Warp Speed. A second Republican Senate aide said that the White House hasn’t responded to the request for more information about Warp Speed 2.0 that Sens. Jim Inhofe (R-Okla.) and Richard Burr (R-N.C.) sent a month ago. A White House spokesperson said that the administration has briefed and discussed on a bipartisan basis the needs for research and development funding for next-generation vaccines and treatments.
While the U.S. has moved out of crisis mode, experts say that the nation’s public health infrastructure still is in no shape to handle another surge of Covid-19, not to mention another threat. Ezekiel Emanuel, vice provost of global initiatives at the University of Pennsylvania and a former Obama White House health policy budget adviser, called additional funding a “small down payment” that would pay off as an investment in longer-term preparedness. “We have not stress tested our current Covid testing, vaccination, and treatment apparatus,” Yale University professor Howard Forman said. “It is unclear what we will face in the later fall and winter.” | Medicare patients deserve access to proven, innovative medical technologies For too long, Medicare beneficiaries have had to wait years for the Centers for Medicare and Medicaid Service (CMS) to develop coverage policies for innovative medical devices. CMS now has an opportunity to give patients timely access by establishing a dedicated coverage pathway for important new medical device therapies in the upcoming Transitional Coverage for Emerging Technologies (TCET) rule. Learn more about how Congress and CMS can accelerate coverage of innovative devices through TCET. | What does the fox (bill) say? Rep. Ami Bera (D-Calif.) just introduced legislation to cap uninsured Americans’ costs for rabies vaccines, months after a personal run-in with a rabid fox that bit at least nine people on the Capitol grounds in April, my colleague Sarah Owermohle reports.
Bera and other victims — including Sarah’s former colleague, agriculture reporter Ximena Bustillo — swiftly received multiple doses of preventive rabies vaccines (CDC recommends four, but patients packed in immunoglobulin and tetanus shots as well). For uninsured patients, those post-exposure vaccines can be roughly $400 apiece, which, when combined with costs from emergency rooms (where the shots are almost exclusively administered) can total more than $6,500 in medical bills.
Bera’s Affordable Rabies Treatment Act would set up a reimbursement program to reduce those costs for uninsured people. Registered providers would need to submit claims to HHS, so there’s no dollar amount tied to the program right now. But CDC estimates that about 60,000 Americans (insured and not) need to get the post-exposure regimen each year.
“After being bit by a rabid fox, I was fortunate to have access to readily available and low-cost vaccines,” Bera said in a statement. “But for too many Americans, the costs of treatment would break their banks.” | What we're reading - Lilly is accused by the federal government of discriminating against older sales reps, STAT
- Patients face barriers to routine care as doctors warn of ripple effects from broad abortion bans, Politico
- On the Texas-Mexico border, a bold plan to diversify Alzheimer’s research takes shape, STAT
- Few places have more medical debt than Dallas-Fort Worth, but hospitals there are thriving, Kaiser Health News
| Thanks for reading! More next week,  | | | |
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