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I usually don’t get too worked up about the introduction of new bills: lawmaking is a long road, and talk is cheap, so I try to avoid giving too much attention to process.
But in the case of 340B, that rule is out the window. We’re in period now where everyone is trying to set the terms of the debate to come. That’s why a discussion draft of a 340B bill pushed out by a handful of Senators earlier this year was a big deal.
And what’s why the newest effort — a bill from Reps. Larry Bucshon, Buddy Carter, and Diana Harshbarger — is also worth tuning in to. The new effort, the 340B ACCESS Act, mostly follows the broad parameters of the ASAP 340B group, which is the odd-bedfellow coalition of PhRMA and community health centers. ASAP 340B has a great infographic on the new bill.
That means restrictions on contract pharmacies, especially for the big, abusive hospitals, and a reasonable, specific patient definition. There are also provisions that would ensure that discounts flow to patients. Naturally, 340B Health hates it (per comments to 340B Report) and PhRMA is a fan.
Look, this text is not going to become law. Not anytime soon, anyway. But it’s a critical starting point for the debate to come.
(Part of that debate will happen next week, when the House Energy and Commerce Committee holds a hearing on 340B oversight. Should be fun for us geeks.)
It’s a slow week, or it’s supposed to be (today is a little more than I was expecting), so I wanted to spend a little time thinking ahead to the second round of IRA price controls.
For all of the attention around the IRA, the lawsuits, the first ten products, and so on, there hasn’t been a lot of chatter around exactly which medicines will be caught in the 2027 “negotiation” cycle.
That cycle isn’t that far away: selected drugs will be named on Feb. 1, 2025, which is, in the grand scheme of things, right around the corner.
As a reminder, the 2027 cohort will be drawn only from Part D, and it’ll include 15 drugs. Prices will be negotiated over the course of the year, with an official price announced by the end of November. Those prices will go into effect Jan. 1, 2027.
So here are the 15 meds I think* will make that list:
Austedo
Cabometyx
Calquence
Creon
Ibrance
Invega Sustenna
Linzess
Ofev
Ozempic
Pomalyst
Repatha
Tradjenta
Trelegy Ellipta
Tresiba
Xtandi
Tomorrow, I’ll get into some of the implications here, but it’s worth acknowledging the most obvious one: the discussion of the 2027 cycle is going to be all about Ozempic and Wegovy (which share an ingredient and will therefore be treated as one med, along with Rybelsus).
By sales, that’s the biggest drug on the list by far. It’s also one where the Medicare status remains up in the air (Wegovy for obesity can’t be covered in Medicare, though it can be used for certain comorbid conditions). And it’s the one that is dominating public discourse.
So the February announcement and, really, the rest of the process are going to be all O-O-O-Ozempic.
* There is a methodology here, but it’s a loose one. I looked at the most recent year for which Medicare gross spending is available, and sorted meds by spending. Then I took out ineligible drugs: ones that were in the first round of price controls, those that might go generic in time, a couple of small-biotech exceptions, one orphan drug, and a handful of products that haven’t been on the market long enough.
Then I looked at sales growth to estimate which products are likely to be driving spending when CMS examines the data. That means I’m biased toward fast-growing meds, and that may drive differences between these estimates and the guesses of others. I reserve the right to update as more data becomes available or as people point out my omissions, oversights, and mistakes.
“Hey, read this IQVIA report” is something I’ve been saying a lot lately. And I’ll say it again: its look at the oncology marketplace is also worth checking out, especially with ASCO about to kick off. As usual, I’m mostly interested in the economic bits, which show spending will continue to grow by double-digits, launch prices are up, and HTA are not universally rosy.
Mark my words: “MTF” is going to be the acronym of the year in 2025. It stands for Medicare transaction facilitator, and it’s the process by which money will flow once the IRA is in place. But the government hasn’t done much to define the system, and that has people worried, as this fantastic Bloomberg Law story makes clear.
Democrats are talking a lot about prescription drug prices in ads for House and Senate candidates, but Republicans aren’t. I don’t think that’s remotely surprising, but the specifics — which Politico wrote on — are still vaguely interesting.
I like this Health Affairs Forefront piece by Vanderbilt’s Stacey Dusetzina on the lessons of hep C, and what we can do to ensure broader access in similar situations in the future. She puts forward the idea of the feds helping coordinate state contracting and “Netflix-style” approaches, which is the the kind of creativity we probably need.
Novo Nordisk responded to Bernie Sanders’ demand for information on pricing, with Bloomberg reporting they told Sanders pretty much exactly what you would think they’d say: net prices are low and falling, and if the current state of things is an issue, that’s more because the system is broken, not Ozempic.
This is a very Washington op-ed. It argues that a letter to the editor on march-in rights from 2002 (from the two guys who wrote the law, and who took a dim view of using march-in for drug prices) has been blown out of proportion, and if only people would look more closely at other minutiae from decades ago, they’d come to a different conclusion.
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