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I’m low-key pumped for Jan. 1, 2026, which is the first day of Medicare price controls for the 10 “selected drugs” that we’ve spent so much time discussing.
I’m mostly interested because it’s going to be a wild natural experiment to see how one particular medicine — Stelara — gets treated.
Stelara is in a weird IRA black hole. It will have biosimilar competition next year, but because of the various gaps in the IRA timetables, it wasn’t excluded from price controls. So as of Jan. 1, 2026, there will be:
Regular old branded Stelara at a commercial price (plus rebates) for the commercial market
IRA-price-controlled Stelara at a 66% discount to list price in Part D
A handful of biosimilars at as-yet-undetermined prices that will start entering the market in February 2025
Yesterday, that list got an additional entrant that makes things even wilder:
A white-labeled Stelara biosimilar from Cigna/Evernorth at 80% off, also due to hit in February
So what medicines get preferred by Part D plans? The one with the MFP? One of the biosimilars? What kind of formulary placement will we see? How will CMS react? What about commercial plans? We can assume that Evernorth/Express Scripts will push its patients toward its drug. Will CVS follow suit with a Cordavis version? What will happen if there are even-cheaper biosimilars that aren’t being sold by a PBM? Will those versions get adopted? Blackballed? By whom?
There are a thousand threads to pull on here, and it’s already late on a Friday. But Stelara is going see a handful of mega-trends — formulary design in post-IRA Part D, the PBM vertical integration in a quasi-drug-company role, the gross-to-net bubble — all collide.
I’m not bright enough to map the chaos-theory permutations of what might happen next, but I can’t wait to see what kinds of winds gets stirred up by these butterfly wings.
The annual Association for Accessible Medicines’ U.S. Generic & Biosimilar Medicines Savings Report is always one of the core resources for understanding the size and scale the the generic marketplace in the United States, and you should read it for that reason alone. But the report also has some great deep cuts, notably the discussion on pages 18 and 19 that shows how PBMs are working to raise out-of-pocket burdens for those using generic meds.
Good Bloomberg piece here on employers working overtime not to pay for gene therapies. It probably went pretty easy on employers, though. The threatened tsunami of gene therapy demand hasn’t materialized, and there are various avenues in which plans can protect themselves from “lightning strikes.” And yet we’re not hearing much about that. One of the things that keeps me awake at night is the fear that the incredible power of gene therapy is going to get buried by a system that cannot and will not figure out ways to ensure access, even though the budget impact remains minimal.
I liked this Association of Health Care Journalists piece on the IRA stories that health care reporters should be covering. All of the benefit design stuff hitting in January — especially the OOP and “smoothing” — needs a ton of really good, consumer-friendly service journalism that just hasn’t emerged yet.
I keep not linking to this smart STAT News First Opinion on changes to the Medicare “coverage with evidence development” program because I feel like it deserves a thoughtful summary, not just a quick link. But then I triage it and triage it and triage it, and suddenly its Friday. So let me just say: the article — by the Tufts CEVR folks, plus ATI’s Anna Kaltenboeck — raises some great questions about how the government can more flexibly keep an eye on medicines after they’ve been approved. I’m not convinced that they have things exactly right, but the existing system is unquestionably wrong.
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