Late-Breaking News (PhRMA Sues Over the IRA) Means a Late Curve

So my first draft of Curve today started thusly: “It feels like it might actually be a more languid day in the world of drug pricing …” 

lol

Anyway. Sorry about the late delivery.

PhRMA filed the fourth lawsuit seeking to throw out the Inflation Reduction Act’s price-control provisions. There is some early coverage from STAT and Endpoints, and you can read the actual filing here.

The group was joined in the suit by the Global Colon Cancer Association and the National Infusion Center Association. The filling said colon cancer patients “will be harmed by reductions in innovation in developing new drugs and adapting existing drugs to new indications directly and foreseeably caused by the IRA” and that infusion centers will “incur losses on services to Medicare patients.”

I am, as usual, in a little over my head legally, but it looks like PhRMA’s constitutional arguments are distinct from those in the Merck and BMS lawsuits (but not dissimilar from the Chamber of Commerce effort), focusing on the Fifth Amendment’s due process clause and the Eighth Amendment’s excessive fines prohibition. More to come as everyone digs in.

VeryWell Health had a helpful guide for patients looking to save money on their diabetes/obesity medicines, especially in light of the impending end of Lilly’s generous program around its diabetes med, Mounjaro.

When the product launched last year, Lilly offered the medicine for $25 with a coupon, regardless of whether Mounjaro was covered by a patient’s insurance or not. Not surprisingly, that helped the company ramp up prescriptions.

And while that program has tightened up over the past year or so, the dramatic impact will happen when the $25-even-for-patients-whose-Mounjaro-isn’t covered deal ends on June 30. There will still be copay assistance for individuals whose health plan already covers the med.

A “bridge” program to get launch medicine in the hands of patients ahead of broad coverage is not wildly novel, but given the attention on the class of meds and Lilly’s transparency around the program, it’s an interesting case study of how the programs work.

During the company’s earnings call in April, Lilly displayed this slide …

… and mentioned that “U.S. pricing headwind versus prior year will ease considerably driven by Mounjaro access and saving cards dynamics.” The gap between the top line and the line under it is the value of the medicine Lilly has been essentially giving away.

There was even more detail given on the February earnings call:

Again, none of this should be considered groundbreaking, but it is an illuminating look at the dynamics behind what might be a minor news cycle over the next couple of weeks.

It was a good day for news about the development of small-molecule drugs. Empress Therapeutics launched on the theory that pills will never go out of style and “if you create something that … really impacts a patient’s life, society will value that.” And Lilly bought DICE Therapeutics for $2.4 billion to get access to the company’s oral psoriasis program.

But it was an even better day for snark about how maybe the IRA isn’t killing small-molecule medicines, if the makers of oral therapies seem to be finding funding and exits. Of course, that misses the point. The IRA isn’t going to kill every small molecule in development, but slow-to-launch meds and therapies aimed at the Medicare population will be particularly vulnerable. Those high-risk areas are not where DICE is playing, but haters gonna hate, I guess.

• In terms of information density, it’s hard to beat this Endpoints Q-and-A with Genentech chief Alexander Hardy, who manages to give a summary of just about every anti-IRA talking point in the course of the interview. Well worth the read.

• MedPAC’s job is to suggest changes to the Medicare program that will make just about everybody mad, and Medscape has a worthwhile roundup of all the people made about its recommendations for Medicare Part B.

• The White House had a summit on naloxone affordability solutions, though the Washington Post coverage didn’t seem to have much detail on the solutions to come from the summit.

• The IRA-lawsuit coverage is becoming a little repetitive, so I’m always interested in when new lawyers/law professors get quoted. This piece in The Hill has a couple new names, though I’m not sure there’s a lot of new insights.

• What exactly is the Mark Cuban Cost Plus Drug Company? I mean, it’s not quite an online pharmacy (though it acts like one), and it’s not really a PBM (though it works with some upstart PBMs), and it’s definitely not a manufacturer (yet). This Becker’s Payer Issues story positions the company as a “health plan benefit,” in part, which only reinforces the sui generis nature of Cuban’s venture.