Two More Companies Enter the IRA-Lawsuit Fray

There will be a point, I guess, where IRA lawsuits are so common that they’re not worth noting. But we’re not at that point yet (mostly … more on that idea below). Yesterday, Janssen filed suit to stop price controls. Astellas made a similar move on Friday.

I’ve tried to capture the state of play in the graphic below. A fully hyperlinked version is here.

A few interesting notes:

• I don’t see any novel arguments in the new filings. Janssen and Astellas are both citing First Amendment compelled-speech concerns, as well as Fifth Amendment takings objections. That aligns them with the Merck and BMS suits. They’re also alleging a due process violation, which is also a part of the PhRMA and the U.S. Chamber of Commerce suits.

• Both the Astellas and Janssen suits are being run through the lawyers at Covington and Burling. The other two company-based suits are using Jones Day. Both powerhouses.

• At this point, five of the 10 companies likely to be targeted in the first round of price controls have moved against the government. (I’m counting AbbVie, whose Imbuvica medicine is cited in the U.S. Chamber lawsuit.)

• That means that there are five companies at risk that haven’t (yet) filed their own suit: Boehringer Ingelheim (Jardiance), Amgen (Enbrel), AstraZeneca (Symbicort), Pfizer (Ibrance) and GSK (Breo Ellipta). Keep those on your bingo card.

• Astellas, weirdly, filed on Friday -- even putting out a press release on their website -- and yet no one seemed to notice. Like, there are still stories coming out this morning that seem to be missing the existence of the suit. I’m sure there are PR implications here …

So what’s next? I believe that BMS will file its motion for summary judgment on Friday, though I doubt there will be anything new there. I’m also watching for the court’s reaction to the U.S. Chamber’s request for a preliminary injunction to stop things in their tracks.

It’s earnings season, my second-favorite season (I’m a sucker for Halloween, though, unlike Halloween, earnings season comes around every three months). I flagged UnitedGroup’s absurdly profitable quarter earlier this week, but Novartis is the firm pharma company to make news, at least how I define new.

CEO Vas Narasimham was asked two IRA-related questions, and he gave fairly standard responses. (e.g.: “We are carefully looking at assets in terms of potential IRA impact.”)

But there was one line that gave me pause. Vas was asked about Leqvio, a small-molecule cholesterol medicine. He gave some standard lines about the 9-vs-13-year pill penalty, but he also implied that there ought to be an exemption for certain advanced small-molecule technologies such as siRNA (which is the underlying mechanism for Leqvio). Not sure where the idea came from (or where it’s going!), but something else to add to the watchlist.

Elsewhere:

• You guys aren’t going to believe this, but the Arnold Ventures guy thinks that Leqembi isn’t worth it and will create a “harsh financial reality” for Medicare, per Fierce. All joking aside, I really don’t mind pharma skeptics getting press (marketplace of ideas, etc.). But centering an article around a non-physician’s take on clinical significance is probably not a journalistic best practice.

• While we’re talking Leqembi, BIO’s Good Day BIO newsletter has a nice wrap of some congressional commentary on CMS’ restrictive approach to Alzheimer’s reimbursement. (You can sign up for their daily missive here.)

• The ICER folks have a PharmacoEconomics piece out defining and defending the equal-value life-year (evLY) metric as a viable alternative to the quality-adjusted life-year, especially in the United States, where many government programs are explicitly barred from using QALYs.