The Empire Strikes Back: The First Government Brief in the AZ IRA Case Hit Last Night

Lots of earnings this morning that I haven’t processed yet. Hoping to give those a good look this weekend. Until then …

The government formally responded to AstraZeneca’s lawsuit alleging that CMS is not implementing the IRA correctly. As you’ll recall, AZ’s beef is a little different than most of the other lawsuits. It largely skipped the constitutional arguments in favor of technical ones, making the point that CMS was playing fast and loose with the definition of “drug” and “marketing.”

With the clear caveat that my opinion doesn’t matter in the slightest, the HHS response doesn’t feel super-compelling. Throwing up procedural roadblocks — the AZ objections don’t tie back to the AZ drug targeted, the guidance could change after the first year, the IRA bars companies from bringing lawsuits such as this — feels like legal-weasel stuff. It may be strong as a matter of law! My opinion doesn’t matter! Still … 

Once HHS gets into the meat of things, their arguments about what Congress intended, language-wise, don’t seem open-and-shut. Rather, it seems like an interesting gray-area dispute and the exact kind of thing that a judge’s perspective would help with.

Let me try to keep this brief because I fear I’m being repetitious. But the CMS “patient-focused listening session” for Entresto was held yesterday, and it was a dud.

I don’t want to take anything away from the presenters. They did great. You can read ‘em here. 

But half of the speaking slots went unfilled yesterday, and more than half of the remaining 10 slots went to people or organizations that have already given feedback this week. In other words, the evidence is pretty strong that CMS is hearing from a small, probably non-representative, self-selected sliver of the patient community. 

That’s a terrible way to grab patient feedback, but you don’t have to take my word for it. Health Affairs just published a detailed look at how CMS should have done patient input and — spoiler! — it looks nothing like the process in place right now.

Stelara is one of the more interesting IRA test cases. It’s probably going to be subject to competition — yesterday’s approval of a biosimilar competition, due to launch in a couple of years, makes that more certain — but how and when CMS will pull the drug from negotiations makes for an interesting question. 

Unions are worried that PBM reform is going to hobby ERISA and make insurance more expensive and less predictable, according to Axios. 

We shared it here yesterday, but STAT is out with coverage of the Medicaid best-price concerns being raised by lawmakers, which is a sign that the topic is finally getting traction.  

Maryland’s PDAB should be setting price caps by next summer, according to State of Reform coverage. I’ll take the over. 

This Endpoints Q-and-A with Puretech’s Daphne Zohar is a useful snapshot of what biotech companies want out of Congress.