The Starting Gun for Price Controls Will Sound Tomorrow (But the Finish Line Is Still a Year Away)

So the plan was to take the first half of this week as vacation, returning bright-eyed and bushy-tailed for the “selected drugs list” announcement at the end of the week. As I noted last week, that announcement is now apparently slated for tomorrow, so I’m dropping a quick Curve today (and probably tomorrow and Wednesday, too).

Alas.

Tomorrow still appears to be the day for the announcement of the first ten medicines that Medicare will price-control over the next year. As a reminder -- especially amidst all of the hoopla of the next 48 hours -- this is the starting gun, not the finish line.

The process that begins tomorrow will wrap Sept. 1, 2024 with the actual announcement of “negotiated” prices. That announcement happen right in the middle of presidential election season. So tomorrow is, at best, a dry run for the real show. And I won’t be taking vacation that week, I’ll tell you that.

Anyway, if you want to catch up quick, the New York Times newsletter, The Morning, has a fairly good overview of what’s going down.

There wasn’t a lot of handicapping anywhere in the media about which medicines will make the list tomorrow, which suggests a) that the individual medicines remain a closely guarded secret and b) no one quite knows how the government is approaching things.

The single biggest wonky question that will get answered when the list is released is how the government is going to define “bona fide” generic competition. CMS granted itself a lot of leeway in that definition (more on that in a sec), and tomorrow will give the first hint about how it plans to use that leeway.

Everything else, really, is just showmanship. Buckle up.

Speaking of leeway around the definition of “bona fide” generic competition, that’s a big element of the newest lawsuit seeking to stop the implementation of price controls. AstraZeneca filed suit on Friday, making it the sixth company -- and eighth group overall -- to raise legal objections.

The AZ suit is profoundly different from the other seven, however, leaning into the idea that it is the implementation of the law -- not the law itself -- that is most problematic. The company flags two major objections: one is the loosey-goosey definition of generic competition, and the other is the definition of a “single-source” drug.

The suit uses three different drugs to make the point. It cites Lynparza and Calquence as examples of meds that will be caught by the narrow definition of “single-source” drug. (Both medicines have been re-introduced in easier-to-take forms). And it uses Soliris as an example of how rare disease drugs are often developed for multiple uses. None of those three are expected to be up in the first round of negotiations.

If you’re rushed for time, the AZ release is worth the read, because even though the legal argument isn’t centered around orphan drugs, they craft their broader narrative around orphan medicines. It’s clever -- and effective -- framing.

And if you have a little extra time, take a look at the lawsuit. Again, I’m no legal eagle, but the claims here feel like they’re more likely to put the government on its back foot.

Is there a lot more that’s happened since last I wrote? Yup. But here are the highlights:

• You can probably ignore the first 80% of this Politico piece from law professor Nicholas Bagley, but he makes a critical point toward the end of the article: the IRA doesn’t do anything to draw a distinction between low-value medicines and high-value medicines.

• The FTC appears to be walking back its half-baked plans to mess with the Amgen takeover of Horizon, per the Wall Street Journal.