More Sound and Fury on the Orange Book (Signifying Nothing)

If you want to search Cost Curve back issues or link to anything you read here, the web links and archive are online at costcurve.beehiiv.com. You can subscribe there, too.

I’d like to be done talking about the Orange Book issue. 

The main reason there is an Orange Book “issue” is that no one quite knows what the rules are. The FTC thinks one thing, industry thinks another, and the organization that oversees the actual list of patents that comprises the Orange Book -- the FDA -- appears to have zero interest in actually setting down any rules. 

(Obligatory link to the STAT story about the FDA and the Orange Book.)

Yesterday was supposed to be the deadline by which companies acceded to the FTC’s demand that certain patents be removed from the list. At least one company, GSK, told the agency to pound sand. That’s according to Endpoints, which also published a strong statement from Novo Nordisk pushing back on the FTC’s view of the world. (Novo stopped short of making a commitment on the Orange Book listings.)

So the game of chicken between industry and the FDA continues, I guess. And it will probably go on and on until the FDA steps in. 

Yesterday, I was somewhat snarky about Donald Trump’s claim that he alone had solved the insulin pricing issue. But USC’s Dana Goldman reminded me (and noted on LinkedIn) that I’d missed an unheralded (or, certainly, under-heralded) Trump-era policy that did indeed address insulin pricing: the Medicare Senior Savings Program. 

The Senior Savings effort was a collaboration between insulin manufacturers and plan sponsors that made $35 insulin available in participating Medicare plans. There was solid but not universal uptake -- a 2021 press release put the number of participating Medicare Advantage/Part D plans at 1,750 -- so it’s not fair to suggest that it was just another flavor of the $35 price cap under the IRA, which is comprehensive and structured differently. But neither is it fair to suggest that there was no prior effort to address insulin costs in Medicare.

Much like saying “Candyman,” I sometimes worry about flagging research that will be used non-constructively to bolster overly simplistic arguments. So I’m wary of pointing out that Rand has updated its much-cited numbers on the difference between U.S. and ex-U.S. prices. 

The old numbers were from 2018, the update looks at 2022 figures, and it shows that -- yeah -- U.S. prices are higher. 

The flaws in this kind of approach are fairly obvious. List prices are a pretty lousy metric. Rand does include an attempt to correct for net prices, done as a kind of buried, secondary analysis, but it is incredibly simplistic. And there’s not a lot of discussion about the consequences of the pricing environment ex-US, which is that those countries get fewer medicines, more slowly. None of that will probably matter to those who want to wield the Rand numbers as a weapon. 

Elsewhere: 

• Independent pharmacists are getting hammered by new rules in Medicare Part D that require them to settle up with PBMs at the moment a medicine is sold, rather than waiting months to reconcile accounts. That creates a cash-flow issue that KFF Health News documents well in this piece. I feel like we need a national reporter to declare “survival of the pharmacy” to be his or her beat … the slow-motion destruction of the pharmacy business is one of the great under-told health care narratives of the 2020s.

Header image via Flickr user flwi5y fp.