A Great Overview of the PDAB Process Underscores the Flaws of State Price Controls

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This is a must-read piece about prescription drug affordability boards. It’s from Health Affairs Forefront and pulled together by the folks over at NPC, and it does an elegant job of both laying out the current state of affairs and detailing where things can go horribly wrong. 

It’s a sober and data-driven analysis that lets the facts do the talking. 

For me, the takeaway is really driven home by the chart that accompanies the piece, which shows the selection factors for each of the four states with operational PDABs (Colorado, Maryland, Washington, and Minnesota). 

It’s clear that a lot of the factors that should, in theory, be influencing this kind of decision-making are entirely absent, essentially guaranteeing that decisions are going to be made in a way that is arbitrary and inconsistent at best. 

Add that to the intrinsic risks of price-setting, and all kinds of low-key disasters become possible. The paper outlines some of them: payer-related access challenges, reduction in certain kinds of R&D spending, impact on providers. 

The NPC questions are all posed fairly, in the interest of debate. And I hope this piece is the foundation of a constructive dialogue. 

The alternative is name-calling, and that’s not getting us anywhere.

It’s a slow day, and I have a number of new subscribers (thanks, Bill Roth!), so I don’t want anyone to leave disappointed. So even though there’s not a lot of action today, here’s an incomplete list of the things that I’ll be watching for in the days and weeks to come: 

• Starting with PDABs: there’s a Colorado PDAB meeting tomorrow, including a discussion about whether Stelara is “unaffordable.” The Stakeholder Council of the Maryland PDAB is gathering on June 24. 

• Reuters said last week that administration action on march-in rights could be coming “within days.” Still, this is a complicated and controversial issue that I can’t imagine anyone will want to rush, so I’d take “within days” with a grain of salt. I’m setting next Friday as the over/under. But I’d love your input here:

  Poll: When will the Biden administration take action to finalize its march-in plan?

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• There are a ton of IRA lawsuits still sitting out there. Merck’s case has been on the judge’s desk since November. The Chamber of Commerce suit, which was one of the faster-moving cases early on, is still awaiting a decision. Novo and Novartis have both participated in oral arguments (and their judge has already ruled on other IRA cases). Boehringer Ingelheim is getting a hearing on June 20. 

• The IRA appeals, too, are moving right along. There’s already been an oral argument in PhRMA’s case. BMS, J&J, and AstraZeneca are all primed to submit briefs in their case by mid-July, with the idea of having arguments sometime this fall. 

• And while we’re on lawsuits, J&J has a June 28 deadline to file its response to a suit alleging that the company failed its employees by choosing a health plan with higher-than-necessary drug costs. 

• I’ll do similar calendaring at some point soon on all of the various 340B actions, which are, if anything, more complex than the IRA suits in their topical and geographic variety. 

• Speaking of 340B, we’re still waiting for a Senate bill on comprehensive reform. Per Axios today, “Sen. John Thune said he was hopeful the draft could be circulated by August recess.” Thune had previously told Axios the bill could be ready by the end of May, so take the over on that one. 

• I mentioned it yesterday, but I’m curious if there’s still a desire by the House Oversight Committee to drag some PBM officials to the Hill. The committee didn’t make good on its initial threat to hold a hearing this week, but I’m going to assume that negotiations are ongoing and that the PBM leaders will show up at some point. That will be a nice break from the campaign coverage. 

• And this is a reminder that it’s almost earnings season again. UnitedHealth Group should be reporting around July 12, which will be here before you know it.