So. Much. PDAB. Today.

It’s a big day for PDABs. Buckle up. 

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The biggest news is probably Amgen’s suit against the state of Colorado that makes the case that the prescription drug affordability board in Colorful Colorado is in violation of federal law in four different ways. 

In short, Amgen claims the Colorado PDAB is messing with the federal patent system, that the lack of clear standards violates due process, that setting prices for all payers means Colorado would be regulating Medicare and other federal programs, and that the law would impact supply-chain transactions that take place outside of the state. 

A lot of those arguments will also apply to other PDABs, so a legal victory would probably reverberate beyond Colorado’s borders. 

I have no idea how legit those arguments are, though, and there hasn’t been a lot of perspective on the legal prospects of the Amgen gambit. You can read about the suit in the Denver Post or STAT, depending on which paywall you prefer. 

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While we’re talking Colorado, you should probably read the RApport assessment of what’s going on in the Centennial State by patient advocate extraordinaire Gunnar Eisison and Mike Sherman, who used to be the chief medical officer at Harvard Pilgrim/Point32Health.

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I’m tempted to include some snarky media criticism about the Washington Post, which managed to lead its Health 202 newsletter today with a look at the Colorado PDAB … but somehow missed the lawsuit. 

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Still, the PDAB nugget that’s living rent-free in my mind is a comment made at yesterday’s meeting of the Maryland PDAB, where the board green-lit for additional consideration a list of eight medicines and heard testimony that mostly pushed back on the idea of price controls. 

One of the higher-profile members of the board, Johns Hopkins’ Gerald Anderson, expressed confusion about some of the feedback that suggested that setting upper payment limits could, ironically, raise prices on patients. 

This strikes me as a place where there’s a need for more in-depth education (this is where I plug Janssen’s thoughtful report on PDABs as a great resource). The argument here isn’t necessarily simple, but it’s worth laying out. 

First, in a lot of government-backed programs (think Medicaid), patient cost-sharing is already minimal. Changing the upper limit of what payers are charged might save those payers money, but it won’t help patients. So that’s just a matter of being clear about who benefits — and how — from this kind of program. 

Second — and this could be an issue with the IRA, too — PBMs have a bias toward medicines with high prices and high rebates. Upper payment limits would effectively create medicines with lower prices and lower rebates. So it’s possible that PBMs would try to steer patients away from the price-controlled medicines toward higher-rebate products … including by putting the “cheaper” products on formulary tiers with higher cost-sharing. 

If this seems counter-intuitive and unlikely, you and I should probably discuss the current state of biosimilars for insulin or Humira. 

This BIO.News piece on the impact of the IRA on heart disease drugs summarizes the issues around cardiovascular disease well, including a shout-out to the thoughtful (and under-covered) study last week out of Duke. 

There’s a surprising amount of coverage (e.g. Axios, MedPage) of this study that showed that caps on insulin OOP costs did indeed reduce patient burden, but it didn’t necessarily change utilization. I’m not sure what the null hypothesis was here. My hypothesis is that insulin remains such a lightning rod that pretty much any academic work on the subject of insulin cost will find an audience.