Looking Around the Corner at a Report from Minnesota That May Illuminate the 340B Program

I’ll have a bit tomorrow on the PBM lawsuit against the FTC, but if you’re looking for some PBM-related content today, you should check out Dr. Glaucomflecken on the legal action. The video dropped a couple of weeks ago, but since my Insta feed is now pretty much entirely hockey, I somehow missed it.  

Here’s some more great research on how cancer medicines are developed. 

One of the big arguments against the IRA is that oncologic agents move by a different cadence than a lot of other drugs. The first approval is usually in a small subset of patients. Maybe it’s a small cancer, or perhaps in an earlier line of therapy. 

Then, over the years, additional clinical evidence is gathered, the drug’s full utility becomes clear, and additional FDA approvals follow. This is generally not a fast process. 

Lots of folks are worried that this steady progression is going to be majorly screwed up by the IRA, which puts an expiration date on a lot of that research, essentially refusing to reward companies for any development that comes to fruition after nine years (for small molecules). 

Increasingly, it seems clear that the threat here isn’t just theoretical. Last week, there was a great Health Affairs piece that looked at secondary approvals and research conducted post-approval, showing that huge amounts of intellectual capital were invested once a drug was on the market … and the IRA countdown had started.

Yesterday brought even more data characterizing this phenomenon: NPC researchers looked at 56 cancer medicines approved between 2008 and 2018 that had additional indications approved, slicing the data in every which way: kinds of indications, small molecules vs. biologics, drugs with quick development time versus longer development time. 

It provides a great sense of how the IRA might come to harm patients with cancer. For medicines where the development time of additional indications is quick, it might make sense, the researchers suggested, to delay approval until larger indications are ready to go. For medicines where subsequent indications may take longer, there may be a disincentive to pursue those additional uses. 

This is not the outcome that anyone wants.

Today, I’m reintroducing an old Cost Curve feature: “Around the Corner.” The idea is that I take a look at things that haven’t happened yet but will be fascinating when they do hit. 

That means we’re back in the world of 340B. 

Last year, the Minnesota legislature passed, and Tim Walz signed, a 340B transparency bill with some really interesting elements. Every 340B covered entity was required to provide a whole bunch of numbers to the state government, including how much they paid for 340B meds, how much they sold those meds for, and how that’s split with contract pharmacies. 

These data are the key to understanding the whole program, which is generally a black box. We know that providers get a discount … and we have no idea what happens after that. Researchers can look for echos in charity care numbers or other outputs, but that doesn’t get us very far. 

So the fact that this data exists inside of some computer in Minneapolis is a big deal. 

What’s more, those numbers are going to come out of that computer at some point in the next month as a part of a legally mandated report that summarizes all of the data that the state has gathered. 

It’s that report that I’m on pins and needles waiting on. In some ways, I’m sure it’ll be disappointing, mashing up so many individual datapoints into an aggregate that may or may not be useful for policymaking. But I assume there will be something there that allows us to begin seeing inside the black box. 

State health care transparency reports are generally underwhelming, unnoticed things -- heck, even I ignore them most of the time -- but this one ought to be different. 

So that’s around the corner. For what it’s worth, this is the website I refresh every couple of hours. And if you’re a member of the media and want to go deeper in preparation, just hit “reply.”

There’s lots out there over the past 24 hours on the most important story in American health care (the death of retail pharmacy). Most it it is pegged to the Walgreens announcement we talked about yesterday, but there are some broader looks that wrap CVS into the narrative. 

And Axios wrote on the National Community Pharmacists Association’s member survey on whether the screwed-up reimbursement for medicines with IRA price controls would limit access. Sure enough: more than 50% of those who responded to the NCPA’s survey said they were “strongly” considering just not stocking the meds. 

ELSEWHERE: 

• BTW: I’m still hung up on the fact that the Barron’s PBM/opioids story has received almost zero attention from the media. Yesterday, BioPharma Dive dropped a link into their newsletter, and Columbus Dispatch legend Darrel Rowland tweeted it. Otherwise: crickets. 

• “Alternative funding programs” is a nasty little cost-saving technique that’s being sold to health plans. A person with an expensive drug has coverage for that drug removed from their insurance plan, and then the plan goes and seeks charity care for the “uninsured patient.” If you think that’s the kind of Rube Goldberg machine that is going to delay care and amp up anxiety for patients, you’re absolutely right, per this abstract from the ACMP Nexus meeting.

• I’m not sure there’s anything particularly new in this STAT piece by Bayer COO Sebastian Guth in which Guth gives his thoughts on the upcoming election, but it’s a concise summary of what industry’s priorities are going forward.

Header image via Flickr user Dwayne.

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