PBM Bills Advance in Congress. The Big Question: What's Next?

First off, thanks to Frank David for saying such nice things about me on social media. If you subscribed based on Frank’s testimonial, I’m happy to have you here, and I’ll try to make sure your faith in Frank is well placed.

Second: fair warning … there’s a lot to go through today.

The Senate Finance Committee passed, nearly unanimously, its PBM-regulation legislation. It would delink list prices from how PBMs are paid, ban spread pricing in Medicaid, and add some transparency provisions.

But what’s in the bill is less interesting than what happens next. Three Senate committees have PBM bills, there is a vague commitment from Senate Majority Leader Chuck Schumer to bring PBM legislation to a vote (perhaps with insulin price caps), and everyone in the Senate is about to return home until September. So figuring out what gets to the Senate floor, and when, is really the big question.

(For those keeping track, we’re 158 days from the Republican Iowa Caucus, and the assumption tends to be that jack-all squat gets done in election years. We’re on the clock.)

The other question is what the House will do. There’s legislation over there, but there seems to be less consensus -- a PBM bill passed out of committee in the House yesterday, too, but on a party-line vote -- and even House members are trying to make sure that Senators are tracking on their priorities. Rep. Jake Auchincloss, a Massachusetts Dem, sent a letter to the Senate Finance leadership ahead of yesterday’s vote asking for consideration of language that would do away with copay accumulators and require pass-through pricing.

I believe that GoFundMe campaigns reveal where the true holes in the American safety net are. Anyone resorting to crowdfunding medical expenses is truly out of options, and every crowdfunding campaign reflects a profound failure of the health care system.

So I was eager to dive deep into a new JAMA Neurology article that looked at how patients with neurological diseases -- mostly ALS and central nervous system tumors -- used GoFundMe.

The answer, reflected in the chart below, is that it’s really the social-determinants-of-health piece that gets patients and their family. Housing costs loom large. So do medical bills and lost income. Medication is way down the list. That doesn’t mean drug costs aren’t important, but it’s hard to see that as the no. 1 villain.

And it’s not just neurologic disease. As I flagged last month, patients with diabetes are looking for support largely for expenses that aren’t covered by insurance. That study got headlines because it talked about diabetes alert dogs, but the dogs are -- kind of -- just a metaphor for any expense that falls outside of what we think about as health care.

Housing, as the JAMA Neurology study makes clear, is a critical part of health care. We just don’t think about it that way, or think about it that way enough. Instead, we hyper-focus on elements where the story is easier, even if it’s less important.

Like prescription drugs.

• The CEO of Roche, Thomas Schinecker, told reporters today that the IRA is impacting the company’s decision-making. “We have decided that we are not going to do certain trials, or that we are not going to do a merger or acquisition or licensing (deal) because it is becoming financially not viable," Schinecker said.

• There is a handful of ICER-related notes worth tracking:

  • Janssen and Certara have a white paper out that does a damn good job of pointing out the methodological flaws in ICER’s Unsupported Price Increases report, making a case that no one should take the effort seriously, much less build policy around it.

  • ICER’s next assessment will focus on therapies from Alexion and Novartis for paroxysmal nocturnal hemoglobinuria. ICER does not have a great record of dealing well with ultra-orphan diseases, so expect some objections as this one moves forward.

  • And ICER has a draft evidence report out on Orchard’s gene therapy for metachromatic leukodystrophy which suggests that the group will find that treatment falls short of cost-effectiveness thresholds. ICER is assuming the treatment to come in at a one-time cost of $2.8 million.

  • And ICER’s holding a meeting today on gene therapies for sickle-cell disease from Vertex and bluebird.

• I’m curious exactly where Maryland is going to take their Prescription Drug Affordability Board. The group had a meeting earlier this week, and the local NPR station has an interesting quote from the PDAB’s executive director: “There are scenarios where the board should feel comfortable saying, ‘Yes, this drug is not affordable, but maybe an upper payment limit isn't the right approach.’” On the one hand, if the PDAB wants to chill on the idea of price controls, that’s probably a good thing. On the other hand, that quote suggests that the board is operating with an awful lot of flexibility, which cuts both ways.

• There is an emerging consensus that the implementation of the IRA is not taking patient feedback seriously, and the Innovation and Value Initiative’s Jason Spangler leans into that point in a new LinkedIn post.

• I wasn’t tracking on the Lower Out-of-Pocket Now Coalition -- a collection of patient groups and other advocates -- but I’m down with their push for a $2,000 out-of-pocket cap in Obamacare plans, matching the cap to be implemented in Medicare Part D.

• Want to know what the states have been up to this year in terms of health care legislation (think PBM transparency, insulin price caps and the like)? The Washington Post has you covered.

• Medicaid seems to actually be doing an OK job of covering weight-loss medicines through savvy leverage of discounts, according to Bloomberg Law.