The non-Trump news flow remains a trickle. That’s not going to last. Buckle up. It’s going to be an intense 44 days between now and Christmas.
And a shout-out to Jared Reid and everyone else who has served. Happy Veterans Day.
Minnesota is going to drop its big 340B report this week (by statute, Friday is the due date). I wrote about it here last month, and there’s no need to be repetitive. Still: I wanted to make sure you were all tracking.
This will be a test of two things:
Will Minnesota have the know-how and desire to present the data in a way that is usable? State transparency reporting, broadly, tends to be lacking, and it’s possible that Minnesota will muck this up.
Will reporters care? The lack of interest in the HRSA numbers (beyond Ed Silverman in STAT) suggested that the media hasn’t cracked the code on how to talk about 340B. This is an big opportunity for some explanatory journalism for a big-and-getting-bigger topic, and I’ll be curious to see if anyone seizes the opportunity.
Earnings season came to an unofficial close last week. I had, earlier, given an overview of the 340B comments that arose during earnings calls, and it’s probably worth it to highlight what was said about other key policy questions around PBMs and the IRA.
Note that all of these comments were provided before the election. I assume perspectives have shifted somewhat since. I know mine have:
Here’s Albert Bourla at Pfizer:
Now, on IRA: Clearly, IRA overall is negative for innovation and does not promote a spirit that people could provide investments, but there are also some good things about it. So clearly, I would like to see that the out-of-pockets next year will be $167 per month for all your medicines for seniors. That, we want to be maintained. But this forced price setting is not a negotiation and things that needs to change.
And Vas Narasimhan at Novartis
On the IRA, which of course is a top priority for the industry, there’s a broader desire to — and I think important for public health and of course pipelines and oncology, neuroscience, cardiovascular disease, indication expansion — to get the 9 to 13 small molecule versus large molecule aberration corrected and there is legislation tabled currently in Congress to try to get that broad correction to happen. I believe now there’s bipartisan support in the House for that broad correction.
Alongside that, there’s a number of limited fixes that are being proposed by various factors. And one of those is the Mini Act, which targets correcting for genetically targeted therapies, such as siRNAs, ASOs, etc., and trying to get their definition more in line with what was done in 21st-century cures. That also has bipartisan support in the Senate and the House, and a relatively low pay-for, so that’s also out there as well. Actually, a minimal pay-for, I should say.
I think now it’s much more moving through the election period, moving through obviously the establishment of a new session, and then trying to get those bills, whichever combination of the various bills that are out there, there’s also efforts to correct the rare disease, multiple indication for single indication situation, similar definition, etc., and finding a right context to get those bills put in place as well as trying to get the broad fix overall for IRAs. So I think all of those efforts are ongoing.
So we’ll see how that also plays out. I think it will be in the two to three-year period, we get more understanding of all of those various pieces. We continue to of course push for PBM reform in as broad way as we can.
Brian Foard, the Global Business Unit Head, Specialty Care at Sanofi:
I think from an environment standpoint, the Inflation Reduction Act, there’s a couple of things in there. And as we’ve said before, our position is, it’s not really good for innovation just in general, the Inflation Reduction Act.
That said, there are some pieces in there that we do agree with, which one of which is actually quite good for patients is the no more than $2,000 out of pocket and the ability to spread that across the months could potentially allow these patients to have access to medicines that they haven’t had before in the past. And we think that that’s a good thing. So that’s a positive side of things. From an IRA standpoint, our portfolio actually lends us very well to this because we have an innovative portfolio.
I’m going to get a little deeper into the what-ifs around Trump 2.0 later in the week by looking a little more closely at what parts of the new-look Republican establishment have been saying over the past year.
But that will still be speculative and reinforces my general post-element mantra about what comes next: “no one knows anything.”
Given that caveat, there’s still interesting work out there. 340B Report’s analysis (paywalled, sorry) of what could be coming next for the drug discount program is worth reading (as always, you should mentally correct a bit for the outlet’s pro-provider bias). And this Roll Call piece on who might lead HHS next year summarizes the conventional wisdom on the names who might make news. Beyond that, you can probably take the day off.
ELSEWHERE:
PhRMA has a new commercial out in their campaign against PBMs. The idea that rebates on medicines should accrue, in some way, to the people who use those medicines is incredibly popular, and PhRMA is really pressing the point.
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