Magnificant Seven? We Have Another IRA Lawsuit, This One from BI

More legal action! Boehringer Ingelheim filed the seventh lawsuit to stop the implementation of the IRA.

The coverage was kind of ho-hum, if we’re being honest, which I think is a reflection of the fact that reporters see the IRA lawsuits as a dull, repetitive process now. The seventh suit doesn’t spark interest, especially given that we'll probably get answers in the other legal efforts far sooner.

But the BI suit is somewhat distinctive. It’s by far the most exhaustive complaint, raising First Amendment compelled speech issues, Fifth Amendment takings arguments, a Fifth Amendment due process claim and an Eighth Amendment excessive fines objection. No other suit touches all of those bases.

And I think this is the first effort to claim that the IRA is in violation of the very legal basis for CMS -- it says the law “violates the Administrative Procedure Act and the Medicare statute” -- which means there will be something novel for the federal judge in Connecticut to chew on.

All of this suggests that I need to update my litigation chart. Tomorrow!

There seems to be a creeping realization that a lot of health policy going on right now is not remotely doing a good job of capturing patient input, let alone listening to patients.

Exhibit A is probably the Inflation Reduction Act’s price-setting process. We’re hearing a ton about the medicines that CMS might subject to forced “negotiations” and the timeline by which those drugs will be price-controlled, but almost nothing on the patient end.

That’s noteworthy, because CMS made a big deal about patient input when they revised their guidance on how the program would work, promising “patient-focused listening sessions” this fall. But we’re now two months from that announcement, and there’s no information on how those sessions will work or how the input will be considered in the process. If you’re a patient or an advocate and want to prepare, you’re currently SOL.

And people are taking notice. Earlier this month, I flagged a constructive piece in Real Clear where the authors gave CMS a roadmap for the way that patient dialogue could happen, based on the Patient-Centered Outcomes Research Institute’s approach.

Adding to that drumbeat was a LinkedIn piece yesterday by NPC’s Julie Patterson, who said that NPC had gone through the comments to CMS’ original guidance and found that payers and health systems tended to leave out the need for patient feedback. Her article gives a sense of who did advocate for input and why that kind of input is critical.

This feels like a statement of the obvious, but understanding the patient perspective gives another dimension to policy and regulatory decisions, and yesterday brought a great example. CBS News covered the story of Sabrina Walker, a Coloraro mother living with cystic fibrosis. She’s worried that her medicine, Trikafta, has been targeted for state-level price controls and that she might have access issues.

Now, it’s possible that Walker’s concerns will be addressed, but it’s absolutely necessary that they get aired. And that’s the danger from the unserious CMS plan to get patient input: that real concerns are never going to get heard.

I have two choices when I take a day off: I can try to blow through everything over the past 48 hours or just focus on the more recent items. Today, I’m going to try to be comprehensive (but brief!):

• UBS published a report about the CMS “selected drug” list, and Yahoo wrote about it. I’m increasingly fascinated by the medicines at the bottom half of the “top 10,” which is where the real uncertainty seems to lie, driven by unanswered questions about the small-biotech exception and the standards for generic competition.

• More than half of all insurance-plan policies for specialty medicines are more restrictive than the FDA label, according to an analysis in Health Affairs Scholar. That’s trend that has been accelerating over the past few years, the research showed.

• The Business Group of Health’s annual survey of employers is always worth a read, because it gives a glimpse into the mindset of the people who actually fund most of the health care in the United States: employers. And, boy, are they ever worried about drug prices.

• A new report from the Information Technology & Innovation Foundation makes the point that the United States leads the way in R&D-heavy, pre-commercial biotech companies that -- because of the nature of the biz -- are losing a ton of money and therefore should get better tax treatment.

• Getting insurance coverage for OTC birth control is not remotely simple, especially on the technical side (how do retailers without a pharmacy even bill a payer?), but this STAT op-ed starts thinking through solutions should coverage ever become a reality.

• CMS is starting to work through how the cost-smoothing elements of the IRA should run. This is a really interesting, pro-patient element of the law that no one is really talking about. Well worth watching how this evolves, and how it gets marketed.

• It’s a shame this Bloomberg story about PBMs is paywalled because the thesis -- PBMs have moved from profiting from rebate to profiting from opaque fees -- is one of the half-dozen most important trends happening in the prescription drugs universe.

• One way to look at this JAMA Internal Medicine piece about ties between patient advocacy groups and industry is “industry is terrible, therefore these relationships are suspect,” which is pretty much the frame that the paper’s authors use. The other frame is “gee, having more interactions between pharmaceutical companies and the patients they serve -- as long as they’re transparent -- probably leads to smarter, more patient-centric drug development.” But that’s not a real popular way to think about things.

• You’ve heard a version of this before, but if Medicare received Mark Cuban Cost Plus Drug Company prices, it would spend a ton less on generic cardiovascular meds.

This is a stunning visualization on how the use of Keytruda has expanded to help more patients in more ways. There is a policy element here that’s well worth examining, but this is also an opportunity to step back and marvel at what modern biomedical science has delivered.