A New Lawsuit Seeks to Roll Back a 'Dystopian Reality'

First off: a correction. It was Roche’s Genentech unit that won approval last week for Columvi.

Bristol Myers Squibb has joined the let’s-sue-over-the-IRA party, dropping a lawsuit that looks a lot like the one that Merck filed two weeks ago. The similarity may not be entirely coincidental: both companies are working with the same law firm.

And though the Merck suit may have the more bombastic language, the BMS filing has some bon mots in there. Calling the post-IRA landscape a “dystopian reality” is a nice touch.

Anyway: because the new suit is so similar, there isn’t a lot of novel legal analysis required. Still, CNBC does play the tape forward, suggesting that all of this is a play for a Supreme Court ruling. And STAT, citing ISI Evercore analyst Umer Raffet, said that we’re not done with the lawsuits, either.

So stay tuned.

It seems that not a day goes by without some news about coverage for the new generation of obesity drugs. (Today, I’m staring at a piece on lobbying for Medicare coverage and a New England Journal of Medicine “Perspective” calling for Medicaid coverage, using an equity frame.)

It’s a hugely fraught issue because science and economics are colliding here in a way that raises uncomfortable questions. We need to lean into those uncomfortable questions, because otherwise we end up with tone-deaf arguments like the one that set me off last week.

So I’d like to propose an Five Overly Grandoise Truths About Obesity Meds. Arguments that accept these truths are likely to be constructive. Those that ignore them are probably polemics.

1. These medicines work. The weight loss is real, and this class of medicines has been on the market for diabetes for nearly two decades. This isn’t Redux. (Peep the tagline. Man, I’m old.)

2. More data is coming. We will soon know how these medicines impact outcomes in patients with obesity, which will make more clear what the health and pharmacoeconomic benefits are.

3. That outcomes data is likely to be good. To be fair, this is more an educated guess than an Overly Grandoise Truth, but the science here is pretty well understood.

4. The connection between obesity and health is complex. That’s the corollary to (3). There’s plenty of evidence that weight/BMI/whatever is a pretty lousy biomarker, so overconfidence is a bad look at this stage.

5. The new meds are not cheap. That doesn’t mean they’re not a great value. But it’s naive to lose track of the budget impact.

If you accept those truths, you’re left with the unsettling reality that we, as a society, need to grapple with some hard choices, if not now, then in the future, when the data is even more clear.

It’s likely that we’re going to have tools that can improve the public health, and that deploying those tools will be expensive (in the short term, anyway), and that paying those bills may require making tradeoffs. That’s the debate I’m looking for, not pap that goes all-in on a “wonder drugs” narrative or the argument that the budget impact is simply too big to merit a conversation.

Look, I know you all are busy, so I’m reluctant to recommend long reads. But the New Yorker piece on the development of ALS drugs is an excellent portrait of the intersection between science, regulation and advocacy. And the STAT article on health benefit brokers -- and the way that they often side with PBMs rather than their employer clients -- is also illuminating/infuriating.

If you can’t make the time today, they’re worth the printer paper to clip-n-save.

Everything else:

• I really enjoyed this report out of the Innovation and Value Initiative’s Annual Methods Summit. It’s a great overview of how value assessment should be viewed in 2023, with a special focus on equity. The insistence that we need to keep evolving how we approach the topic is a good counter-balance to the Institute for Clinical and Economic Review’s more static worldview.

• JAMA Network Open published another piece on pricing in the insulin market, using a complex set of analyses to demonstrate a trend -- dipping net prices that started midway through the past decade -- that was already pretty well documented.

• Bayer’s Sebastian Guth talked to STAT about the IRA, admitting that Bayer doesn’t have a lot of skin in the game at this point but pivoting to the general industry talking points.

• Senators are asking 340B covered entities for some advice on how to rethink the program. While the lawmakers said that the responses to the six questions posed will be held in confidence, the questions themselves suggest some concerns that patients aren’t benefiting from the program.