Novartis Makes It Nine: Yup ... Another IRA Lawsuit

A long weekend means that there is a mini-deluge this morning. Summer’s over, folks.

The IRA continues to consume most of the oxygen around drug pricing, though the pendulum is swinging back to the legal disputes over the IRA as opposed to the implementation of the law (don’t worry … it’ll swing back).

For starters, the number of lawsuits is now nine: Novartis filed suit late on Friday. The complaint doesn’t really break much new ground -- there are three now-familiar constitutional claims baked in -- but it does put another company on the record.

The assumption seems to be that Novo Nordisk will be the next firm to take legal action. Bloomberg has an overview of what Novo’s path might look like. The way that CMS selected the company’s insulins might be in the crosshairs, which suggests that a Novo suit might focus more on the statute than the constitutionality of the whole endeavor. Something to watch for, anyway.

And, in wilder legal news, the judge overseeing the Chamber of Commerce’s case has recused himself following the news that he owned shares in several drugmakers. He’ll be replaced by Michael Newman, a Trump appointee.

It’s not clear (to me, anyway) whether this will meaningfully change anything in the short term. The Chamber’s lawsuit is the only one where there is a motion for an injunction on the table, so the wheels of justice are spinning a little faster on that suit. I don’t know if the judge switch-a-roo is going to impact timing, but I’ll keep an eye on the docket.

I wrote last week about Harris’ latest reputation data for the pharmaceutical industry, including a sense -- per Harris’ pollster on this, Rob Jekielek -- that pharma might be looking at a “new normal.”

Rob was nice enough to send the trend graph going back 15 years or so (see below), which gives a few more datapoints with which to assess what is “normal.”

As the Danish proverb goes, it’s tough to make predictions, especially about the future, but it feels like pharma’s current position -- 45% of Americans think of the industry positively -- remains somewhat precarious.

The IRA attention can’t help perceptions, there’s a rising anti-science sentiment, the concern around the industry’s business practices is increasing bipartisan. That’s balanced by the fact that we really are living in a pharma-driven golden age of medicine … all of this suggests a certain instability. Keep your seat buckles fastened.

• This book excerpt from Wired about the history of Gleevec is a worthwhile read. It makes the case that Gleevec was patient zero, so to speak, in an acceleration of drug prices. An alternative take on Gleevec, though, is that the medicine was launched at an erroneously low price, and the ensuing price increases, over time, brought the price up to the point where it reflected the clinical value of the drug.

• The Nation, a bastion of progressive thought, warned Republicans that attacking the price-control elements of the IRA would be a losing effort. (“‘Price controls’ is not a bogeyman that will scare many voters,” the piece argues.) If The Nation is right on that point, expect to see something of a pivot to the access concerns linked to the law. Because losing access has been something that, historically, has scared voters.

• There is a lot of commentary out there about the IRA right now, and I plan to ignore everything that doesn’t advance my understanding of the policy, political or regulatory environment.

• That said, I want to link to this newsletter from Peter Coy at the New York Times because I think he elegant captures a central, unresolved point in the whole “negotiation” process: “The real issue here is not that pharma is good and government is bad or the other way around but that there is no clear standard for what a fair price should be for a drug that is available from only one source, that costs a lot to research and develop but very little to manufacture and that provides important health benefits.”

• Add this one to the pile of studies that show that deductibles for chronic disease treatments is bad for the public health: making asthma meds available without a deductible drops out-of-pocket costs and boosts medication use.

• We’re going to hear a lot about patient engagement around the IRA for the next 10 weeks or so, so soaking in as much content there as possible is a wise move. This National Health Council piece from Friday is a good start.

• I need to dig into the actual data here, but here is more evidence that insurance is not actually helping the people it is supposed to help: there is a new analysis that shows that cash-pay options (via Amazon or GoodRx) are cheaper, out-of-pocket, than going through insurance 20% of the time.

• This is a useful accounting of the IRA-related math on where the $160 billion in savings is coming from (and where it’s going).

• I’m not sure what to make of this JAMA Health Forum research that shows that supplemental indications required less R&D investment than initial indications (or the suggestion that there are IRA-related implications). None of this seems particularly surprising to me, but maybe it’s just noteworthy to see it documented?

• The demand for obesity-med stories remains infinite, so here is a Wall Street Journal article 🎁 profiling some of the people currently paying out of pocket for the drugs. Which got me wondering: what does it cost to do Nutrisystem as a diet plan? Here’s the Nutrisystem pricing page. Remember to look at the list price, not the price after rebates lol

• This ProPublica piece should be required reading for anyone curious about where and how health insurance is broken.