This morning is really kind of out of control, news-wise. There are a number of items here that are worthy of more focus, and I reserve the right to look a bit more closely over the course of the week. But I didn’t want to hold anything back. Anyway: the deluge:
Bernie blinked.
Novo Nordisk will testify before Bernie Sanders’ HELP Committee, but it won’t be the guy Bernie wanted to subpoena, and the hearing won’t happen until after the August recess. CEO Lars Jørgensen will appear sometime in September. Sanders had pushed for a different executive — President Doug Langa — and was aiming for an early-July faceoff.
I’m tempted to call this political theater, except that this whole charade is arguably more dangerous than theater. To me, it comes down to a simple question: do we want to see more or fewer breakthroughs on the scale of obesity meds, even if there are budget-impact tradeoffs?
My answer is obviously “more,” but that’s apparently not the only way of looking at it.
In December, I wrote about a narrowly focused paper designed to highlight a legal maneuver around patents from drug manufacturers. It centered on “terminal disclaimers,” which essentially allow a company to link an add-on patent to an earlier patent.
It was one of a series of narrow papers on patent law, all coming out of academics affiliated with Arnold Ventures. Something was afoot:
I wasn’t tracking on the background [around terminal disclaimers], just as I wasn’t tracking on “inequitable conduct,” another narrow legal topic that was subject to a Tu-driven JAMA paper two weeks ago. Or “continuation patents,” the focus of a JAMA analysis by Tu and colleagues in August. All were Arnold-funded.
The fact that there has been a spate of similar papers, all exploring small-but-important elements of the patent system, suggests that we’re in the first phases of what will blossom into a larger policy effort.
So if you haven’t been boning up on patent law, now is the time to start. Because we’re going to see a lot more on this stuff, I suspect.
A New JAMA Paper on Patent Law Is a Good Excuse to Detail the ‘Arnold Playbook’, Dec. 15
Anyway: that December paper absolutely was the first phase in a larger policy effort: the USPTO dropped a proposed rule — Ed Silverman at STAT has the details — that would change the treatment of terminal disclaimers.
It’s hugely likely that the rule won’t ever come into force. Even its proponents give it one-in-20 odds. But that’s almost beside the point. The issue is now on the table.
It’s another piece of evidence that the Arnold Ventures approach of influencing policy by playing the long game — building a research base, introducing legislative/regulatory changes based on that research, advocating for enactment of those changes — is the most effective way to shape the policy environment.
This Health Affairs Forefront piece is a must-read. It’s an overview of why the IRA price-setting process should not try to weigh government involvement in the development of a given drug, but it goes beyond just the IRA element to try to explain why the usual dialogue around the government’s role in drug discovery both overstates the federal involvement and ignores much of the nuance of a drug’s lifecycle.
Colorado’s PDAB has deemed another drug — Novartis’ Cosentyx — “unaffordable.” I’m not sure there’s much new to say here, other than to repeat the core issue with Colorado’s decision-making: the utter lack of a clear standard about what makes a medicine “unaffordable.”
I do not consider these Boston University academics to be particularly aligned with the pharma view of the world, but their Milbank Quarterly paper on the effects of 340B — concluding that, maybe, DSH hospitals (but not community clinics) are the problem — lines up well with the industry critique.
Cash prices for generic drugs at Mark Cuban’s pharmacy beat the out-of-pocket costs for insured patients about 11% of the time, according to new JAMA Health Forum research. The number is consistent with other estimates of the cash-pay market.
I remain fascinated by the PCMA campaign to woo employers with the promise that PBMs are good partners who can help businesses. It’s not that I disagree with the approach … it’s just that the hyperbole that’s being employed erodes credibility. I mocked them for some of the commercials they launched, and there are some cringeworthy lines in this Real Clear op-ed from PCMA head JC Scott, notably the claim that the PBM marketplace is a competitive one because there are “73 full-service companies in the marketplace.”
The CBO scored a patent reform bill from Sens. Cornyn and Blumenthal as saving $3 billion over a decade. Leaving the merits of the policy, designed to chop through patent thickets, aside: those are not big numbers. That means either the policy changes are pretty small-ball or — more likely — the patent-thicket problem isn’t as big as policymakers like to think it is.
Damian Garde — who recently jumped from STAT to Bloomberg — is a sharp reporter, and his latest piece looks at why the IRA doesn’t pose an existential threat to industry. I like his broad, contrarian point, even if some really important context gets thrown out with the bathwater.
This JAMA Forum piece — with the crystal-clear title of “It Is Time to Consider More Price Regulation in Health Care” — deserves a longer response. It’s written by smart folks, but smooshing together price controls for both hospitals and pharmaceuticals oversimplifies the state of American health care in a way that makes the conclusions hard to take seriously.
It’s really important that cost-effectiveness analyses recognize that medicines go generic, a point that gets an airing in this Lancet letter to the editor about Trikafta.
CBO thinks that boosting hep C treatment would be cost-effective. As Billie Eilish says: duh.
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