Could a Chinese Obesity Med Break Open the U.S. Market? (Probably not, but humor me ...)

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I’ve been pretty explicit that I don’t see a way out of the reimbursement crisis coming for obesity meds, though it’s an excuse to talk about all kinds of interesting, ain’t-gonna-happen scenarios (Netflix models!). 

But this Financial Times piece -- about the efforts of the Chinese biopharma industry to come up with their own GLP-1 meds for obesity -- got me thinking about another deus ex machina solve: what are the odds that a biopharma company will try to pick up a Chinese-developed obesity med on the cheap and try to get it approved over here and sold as a cash-pay product for a relatively low price? 

The standard argument against that approach is the EQRx experience, where the company bought a couple of Chinese cancer drugs only to have the FDA turn its nose up at the Chinese-only data packages. That effectively spelled the end of EQRx, as well as the end of the buy-Chinese-drugs-on-the-cheap concept. (Lilly and Novartis had made similar plays in oncology.)

But obesity isn’t cancer, and it’s possible that the FDA might take a more charitable view of Chinese data in endocrinology (not regulatory guidance!). Or someone could build another couple late-stage clinical trials, enrolling Americans, on the back of existing research. 

That’s not necessarily a high-odds proposition, but the FT article makes clear that the size of the obesity market and the fact that it could be, at least for a time, a cash-pay environment, might open the door for a Chinese-developed medicine that doesn’t work as well as the market leaders but costs a whole lot less.

So there’s no news items that are really big enough to be “Inflection Point” today, but there are a couple of items worth a deeper look. 

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The first is a war of words in the pages of JAMA. 

Last month, JAMA published this piece (from the Harvard PORTAL guys) arguing that HTA bodies outside of the United States generally took a dim view of the “added therapeutic benefit” shown by top-selling Medicare drugs. 

The clear counter-argument is that it’s not particularly useful to use the judgments of other countries, which have other values and different economic circumstances, when assessing value in the United States. So it was fantastic to see Janssen’s Anastasia Daifotis make that argument so thoughtfully in her comment.

Of course, the authors of the original piece responded, doubling-down on their original argument. They also suggested that IRA-like price controls should kick in within a year of launch and floated the idea of an American HTA. So if you wondered what the PORTAL agenda is, here you go. 

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The second is an analysis of orphan drug development in JAMA Network Open.

The IRA shields orphan drugs from price controls, but only if there is only one orphan designation. So a team from Tufts looked at how many orphan drugs have an approval for more than one indication. 

Turns out that 23% of orphan products have multiple uses, most of those additional indications are also for orphan conditions. And the FDA usually grants them priority review, suggesting that they treat big unmet needs. The upshot? The IRA could really hurt orphan-drug development: “The potential foregone follow-on indication approvals for serious illness and unmet needs could be nontrivial.”

Elsewhere: 

• The Washington Post tried to figure out why no one has heard of the Inflation Reduction Act’s drug-pricing provisions. I’m not sure they come up with any very good answers, but it’s noteworthy that they’re asking the question. 

• This seems to be a week for Axios to write summary pieces that don’t include anything new but are nonetheless useful overviews. Today, they go at the IRA in a 700-word story that has six bolded sections and ten bullet points, because that’s how they roll. 

• Biosimilars Review & Report asks a question that I hadn’t seen raised before: where is Pfizer’s Humira biosimilar at? 

• I know that Patients for Affordable Drugs comes in for a lot of criticism here for being so wildly committed to its cause that it makes intentionally low-context arguments and tends to favor invective over constructive dialogue. But I have a novel critique on a new op-ed from P4AD’s David Mitchell about the IRA: it’s just kind of boring. Everyone’s talking points are getting a little stale, tbh.

• In the stuff-to-tune-in-to department: there is a Reuters event next Tuesday on “Re-designing U.S. Health Insurance,” that’s likely to be worthwhile. And the American Enterprise Institute is having a session on “The Continued Conundrum of Drug Pricing” on Sept. 14 that looks like it will have some blood enemies on stage together.