Thread by @rgupta729

1/ NEW: Our paper today in @JAMAHealthForum covering:

🔸Evergreening
🔸Pharmaceutical innovation
🔸Anti-competitive behavior
🔸Clinical value
🔸Patient access

We analyze when & for which existing drugs do brand-name manufacturers pursue new formulations:
jamanetwork.com/journals/jama-…

2/ First, we show that brand-name manufacturers are much more likely to reformulate existing drugs that are blockbusters – those w/ >$1 billion in sales – & those that were granted accelerated approval, but NOT those that were the most therapeutically valuable.

3/ Second, we show that timing of new formulations is strategic: while there is an uptick in new formulation approvals right before the first generic version of the original drug, brand manufacturers lose interest in markets after generic competition against their original drugs.

4/ This has implications for patient access. New extended-release drugs, combinations, etc, can absolutely help patients. But often they don’t ⬆️adherence or outcomes. And we show companies aren’t modifying drugs that are particularly therapeutically valuable to begin with.

5/ New formulations, protected by additional patents & exclusivity, are also more expensive than generic versions of the original drug. Health systems & patients pay more. And to the extent that new formulations are helpful, the usefulness is tempered by cost-related nonadherence

6/ It's not surprising that drug companies try to preserve market share for their most profitable drugs. New formulations that aren’t clinically meaningful & timed strategically are evergreening strategies to avoid competition. Discussed here @VincentRK:

7/ The question also becomes: are we incentivizing the right innovation? We know there may be too much emphasis on incremental pharmaceutical innovation as opposed to transformative innovation that we need to address the diseases of the 21st century.

healthaffairs.org/doi/abs/10.137…

8/ As mentioned in a recent @NYT Editorial Board piece, and argued tirelessly by @pritikrishtel & many others, incentives for rewarding innovation need reform. The @uspto needs strengthening and structures for awarding patents require changes.

9/ A number of additional legislative and regulatory changes are needed & thankfully, the issue of evergreening & innovation is drawing attention, including by @OversightDems, in a recent @HHSGov report, & in a recent letter from @US_FDA to @uspto:

10/ I’ve been fortunate to work on this paper with a remarkable team: @jsross119 @cmorten2 @reshmagar @nilaydshah1 and Angela Zhu. An absolute pleasure, as always.

Be sure to check out the full paper in @JAMAHealthForum here:

jamanetwork.com/journals/jama-…

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