Refining Value @RefiningValue
Health economist writing about HEOR/market access, drug development, biopharma refiningvalue.substack.com Joined July 2021-
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There's now 10 Humira biosimilars on the US market priced at 80+% off the brand name version (and 7 at 85+% off) ...and $ABBV still controls 77% of the market...
@BertrandBio @biobrainbox Agree. Pricing unlikely to change w inc PoS. I think risk for Eur (generalizing) is as US-Eur opportunity diff increases, the oft-higher Eur evidence reqs will increasingly not be worth it, especially when it comes to Ph3. Eur will be forced to lower bar or forego access@ margin
Nice slide from $BMY on Medicare Part D redesign - valid for all the BigP but impact dpding on overall exposure to this market segment
@Sports_bios @bradloncar On "malignant competition" it has always been there, no? You just have cheaper options for inlicensing now, improving the economics rather than worsening. To me that is the one trend acting against everything else you mentioned. Still an uphill battle
Interesting comment on GLP-1s in Parkinsons: “’We should know by now that it’s extremely rare that a drug just happens to treat a disease, if not designed for it”. And obvious reply is that we do know failure is extremely common for diseases that a drug IS designed for it. 1/n
We should know by now that it's extremely rare that a drug just happens to treat a disease, if not designed for it. There was no plausible explanation why GLP-1r agonists would be disease-modifying for Parkinson's (despite promising results from smaller trials)
Today I am thinking of the people I’ve met around the world—children, parents, health workers, teachers—who will be harmed by the Trump administration’s decision to try to dismantle USAID and walk back U.S. leadership in global health and poverty reduction. I’m thinking, too, about the dangerous ripple effects this will cause. In an increasingly interconnected world, we’re all better off when lifesaving medicines are developed and delivered, when disease outbreaks are halted, and when nations lift themselves out of poverty. Strong leaders throughout history have understood that foreign aid builds a heathier, safer, more prosperous world—and that’s a goal everyone should be able to get behind.
@Biohazard3737 Is the bulk of the societal value the industry produces in the hiring it does or the drugs it discovers? If societal value is the aim then why does it matter where discovery etc happen? A good amount of development spend will happen in the US anyway given the site-driven costs
@varma_ashwin97 @Frank_S_David PCSK9i trials even worse (larger n, longer follow up, and an argument that OO and FOURIER didn't show the full benefit because f/u wasn't long enough). $NVS ORION-4 will also be worse than Entresto CVOT
In other words, executive branch is meant to get checked and balanced, arguably here. Of course no "right" answer for a given issue including this one.
I think it's a fair take but Senate was also partly created for and has a long history of blunting large and sudden swings driven by popular opinion. Can argue to do what the founders intended of it (and thereby government as a whole) Senate has a responsibility to not confirm
My take on RFK Jr is that while a disagree with many of his ideas and I think he has a questionable temperament, I do think he should be confirmed because in his case he was essentially part of the ticket and many Americans in part voted for him and for change in healthcare.
Some interesting parallels re Deepseek: US-based LLMs and the bio explosion in China:US biotech Still feel it'll be net positive for the industries and consumers at large in both cases
We have moved... We have decided to take a break from X, but we want to keep talking about medicines and public & animal health with all of our followers. Find us on Bluesky ➡️ EMA-EU.bsky.social
I shouldn't try to apply logic here and apologies for the rare political post but if NIH is developing all of the drugs then why are we freezing all of the funding again?
Looking forward to this. Love the premise and can't think of anyone better for it
𝐍𝐞𝐰 𝐒𝐡𝐨𝐰 𝐀𝐧𝐧𝐨𝐮𝐧𝐜𝐞𝐦𝐞𝐧𝐭: Today BiotechTV is excited to announce our newest regular show - Off-Target Effects with @gline. Matt will share his perspective on news, and interview other biotech leaders. Visit the show's dedicated page: biotechtv.com/off-target-eff…
Interesting that Leerink now has a team doing independent cost effectiveness analyses. Seems to be taking more of a GCEA approach. An alternative to ICER? leerink.com/article/a-cpe-…
@matthewherper @michael_gilman @afinley @DShaywitz Would've been up there with Sanofi paying to get out of aflibercept eye development inherited from Aventis..
Prior post on the dementia "effect" studies here refiningvalue.substack.com/p/real-world-b…
Been saying this with all of the GLP RWE. Good hypothesis generation for sure but let's not forget how hard it is to measure / adjust for confounding in these data pts w GLP-1 access fundamentally different - higher SES, education etc
I feel like I shouldn’t have to say this… Association is not causation. This is a retrospective study with obvious potential confounders. It would have been nice to see a dose response (not shown in article) or a before/after initiation of GLP1 analysis (also not shown).
Laudable goal to improve trial data collection efficiency but I'm not sure how it is diff than existing alts and ultimately faces same ? of whether it's actually replacing any trial collection/cost or just adding on. But it's Abernathy so worth paying attn to. 🤞something here
Amy Abernethy, former No. 2 at FDA, outlines new company’s plans to streamline clinical research statnews.com/2024/10/17/amy…
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