Sign in

RefiningValue.bsky.social

@refiningvalue.bsky.social
558 followers 124 following 72 posts

Health economist writing about HEOR/market access, drug development, biopharma refiningvalue.substack.com

PostsRepliesMedia
RefiningValue.bsky.social @refiningvalue.bsky.social · 08/04/2025
Not too often you see HRQoL data in drug commercials. Via Ari Gnanasakthy youtu.be/VDFF6MCFzKM?...
youtu.be
Attruby Commercial (2025)
YouTube video by Commercial Archivist
020
RefiningValue.bsky.social @refiningvalue.bsky.social · 03/04/2025
Oh completely agree on lifestyle. Not sure our HHS secretary realizes that or cares though
010
RefiningValue.bsky.social @refiningvalue.bsky.social · 03/04/2025
I would be surprised given RFK's public skepticism on GLP-1s, suggesting "lifestyle changes" should be the focus
110
Reposted by RefiningValue.bsky.social
Liz Essley Whyte @lizessleywhyte.bsky.social · 01/04/2025
Former FDA Commissioner:
271037372
RefiningValue.bsky.social @refiningvalue.bsky.social · 26/03/2025
Nice paper outlining how RWE can be applied in IRA evaluation of drugs academic.oup.com/healthaffair...
academic.oup.com
Use of real-world evidence in the Medicare Drug Price Negotiation Program: A checklist for the Centers for Medicare and Medicaid Services and manufacturers
Abstract. Under the Inflation Reduction Act's (IRA's) - Medicare Drug Price Negotiation Program, the Centers for Medicare & Medicaid Services' (CMS's)
020
RefiningValue.bsky.social @refiningvalue.bsky.social · 06/03/2025
Glad to see GLP-1s continue to push expanded direct offerings: www.prnewswire.com/news-release...
prnewswire.com
Novo Nordisk introduces NovoCare® Pharmacy, lowering cost of all doses of FDA-approved Wegovy® (semaglutide) to $499 per month and offering easy home delivery for cash-paying patients
NovoCare® Pharmacy provides direct-to-patient, convenient home shipments of all dose strengths of Wegovy® at a reduced cost of $499 per month for cash-paying...
010
RefiningValue.bsky.social @refiningvalue.bsky.social · 05/03/2025
Reports and documentation are a low-hanging fruit for biopharma and can help reduce OpEx, especially that which is currently outsourced to vendors. CSRs, other study reports, payer dossiers, briefing book docs etc etc. Big potential for short to medium-term savings
053
RefiningValue.bsky.social @refiningvalue.bsky.social · 19/02/2025
Short-termism driven by personal timelines rule the day. Greater purpose be damned. Would a Vagelos or Termeer have done the same? I would think not, and hopefully history judges the two archetypes accordingly.
110
Reposted by RefiningValue.bsky.social
Michael Gilman @gilman.bsky.social · 19/02/2025
Was really expecting more of these people.
3154
Reposted by RefiningValue.bsky.social
Robert Califf @robcaliff.bsky.social · 17/02/2025
I am grieving for the many talented & dedicated FDA employees who have been mistreated & those left to do the work of protecting public health. Also for those who will be harmed by this among patients and the public. Those who are complicit in their silence will be judged harshly by history.
19530
RefiningValue.bsky.social @refiningvalue.bsky.social · 13/02/2025
Also, while the FDA of the next 4 yrs may not care, the FDA of the future may care once more. And how many pivotal trials being started now will have a PDUFA date within 4 years? Probably not the vast majority
021
RefiningValue.bsky.social @refiningvalue.bsky.social · 13/02/2025
Even from a development economics perspective. Reaching underserved populations, those away from academic centers, etc much needed to help trial recruitment and trial timelines. Hopefully this is just trying to fly with the political wind without really changing behavior.
110
Reposted by RefiningValue.bsky.social
Luke Timmerman @luketimmerman.bsky.social · 13/02/2025
Defend the NIH. timmermanreport.com/2025/02/defe...
timmermanreport.com
Defend the NIH - TimmermanReport.com
Too many people don’t believe anymore in the American Dream. But if you can’t dream big, you can’t accomplish big things. Today, the National Institutes of Health — biomedical science itself — is unde...
098
Reposted by RefiningValue.bsky.social
Derek Lowe @dereklowe.bsky.social · 12/02/2025
Biopharma companies and CEOs are keeping their heads down at their own peril. They should speak up about what’s happening to the NIH and other science agencies before it’s too late. Silence gives consent. And no one should consent to this.
science.org
Stand Up And Be Counted
17384158
RefiningValue.bsky.social @refiningvalue.bsky.social · 12/02/2025
Ah mightve just assumed George was same as Len. Still feel like with the science emphasis + harder to remove them they're most likely
100
RefiningValue.bsky.social @refiningvalue.bsky.social · 12/02/2025
Other issue here is unlike tech no one is irreplaceable (like Zuck) because no one owns enough voting rights, at least amongst the bigger players -> riskier to act. Len/George at Regeneron most likely to say something imo (especially given general outspokeness and strong Dem support historically)
111
RefiningValue.bsky.social @refiningvalue.bsky.social · 12/02/2025
To some extent same for board members and larger investors. Even moreso w backdrop of hoping IRA implementation isn't as aggressive. But I suspect it could catch up to the industry, much as years of ignoring drug pricing issues has. But for those in charge today it probably won't be "their problem".
110
RefiningValue.bsky.social @refiningvalue.bsky.social · 12/02/2025
Of course not reflective of many (most?) of us working in the industry. Unfortunately, anything at NIH today that will lead to a new drug is way too long a time horizon for leadership to worry about personally (chances are they'll be long gone by the time it comes to fruition).
110
Reposted by RefiningValue.bsky.social
Chris Geidner @chrisgeidner.bsky.social · 11/02/2025
BREAKING: In response to doctors' lawsuit, Judge John Bates, a George W. Bush appointee, orders CDC, NIH, and FDA to put back up websites and datasets cited by the doctors in their lawsuit as having been relied upon and pulled down without notice. storage.courtlistener.com/recap/gov.us...
TOTE ASTRICT COLOR
DOCTORS FOR AMERICA,
Plaintiff,
Civil Action No. 25-322 (JDB)
OFFICE OF PERSONNEL MANAGEMENT et al.,
Defendants.
ORDER
Upon consideration of [6] Plaintiff's motion for a temporary restraining order, [8]
Plaintiff's supplemental declarations, [9] Defendants' opposition, [10] Plaintiff's reply, the
hearing on February 10, 2025, and the entire record herein, and for the reasons stated in the
accompanying Memorandum Opinion, it is hereby ORDERED that
1. Defendants Department of Health and Human Services, Center for Disease Control, and Food
and Drug Administration (hereinafter "defendants") shall, by not later than 11:59 pm on
February 11, 2025, restore to their versions as of January 30, 2025, each webpage and dataset
identified by Plaintiff on pages 6-12 of its Memorandum of Law in Support of the Motion for
a Restraining Order [ECF No. 6-1];
2. Defendants shall, in consultation with Plaintiff, identify any other resources that DF A members
rely on to provide medical care and that defendants removed or substantially modified on or
after January 29, 2025, without adequate notice or reasoned explanation; and defendants shall,
by February 14, 2025, restore those resources to their versions as of January 30, 2025;
296281906753
RefiningValue.bsky.social @refiningvalue.bsky.social · 11/02/2025
Best proxies on non-profit behavior in these circumstances may be in healthcare space w number of large non-profit hospital and insurer (eg blue cross blue shield plans) deals over the years, albeit none of this size. Spoiler is they behave pretty much like their for-profit counterparts
000
Reposted by RefiningValue.bsky.social
Mark Cuban @mcuban.bsky.social · 09/02/2025
This is the most relevant article to NIH and research cuts I’ve seen. Imagine if this was today , how many people would be saying “Why are we studying Gila Monsters and their impact on diabetes ? That’s wasted money !” globalnews.ca/news/9793403...
globalnews.ca
How a Canadian scientist and a venomous lizard helped pave the way for Ozempic - National | Globalnews.ca
In 1984, Dr. Daniel Drucker, an endocrinologist from the University of Toronto, discovered a hormone that helped pave the way for popular diabetes drugs such as Ozempic.
11264858712423
RefiningValue.bsky.social @refiningvalue.bsky.social · 07/02/2025
Pharma bet that Trump>Biden may be tested sooner than I thought w the news of FDA cuts. Especially if review timelines / meeting timelines start getting impacted
010
RefiningValue.bsky.social @refiningvalue.bsky.social · 05/02/2025
Coupling modeling of price change w contractual agreement on price drop at date x (a la Peter Kolchinsky's contractual genericization) could be a win-win here and reduce some uncertainties. Re competitive landscape maybe something like NICE's TA-level CEA in RCC but that has it's own issues
110
RefiningValue.bsky.social @refiningvalue.bsky.social · 27/01/2025
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
000
RefiningValue.bsky.social @refiningvalue.bsky.social · 25/01/2025
If we assume they kept the highest NPV internal assets going then you can compare the top internal v top external assets from that time (not like he killed everything at Sanofi). I guess you can argue forecasting sucks and w larger net it mightve been different but hard to say.
100
RefiningValue.bsky.social @refiningvalue.bsky.social · 25/01/2025
Regeneron seems to be the clearest example to me. Maybe Genmab? Vertex?
010
RefiningValue.bsky.social @refiningvalue.bsky.social · 24/01/2025
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?
031
RefiningValue.bsky.social @refiningvalue.bsky.social · 24/01/2025
Not sure if it's a great example against external. Genzyme and extension of Regeneron deal under Viehbacher are still a huge part of sales and growth for the co today vs the internal assets from the time (eg Toujeo) which haven't done nearly as well
110
RefiningValue.bsky.social @refiningvalue.bsky.social · 22/01/2025
Of course the elephant in the room is still that clinical development will remain super expensive, largely driven by Western development infrastructure costs. No China advantage there from what I can tell. Although it is nice to see alternative models from Beigene etc v the traditional CRO model
000
RefiningValue.bsky.social @refiningvalue.bsky.social · 22/01/2025
And there it's really a positive unless we think it will lead to a reduction in novel targets being pursued which I don't buy as likely. Better discovery economics -> better margins -> greater ability to weather pricing pressure and remain a sustainable ecosystem for new development.
100
RefiningValue.bsky.social @refiningvalue.bsky.social · 22/01/2025
Excellent piece and nicely balanced on the "China asset farm" issue. While others' concerns on impact to the US bio ecosystem are understandable I think it's also important to consider the macro impact re impact on overall discovery/development economics.
111
Reposted by RefiningValue.bsky.social
Derek Lowe @dereklowe.bsky.social · 06/01/2025
Re-upping this reply thread from last night. Drugs don't come from nowhere, folks. And we're not ripping off the NIH, either.
57823
RefiningValue.bsky.social @refiningvalue.bsky.social · 27/11/2024
Huh interesting I think i forgot they were a few months before. Was just thinking about the sales over time graphs and assumed Oncology less of an access story anyway especially back then
100
RefiningValue.bsky.social @refiningvalue.bsky.social · 27/11/2024
To me the two are correlated (access and blockbuster potential) but I think you're more optimistic than me wrt improved access with new entrants Hopefully I'm wrong on this one :)
110
RefiningValue.bsky.social @refiningvalue.bsky.social · 27/11/2024
Keytruda came later but won w new indications which likely won't be possible here. Is there any example of a similar profile product taking large share this late? And especially in a specialty/high UM therapeutic area? Lipitor etc back in the day but that was another time wrt the access landscape
200
RefiningValue.bsky.social @refiningvalue.bsky.social · 27/11/2024
I agree cash pay / direct offerings are an area to watch. I just don't think the traditional insurance path is going to be straightforward by any means despite the market excitement for follow-ons. All analogs i can think of (eg in PSO, AD, RA, etc) never became mega blockbusters in current pbm era.
110
RefiningValue.bsky.social @refiningvalue.bsky.social · 26/11/2024
All the above when you have similar efficacy/safety profile* If they have truly better efficacy and esp w different MoA it's another story
010
RefiningValue.bsky.social @refiningvalue.bsky.social · 26/11/2024
New entrants not only face inability to drive short-term competitive volume (and related rebates) but pretty much can't do better than parity. Same story we've seen in RA, PSO, AD, etc and to some extent in biosimilars. Really need super strong demand or get relegated to niche populations (2L etc)
220
RefiningValue.bsky.social @refiningvalue.bsky.social · 26/11/2024
Going from 1 to 2 drives rebate pressure from effectively 0 to something. Plus no stickiness with acute treatment. GLP market too mature at this point with high rebates already in place and lot of sticky patients that would require medical exemption ($$$) for preferential coverage.
110
RefiningValue.bsky.social @refiningvalue.bsky.social · 26/11/2024
If there's anyone to have an especially aggressive legal strategy there it's Amgen
010
RefiningValue.bsky.social @refiningvalue.bsky.social · 26/11/2024
To me base case is they price to parity and hope they can get parity access (although it will be tough to match the LLY NVO rebates due to volume gap which likely means they cant get there with most payers unless they have super strong demand). Maybe cash pay is where they'll have more room to play
100
RefiningValue.bsky.social @refiningvalue.bsky.social · 26/11/2024
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? www.leerink.com/article/a-cp...
leerink.com
A CPE Exclusive: Cobenfy™ for Adults Living with Schizophrenia | Leerink Partners
Leerink Partners' Articles – sharing our deep expertise and experience in Healthcare to help fuel our customers' next breakthrough innovation.
040
RefiningValue.bsky.social @refiningvalue.bsky.social · 22/11/2024
Also the IRA benefit for biologics over small molecules I would guess?
110
RefiningValue.bsky.social @refiningvalue.bsky.social · 22/11/2024
bsky.app/profile/abfr...
010
RefiningValue.bsky.social @refiningvalue.bsky.social · 22/11/2024
go.bsky.app/6S4Q9Mn
250
RefiningValue.bsky.social @refiningvalue.bsky.social · 22/11/2024
He also misunderstands (although not the first time) how drug pricing works. Demand is not perfectly inelastic.
051
RefiningValue.bsky.social @refiningvalue.bsky.social · 20/11/2024
Fantastic overview of methods to quantify the various components of the ISPOR value flower in GCEA #HEOR #biosky pmc.ncbi.nlm.nih.gov/articles/PMC...
pmc.ncbi.nlm.nih.gov
Valuing the Societal Impact of Medicines and Other Health Technologies: A User Guide to Current Best Practices
This study argues that value assessment conducted from a societal perspective should rely on the Generalized Cost-Effectiveness Analysis (GCEA) framework proposed herein. Recently developed value asse...
010
RefiningValue.bsky.social @refiningvalue.bsky.social · 19/11/2024
Did not realize this. Alex Azar-Pence connection too potentially with Lilly HQ in Indianapolis
020
RefiningValue.bsky.social @refiningvalue.bsky.social · 19/11/2024
Absolutely. Great piece!
000