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Inmaculada Hernandez
Associate Professor at UC San Diego
Inmaculada (Inma) Hernandez is a Professor with tenure at the University of California, San Diego (UCSD) Skaggs School of Pharmacy and Pharmaceutical Sciences.14 She is a pharmaceutical health services researcher whose work focuses on improving medication use, outcomes, and equity in access.15
Dr. Hernandez has made significant contributions to her field:
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Research: She has authored over 140 scientific articles, with her research primarily focusing on evaluating clinical and economic outcomes of oral anticoagulant agents and studying pharmaceutical pricing.12
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Academic achievements: She earned her PharmD from the University of Navarra (Spain) in 2013 and her PhD in Health Services Research and Policy from the University of Pittsburgh in 2016.25
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Career progression: She began her faculty career at the University of Pittsburgh in 2016 and joined UCSD as an Associate Professor with tenure in 2021.2 As of July 2023, she has been promoted to full Professor at UCSD.6
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Recognition: Dr. Hernandez was recognized on the Forbes 30 under 30 list in 2018.23 In 2021, she became the first pharmacist to receive the AcademyHealth Alice S. Hersh Emerging Leader Award.15
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Professional affiliations: She is a Fellow of the American College of Cardiology and the American Heart Association.15 Currently, she serves as the National Academy of Medicine Fellow in Pharmacy.14
Dr. Hernandez's research program intersects health services research, pharmaceutical policy, and pharmacoepidemiology, with a focus on improving transparency in drug pricing and reimbursement systems.46
Highlights
The numbers that many are wondering about - how did the negotiated prices (MFPs) compare to the net prices before negotiation? Out in Health Affairs forefront, with Sean Sullivan, Olivier Wouters, Emma Cousin Ayuri Kirihennedige
https://lnkd.in/grU8QnKV
Stelara -42%, followed by Entresto -36%, Enbrel -33%, Imbruvica and Januvia -30%, Eliquis -20%, Xarelto -18%, Jardiance -9%, Novlog/Fiasp and Farxiga at the ceiling (0%).
💬 💡 Some thoughts / speculation not in the blog:
🔶Where Januvia and Entresto MFPs fell, versus where Jardiance or Farxiga MFPs fell makes me think that manufacturer response in the offer/counteroffer process mattered. This was not price setting, this was negotiation - otherwise somebody explain me how Farxiga is at ceiling and Januvia at -30% and Entresto at -36% given scenarios faced.
🔶When I read the guidance the first time, my impression was that this would be about net prices and adjustments based on CER. I have been operating under that reductionist bias this past year, thinking I was most probably downplaying the effect of additional factors. But with these MFPs, CMS didn’t change my mind: 🔷Two drugs are at the ceiling 🔷We predicted MFPs reasonably well without any data on additional factors (see post from Aug 15)
🔶Clinical effectiveness research data matter! Clear takeaway from Eliquis vs Xarelto and Jardiance vs Farxiga MFPs. Happy to see this signal, because it will encourage evidence generation ➡If you have a drug that may be negotiated in a few years, hire the fantastic pharmacoepidemiologists / HEOR professionals in the work force and generate CER evidence for your product
🔶 The negotiation may have elements of uncertainty BUT the outcome is predictable--we guessed quite a few MFPs in close range with no access to confidential data. This predictability should address arguments around regulatory uncertainty deterring investment
🔶On winners and losers… 🔷$2bn of the $6bn is Eliquis. But how much of that will be offset by waived mandatory discounts? To answer that accurately, one needs to project what proportion of claims will be filled in each phase. However, if you want a lower bound back-of-the-envelope estimate, 10% of gross is a good guess 🔷If you are impatient like me and do not want to wait for the full analysis… 🔺 See point above on Eliquis 🔺 Then look at Entresto example on mandatory discounts. ➡ If pending generic litigation resolves in favor of Novartis and there is no generic entrant by 2026, my guess is that Entresto will be the drug with the largest net impact (the drug generating the most savings)
Note: There is a second post coming up with an in the weeds explanation on estimates of rebates
Today in Value in Health, we published a paper with our predictions for negotiated prices https://lnkd.in/gYTQvhqG with Sean Sullivan Olivier Wouters Emma Cousin Ayuri Kirihennedige Nico Gabriel ISPOR—The Professional Society for Health Economics and Outcomes Research
✅ ✅ We got predictions for 5 drugs within the 5% range of MFP (in green) ✔ We got 3 additional drugs within 20% MFP (in yellow).
🌿 [Explanation in the weeds]🌿 You will see that Sullivan et al. vs MFP differences vary between the 30-day supply equivalents and the unit prices. This is because of different assumptions CMS made in estimating 30-day supply equivalents – for instance, according to CMS, one needs 55.6 tablets of apixaban for a 30-day supply (we assumed 60 tablets, as this is a twice a day drug). In other words, if one looks at the 30-day supply numbers, the MFP for a claim for 60 tablets of apixaban (30-day supply) is $231. But if one looks at MFP per unit, the MFP is $4.15*60=$249. This explains why the differences between our numbers and MFPs vary based on whether one looks at unit prices or prices per 30-day supply. This is particularly pronounced for Imbruvica as price changes with strength AND dosage form.
❌ I acknowledge we were very off on Enbrel. We originally thought CMS would stay at the ceiling (which it did). We moved our prediction down to match infliximab net price to follow a systematic approach consistent with the guidance and our prior work (we considered infliximab as an alternative, and we found no difference in our review of comparative effectiveness data, see Value in Health paper). Per the guidance, that would have moved the MFP to infliximab net price. And with competition among Humira biosimilars, it was not that far-fetched to think CMS may have been a bit more aggressive than the ceiling… I guess we were wrong.
▶ I will not comment on every single product, as the Value in Health paper outlines our rationale nicely. I will just say that CER data matters! 🎉 Price differentials between apixaban / rivaroxaban and dapagliflozin/empagliflozin nicely reflect differences in relative clinical benefit—This is an important signal to industry
❗ Quick remainder that 22% average price reduction (as compared to net price) does not mean 22% savings! More on this in yesterday’s post: https://lnkd.in/gBe6dadg
Thankful to The Commonwealth Fund for the funding of this work, Value in Health editors for moving this along peer-review in a timely manner recognizing the timeliness of the results, and ISPOR—The Professional Society for Health Economics and Outcomes Research for letting us present some of our estimates earlier this year at #ISPOR2024
#drugnegotiation #InflationReductionAct #pharmaceuticalpolicy #drugprices #pharmaceuticalmarket
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