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Rachel Sachs @rachelsachs.bsky.social · 1m

Now up at Health Affairs Forefront, Kristi Martin and I analyze CMS's final guidance for the 2028 cycle of the Medicare drug price negotiation program, including key provisions that CMS both did and did not change from the draft guidance. www.healthaffairs.org/content/fore...

Administration Releases Medicare Drug Price Negotiation Program Final Guidance For 2028 | Health Affairs Forefront

The final guidance for the 2028 cycle of the Medicare drug price negotiation reflects CMS’s continued effort to balance statutory requirements with transparency, responsiveness to stakeholder input, a...

www.healthaffairs.org

Reposted by Rachel Sachs

Adrianna McIntyre @adrianna.bsky.social · 1d

Zero-claim enrollees would be risk-pool-improving and premium-reducing.

Reasonable people can debate whether/to what extent the increase in zero-claim enrollees might reflect increased broker-driven fraudulent enrollment, but not whether that enrollment increases (individual) premiums.

Sarah Karlin-Smith @sarahkarlin-smith.bsky.social · 1d

Oz seems to suggest there are very large number of people who have ACA plans who don't file claims in any year - suggesting fraud going on and this is why premiums are going up.

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Rachel Sachs @rachelsachs.bsky.social · 3d

And here's a link to the @healthaffairs.bsky.social podcast on health care M&A with Bob, in case people missed it! www.healthaffairs.org/do/10.1377/h... 2/2

Podcast: Whether Health Care M&A is Cooked Or Not w/ Bob Herman | Health Affairs Podcast

Health Affairs' Jeff Byers welcomes Bob Herman of STAT News to the program to discuss the state of deals in the health care space, how vertical integration and consolidation have played a role in merg...

www.healthaffairs.org

Rachel Sachs @rachelsachs.bsky.social · 3d

Glad to see my piece with Hayden Rooke-Ley on consolidation in the pharmaceutical wholesaler market out now in @nejm.org. Back in April, @bobjherman.bsky.social called this an "under the radar" issue - hopefully that's beginning to change. www.nejm.org/doi/full/10.... 1/2

Pharmaceutical Wholesalers — Under-the-Radar Middlemen? | NEJM

Lawmakers and regulators have grown alarmed about vertical integration and the role of “middlemen” in the U.S. health care system. Yet pharmaceutical wholesalers have largely evaded public scrutiny.

www.nejm.org

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Reposted by Rachel Sachs

Stacie Dusetzina @dusetzinas.bsky.social · 7d

Narrator: It is not a reasonable cash price.

Meg Tirrell @megtirrell.bsky.social · 7d

TrumpRx program promises discounts of 40-85% for Americans buying drugs directly from manufacturers

White House fact sheet says discounts are off list prices

Pfizer’s Xeljanz list price = $6,073/month

40% discount = $3,643/month

@dusetzinas.bsky.social: “How is this a reasonable cash price?”

TrumpRx prescription drug discounts
Eucrisa- dermatitis - 80% discount
Duavee- osteoporosis- 85% discount
Zavzpret- migraine - 50% discount
Xeljanz- rheumatoid arthritis - 40% discount

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Rachel Sachs @rachelsachs.bsky.social · 7d

On May 12, the White House issued an MFN EO in the morning and CMS issued the IPAY 2028 draft guidance in the afternoon. There was another MFN announcement today, and now CMS has issued the final guidance for IPAY 2028 this afternoon. Looking forward to reading. www.cms.gov/priorities/m...

Guidance and Policy Documents | CMS

Initial Price Applicability Year 2028CMS issued final guidance for the third cycle of negotiations for the Medicare Drug Price Negotiation Program, along with additional information on CMS' support fo...

www.cms.gov

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Rachel Sachs @rachelsachs.bsky.social · 7d

"[I]t all happened without it being clear to the outside world exactly what Pfizer had given up or what the United States has gained. (Much will depend on the details of the agreements laid out Tuesday.)" Pfizer described the agreement as "voluntary" and "confidential," exacerbating this challenge.

Matthew Herper @matthewherper.bsky.social · 7d

Trump, Pfizer, and the art of a drug pricing deal www.statnews.com/2025/09/30/w... via @statnews.com

Trump, Pfizer, and the art of a drug pricing deal

The Trump administration’s posture toward the pharma industry has largely been driven by threats, and a tense negotiation over prices. On Tuesday, in the Oval Office, there was talk of friendship.

www.statnews.com

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Rachel Sachs @rachelsachs.bsky.social · 7d

Today's White House fact sheet doesn't clearly address this issue. It states that it "guarantee[s] MFN prices on all new innovative medicines" but does not state whether those are list prices or net prices. It would've been easy to clarify if it meant net prices. www.whitehouse.gov/fact-sheets/...

Sarah Karlin-Smith @sarahkarlin-smith.bsky.social · 7d

Keeping thinking of this from @rachelsachs.bsky.social this summer re MFN news: For unapproved drugs, industry might be able to announce list prices that are the same in the US & other countries but then achieve differential prices through negotiation ex-US that would not be available in US.

Most Favored Nation Pricing: Trump Ups Pressure On Voluntary Action, Clarifies Demands

The new 60-day deadline for striking a deal with the drug industry underscores the challenges the Administration may be having in developing non-voluntary policies to achieve MFN pricing in the US.

insights.citeline.com

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Rachel Sachs @rachelsachs.bsky.social · 7d

Now we have a fact sheet released by the White House. It does not provide clear answers to most of the Qs below. www.whitehouse.gov/fact-sheets/...

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Rachel Sachs @rachelsachs.bsky.social · 7d

If the admin is going to run its own website, what funding/staff will they use to build/run it? What is the relationship between these "lower prices" and current net prices? What is the relationship between these "lower prices" and international prices? Can patients use insurance here? Etc. /end

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Rachel Sachs @rachelsachs.bsky.social · 7d

Drug pricing is complex, and the answers to Qs like these are critical for understanding the impact of any announcement. Which drugs are going DTC? Which patients are eligible? Can they afford $100s/1000s per month out of pocket? When companies tout "lower prices," list or net? In which programs? /1

Stacie Dusetzina @dusetzinas.bsky.social · 7d

I'm starting to think these big press releases are just meant as a distraction from everything else going on. Direct sales of branded drugs is a solution for a tiny number of people. Also noting that the devil is in the details on which drugs Pfizer chooses and how much the NET prices decrease.

Yashar Ali 🐘 @yasharali.bsky.social · 7d

NEWS

The White House is planning to unveil a direct-to-consumer website for Americans to buy drugs, dubbed TrumpRX, as well as announce that Pfizer plans to lower prices on several of its medications in the U.S.

Full Story: on.wsj.com/4q2H6Jc

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Rachel Sachs @rachelsachs.bsky.social · 8d

ICYMI last week, reposting this @kff.org analysis from @jcubanski.bsky.social and @tricia-neuman.bsky.social about the reconciliation law's changes to the Medicare negotiation program that are expected to keep prices higher for longer for both Medicare and beneficiaries. www.kff.org/medicare/peo...

People with Medicare Will Face Higher Costs for Some Orphan Drugs Due to Changes in the New Tax and Budget Law | KFF

This brief analyzes changes in the new tax and budget reconciliation law that modify which drugs will be selected for Medicare drug price negotiation, which will lead to higher Medicare spending and h...

www.kff.org

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Rachel Sachs @rachelsachs.bsky.social · 12d

While we wait for more info on what, exactly, the pharma tariff announcement applies to, reupping this March piece from @martawosinska.bsky.social on pharma tariffs, including how Medicare/Medicaid inflation rebates may limit companies' ability to pass them through. www.brookings.edu/articles/pha...

Will pharmaceutical tariffs achieve their goals? | Brookings

Marta Wosińska explains the likely impact of pharmaceutical tariffs on drug prices, onshoring, drug shortages, and derisking from China.

www.brookings.edu

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Rachel Sachs @rachelsachs.bsky.social · 15d

That is, it seems (from the NDC Directory) that existing products are all ANDAs. But generic manufacturers generally can't revise labeling on their own. One possibility is that FDA is trying to update the branded (NDA) label, which would then allow generics to change their labels. /end

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Rachel Sachs @rachelsachs.bsky.social · 15d

However, if you examine the FDA's NDC Directory, there are already a number of oral leucovorin products on the market. Why approve this NDA? One inference based on the notice (but again, will wait to learn more) is that it's about the label. /4

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Rachel Sachs @rachelsachs.bsky.social · 15d

But the FDA notice appears related to the autism announcement, as there is language in the notice on the subject. /3

Published case reports provided patient-level data on over 40 patients,
including both adults and pediatric patients, with genetically confirmed CFD due to variants in
the FOLR1 gene who were treated with oral leucovorin. Patients had heterogenous clinical
symptoms that included global developmental delays with autistic features and psychomotor
regression, intractable epilepsy, and cerebellar ataxia. In some patients, leucovorin dosing was
titrated based on levels of 5-methyltetrahydrofolate (5-MTHF) in the cerebrospinal fluid (CSF)
or symptoms

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Rachel Sachs @rachelsachs.bsky.social · 15d

Of note, if you click on the Federal Register notice, it states that this document has now been withdrawn. I'm not sure what plans are to re-issue it and will look forward to learning more. /2

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Rachel Sachs @rachelsachs.bsky.social · 15d

Those who don't subscribe to the Federal Register might be missing some very unusual developments today on the leucovorin front. There's a notice that FDA is approving a previously withdrawn NDA for leucovorin tablets. That in itself is unusual. /1

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Reposted by Rachel Sachs

Jason L. Schwartz @jasonlschwartz.bsky.social · 18d

Yes! Exactly the types of affordability/access divides that VFC was created in ‘94 to address. (And it’s done so!) The immediate issue here is a pretty niche one—15% of families who opted for a non-preferred option for 1 dose of 1 vaccine—but likely a harbinger of more consequential changes to come.

Rachel Sachs @rachelsachs.bsky.social · 18d

Thread. ACIP's reversal this morning imposes new financial barriers to accessing the MMRV vaccine for VFC-eligible families, while AHIP's public statements mean that privately insured families will continue to have access with no cost-sharing, at least for now.

Jason L. Schwartz @jasonlschwartz.bsky.social · 19d

They reversed the confusing VFC vote that would have preserved MMRV coverage for kids <4. But contrary to how the chair described the effect of this new vote, it really just means that VFC-eligible families of <4 kids won’t have free access to MMRV (which they no longer recommend) even if desired.

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Rachel Sachs @rachelsachs.bsky.social · 18d

Thread. ACIP's reversal this morning imposes new financial barriers to accessing the MMRV vaccine for VFC-eligible families, while AHIP's public statements mean that privately insured families will continue to have access with no cost-sharing, at least for now.

Jason L. Schwartz @jasonlschwartz.bsky.social · 19d

They reversed the confusing VFC vote that would have preserved MMRV coverage for kids <4. But contrary to how the chair described the effect of this new vote, it really just means that VFC-eligible families of <4 kids won’t have free access to MMRV (which they no longer recommend) even if desired.

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Reposted by Rachel Sachs

Jason L. Schwartz @jasonlschwartz.bsky.social · 19d

True. (And even though not all insurers are part of AHIP—UnitedHealth, most notably—I suspect they’ll all just ignore the ACIP chaos and stay the course.) Bigger complication of this outcome is probably for CHIP, as someone mentioned in the replies

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Rachel Sachs @rachelsachs.bsky.social · 19d

Others seem to be saying yes, postponed to tomorrow.

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Rachel Sachs @rachelsachs.bsky.social · 19d

Yes - so AHIP's statement from earlier this week becomes more important: www.ahip.org/news/press-r...

AHIP Statement on Vaccine Coverage

AHIP is the national association whose members provide health care coverage, services, and solutions to hundreds of millions of Americans every day. We…

www.ahip.org

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Rachel Sachs @rachelsachs.bsky.social · 19d

As others have noted, this vote would end the ACA requirement for private insurers to cover these vaccines. BUT recall that AHIP just announced health plans "will continue to cover all ACIP-recommended immunizations... recommended as of September 1, 2025" through 2026. www.ahip.org/news/press-r...

Liz Szabo @lizszabo.bsky.social · 19d

The CDC's Advisory Committee on Immunization Practice voted to stop recommending kids get the combined MMRV (measles mumps rubella chickenpox) vaccine, saying kids should get separate shots for MMR and chickenpox. But they said the fed govt should continuing provider MMRV for free to low-income kids

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Rachel Sachs @rachelsachs.bsky.social · 19d

Thread (with context regarding the kinds of questions ACIP members were asking, for further support for Jason's conclusion).

Jason L. Schwartz @jasonlschwartz.bsky.social · 19d

None of the ACIP understand that they just voted to maintain VFC coverage for the MMRV vaccine for kids under 4 (50% of US kids) through one vote—a good thing!—while removing the overall recommendation for any kid to get it (and thus ending ACA coverage requirement for kids with private insurance).

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