Rachel Sachs

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...

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

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.

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

Narrator: It is not a reasonable cash price.

On May 12, the White House issued an MFN EO in the morning and CMS issued the IPAY 2028 draft guidance in the afternoon.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...

"[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.

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/...

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/...

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

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

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...

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...

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.

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...

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

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

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

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

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

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

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.

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.

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

Others seem to be saying yes, postponed to tomorrow.

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…

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

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...

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

Many new ACIP members claim to want people to be able to choose whether to receive certain vaccines. But some of their votes would remove certain vaccines from VFC purchasing, significantly limiting people's ability to afford them. Stunning that some members appear to not understand this point.

In other cases, they're more difficult to understand/explain. For those who are more expert in STLDI issues, is it clear why the STLDI score should be binary? That is, it doesn't distinguish between different ways STLDI plans would be regulated beyond the fed guidance (using words like "any"). /end

In some cases, these distinctions seem related to the data sources underlying the element (see "licensure compacts," D.2, as an example, involving both binary 0/100 scores and tiered 0, 50, 75, and 100 (no 25!) or 0, 50, 100 (also no 75!) scores based on external data). /2

Thread. As @adrianna.bsky.social notes, the scoring system for these funds is confusing. Some elements are scored anywhere from 0-100 based on the "quality of details" in an application. Others are binary - either 0 or 100 (below). Others are tiered - 0, 25, 50, 75, or 100 points. /1

US FDA Cancer Reviewers Heading For The Exits, Potentially Impacting Review Timelines US FDA's cancer drugs division is feeling the effect of drug reviewer departures, despite efforts to keep them at the agency.

ICYMI, here's @sarahkarlin-smith.bsky.social's reporting on cancer drug review staff (insights.citeline.com/pink-sheet/a...), in addition to the NYT analysis (www.nytimes.com/2025/07/08/m...).

Trump Is Shutting Down the War On Cancer

Deeply researched article detailing the Trump admin’s “deliberate and targeted attack” on cancer research. Attacks on NIH are compounded by efforts to undermine FDA (causing many cancer drug reviewers to depart) and to patients’ ability to get and retain insurance. www.nytimes.com/2025/09/14/m...

Thread. Super interesting new article with implications for a wide range of important topics in health policy, including hospital finances, patient outcomes, hospital capacity, insurance design, and more.