Evidence map›Paper›PMID 41171065›Full record

ArticleJournal of managed care & specialty pharmacy2025

Halting hyaluronidase hopping to maintain the integrity of Medicare drug price negotiation.

John Kim, Aaron S Kesselheim, Benjamin N Rome

Abstract read
In one paragraph

Article in Journal of managed care & specialty pharmacy, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Not yet cited in PubMed.

0numbers the graph read from it
0cells of the map it votes in
0citing papers in PubMed
–field-weighted citation impact
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

0 citing papers in PubMed.

No citing paper in PubMed yet.

4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

3 authors.

John KimProgram On Regulation, Therapeutics, And Law (PORTAL), Division of Pharmacoepidemiology and Pharmacoeconomics, Department of Medicine, Brigham and Women's Hospital and Harvard Medical School, Boston, MA.
Aaron S KesselheimProgram On Regulation, Therapeutics, And Law (PORTAL), Division of Pharmacoepidemiology and Pharmacoeconomics, Department of Medicine, Brigham and Women's Hospital and Harvard Medical School, Boston, MA.
Benjamin N RomeProgram On Regulation, Therapeutics, And Law (PORTAL), Division of Pharmacoepidemiology and Pharmacoeconomics, Department of Medicine, Brigham and Women's Hospital and Harvard Medical School, Boston, MA.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

The Inflation Reduction Act empowered Medicare to negotiate drug prices for certain drugs, but the initial program guidance treated fixed-dose combination drugs separately, which would allow manufacturers of biologics to launch subcutaneous versions coformulated with hyaluronidase to defer negotiation eligibility, which we call "hyaluronidase hopping." In May 2025, the Centers for Medicare & Medicaid Services issued draft guidance requesting comments on a policy that could partially address hyaluronidase hopping by selecting and negotiating fixed-dosed combination products that contain therapeutically inactive ingredients (eg, hyaluronidase) alongside the original noncombination product. This proposed change was not adopted in the final guidance released in September 2025, although it will still be under consideration in future years. Adopting the proposed change is one of several policies needed to safeguard negotiation from hyaluronidase hopping to protect savings and patient access.

Indexed as

Drug CostsHyaluronoglucosaminidaseMedicareNegotiatingCenters for Medicare and Medicaid Services, U.S.Drug CombinationsHumansUnited StatesDrug CombinationsHyaluronoglucosaminidase

Identifiers

PMID41171065
PMCPMC12577718

What OpenQuestion holds

Textmetadata
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Registered trials

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Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.