Evidence map›Paper›PMID 38757153›Full record

ArticleInternational journal of technology assessment in health care2024

Can requests for real-world evidence by the French HTA body be planned? An exhaustive retrospective case-control study of medicinal products appraisals from 2016 to 2021.

Judith Fernandez, Céleste Babin, Camille Thomassin, Floriane Pelon, Sophie Kelley, Pierre Cochat, Margaret Galbraith, Driss Berdaï, Antoine Pariente, Francesco Salvo and 1 more

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Article in International journal of technology assessment in health care, 2024. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 1 paper.

0numbers the graph read from it
0cells of the map it votes in
1citing 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

1 citing paper in PubMed.

  1. Review
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

11 authors.

Judith FernandezHTA Department, Haute Autorité de Santé, La Plaine Saint-Denis, France.ORCID https://orcid.org/0000-0003-3923-7139
Céleste BabinHTA Department, Haute Autorité de Santé, La Plaine Saint-Denis, France.
Camille ThomassinHTA Department, Haute Autorité de Santé, La Plaine Saint-Denis, France.
Floriane PelonHTA Department, Haute Autorité de Santé, La Plaine Saint-Denis, France.
Sophie KelleyHTA Department, Haute Autorité de Santé, La Plaine Saint-Denis, France.
Pierre CochatScientific Board and Chairman of the Transparency Committee, Haute Autorité de Santé, La Plaine Saint-Denis, France.
Margaret GalbraithHTA Department, Haute Autorité de Santé, La Plaine Saint-Denis, France.ORCID https://orcid.org/0000-0002-6064-5957
Driss BerdaïCHU de Bordeaux, Pharmacoepidemiology and Appropriate use of Medicine Team, Public Health Department, Clinical Pharmacology Unit Bordeaux, Nouvelle-Aquitaine, France.
Antoine ParienteCHU de Bordeaux, Pharmacoepidemiology and Appropriate use of Medicine Team, Public Health Department, Clinical Pharmacology Unit Bordeaux, Nouvelle-Aquitaine, France.
Francesco SalvoUniversity of Bordeaux, INSERM, BPH, U1219, Team AHeaD Talence, Aquitaine, France.
Antoine VanierHTA Department, Haute Autorité de Santé, La Plaine Saint-Denis, France.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

objectivesIn France, decisions for pricing and reimbursement for medicinal products are based on appraisals performed by the National authority for health (

methodsThis analysis encompassed all appraisals finalized between January 1, 2016 and December 31, 2021 and compared products for which the appraisal led to a PRS request with those that did not.

resultsSix hundred positive opinions for reimbursement were identified, with a PRS request present in 17 percent (n = 103) of cases. The independent characteristics associated with a PRS request were a mild or moderate clinical benefit score, a major to moderate or minor clinical added value score, previous availability under an early access program, and certain therapeutic areas (neurology, pulmonology, and endocrinology). These findings suggest two different profiles of PRS requests: (i) products for which there is uncertainty in the size of the clinical benefit and (ii) innovative products for which a substantial benefit is expected but uncertainties persist.

conclusionsThese results will assist health technology developers to better anticipate data generation to promptly address uncertainties identified by HAS. It may also help HAS and other assessment agencies to work together to improve postlaunch evidence generation according to the characteristics of the medicinal products.

Indexed as

Technology Assessment, BiomedicalCase-Control StudiesFranceHumansRetrospective Studieshealth technology assessmentlife-cycle assessmentpostlaunch evidence generationreal-world datareal-world evidence

Identifiers

PMID38757153
PMCPMC11569913

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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.