Evidence map›Paper›PMID 40261477›Full record

ArticlePharmacoEconomics - open2025

Indirect Treatment Comparisons in EUnetHTA Relative Effectiveness Assessments: Learnings and Recommendations for the Implementation of EU Joint Clinical Assessments.

Sophie van Beekhuizen, Menglu Che, Loraine Monfort, Mahmoud Hashim, Ali Azough, Nicole Kubitz, Adrian Griffin, Martin Price

Abstract read
In one paragraph

Article in PharmacoEconomics - open, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 2 papers.

0numbers the graph read from it
0cells of the map it votes in
2citing 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

2 citing papers in PubMed.

  1. Article
  2. Article
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

8 authors.

Sophie van BeekhuizenCytel, Inc., Rotterdam, The Netherlands. Sophie.VanBeekhuizen@cytel.com.ORCID http://orcid.org/0009-0008-1567-9155
Menglu CheCytel, Inc., Toronto, ON, Canada.ORCID http://orcid.org/0000-0002-0594-5797
Loraine MonfortCytel, Inc., Toronto, ON, Canada.ORCID http://orcid.org/0009-0008-2946-1229
Mahmoud HashimJanssen Pharmaceutica NV, Beerse, Belgium.ORCID http://orcid.org/0000-0002-5775-9590
Ali AzoughJanssen EMEA, High Wycombe, UK.ORCID http://orcid.org/0009-0009-2815-5964
Nicole KubitzJanssen-Cilag GmbH, Neuss, Germany.ORCID http://orcid.org/0009-0002-3741-0452
Adrian GriffinJohnson & Johnson, High Wycombe, UK.
Martin PriceJanssen EMEA, High Wycombe, UK.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundBeginning in January 2025, all new active substances must undergo evaluation of relative clinical effectiveness through European Union (EU) joint clinical assessments (JCAs). In the absence of head-to-head data, indirect treatment comparisons (ITCs) become indispensable in meeting the numerous population, intervention, comparators and outcomes (PICO) criteria to support decision-making.

objectiveThis study examined ITCs in European Network for Health Technology Assessment (EUnetHTA) relative effectiveness assessments (REAs) to obtain valuable insights into their potential implications for future JCAs.

methodsThe EUnetHTA website was hand-searched for REAs of pharmaceutical products between 2010 and 2021. Information on PICO, ITC methods, ITC limitations/critiques, and relative effectiveness conclusions were systematically extracted. On the basis of the final EUnetHTA critiques, suitability of ITC evidence was categorised by the current study authors as appropriate, unsuitable or unclear.

resultsTwenty-three REAs were identified. Twelve REAs included an ITC, of which six were in oncology indications. Across the REAs, 64 comparisons were required, with a median of four comparators per REA (range 1-18). In total, 25 comparisons were informed by indirect evidence; the suitability of ITCs was categorised as unclear in all but one of the 25 comparisons.

conclusionMultiple analyses and ITCs were necessary to address multiple PICOs. Although most ITCs were categorised as unclear within the REAs, they were still considered appropriate to inform decision-making. The EU JCA process will most likely require health technology developers to use various ITC approaches to address the multiple PICOs requested, recognising the inherent limitations of these methodologies. Efforts to address potential challenges for EU JCA should focus on supporting JCA assessors/co-assessors and national HTA agencies in the evaluation and interpretation of ITCs to enable decision-making.

Identifiers

PMID40261477
PMCPMC12209061

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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.