Evidence map›Paper›PMID 39990187›Full record

ArticleJournal of market access & health policy2025

Avoiding Error and Finding the Right Balance in European Health Technology Assessments: Insights Generated by the European Access Academy.

Elaine Julian, Tom Belleman, Maria João Garcia, Maureen Rutten-van Mölken, Robin Doeswijk, Rosa Giuliani, Bernhard J Wörmann, Daniel Widmer, Patrick Tilleul, Ruben Casado Arroyo and 10 more

Abstract read
In one paragraph

Article in Journal of market access & health policy, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 4 papers.

0numbers the graph read from it
0cells of the map it votes in
4citing 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

4 citing papers in PubMed.

  1. Article
  2. Article
  3. Article
  4. 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

20 authors.

Elaine JulianSecretariat of the European Access Academy (EAA), 4059 Basel, Switzerland.
Tom BellemanErasmus School of Health Policy and Management, Department Health Technology Assessment, Erasmus University Rotterdam, 3062 PA Rotterdam, The Netherlandsm.rutten@eshpm.eur.nl (M.R.-v.M.).ORCID https://orcid.org/0000-0002-9086-6558
Maria João GarciaF. Hoffmann-La Roche Ltd., 4070 Basel, Switzerland.ORCID https://orcid.org/0000-0001-9009-3826
Maureen Rutten-van MölkenErasmus School of Health Policy and Management, Department Health Technology Assessment, Erasmus University Rotterdam, 3062 PA Rotterdam, The Netherlandsm.rutten@eshpm.eur.nl (M.R.-v.M.).ORCID https://orcid.org/0000-0001-8706-3159
Robin DoeswijkEuropean Hematology Association (EHA), 2514 AA The Hague, The Netherlands.
Rosa GiulianiGuy's and St Thomas' NHS Foundation Trust, London SE1 7EH, UK.
Bernhard J WörmannGerman Association of Hematology and Oncology (DGHO), 10117 Berlin, Germany.
Daniel WidmerEuropean Union of General Practitioners (UEMO), 1000 Brussels, Belgium.ORCID https://orcid.org/0000-0003-0207-0136
Patrick TilleulAPHP and Faculty of Health, University of Paris-Cité (Former Member), 75006 Paris, France.ORCID https://orcid.org/0000-0002-5202-7999
Ruben Casado ArroyoCardiac Electrophysiology Laboratory, Université Libre de Bruxelles- Erasme Hospital, 1070 Brussels, Belgium.ORCID https://orcid.org/0000-0002-3876-6074
Valentina StrammielloEuropean Patients' Forum (EPF), 1040 Etterbeek, Belgium.
Kate MorganMyeloma Patients Europe (MPE), 1050 Brussels, Belgium.ORCID https://orcid.org/0009-0003-0276-4231
Marcus GuardianInternational Horizon Scanning Initiative (IHSI), 1140 Brussels, Belgium.
Michael ErmischMedicines Division, National Association of Statutory Health Insurance Funds (GKV-SV), 10117 Berlin, Germany.
Renato BernardiniDepartment of Biomedical and Biotechnological Sciences (BIOMETEC), Section of Pharmacology, University of Catania, 95124 Catania, Italy.
Fabrizio GianfrateDepartment of Health Economics, University of Ferrara, 44121 Ferrara, Italy.
Stefano CapriSchool of Economics and Management, Cattaneo-LIUC University, 21053 Castellanza, Italy.ORCID https://orcid.org/0000-0003-4633-4420
Carin A Uyl-de GrootErasmus School of Health Policy and Management, Department Health Technology Assessment, Erasmus University Rotterdam, 3062 PA Rotterdam, The Netherlandsm.rutten@eshpm.eur.nl (M.R.-v.M.).ORCID https://orcid.org/0000-0001-5808-302X
Mira PavlovicMedicines Development and Training (MDT) Services, 75020 Paris, France.
Jörg RuofSecretariat of the European Access Academy (EAA), 4059 Basel, Switzerland.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundWe examined four potential challenges for the implementation of the European Union (EU) Regulation 2021/2282 on Health Technology Assessment (EU HTAR): interaction with the European Medicines Agency (EMA), expert input, the interface of European health technology assessment (EU HTA) joint procedures with those within Member States, and the management of conflict of interest. This research aims to explore how to address these challenges in a balanced manner and prioritise key actions for effective collaboration in the context of the EU HTA.

methodsThe methodology included a pre-convention survey among relevant stakeholders as well as working groups and the plenary ranking of discussion outcomes at the European Access Academy (EAA) Spring Convention 2024.

resultsIn the survey, 65.5% of respondents indicated that experts are currently not sufficiently included in the upcoming joint scientific consultations and clinical assessments; only 37.9% suggested that the EU HTA joint procedures would accelerate national appraisal decision-making, and 58.6% believed that the principles of 'transparency' and 'competency' are balanced in the EU HTA position on conflict of interest. The top priority action points identified in the working groups were the involvement of the best available expertise, the early and inclusive involvement of experts, strengthened early scientific dialogue, and the fostering of the political willingness/financial support of EU Member States to increase capacities.

conclusionsThe key topics identified were an approach to conflict of interest that balances transparency obligations and the need for expertise, strengthens the involvement of clinical and patient experts, intensifies early interaction between the EMA and EU HTA, and increases the involvement of the EU Member States.

Indexed as

best available evidenceEUHTAEuropean access academyEuropean medicines agencyhealth policyhealth technology assessment

Identifiers

PMID39990187
PMCPMC11843953

What OpenQuestion holds

Textmetadata
LicenceCC BY
Read underepoch 390

Registered trials

None linked

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.