Implementing managed entry agreements in practice: The Dutch reality check
Open accessAbstract
• Conditional financing of drugs in the Netherlands: example of Managed Entry Agreements. • Despite the scheme’s promise, retrospective policy evaluation demonstrates numerous shortcomings. • Shortcomings related to procedural, methodological and decision-making aspects of scheme implementation. • Despite their promise, the value of Managed Entry Agreements may be questionable. • Future schemes should aim to incorporate learnings from the Dutch case study. Conditional financing (CF) of expensive hospital drugs was applied in the Netherlands between 2006 and 2012; a 4-year coverage with evidence development (CED) framework for expensive hospital drugs. This study aims to evaluate the CF framework, focusing on Health Technology Assessment (HTA) procedures. Using a standardised data extraction form, researchers independently extracted information on procedural, methodological and decision-making aspects from HTA reports of drugs selected for CF. Forty-nine drugs were chosen for CF, of which 12 underwent the full procedure. The procedure extended beyond the envisioned 4 years period for 11/12 drugs. Outcomes research studies conducted as part of CF provided insufficient scientific data to reach conclusions on appropriate use and cost-effectiveness of 5/12 drugs. After re-assessment, continuation of reimbursement was advised for 10/12 drugs, with 6 necessitating yet additional conditions for evidence generation. Notably, advice to discontinue reimbursement for 2/12 drugs has not yet been implemented in Dutch healthcare practice. Theoretically, CF provided an option for quick but conditional access to drugs. However, numerous aspects related to the design and implementation of CF negatively affected its value in practice. Future CED schemes should aim to incorporate learnings from the CF example to increase their impact in healthcare practice.
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In the Netherlands, conditionally reimbursed interventions are reassessed after a predetermined time, usually 4 years, using findings from additional research, which may result in a disinvestment decision.
“After a predetermined time, usually 4 years, the reimbursement of the intervention will be reassessed using the findings from this additional research, which may result in a disinvestment decision [19, 20].”
From What influences the outcome of active disinvestment processes in healthcare? A qualitative interview study on five recent cases of active disinvestment (2021) · cites this paper as [20]
The Introduction describes a planned four-year reassessment of conditionally financed hospital drugs using outcomes research, and section 3.3.3 reports advice to discontinue reimbursement for 2 of 12 drugs. But the Discussion says only one drug completed the procedure within the envisioned four years. Thus the paper supports four years as the planned interval, not as the usual interval in practice; it also concerns hospital drugs rather than conditionally reimbursed interventions generally. (LLM, conf=0.88)
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Rotteveel, A. H., Lambooij, M. S., van de Rijt, J. J. A., van Exel, J., Moons, K. G. M., & de Wit, G. A. (2021) · BMC Health Services Research · doi:10.1186/s12913-021-06298-3 · Cited by 16 · see citing works
- Authors
- Makady, A., van Veelen, A., de Boer, A., Hillege, H., Klungel, O. H., & Goettsch, W.
- Affiliations
- Utrecht University (NL)
- University Medical Center Groningen (NL)
- Corresponding author
- Makady, A.
- Venue
- Health Policy
- Publisher
- Elsevier BV
- Published
- 2019-03
- Volume
- 123
- Issue
- 3
- Pages
- 267-274
- ISSN
- 0168-8510 (ISSN-L)
- OpenAlex
- W2894349822
- Cited by
- 61
- References
- 0
- Citations by year
- 2026: 5 · 2025: 4 · 2024: 9 · 2023: 5 · 2022: 9 · 2021: 13 · 2020: 9 · 2019: 6
- FWCI
- 10.00
- Type
- journal article
- Language
- en
- Open access
- hybrid
- doi.org
- Licence
- public-domain
- www.elsevier.com/tdm/userlicense/1.0/ (tdm)
- Locations
- Health Policy (publishedVersion, public-domain)
- PubMed (publishedVersion)
- University of Groningen research database (University of Groningen / Centre for Information Technology) (publishedVersion, other-oa)
- University of Groningen research database (University of Groningen / Centre for Information Technology) (submittedVersion, other-oa)
- Utrecht University Repository (Utrecht University) (submittedVersion, other-oa)
- Topics
- Social Sciences › Economics, Econometrics and Finance › Economics and Econometrics › Pharmaceutical Economics and Policy
- Social Sciences › Economics, Econometrics and Finance › Economics and Econometrics › Health Systems, Economic Evaluations, Quality of Life
- Social Sciences › Economics, Econometrics and Finance › Finance › Healthcare Systems and Reforms
- Keywords
- managed entry agreements, coverage with evidence development, health technology assessment, drug reimbursement, policy evaluation, Dutch healthcare system
- MeSH terms
- Cost-Benefit Analysis, Decision Making, Health Policy, Humans, Netherlands, Reimbursement Mechanisms, Retrospective Studies, Technology Assessment, Biomedical, Program Evaluation, Drug Costs, Drug Approval, Hospital Costs
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