Impact of health technology assessment and managed entry schemes on reimbursement decisions of centrally authorised medicinal products in Belgium

  • Philippe Van WilderEmail author
  • Magali Pirson
  • Alain Dupont



Centrally authorised medicinal products (CAMPs) in the European Union may offer added therapeutic value (ATV) but may be linked to high prices and limited efficiency. Health technology assessment (HTA) and managed entry schemes (MES) may facilitate the reimbursement decision by providing reliable estimates of the medicinal product’s value and costs and by controlling the remaining uncertainty, respectively. We investigated the impact of HTA criteria and the initiation of a MES on the reimbursement decision of CAMPs in Belgium.


We selected all reimbursement submissions for new centrally authorised medicinal products in the 2010–2015 period. We retrieved data relating to the reimbursement decision, the HTA outcome and the use of a managed entry scheme.


The decision of the Minister was available for 115 dossiers, covering 36 (31.3%) orphan medicinal products (OMPs) and 79 ATV products. A MES was used in 41 submissions. A positive reimbursement decision was obtained in 65% of cases. The significant factors affecting the reimbursement decision were the approval of ATV, the medical need if it was considered ‘important or major’ and the use of a managed entry scheme. Price, budget impact and efficiency had no significant impact.


Added therapeutic value and high medical need increase the odds for a positive reimbursement decision. No impact could be demonstrated of the cost-related HTA criteria. Cost elements may be biased by the use of a confidential MES. Without a MES, only 53% of the centrally authorised medicinal products, including OMPs, are reimbursed in Belgium.


Access HTA Managed entry schemes Medicinal products Innovation 



Lieven Annemans (PhD, Ghent University) and Alexander Barbary (M Medicine, Ghent University) contributed to the data analysis. We are grateful to the staff of the Pharmaceutical Policy Department of the NIHDI for providing the relevant administrative data of the medicinal products.

Contributions of authors statement

Philippe Van Wilder and Alain Dupont conceived the study, analysed the data and wrote the paper. Magali Pirson analysed the data and reviewed the paper.

Supplementary material

228_2019_2665_MOESM1_ESM.docx (50 kb)
ESM 1 (DOCX 50 kb)


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Copyright information

© Springer-Verlag GmbH Germany, part of Springer Nature 2019

Authors and Affiliations

  1. 1.Research Centre in Health Economy, Management of Care Institutions and Nursing Sciences, Public Health SchoolUniversité Libre de BruxellesBrusselsBelgium
  2. 2.Department of clinical pharmacology and pharmacotherapyVrije Universiteit BrusselBrusselsBelgium

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