Impact of health technology assessment and managed entry schemes on reimbursement decisions of centrally authorised medicinal products in Belgium
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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.
KeywordsAccess 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.
- 1.The Council of the European Communities (1989) Directive 89/105/EEC, OJ L40:65–71Google Scholar
- 2.High Level Pharmaceutical forum. Conclusions and recommendations. Accessed via https://publications.europa.eu/en/publication-detail/-/publication/4fddf639-47cc-4f90-9964-142757d2515a. Acessed 30 Oct 2018
- 3.The European Parliament and the European Council (2011) Dir. 2011/24/EU. OJ L88:45-65Google Scholar
- 4.EUnetHTA. Joint Action 3 2016–20. Accessed via https://www.eunethta.eu/ja3-archive/. Acessed 30 Oct 2018
- 5.Royal Decree of December 21st (2001) Articles 81 to 85Google Scholar
- 6.Royal Decree of December 21st (2001) Accessed via https://www.inami.fgov.be/SiteCollectionDocuments/specialites_pharmaceutiques_AR_20011221.pdf. Acessed 30 Oct 2018
- 7.European Network for Health Technology Assessment. Core template. Accessed via: https://www.eunethta.eu/hta-core-model/
- 9.WHO Collaborating Centre for Drug Statistics Methodology. ATC/DDD index. Accessed via https://www.whocc.no/atc_ddd_index/?code=L&showdescription=yes. Acessed 30 Oct 2018
- 11.European Medicines Agency. Annual reports 2010 to 2015. Accessed via: http://www.ema.europa.eu/ema/index.jsp?curl=pages/about_us/document_listing/document_listing_000208.jsp&mid=WC0b01ac058002933a. Acessed 30 Oct 2018
- 12.European Commission (2000) Regulation (EC) no 847/2000. OJ L103:5–8Google Scholar
- 14.National Institute for Health and Disease Insurance (NIHDI). MORSE report 2014. Accessed via http://www.inami.fgov.be/SiteCollectionDocuments/rapport-morse-2014.pdf. Acessed 5 Nov 2018
- 17.Mc Conaghie A. Glybera, the most expensive drug in the world, to be withdrawn after commercial flop. Available via: https://pharmaphorum.com/news/glybera-expensive-drug-world-withdrawn-commercial-flop/. Acessed 5 Nov 2018
- 18.McCabe C, Bergmann L, Bosanquet N, Ellis M, Enzmann H, von Euler M, Jönsson B, Kallen KJ, Newling D, Nüssler V, Paschen B, de Wilde R, Wilking N, Teale C, Zwierzina H, Biotherapy Development Association (2009) Market and patient access to new oncology products in Europe: a current, multidisciplinary perspective. Ann Oncol 20:403–412CrossRefPubMedGoogle Scholar
- 19.Cleemput I, Devriese S, Christiaens W, Kohn L (2016) Multi-criteria decision analysis for the appraisal of medical needs: a pilot study. Health Services Research (HSR) Brussels: Belgian Health Care Knowledge Centre (KCE). KCE Reports 272. D/2016/10.273/68Google Scholar
- 20.NIHDI. Search engine for reimbursable medicinal products. Accessed via http://ondpanon.riziv.fgov.be/SSPWebApplicationPublic/fr/Public/ProductSearch. Acessed 5 Nov 2018
- 22.Haute Autorité de Santé. Annual reports from 2005 till 2016. Accessed via https://www.has-sante.fr/portail/jcms/c_1070314/fr/historique-des-rapports-annuels-d-activite. Acessed 5 Nov 2018
- 24.Morel T, Arickx F, Befrits G, Siviero P, van der Meijden C, Xoxi E, Simoens S (2013) Reconciling uncertainty of costs and outcomes with the need for access to orphan medicinal products: a comparative study of managed entry agreements across seven European countries. Orphanet J Rare Dis 8:198CrossRefPubMedPubMedCentralGoogle Scholar
- 25.Royal Decree of February 1st (2018) Articles 112 till 115Google Scholar
- 26.Pauwels K et al (2017) Managed Entry Agreements for oncology drugs: lessons from the European experience to inform the future. Front PharmacolGoogle Scholar