Governance of conditional reimbursement practices in the Netherlands

Health Policy

Volumn 119, Issue 2, 2015, Pages 180-185

  Boon, Wouter ^a   Martins, Luis ^b   Koopmanschap, Marc ^c  

^a UTRECHT UNIVERSITY   (Netherlands)

^b Chemical Design and Synthesis Unit   (Netherlands)

^c ERASMUS UNIVERSITY ROTTERDAM   (Netherlands)

Author keywords

Conditional approvals; Decision making; Drug reimbursement; Orphan drugs; Pharmaceuticals

Indexed keywords

ORPHAN DRUG;

ARTICLE; COST EFFECTIVENESS ANALYSIS; DRUG INDUSTRY; EVALUATION STUDY; GOVERNMENT; HEALTH CARE QUALITY; HUMAN; MEDICAL DECISION MAKING; NETHERLANDS; ORGANIZATION AND MANAGEMENT; ORGANIZATIONAL STRUCTURE; OUTCOMES RESEARCH; PRODUCTIVITY; REIMBURSEMENT; COST BENEFIT ANALYSIS; DRUG APPROVAL; DRUG LEGISLATION; DRUG MANUFACTURE; ECONOMICS; GOVERNMENT REGULATION; LEGISLATION AND JURISPRUDENCE;

COST-BENEFIT ANALYSIS; DRUG APPROVAL; GOVERNMENT REGULATION; HUMANS; LEGISLATION, DRUG; NETHERLANDS; ORPHAN DRUG PRODUCTION; REIMBURSEMENT MECHANISMS;

EID: 84922762092     PISSN: 01688510     EISSN: 18726054     Source Type: Journal    
DOI: 10.1016/j.healthpol.2014.10.013     Document Type: Article

References (20)

1. Heemstra H.E., de Vrueh R.L.A., van Weely S., Büller H.A., Leufkens H.G.M. Orphan drug development across Europe: bottlenecks and opportunities. Drug Discovery Today 2008, 13:670-676.
2. Braun M.M., Farag-El-Massah S., Xu K., Coté T.R. Emergence of orphan drugs in the United States: a quantitative assessment of the first 25 years. Nature Reviews Drug Discovery 2010, 9:519-522.
3. Drummond M.F., Wilson D.A., Kanavos P., Ubel P., Rovira J. Assessing the economic challenges posed by orphan drugs. International Journal of Technology Assessment In Health Care 2007, 23:36-42.
4. Simoens S. Pricing and reimbursement of orphan drugs: the need for more transparency. Orphanet Journal of Rare Diseases 2011, 6:42.
5. Picavet E., Dooms M., Cassiman D., Simoens S. Orphan drugs for rare diseases: grounds for special status. Drug Development Research 2012, 73:115-119.
6. McCabe C., Claxton K., Tsuchiya A. Orphan drugs and the NHS: should we value rarity?. British Medical Journal 2005, 331:1016-1019.
7. Heemstra H.E. From research on rare diseases to new orphan drug development 2010, Utrecht University, Utrecht, (PhD Thesis).
8. Sandmann F.G., Franken M.G., Steenhoek A., Koopmanschap M.A. Do reassessments reduce the uncertainty of decision making? Reviewing reimbursement reports and economic evaluations of three expensive drugs over time. Health Policy 2013, 112:285-296.
9. Gress S., Niebuhr D., Rothgang H., Wasem J. Criteria and procedures for determining benefit packages in health care. A comparative perspective. Health Policy 2005, 73:78-91.
10. Kesselheim A.S., Gagne J.J. Strategies for postmarketing surveillance of drugs for rare diseases. Clinical Pharmacology and Therapeutics 2014, 95:265-268.
11. Hutton J., Trueman P., Henshall C. Coverage with evidence development: an examination of conceptual and policy issues. International Journal of Technology Assessment in Health Care 2007, 23:425-432.
12. Franken M., le Polain M., Cleemput I., Koopmanschap M. Similarities and differences between five European drug reimbursement systems. International Journal of Technology Assessment In Health Care 2012, 28:349-357.
13. Meyer F. Health Technology Assessment, pricing and reimbursement in France and European collaboration, Tokyo 2012, (presentation at University of Tokyo:. http://www.pp.u-tokyo.ac.jp/HTA/events/2012-09-06/documents/hta20120906-meyer.pdf.
14. CVZ Procedure herbeoordeling intramurale geneesmiddelen 2010, CVZ, Diemen.
15. Franken M., Koopmanschap M., Steenhoek A. Health economic evaluations in reimbursement decision making in the Netherlands: time to take it seriously?. Zeitschrift für Evidenz, Fortbildung und Qualität im Gesundheitswesen 2014, 108(7):383-389.
16. Niezen M., de Bont A., Stolk E., Eyck A., Niessen L., Stoevelaar H. Conditional reimbursement within the Dutch drug policy. Health Policy 2007, 84:39-50.
17. CVZ Healthcare professionals on cost-effectiveness-proceeds of five kitchen table discussions 2013, CVZ, Diemen.
18. Garattini S., Bertele V. Adjusting Europe's drug regulation to public health needs. Lancet 2001, 358:64-67.
19. Boon W.P.C., Moors E.H.M., Meijer A., Schellekens H. Conditional approval and approval under exceptional circumstances as regulatory instruments for stimulating responsible drug innovation in Europe. Clinical Pharmacology and Therapeutics 2010, 88:848-853.
20. Eichler H., Pignatti F., Flamion B., Leufkens H.G.M., Breckenridge A. Balancing early market access to new drugs with the need for benefit/risk data: a mounting dilemma. Nature Reviews Drug Discovery 2008, 7:818-826.