title: Do reassessments reduce the uncertainty of decision making? Reviewing reimbursement reports and economic evaluations of three expensive drugs over time.
abstract: OBJECTIVE
  To investigate the desirability and feasibility of a cyclic reimbursement process to address uncertainty accompanying initial decision making.
  
  
  METHODS
  We performed desk research for three expensive outpatient drugs: imatinib, pegfilgrastim, and adalimumab. We analysed the evidence base at the time of decision making (T=0) and May 2011 (T=1). For T=0, public reports of the Dutch reimbursement agency were investigated regarding available clinical and economic evidence, and a systematic review was performed to retrieve additional economic evidence. For T=1, the systematic review was extended till May 2011.
  
  
  RESULTS
  The evidence base at T=0 lacked information on clinically relevant outcomes such as mortality, morbidity, and quality of life (5/8 reports), (long-term) adverse events (2/8 reports) and experience in use (1/8 reports). One budget impact analysis and one economic evaluation were available but no pharmacoeconomic dossiers. The systematic review identified 39 cost-utility studies (of 52 economic evaluations) for T=1, characterised by methodological heterogeneity.
  
  
  CONCLUSIONS
  Given the considerable uncertainty accompanying initial decision-making, a more cyclic reimbursement process seems feasible to reduce uncertainty regarding the therapeutical and economical value of expensive drugs. A mandatory evidence development requirement seems desirable to sufficiently meet decision makers' needs.
authors.affiliation: Institute of Health Policy and Management (iBMG), Erasmus University Rotterdam, PO Box 1738, 3000 DR Rotterdam, The Netherlands. Electronic address: fsandmann@gmx.com.
authors.forename: Frank G
authors.initials: FG
authors.lastname: Sandmann
authors.forename: Margreet G
authors.initials: MG
authors.lastname: Franken
authors.forename: Adri
authors.initials: A
authors.lastname: Steenhoek
authors.forename: Marc A
authors.initials: MA
authors.lastname: Koopmanschap
mesh_terms: D000068879:Adalimumab; D000893:Anti-Inflammatory Agents / Q000191:economics*; D061067:Antibodies, Monoclonal, Humanized / Q000191:economics*; D000970:Antineoplastic Agents / Q000191:economics*; D001549:Benzamides / Q000191:economics*; D003657:Decision Making; D016527:Drug Costs / Q000706:statistics & numerical data; D017850:Economics, Pharmaceutical; D055317:Evidence-Based Practice; D000069585:Filgrastim; D016179:Granulocyte Colony-Stimulating Factor / Q000191:economics*; D005102:Health Expenditures / Q000706:statistics & numerical data; D006801:Humans; D000068877:Imatinib Mesylate; D007349:Insurance, Health, Reimbursement / Q000191:economics*; D009426:Netherlands; D010879:Piperazines / Q000191:economics*; D011092:Polyethylene Glycols; D011743:Pyrimidines / Q000191:economics*; D011994:Recombinant Proteins / Q000191:economics; D012051:Reimbursement Mechanisms; D035501:Uncertainty
chemical_list: D000893:Anti-Inflammatory Agents; D061067:Antibodies, Monoclonal, Humanized; D000970:Antineoplastic Agents; D001549:Benzamides; D010879:Piperazines; D011743:Pyrimidines; D011994:Recombinant Proteins; D016179:Granulocyte Colony-Stimulating Factor; C455861:pegfilgrastim; D011092:Polyethylene Glycols; D000068877:Imatinib Mesylate; D000068879:Adalimumab; D000069585:Filgrastim
keywords: Adalimumab; Drug reimbursement; Evidence development; Imatinib; Pegfilgrastim; Systematic review