title: Evaluation of patient registries supporting reimbursement decisions: the case of oxaliplatin for treatment of stage III colon cancer.
abstract: BACKGROUND
  Access with evidence development has been established for expensive intramural drugs in The Netherlands. The procedure involves a 4-year period of conditional reimbursement. During this period, additional evidence has to be gathered usually through a patient registry. Given the costs and time involved in gathering the data, it is important to carefully evaluate the registry.
  
  
  OBJECTIVE
  This study aimed to develop a model for the regular evaluation of patient registries during an access with evidence development process and find the optimal length of the registry period.
  
  
  METHODS
  We used data from a recent registry in The Netherlands on oxaliplatin as a treatment option for stage III colon cancer. We added simulated follow-up data to the empirical data available and applied value of information analysis to balance the gains of extending the period and amount of data gathering against the costs of registering patients.
  
  
  RESULTS
  We show that given the assumptions on cohort size, follow-up time, and purpose of the registry, the current (partly simulated) registry was not very efficient. Notably, the observation period could have been stopped to make a definite reimbursement decision after a maximum of 2 years rather than the fixed 4-year period.
  
  
  CONCLUSIONS
  Patient registries may be an efficient way to gather data on new medical treatments, but they need to be carefully designed and evaluated, in particular regarding their follow-up time. For each purpose, data gathering can be tailored to make sure decisions are taken at the moment that sufficient data are available.
authors.affiliation: Department of Epidemiology, Unit Health Technology Assessment, University Medical Center Groningen, University of Groningen, Groningen, The Netherlands. Electronic address: l.mohseninejad@gmail.com.
authors.forename: Leyla
authors.initials: L
authors.lastname: Mohseninejad
authors.affiliation: Department of Health Policy and Management, Institute for Medical Technology Assessment, Erasmus University, Rotterdam, The Netherlands.
authors.forename: Chantal
authors.initials: C
authors.lastname: van Gils
authors.affiliation: Department of Health Policy and Management, Institute for Medical Technology Assessment, Erasmus University, Rotterdam, The Netherlands.
authors.forename: Carin A
authors.initials: CA
authors.lastname: Uyl-de Groot
authors.affiliation: Department of Epidemiology, Unit Health Technology Assessment, University Medical Center Groningen, University of Groningen, Groningen, The Netherlands.
authors.forename: Erik
authors.initials: E
authors.lastname: Buskens
authors.affiliation: Department of Epidemiology, Unit Health Technology Assessment, University Medical Center Groningen, University of Groningen, Groningen, The Netherlands.
authors.forename: Talitha
authors.initials: T
authors.lastname: Feenstra
mesh_terms: D000970:Antineoplastic Agents / Q000191:economics / Q000627:therapeutic use*; D003110:Colonic Neoplasms / Q000188:drug therapy* / Q000191:economics / Q000453:epidemiology; D006801:Humans; D007349:Insurance, Health, Reimbursement / Q000191:economics / Q000639:trends*; D009367:Neoplasm Staging / Q000191:economics / Q000639:trends; D009426:Netherlands / Q000453:epidemiology; D009944:Organoplatinum Compounds / Q000627:therapeutic use*; D000077150:Oxaliplatin; D012042:Registries; D015996:Survival Rate / Q000639:trends; D016896:Treatment Outcome
chemical_list: D000970:Antineoplastic Agents; D009944:Organoplatinum Compounds; D000077150:Oxaliplatin
keywords: access with evidence development; decision theory; patient registry; reimbursement; value of information