title: Reimbursement of targeted cancer therapies within 3 different European health care systems.
abstract: OBJECTIVE
  Targeted cancer therapies (TCTs) are drugs that specifically act on molecular targets within the cancer cell, causing its regression and/or destruction. Although TCTs offer clinically important gains in survival in one of the most challenging therapeutic areas, these gains are followed by considerable increases in health care expenditures. The aim of this study was to identify differences in the recommendations for TCTs in 3 European health care systems (Serbian, Scottish, and Dutch) and to examine the role of pharmacoeconomic (PE) assessments in such recommendations.
  
  
  METHODS
  A list of currently approved TCTs cited from the European Medicines Agency was cross-referenced with drug reimbursement reports issued by the National Health Insurance Fund for Serbia, the Scottish Medicines Consortium for Scotland, and the National Health Institute for the Netherlands. The following key variables were gathered from the reports: drug indication, registration status, reimbursement status, and outcome of the PE evaluation.
  
  
  RESULTS
  There were 41 TCTs approved by the European Medicines Agency for 70 cancer indications. Of the total number of TCT indications, 20 were reimbursed in Serbia, and 25 are still without a decision from the national agency. The remaining TCT indications (n = 25) are not registered in Serbia. None of the submissions or the PE analyses were publicly available. The Scottish Medicines Consortium positively assessed 26 TCT indications and rejected 30. All appraisals were published, and the majority contained full PE assessments. Finally, the Dutch agency accepted 60 TCT indications and disapproved the use of 1. The majority of reimbursed drugs were exempted from PE evaluation in accordance with 2 recent policies regarding expensive hospital drugs.
  
  
  CONCLUSIONS
  In the 3 examined health care systems, the reimbursement status of the TCTs differed significantly. Level of PE application within the TCT evaluation procedures seemed to largely affect the final reimbursement decisions. Although, there are special policies in the Netherlands that enabled fast access for 98% of the TCTs that applied for reimbursement, a clear definition of cost-effectiveness threshold and strict requirements for full cost utility assessments in Scotland led to acceptance of only 46% of the TCT submissions. More precise PE guidelines must still be designed for TCT reimbursement in Serbia. Guidelines must account for specific epidemic and economic conditions of the country and could build on the experiences of Scotland and the Netherlands.
authors: Unit of PharmacoEpidemiology & PharmacoEconomics (PE2), Department of Pharmacy, University of Groningen, Groningen, the Netherlands; Mihajlović Health Analytics, Novi Sad, Serbia. Electronic address: jovan@miha.rs.
authors: Jovan
authors: J
authors: Mihajlović
authors: Unit of PharmacoEpidemiology & PharmacoEconomics (PE2), Department of Pharmacy, University of Groningen, Groningen, the Netherlands.
authors: Christiaan
authors: C
authors: Dolk
authors: Tolley Health Economics Ltd, Buxton, United Kingdom.
authors: Keith
authors: K
authors: Tolley
authors: Department of Pharmaceutical and Pharmacological Sciences, KU Leuven, Leuven, Belgium.
authors: Steven
authors: S
authors: Simoens
authors: Unit of PharmacoEpidemiology & PharmacoEconomics (PE2), Department of Pharmacy, University of Groningen, Groningen, the Netherlands.
authors: Maarten J
authors: MJ
authors: Postma
mesh_terms: D003362:Cost-Benefit Analysis; D016527:Drug Costs; D017850:Economics, Pharmaceutical; D006801:Humans; D058990:Molecular Targeted Therapy / Q000191:economics*; D009369:Neoplasms / Q000188:drug therapy*; D009426:Netherlands; D019057:Quality-Adjusted Life Years; D012051:Reimbursement Mechanisms; D012606:Scotland; D055771:Serbia
keywords: Europe; Serbia; health care policy; pharmacoeconomics; reimbursement; targeted cancer therapy