Reimbursement of targeted cancer therapies within three different European health care systems

Objectives: To identify differences in the recommendations for targeted cancer therapies (TCT) in three distinctive European health care systems: Serbian, Scottish and Dutch, and to examine the role of cost effectiveness analyses (CEA) in such recommendations. Methods: A list of currently approved TCTs cited from the European Medicines Agency (EMA) was cross-referenced with the drug reimbursement reports issued by Health Insurance Fund (RFZO) for Serbia, Scottish Medicines Consortium (SMC) for Scotland and Health Institute (ZI) for the Netherlands. The following key variables were gathered from the reports: drug indication, registration status, reimbursement status and outcome of the cost effectiveness evaluation. Results: There were 44 TCTs indicated for 75 cancer sites and approved by EMA. Out of total number of drugs per indication (d/i= 75), 20 were reimbursed in Serbia, and 15 are still without the decision from RFZO. Remaining majority of TCTs is not registered in Serbia. None of submissions neither CEAs were publically available. SMC positively assessed 25 d/i and rejected as much as 30. All appraisals were published, and majority contained full CEAs. Finally, Dutch ZI accepted total of 59 d/i and disapproved use of only 5 d/i. The majority of reimbursed drugs were exempted from CEA in accordance with the policy for expensive hospital drugs. Conclusions: Although data collected for Serbia did not allow us to evaluate practiced policy in broader extent, it is certainly surrounding with the smallest number of reimbursed TCTs. Surprisingly, TCTs in Scotland were comparable to this number, yet reasons for such an outcome were fairly different. It seems that full application of CEA in TCTs submission contributed to 55% of SMC negative recommendations. Its Dutch counterpart, ZI, issued only 8% of negative decisions to TCTs. The mode for a success rate in the Netherlands was special policy that enabled reimbursement of TCTs without CEA