Reimbursement of Targeted Cancer Therapies Within Three Different European Health Care Systems.

 Targeted cancer therapies (TCT) are drugs that specifically act on molecular targets within the cancer cell causing its regression and/or death. Although TCT showed clinically important gains in survival within the indications that did not see any improvements in past, they also came at considerable cost.  Different policies in drugs’ pricing and reimbursement among European countries that were applied to address this issue resulted in significant imbalances in TCT access. To demonstrate these inequities we examined three distinctive systems in Europe: the Serbian, Scottish and Dutch.  The assessments of new drugs in Serbia are performed by the National Health Insurance Fund (NHIF). Additionally to the common requests for clinical efficacy, the cost-utility and budget impact analyses (CUA and BIA) are obligatory part of this process. However, more details on their content or reports of previous assessments are not publically available.  In Scotland, drug assessments are conducted by the Scottish Medicines Consortium (SMC) which examines a drug’s clinical value and cost effectiveness (CE). A drug is generally considered cost effective if its incremental CE ratio (ICER) falls below £30,000/QALY. The SMC recognises certain decision modifiers that can enable a positive recommendation despite otherwise unacceptable ICER.  The National Health Institute of the Netherlands (NHINL) evaluates efficacy and CE of new health technologies within the country. As for the CE assessment, a positive decision depends rather on correctness of the methodology applied than on the specific ICER reached. Two recent policies facilitate reimbursement of expensive hospital drugs and thus can be applied to TCT: the Policy Rule for Expensive Hospital and Orphan Drugs (PREHO) and updated fast access PREHO (UFAP). They both exempt certain hospital drugs from full CE evaluation (permanently or contemporarily).