Onkológia 2/2017
Quantification of the impact of cost-effectiveness threshold on cancer drugs reimbursement in Slovakia
Purpose: A part of the decision-making on reimbursement of new drugs in Slovakia is a cost-effectiveness analysis. Since 2011, there is defined threshold value of costs/QALY in the Slovak legislation. Drugs for which the threshold value is exceeded, cannot be included in the standard system of reimbursement and are available only under the exemptions. This paper assesses the efforts of manufacturers to include innovative cancer drugs to the reimbursement system before and after adoption of cost/QALY. Expenditures for cancer medicines not included in the reimbursement system were also evaluated. Materials and methods: We used data acquired from publicly available sources on the registration and categorisation of drugs from electronic portals of state authorities (MoH and SIDC) and data on consumption of drugs from NHIC. Results: It was found that once the costs/QALY threshold was introduced, the number of requests for reimbursement of new cancer drugs dropped. While in the period before introduction of cost/QALY threshold manufacturers requested reimbursement in 80.00% of newly registered drugs, after its introduction it was only 33.96%. Another finding was that after the introduction of the cost per QALY threshold, the expenses for reimbursement exceptions increased significantly. While in 2006, the share of expenses for exceptions was 0.21%, in 2011 it was 1.06% and in 2015 it had reached 7.13%. Conclusion: It is questionable whether the costs/QALY threshold still holds its significance in the decision-making and whether reimbursement decisions should be based solely on cost/QALY, or whether also other criteria should be taken into account. Legislation makes broader use of various agreements between payers and manufacturers impossible in Slovakia, while these are used in other countries for reducing the medical and financial risk linked to the introduction of innovative drugs. In order to introduce innovative reimbursement mechanisms it is necessary to amend legislation and set processes and capacities in the healthcare system.
Keywords: cancer drugs, reimbursement, cost-effectiveness, QALY
