REIMBURSEMENT OF INNOVATIVE DRUGS IN SLOVAKIA - PHARMACOECONOMICS OF AGOMELATIN IN DEPRESSION
Author(s)
Tomek D1, Psenkova M2, Hanzelova M31Slovak Society for Pharmacoeconomics, Bratislava, Slovak Republic, 2Pharm-In, Bratislava, Slovak Republic, 3Servier Slovakia, Bratislava, Slovak Republic
Presentation Documents
OBJECTIVES: Although health spending is well below the OECD average when considered as a share of GDP, Slovakias pharmaceutical expenditures accounts 32% of total health care budget. The accessibility and availability of innovative drugs is good. Mandatory HTA (pharmacoeconomy) is incorporated in all relevant legislation, MoH set the official threshold by l1 = €18,000/QALY and l2 = €26,500/QALY. METHODS: We have analysed the legislation and official reimbursement decisions and commentaries, published by the MoH in 2009. We analysed the applicants documentation including pharmacoeconomic analysis, as a mandatory part of the application. RESULTS: The main drug reimbursement body - Categorisation committee of the MoH - and pharmacoeconomic advisory committee evaluated the applicants dossier for the drug agomelatine (Valdoxan®, Servier Slovakia) for the treatment of depression. The pharmacoeconomic part of the application fulfiled all legislative aspects. The CUA analysis was taken from Swedish pharmacoeconomic model and extrapolated in Slovak environment. CMA in Slovak conditions shows lower drug costs for agomelatine as for comparator. The price sensitivity analysis of comparators was done. The reassessment of CEA after price cut of comparators (up to - 10%, due to international price referencing) has showed the positive results for agomelatine and robustness of previous price sensitivity analysis. CONCLUSIONS: : The focus of the MoH drug policy is on more rational spendings , especially on reference pricing and HTA. There are first results of these new procedures, where the real impact of the HTA in the decision processes is demonstrated. Agomelatin, a new agent in therapy of depression fulfilled, the necessary legislative conditions including pharmacoeconomic aspects to be listed in the positive reimbursement list.
Conference/Value in Health Info
2009-10, ISPOR Europe 2009, Paris, France
Value in Health, Vol. 12, No. 7 (October 2009)
Code
PMH74
Topic
Health Policy & Regulatory
Topic Subcategory
Reimbursement & Access Policy
Disease
Mental Health