REIMBURSEMENT OF INNOVATIVE DRUGS IN SLOVAKIA - PHARMACOECONOMICS OF USTEKINUMAB IN PSORIASIS

Author(s)

Tomek D1, Bielik J21Slovak Society for Pharmacoeconomics, Bratislava, Slovak Republic, 2Trencin University, Trencin, Slovak Republic

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 biologic drug ustekinumb (Stelara®, Jannssen Cilag Slovakia) for the treatment of psoriasis. The pharmacoeconomic part of the application fulfiled all legislative aspects. The CEA shows that ustekinumab is more cost effective in cost of theraphy responder analysis vs. other biologics in the Slovak market for psoriasis treatment by 2% - 60%. The price sensitivity analysis of comparators was done. The reassessment of CEA after massive price cut of comparators (up to -32%, due to international price referencing) has showed the positive results for ustekinumab 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. Ustekinumb a new agent in therapy of psoriasis fulfilled the necessary legislative conditions including pharamacoeconomic 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

PSY57

Topic

Health Policy & Regulatory

Topic Subcategory

Reimbursement & Access Policy

Disease

Systemic Disorders/Conditions

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