QUALITY ASSURANCE OF FOURTH HURDLE CONCERNING TO DRUGS AND MEDICAL DEVICES

Author(s)

Tesar T*1, Babela R2 1Union Health Insurance Fund, Bratislava, Slovak Republic, 2St. Elizabeth University of Health and Social Sciences, Bratislava, Slovak Republic

OBJECTIVES: From 2011, there are basic thresholds (λ1=24 x average monthly salary € / QALY and λ2 = 35 x average monthly salary € / QALY) defined directly in the Slovak legislation reflecting the benefits displaced elsewhere in the Slovak health care system when funds are allocated to new medicines and medical devices. The objective of this study was to analyse the quality of submitted economic studies, related critical appraisals process and impacts of the new legislation on the access to medicines and medical devices.  METHODS: We created a working group to review previously submitted economic evaluations and related critical appraisals in order to identify potential technical and methodological problems. The working group scrutinized previous submissions and critical appraisals, concerning to chosen ATC groups of drugs and groups of medical devices, published between June 2012 and June 2013 at the webside of MoH. RESULTS: Pharmacoeconomic evaluations of drugs and medical devices within decision making process concerning to reimbursement are mandatory but the quality of studies are very often rather poor. The concept “the QALY is a tool not a rule” was slightly modified in Slovakia. Our analysis shows that implicit thresholds included into the Slovak legislation have influenced decision making process concerning to drugs and medical devices. In the defined time period 4 drugs exceeded the basic thresholds described in the Slovak legislation, however 108 drugs and medical devices were refused to include into the reimbursement list, because of  the poor quality of provided pharmacoeconomic studies from the side of applicants.   CONCLUSIONS: The transparent method of HTA can improve the consistency of reimbursement decisions making related to drugs and medical devices in Slovakia. However significant improvements in the quality of submitted pharmacoeconomic dossiers have to be the first step towards the better access to drugs and medical devices for the Slovak patients.

Conference/Value in Health Info

2013-11, ISPOR Europe 2013, The Convention Centre Dublin

Value in Health, Vol. 16, No. 7 (November 2013)

Code

PHP54

Topic

Health Policy & Regulatory

Topic Subcategory

Health Disparities & Equity

Disease

Multiple Diseases

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