THE INFLUENCE OF COST-EFFECTIVENESS ISSUES OF THE APPRAISED ORPHAN DRUGS ON RECOMMENDATIONS OF AGENCY FOR HEALTH TECHNOLOGY ASSESSMENT IN POLAND (AHTAPOL)
Author(s)
Ofierska-Sujkowska G, Jagodzinska-Kalinowska K, Matusewicz WAgency for Health Technology Assessment in Poland, Warsaw, Poland
Presentation Documents
OBJECTIVES: The aim of the present analysis was to identify what was the influence of prices and the corresponding low cost-effectiveness estimates of the appraised orphan drugs on AHTAPol recommendations. The main task of AHTAPol, established in 2005, is to assess and appraise all medical technologies and services claiming public money founding. Pharmacoeconomic evaluations of new therapies are required for all reimbursement decisions and orphan drug manufacturers cannot be exempted from providing a full pharmacoeconomic or HTA reports. Recommendations issued by AHTAPol have been based on Manufacturer`s submission, additional officially published data, experts opinions and Polish public payer (National Health Fund) evaluation. METHODS: All recommendations issued by the AHTAPol until the end of 2010 were reviewed and analyzed from the official Web site of AHTAPol. The orphan drugs recommendations were identified and categorized into types of recommendations (positive or negative) and reasoned. RESULTS: Among 286 AHTAPol decisions studied, 26 (9%) applied to orphan drugs. AHTAPol gave positive recommendations for reimbursement to 19 of 26 of orphan drug submissions (73%). 7 (27%) were not approved and received negative recommendations. Only in one case cost-effectiveness estimates and the corresponding high prices were emphasized as a main reason of negative recommendations. In 1 case the reason was connected with drug safety issues, while in 5 cases with insufficient evidence of efficacy. CONCLUSIONS: The cost-effectiveness issues of the appraised orphan drugs were not important argument in negative recommendations of the AHTAPol. In fact the insufficient evidence of clinical efficacy were the most important and therefore prevailing argument for issuing negative opinions of AHTAPol recommendations.
Conference/Value in Health Info
2011-05, ISPOR 2011, Baltimore, MD, USA
Value in Health, Vol. 14, No. 3 (May 2011)
Code
PHP55
Topic
Health Service Delivery & Process of Care
Topic Subcategory
Hospital and Clinical Practices
Disease
Multiple Diseases