THE VALUE OF INVESTIGATIONAL MEDICAL PRODUCTS
Author(s)
Penzes M1, Kalo Z1, Pozsgay C2, Kalotai Z31Eötvös Loránd University, Budapest, Hungary, 2National Institute for Quality- and Organizational Development in Healthcare and Medicines, Budapest, Hungary, 3Novartis Hungary, Budapest, Hungary
OBJECTIVES: A former study indicated that clinical trial related activities generated 250-300 million USD revenue in 2008 for Hungarian health care providers and clinical research organizations, and so 0.15% of the Hungarian GDP was attributable to clinical trials. The purpose of this study was to measure the total annual value of investigational medical products (IMPs) provided by sponsors in clinical trials in Hungary. METHODS: All phase II-IV trials licensed in Hungary in 2010 were selected to assess value of IMPs due to savings from free supply of drugs for patients treated in clincal trials. Phase I and bioequivalence studies were excluded since participants are healthy volunteers without need for treatment. We retrieved the following data from clinical trial master files at the Directorate General of National Institute of Pharmacy: EudraCT number, full title of the trial, therapeutic area, interventions, length of treatment, product names, number of treatment arms in the trial, planned number of study participants in Hungary, study design, clinical trial authorisation date. Drug prices were estimated based on the price of comparator or similar drugs in the same therapeutic area. 290 HUF/Euro exchange rate was applied. RESULTS: The estimated annual value of IMPs in phase II-IV clinical trials was 29 million € in Hungary in 2010. Phase III. trials contributed by 65% to the total amount, while phase II and phase IV trials added 15% and 20%. The value of IMPs depended on the therapeutic area. CONCLUSIONS: Significant savings could be generated from avoided drug costs for clinical trial participants, the value of IMPs was equal with 2,5% of the public pharmaceutical budget (1,18 billion €) by the National Health Insurance Fund. Our study confirms a neglected economic benefit of clinical trials.
Conference/Value in Health Info
2012-11, ISPOR Europe 2012, Berlin, Germany
Value in Health, Vol. 15, No. 7 (November 2012)
Code
PHP31
Topic
Health Policy & Regulatory
Topic Subcategory
Pricing Policy & Schemes
Disease
Multiple Diseases