CONCEPTUAL FRAMEWORK FOR THE EVALUATION OF PATIENT ACCESS SCHEMES (PAS) IN THE EU
Author(s)
Kiss Z1, Hortobagyi L1, Szegvari B2, Muszbek N31United BioSource Corporation, Budapest, Budapest, Hungary, 2UCB Hungary Ltd, Budapest, Budapest, Hungary, 3United BioSource Corporation, Budapest, Hungary
Presentation Documents
OBJECTIVES: Patient access or risk sharing schemes (PASs) have recently been increasingly used, enabling easier and swifter access to new treatments, especially in oncology. However, PASs frequently do not deliver the required results. The aim was to create a conceptual framework that allows the selection of the most appropriate PAS in different countries. METHODS: A targeted literature review has been conducted to identify PAS specific literature in oncology. Based on the review and the evaluation of the currently implemented PASs in the EU, a three-level conceptual framework has been constructed. It is based on a list of criteria identified as country-specific prerequisite for the different types of PASs. Each criterion can be achieved by different tools/techniques, each with a list of basic requirements. PASs for each country can be evaluated using simple scoring system for each criterion. The proposed framework has been validated by EU industry experts and payer’s representatives and tested for the UK and Hungary. RESULTS: The literature review identified large number of abstracts and studies; however only 14 met the inclusion criteria. These were mainly from the UK and US. The criteria evaluated authorities’ roles and responsibilities, transparency throughout the negotiation process and implementation phase for all stakeholders, presence of trust and cooperation among payers and manufacturers, availability of budget, clear patient pathways, data availability, administration capacity and appropriate incentives for the stakeholders. The test results were in accordance with the expert’s views and emphasized the insights from recent experiences and case studies. CONCLUSIONS: The conceptual framework offers a good starting point for the evaluation of the potential success of the different PASs in oncology in a given country. Future steps could include extension of therapeutic area, incorporation of relative weights for the criteria and extending the countries used for validation.
Conference/Value in Health Info
2012-11, ISPOR Europe 2012, Berlin, Germany
Value in Health, Vol. 15, No. 7 (November 2012)
Code
PCN157
Topic
Health Policy & Regulatory
Topic Subcategory
Risk-sharing Approaches
Disease
Oncology