MANAGED-ENTRY AGREEMENTS- POSSIBLE OPTIONS FOR VACCINES?
Author(s)
Baron-Papillon F1, Easley C2, Saint Sardos C1, Lucas F2
1Sanofi Pasteur MSD, LYON, France, 2Pope Woodhead & Associates Ltd, St. Ives, UK
OBJECTIVES: Vaccines face increasing reimbursement and access challenges in many European markets. Decision makers are facing uncertainties in terms of budget impact planning, vaccines' expected impact and vaccination implementation. This has led to major delay in the population access to vaccination, and to commoditization of some vaccinations. However, innovation in vaccines access has been more limited than for pharmaceuticals, where there is a longer history of adapting to pricing and access pressure. Building on the experience of managed entry agreements (MEAs) used for drugs, the project aimed to develop a framework of MEAs and value-added services specifically applicable to vaccines. METHODS: Literature and web searches were performed to document MEA taxonomy and identify real world European MEA examples for pharmaceuticals and vaccines. This was followed by an on-line/telephone survey with SPMSD access professionals in 14 countries to access unpublished information and assess the acceptability of different MEA types across Europe. Outputs were developed into a vaccines specific MEA framework and guidance for implementation. RESULTS: To date, there is very little experience with vaccine MEAs in Europe; however, interesting value-added service examples were identified (e.g. educational campaign support). The vaccine-specific MEA framework developed (aligned with current taxonomy) focused on financial schemes (e.g. staggered entry approaches, volume-based discounts, price-volume agreements), coverage with evidence development and value-added services (e.g. vaccination implementation support). Pay-for-performance MEAs were less applicable. Budget holder feedback in selected countries confirmed their interest in co-creating such MEA/service approaches with vaccine companies. CONCLUSIONS: To enable decision makers to continue investing in innovative vaccines that address public health needs, a shift towards new value-based acquisition models is key. A broader, more flexible approach to vaccines access, including MEAs, can address the needs of budget holders and other external stakeholders as well as manufacturers.
Conference/Value in Health Info
2014-11, ISPOR Europe 2014, Amsterdam, The Netherlands
Value in Health, Vol. 17, No. 7 (November 2014)
Code
PIN125
Topic
Health Policy & Regulatory
Topic Subcategory
Risk-sharing Approaches
Disease
Infectious Disease (non-vaccine)