• Conference Proceeding

Pricing and reimbursement environment for a biologic obtaining a licence in a second indication in key European countries

Citation

Ling, C. S., Balp, M. M., Bjoerk, B., Quijano, M., & Heyes, A. E. (2014). Pricing and reimbursement environment for a biologic obtaining a licence in a second indication in key European countries. In [17], p. A429. .

Abstract

In Europe, the reimbursement and funding process for biologic therapies is highly complex, with substantial differences between countries and further variations at regional and local levels in some countries. The process for a biologic obtaining a license in a second indication is even less clear

OBJECTIVE??We sought to gain a better understanding of the pricing and reimbursement processes, and evidence requirements at national, regional, and local levels with regard to a biologic obtaining a license in a second non-oncology indication in the United Kingdom (UK), France, Italy, and Spain

METHODS
??In late 2013 and early 2014, we undertook a series of telephone interviews with payers and payer advisers (Table 1). These discussions lasted one hour and followed an interview guide that had been developed in advance
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In countries with a largely national system and no major local variations in terms of funding flow for biologics (UK [England], and France), five telephone interviews were conducted. In countries with large variations at local and regional levels (Italy, and Spain), a greater number of interviews were conducted to capture these variations (18 and 17 interviews, respectively)
RESULTS

RESULTS: UK (England)
In the UK (England), the pricing and reimbursement process is agreed at a national level, with few restrictions at regional and local levels. National Health Service (NHS) England is likely to be responsible for funding of new biologics and relies on guidance from the National Institute for Health and Care Excellence (NICE) before adopting a product in a new indication; therefore, demonstrating cost-effectiveness is key

CONCLUSIONS??A biologic obtaining a license in a new indication must undergo the same process as a new product??The processes and restrictions for biologics may be stricter than for other medications because of their perceived high cost??The level of national, regional, and local requirements and restrictions varies; it is important that appropriate evidence is submitted to decision makers at each level