REIMBURSEMENT AND PRICING OF INNOVATIVE MEDICINES- EU5 POLICIES AND IMPLICATIONS FOR MARKET ACCESS
Author(s)
Nwogu G, Brown A, Falk K, Murray G, Pritchett L, Wiesinger A
Abacus International, Manchester, UK
OBJECTIVES: The use of innovative medicines has been associated with increased healthcare-related expenditure in the EU5 (Italy, France, Spain, UK and Germany). In some countries, this has raised concerns over the clinical and economic assessment of such medicines and has led to the introduction of additional criteria to guide their evaluation and use. While a need to stimulate pharmaceutical innovation is widely recognized, cost containment is significant in decision-making. The objective of this research is to identify how members of the EU5 assess the innovative value of pharmaceuticals; understand the policies surrounding their market access and highlight potential drivers. METHODS: We assessed publicly available country guidelines and regulations to understand the evaluation and reimbursement process for innovative medicines. Findings were considered in light of definitions of innovation, market access conditions, reimbursement agreements and sources of funding. RESULTS: Across the EU5, definitions for innovative medicines vary. In Italy, the approach involves an algorithm which forms the basis of the assessment and reimbursement process for innovative medicines at national level. In Spain, although innovation is considered alongside clinical and economic parameters in the evaluation of drugs, there are no special considerations for reimbursement. France and Germany are both found to value innovation as a core criterion in the standard appraisal process with opportunities to facilitate market access in France and with prospects for price negotiations in Germany. In the UK, innovation is included as a modifying factor; however, the recently introduced Early Access to Medicines Scheme, allows the UK to present a landscape facilitating the development of innovative medicines. CONCLUSIONS: There are similarities and differences in the approaches used by the EU5 country members in their assessment and reimbursement of innovative medicines. While in some countries, innovative medicines benefit from lowered hurdles for market access; in other countries, innovation proves less impactful.
Conference/Value in Health Info
2015-11, ISPOR Europe 2015, Milan, Italy
Value in Health, Vol. 18, No. 7 (November 2015)
Code
PHP217
Topic
Health Policy & Regulatory, Health Technology Assessment
Topic Subcategory
Approval & Labeling, Decision & Deliberative Processes, Reimbursement & Access Policy
Disease
Multiple Diseases