MARKET ACCESS AND REIMBURSEMENT OPTIONS FOR ORPHAN DURG HOSPITAL ONLY MEDICINES IN EUROPE – ONE SIZE FITS ALL?

Author(s)

Vosgerau S1, Paulus G1, Plantoer S2
1IMS Health, Munich, Germany, 2IMS Health GmbH & Co. OHG, Munich, Germany

Orphan drugs are medicines used to the treat life-threatening or chronic diseases affecting very rare diseases. From April 2000 to October 2010, 720 drugs received orphan drug designation from the European Medicines Agency (EMA). Hereof, 63 were granted marketing a marketing authorization. Since then - with an annual orphan drug sales volume of more than $6 billion - there has been a steady increase in applications for orphan designation with the Committee for Orphan Medicinal Products (COMP), averaging ten positive recommendations per month. Although central approval of orphan drugs covers 30 European countries, it does not necessarily provide for national availability as each national authority has to agree to market access and reimbursement. Further, the hospital sector is known for its high diversity in terms of national access mechanisms and degree of centralization, exemplified by the Nordic Countries: In Denmark and Norway a highly centralized hospital sector prevails with one main hospital procurement agency (AMGROS in Denmark and LIS in Norway), while in Sweden and Finland several county councils are authorized to make decisions independently from each other. The objective of the present study is to identify and evaluate possible short cut routes to market access and reimbursement for orphan drug hospital only medicines (OD-HOM) in EU and further investigate country specific requirements for identified short cut routes to market access and reimbursement for OD HOM in EU as strategic options. A literature review and further desk research was performed. The following countries are included in the analysis: Nordic Countries, Germany, France, Netherlands and Spain. The results of the ongoing OD-HOM research will be displayed as a summary of options and requirements by country. The evaluation of market access options for OD-HOM can ease market access and reimbursement and influence international launch sequences of innovative orphan drugs.

Conference/Value in Health Info

2014-11, ISPOR Europe 2014, Amsterdam, The Netherlands

Value in Health, Vol. 17, No. 7 (November 2014)

Code

PHP291

Topic

Health Policy & Regulatory

Disease

Multiple Diseases

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