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-  2016 

Systematic review on the evaluation criteria of orphan medicines in Central and Eastern European countries

DOI: 10.1186/s13023-016-0455-6

Keywords: Rare disease, Orphan drug, Economic evaluation, Technology assessment, Cost effectiveness, Drug approval, Central and Eastern Europe

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Abstract:

In case of orphan drugs applicability of the standard health technology assessment (HTA) process is limited due to scarcity of good clinical and health economic evidence. Financing these premium priced drugs is more controversial in the Central and Eastern European (CEE) region where the public funding resources are more restricted, and health economic justification should be an even more important aspect of policy decisions than in higher income European countries

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