期刊
EXPERT REVIEW OF PHARMACOECONOMICS & OUTCOMES RESEARCH
卷 12, 期 1, 页码 23-29出版社
EXPERT REVIEWS
DOI: 10.1586/ERP.11.95
关键词
European Union; market access; marketing authorization; orphan drugs; price and reimbursement; regulation
Orphan drugs target small populations of patients. In order to make the field more attractive to pharmaceutical companies and encourage R&D in rare diseases, incentives were put forward by the EU, which are discussed in this article. Because they often are the only available option to treat a disease, some orphan drugs are considered to have high value and as such benefit from high prices on national markets. This has made orphan drugs an attractive market for pharmaceutical companies, with approximately 40 approved orphan drugs generating over $200 million each in yearly sales. The resulting burden this puts on national health insurances may lead to a change in regulation and will certainly lead to new national pricing and reimbursement strategies. They will need to be coherent, fair, effective and sustainable so as to be predictable for companies. Reflection on the subject needs to be initiated.
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