The first of these was the US Orphan Drug Act of 1983, which granted tax credits, an accelerated approval process, and an additional two years’ market exclusivity over non-orphan drugs. However, over time, governments have enacted legislation to encourage orphan drug development and improve patient care. Historically there were few incentives for the pharmaceutical industry to invest in orphan drug development, which was expensive, given the small numbers of patients who would benefit from such treatments and high development costs. How can orphan drug manufacturers demonstrate value and improve access to drugs? In this first of two articles on the subject, Ewan Bennett outlines ways to achieve reimbursement in countries where health technology assessment (HTA) approval is required.
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