Senturion Services Q&A – Understanding orphan drugs and the 340B program
Summary
Orphan drugs are intended to treat rare disease (those affecting fewer than 200,000 people in the US). However, under the regulations of the 340B program, manufacturers are not required to provide orphan drugs to covered entities at the discounted 340B rate. HRSA will continue to improve the list to ensure covered entities have the information they need to comply with the orphan drug exclusion. Orphan drugs should be purchased on a non-340B account, whether that’s GPO or some other type of arrangement with the covered entity’s wholesaler. Many covered entities have not established these contracts, and by paying full price for the orphan drugs, they are leaving potential savings on the table.
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