More orphan approvals and rising prices have made payers more sensitive about reimbursement. If high prices lead to drugs not being covered or cost-sharing becoming unaffordable, patient access could be affected. The decision to reimburse a million-dollar drug will most likely depend on the drug’s value and not its price alone. In Vivo looks at the history of the Orphan Drug Act in the US and how it affected the coverage of orphan drugs, the effect of the large number of new drugs launched in recent years, and how drug companies have a history of pricing drugs in accordance with what the market will bear.