The Cost Of ‘Stacking’ Orphan Indications And A Case For Reform
Restricting orphan drug approvals could save the US billions of dollars, study from University of California’s Center for Health Policy and Economics suggests.
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Focusing on orphan-first drugs may be best route to address pricing concerns, Health Affairs study suggests after finding that just one-fifth of spending on 15 top-selling partial orphan drugs was for the drugs’ rare disease indications.
Congress should give FDA more flexibility to administer orphan designations, such as the ability to revoke designations later if the disease prevalence grows beyond the rare disease threshold.
Revlimid, Copaxone, Sensipar, Enbrel, Acthar Gel and Gleevec will be the subject of a US House Committee on Oversight and Reform in an upcoming drug price hearing.