Orphan Indications In Medicare: Inspector General Will Examine Top-Selling Drugs
OIG will focus on successful drugs that have been repurposed as orphans, noting nine of the 10 top selling drugs have both orphan and non-orphan indications.
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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.
Restricting orphan drug approvals could save the US billions of dollars, study from University of California’s Center for Health Policy and Economics suggests.
The former US FDA principal deputy commissioner argues that accelerated approval, fast track and breakthrough designation standards may need updating, along with orphan and pediatric exclusivity requirements, to enhance the programs' efficacy.