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The Cost Of ‘Stacking’ Orphan Indications And A Case For Reform

 
• By Cathy Kelly

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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Several Drugs Had More Of A Decade Of Additional Orphan Exclusivity

The US health care system may have incurred $561bn in avoidable costs since passage of the Orphan Drug Act in 1983 from drugs obtaining numerous orphan indications that delayed price competition, a study led by William Padula, University of California’s Leonard D. Schaeffer Center for Health Policy and Economics, et al. suggests.

The analysis indicates “limiting the total number of rare disease approvals or overall years that a pharmaceutical can benefit from...

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Crisis Or Opportunity? US MFN Policy Could Test Japan’s Appetite For Reforms

 
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