Orphan Drug Pricing Heading To Negotiating Table in US?
The Institute for Clinical and Economic Review is launching an initiative to adapt its value assessment approach to orphan and ultra-orphan drugs, including a possible consideration of what should be a fair return on investment for manufacturers.
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Proposed $20m funding boost for rare disease development includes review of orphan incentives, including how to potentially stimulate development in ultra-orphan diseases.
Agency is already approving drugs for diseases with much smaller patient populations than the traditional rare disease, officials note.
Is the lower sale price making the opportunity for a priority review voucher less an incentive for orphan development?