Expanded Access Advocates Seek Reimbursement Mandate, Manufacturer Incentives From Congress
Next round of biomedical innovation legislation provides opportunity to require insurance reimbursement of investigational drugs and related medical services, as well as new incentives for small biotech companies to offer expanded access programs, stakeholders say.
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Sponsors will have little obligation to conduct due diligence of adverse events experienced with right-to-try drug use under a proposed FDA rule, leading critics to once again raise safety concerns with the pathway for accessing experimental medicines. The agency will not help patients or companies determine whether drugs qualify for right-to-try.
Potential treatments from BeiGene, AstraZeneca, Bayer and Cancer Prevention Pharmaceuticals are under review at the European Medicines Agency.
All three areas need work following enactment of the original 21st Century Cures Act, authors Fred Upton and Diana DeGette write in vision statement.