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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All three areas need work following enactment of the original 21st Century Cures Act, authors Fred Upton and Diana DeGette write in vision statement.
Right To Try Conversation Should Be Redirected Toward Reimbursement Of Unapproved Drugs, Experts Say
King & Spalding Partner David Farber called for amending Medicare and Medicaid statutes so that unapproved treatments can be reimbursed for terminally ill patients who have exhausted all other options.
Proponent says companies ready to use new expanded access pathway that US FDA will have essentially no involvement in.