Gilead Plays Hardball With Hep C Patient Assistance
Gilead Sciences recently began limiting enrollment in its Sovaldi and Harvoni patient assistance program in an attempt to pressure payors to expand their coverage criteria. The big question is how payors are likely to react.
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“Nonprescription Drug Product with an Additional Condition” for OTC use proposed rule would add to drug firms’ workloads for some OTC switches. Along with NDAs, sponsors would need to show a DFl isn’t sufficient to ensure a consumer can appropriately self-select and use a drug OTC and how an “additional condition” system would work.