Vertex Pharmaceuticals Incorporated is taking pharma’s opposition to the Department of Health and Human Services oversight of patient assistance programs to a new level in a recently-filed lawsuit, seeking to overturn Office of Inspector General opposition to the company’s plan to underwrite a fertility preservation program for patients enrolled in government-sponsored insurance that are treated with its gene therapy Casgevy.
Key Takeaways
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The Vertex lawsuit challenges the HHS Office of Inspector General position that a fertility preservation program for patients prescribed Casgevy, the company’s gene therapy for sickle cell disease, could violate the Anti-Kickback statute.
The program, which now is only available to those with commercial insurance, could cost up to $70,000 per patient, though...
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