Vertex Opens New Front In Patient Assistance Conflict Between Pharma, HHS Inspector General

 
• By Cathy Kelly
  
Generate a summary of this article
Listen to this article
Beta

Vertex’s fertility preservation assistance program would provide up to $70,000 in financial support for in vitro fertilization and other services to patients prescribed Casgevy.

Vertex is challenging the HHS Government Watchdog.

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

  • 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...

Pink Sheet Podcast

Learn what's happening at the US FDA. On the go.

Derrick Gingery and the team bring you a weekly "Drug Fix".

SpotifyApple PodcastsWebsite

More from Cell & Gene Therapies

test carousel-PINKSHEET

 
• By Saba Afreen

test carousel-test

Diversity Action Plans Should Be Brief And Waiver Requests Filed Early, US FDA Says - Clone

 
• By Sue Sutter

In what could amount to a de facto enforcement mechanism, the new draft guidance also “strongly encourages” sponsors to share details about their diversity action plan and enrollment goals with the public.

Testing all options - Akash

 
• By Akash

This is an test article.

More from Advanced Technologies

CAR-T Therapies: Rethinking Of Postmarketing Requirements And REMS Urged

 
• By Sue Sutter

Long-term follow-up requirements have taken a conservative approach but could be ripe for re-examination and global harmonization given the years of experience with the products, Kite Pharma executive director says; former FDA gene/cell therapy office head Wilson Bryan calls for elimination of the classwide REMS.

test

 
• By Sabbah and Saba Afreen

test

Gene Therapies: CoGenT Pilot Could Help With Regulatory Convergence Earlier In Development TEST

 
• By Sue Sutter

Program for collaborative reviews of gene therapy applications is getting under way with the European Medicines Agency. After launch, the pilot could be expanded to earlier discussions around CMC and pharm/tox data requirements, FDA’s Nicole Verdun said.