Vertex Pharmaceuticals initiated legal action on Monday, filing a lawsuit aimed at enabling the provision of fertility support and treatment services to patients undergoing its gene editing therapy Casgevy (exagamglogene autotemcel) under federal government insurance.
The lawsuit challenges a verbal decision made by the Department of Health and Human Services’ (HHS) Office of the Inspector General (OIG) in January 2024, which declined to issue a favorable advisory opinion endorsing Vertex’s fertility preservation program for Casgevy patients. According to Vertex’s complaint, the agency cited concerns that the program could breach anti-kickback regulations and might foster fraud and abuse, while not sufficiently promoting access to gene therapy care. Despite Vertex’s request for a formal written opinion, the biotech alleges it has yet to receive such documentation.
“In the time since filing our initial request, more than five months have passed without a written advisory opinion from the OIG,” stated Vertex in its lawsuit.
Casgevy, approved by the FDA in December 2023 for sickle cell disease and again in January 2024 for transfusion-dependent beta thalassemia, requires patients to undergo intensive chemotherapy to deplete blood stem cells in their bone marrow as part of the treatment process. This procedure often results in severe side effects, including infertility. Fertility preservation options such as freezing eggs, embryos, sperm, or reproductive tissue are crucial for patients facing these risks.
Vertex argues in its lawsuit that due to the limited accessibility of fertility preservation services, many patients are forced to delay or forgo treatment, potentially worsening their health to the point of disqualification from Casgevy therapy.
The biotech developed its fertility preservation program to alleviate these challenges, offering financial support for essential fertility services. Vertex contends that the HHS and OIG’s stance that the program violates anti-kickback laws has exacerbated the difficulties faced by sickle cell disease and beta-thalassemia patients unnecessarily.
The defendants named in the lawsuit include the HHS, OIG, Secretary Xavier Becerra, and Inspector General Christi Grimm.
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