Vertex has filed a complaint against the Department of Health and Human Services, seeking to make its fertility preservation program available to federally insured patients needing Casgevy treatment.
Vertex Pharmaceuticals on Monday filed a lawsuit that, if successful, would allow it to offer fertility support and treatment services for patients receiving its gene editing therapy Casgevy (exagamglogene autotemcel) who are insured through the federal government.
The lawsuit challenges an oral decision by the Department of Health and Human Services’ (HHS) Office of the Inspector General (OIG) in January 2024 not to issue a favorable advisory opinion backing Vertex’s fertility preservation program for patients who need to take Casgevy. According to Vertex’s suit, the agency claimed that the program violated anti-kickback regulations and “poses more than a low risk of fraud and abuse, and does not promote access to gene therapy care.” Vertex asked the OIG to lay out its opinion in writing, but the biotech alleges that it still has not received the document.
“As of the date this complaint was filed, more than five additional months have elapsed, yet OIG has not issued a written advisory opinion,” the lawsuit read.
The FDA first signed off on Casgevy in December 2023, allowing its use in patients with sickle cell disease, and then approved it again in January 2024 for transfusion-dependent beta thalassemia.
As part of the Casgevy treatment process, patients need to first undergo high-dose chemotherapy to deplete blood stem cells in their bone marrow. Patients often experience serious side effects from this conditioning regimen, one of which is infertility. Fertility preservation can include freezing eggs, embryos, sperm or reproductive tissue for future use.
However, because fertility preservation services are often inaccessible, many patients “make the difficult decision to delay or forego treatment,” Vertex wrote in its lawsuit, adding that this, in turn, could worsen their condition “to the point that they are no longer eligible for treatment.”
Vertex came up with its fertility preservation program to provide these patients with financial support for necessary fertility services. The biotech alleged in its lawsuit that by insisting that the program violates anti-kickback statutes, the HHS and OIG have “severely and unnecessarily compounded the struggle” of sickle cell disease and beta-thalassemia patients.
The HHS and the OIG are named as defendants in the suit, alongside Secretary Xavier Becerra and Inspector General Christi Grimm.
