Vertex sued the federal government on Monday in an effort to expand its fertility support program to certain patients taking its new gene therapy for sickle cell disease and transfusion-dependent beta thalassemia.
The therapy, Casgevy, was approved last year to treat the two inherited blood disorders. Although the conditions can be life-threatening, treatment with Casgevy first requires a high-dose chemotherapy regimen, which can potentially be sterilizing.
Vertex created a financial support program to help eligible patients access fertility preservation services, which the company says are rarely covered by commercial or government insurance. But in January, the US Department of Health and Human Services’ Office of Inspector General confirmed its decision that the fertility program would violate anti-kickback laws, posing “more than a low risk of fraud and abuse.”
As a result, Vertex says it can only offer its program to those with commercial insurance, despite the fact that “nearly half” of sickle cell patients receive coverage through Medicaid, the federal-state program for low-income people.
“The federal government now stands as the barrier between thousands of predominantly Black Americans and the necessary medical care that would protect their basic right to have biological children,” the company said in its complaint.
Vertex asked the US District Court for the District of Columbia to issue a declaratory judgment that the program doesn’t violate the Anti-Kickback or Beneficiary Inducement statutes, arguing that it “strains credulity” to suggest a patient would choose Casgevy for fertility treatments “rather than to be potentially cured of a debilitating illness.” The company added in the complaint that it “will not use the Fertility Preservation Program to solicit new patients for Casgevy.”
“No one should have to give up their dreams of having children in order to access a treatment for their disease if they don’t have to,” a company spokesperson told Endpoints News Monday.
HHS’ OIG declined to comment.