Vertex Pharmaceuticals has filed a lawsuit against the U.S. Department of Health and Human Services (HHS) seeking to be permitted to offer its fertility support services program to patients on Medicaid who have been prescribed its Casgevy gene-editing treatment.
The lawsuit was filed in the U.S. District Court for the District of Columbia; the defendants named are the HHS; Xavier Becerra, in his official capacity as secretary of the HHS; the HHS' Office of the Inspector General (OIG); and Christi A. Grimm, in her official capacity as the OIG's inspector general.
Casgevy received U.S. Food and Drug Administration (FDA) approval in December 2023 for the treatment of sickle-cell disease (SCD) and transfusion-dependent beta thalassemia (TDT) in January 2024.
The lawsuit challenges a decision by the OIG in January 2024 not to issue a favorable advisory opinion backing Vertex's fertility preservation program for patients for whom Casgevy has been prescribed.
The OIG said in an oral decision that the program could violate anti-kickback laws, such as the Anti-Kickback Statute or the Beneficiary Inducement Statute, as it "poses more than a low risk of fraud and abuse to federal healthcare programs."
In the suit, Vertex claimed that it had requested that the OIG commit its opinion to writing, but at the time of filing, the OIG had not done so. The company argues that its fertility support program does not violate anti-kickback statutes.
Treatment with Casgevy requires the administration of high doses of chemotherapy (myeloablative conditioning), which may result in infertility. Fertility preservation programs and services are not often covered by insurance; however, Vertex noted that it will offer its fertility support program "that provides financial support for medically necessary fertility services for patients prescribed the Product whose insurance does not cover those services and who meet certain financial need and other eligibility criteria."
Vertex noted in the suit that its fertility support program is available to patients who are commercially insured, but that no such fertility programs are available for patients with Medicaid coverage. Thus, the company said it had requested an advisory opinion.
"Even though Medicaid and most other insurers already deny Americans with SCD or TDT fertility coverage, the federal government, through OIG's refusal to issue a favorable advisory opinion, has effectively prohibited those patients from receiving free fertility services from others -- leaving them with the Hobson's choice between undergoing a potentially curative treatment or becoming biological parents," Vertex wrote in the filing.
In addition, the company noted that in the absence of accessible fertility support services, many patients might make "the difficult decision to delay or forego treatment because they wish to be biological parents … with the possible consequence that their condition deteriorates to the point that they are no longer eligible for treatment."
