NEW YORK – Vertex Pharmaceuticals has started the process to appeal a federal district court's decision that providing fertility preservation services to Medicaid patients receiving its gene-editing therapy Casgevy (exagamglogene autotemcel) would violate anti-kickback laws.
Vertex sells Casgevy for treating sickle cell disease and transfusion-dependent thalassemia. The US District Court for the District of Columbia at the end of March ruled against Vertex, which last year had sued the US Department of Health and Human Services and the HHS Office of Inspector General over a fertility preservation program it had planned to offer to certain patients receiving its drug.
In March, Vertex said it was "evaluating the best next steps" and was "committed to the sickle cell and beta thalassemia communities and will continue to look for a path forward for patients." Now, Vertex has filed a notice of appeal with the US Court of Appeals for the District of Columbia Circuit.
Vertex did not immediately respond to a request for comment on its decision to appeal.
Casgevy, which has a list price of $2.2 million, is the first drug the US Food and Drug Administration has approved that incorporates CRISPR gene-editing. However, like other drugs in the gene therapy field, it carries a risk of infertility since patients go through intensive conditioning with chemotherapy.
Vertex had sought an advisory opinion from the OIG on whether it would be allowed to pay for fertility preservation treatment for Medicaid patients receiving Casgevy, which it already offers to some commercially insured patients. The OIG told Vertex it would not issue a favorable advisory opinion on the program, leading Vertex to sue the department.
The court ultimately sided with the OIG, determining that providing such services to patients for free would run afoul of the Anti-Kickback Statute (AKS) and the Beneficiary Inducement Statute (BIS). These statutes restrict drugmakers from paying remuneration to persuade federal healthcare programs to buy their products.
"Although Vertex does admirable work in pressing its view of nuanced statutes, the Court ultimately concludes that HHS's interpretation was lawful and thus grants its motion and denies plaintiff's," James Boasberg, chief judge of the US District Court for the District of Columbia, wrote in an opinion last month.