Vertex’s effort to provide fertility support services to those on government insurance programs who want to take the company’s CRISPR Therapeutics-partnered gene therapy Casgevy and maintain their reproductive ability was slapped down in a Washington D.C. federal court, with a judge ruling that the services would violate anti-kickback laws.
The company’s fertility support program proposed offering up to $70,000 for fertility procedures for eligible patients with sickle cell disease (SCD) or transfusion-dependent beta thalassemia (TDT) who receive Casgevy. Considering that such fertility treatments often aren’t covered by federal insurance programs and some 50% to 60% of those with SCD are enrolled in Medicaid, Vertex figured many of those who may want the one-time curative treatment might be deterred by the reproductive side effects of the chemotherapy that’s required before infusion.
The U.S. Department of Health and Human Services (HHS), however, saw the offering as an effort to “remove a financial barrier” that could encourage healthcare providers to recommend more patients to receive the $2.2 million gene therapy versus “competitor drugs or other clinically appropriate treatments,” the agency’s Office of the Inspector General (OIG) wrote in its advisory opinion.
Thus, the program would violate the anti-kickback statute as well as the beneficiary inducement statute, two congressional mandates that aim to restrict fraud in the Medicare and Medicaid system, the OIG said.
The D.C. District Court’s Chief Judge James E. Boasberg ultimately agreed, swatting away Vertex’s arguments that the framework could fall under established exceptions to the statutes and determining that the company’s motive was to influence patients to pursue treatment with Casgevy over other options.
Vertex is “disappointed by this decision and currently evaluating the best next steps,” a company spokesperson said in an emailed statement.
“This ruling forces patients to choose between having children and getting the latest innovation in medical care. A choice they should not be forced to make,” the spokesperson said. “We are committed to the sickle cell and beta thalassemia communities and will continue to look for a path forward for patients.”
The drugmaker began its first Casgevy commercial infusions at the end of last year.
Such fertility support services aren’t unique to Vertex and Casgevy, as chemotherapy is typically used as a first step to prepare the bone marrow for gene therapies.
Bluebird bio, for one, went through the same process with HHS in its own attempt to secure coverage for the services in relation to its three gene therapies, Lyfgenia, Zynteglo and Skysona. In its response, OIG pointed to the same argument that the program would provide “remuneration” to patients.
The company had been engaging with HHS for over two years, emphasizing that the government’s decision “risks exacerbating an already gaping inequity between patients insured through Medicaid and those who are covered by commercial insurance.”