NEW YORK – The US Department of Health and Human Services this week urged a federal district court to affirm its stance that a fertility preservation program proposed by Vertex Pharmaceuticals would run afoul of anti-kickback laws.
This new filing with the US District Court for the District of Columbia marks the latest update in an ongoing clash between Vertex and the federal government over the drugmaker's desire to cover fertility preservation services for some patients who receive Casgevy (exagamglogene autotemcel), a CRISPR-based gene-editing therapy that last year was approved to treat sickle cell disease (SCD) and transfusion-dependent beta thalassemia (TDT).
Casgevy, developed by Vertex and CRISPR Therapeutics, is designed to treat and potentially even cure SCD and TDT. However, a conditioning process that patients undergo prior to receiving the treatment is known to reduce both female and male fertility.
With this issue in mind, Vertex has launched a program to pay for fertility preservation services for certain patients who receive Casgevy, including eligible commercially insured patients.
However, the Office of Inspector General at HHS has told Vertex that such a program, if offered to patients insured by government programs such as Medicaid, would run afoul of the Anti-Kickback Statute (AKS) and the Beneficiary Inducement Statute (BIS), which restrict drugmakers from paying remuneration to persuade federal healthcare programs to buy their products.
Vertex in July filed a complaint in which it sought declaratory judgment from the district court that would allow it to extend its fertility preservation program to patients insured by public payors. Among other arguments in favor of its program, the company said offering such services wouldn't influence doctors' decisions to prescribe Casgevy or induce patients to undergo treatment in exchange for free fertility treatment.
That argument is beside the point, according to HHS.
"The point is that Vertex's offer of fertility treatment in exchange for purchasing its product, and only its product, is meant to induce patients to choose that product when they otherwise might not," or might otherwise choose a different treatment option, lawyers for the agency wrote in the most recent case filing, in which HHS urges the court to issue a judgment in its favor.
Vertex's arguments against describing its proposed program as a violation of these federal laws are a "distraction," the agency said.
Vertex's emphasis on the benefits of its fertility preservation program do not amount to an argument that it wouldn't violate fraud and abuse laws, the agency said. In fact, the agency said, Vertex has designed the program in an effort to encourage patients who might otherwise be deterred by this side effect to receive the product, which has a list price of $2.2 million.
The AKS, which contains various exceptions to the statute, does not contain an exception for "remuneration with arguable social merit," HHS said.
"Vertex cannot explain away the fact that its offer to give patients $70,000 in free fertility services in exchange for purchasing its product plainly would fall within the AKS's prohibition on offering 'any remuneration … to induce' the purchase of services covered by a federal healthcare program," HHS said in the court document.