HHS Says Vertex is ‘Grasping at Straws’ With Casgevy Fertility Suit

Along with its gene editing therapy Casgevy, Vertex is offering fertility preservation support for its patients—a program that the HHS claims violates anti-kickback statutes.

In a court filing on Monday, the Department of Health and Human Services fired back at Vertex Pharmaceuticals, standing by a directive that the biotech’s proposed fertility services program to go with its gene editing therapy Casgevy would violate anti-kickback statutes.

Vertex sued the HHS in July 2024 after the department’s Office of the Inspector General (OIG) decided not to issue a favorable opinion on the company’s fertility support for Casgevy patients.

The gene editing treatment process involves pre-treatment with high-dose chemotherapy to empty the bone marrow of stem cells. As a result, patients often suffer from serious side effects, including infertility. Vertex offers financial support to help its patients avail themselves of fertility preservation services such as freezing eggs, embryos or reproductive tissues.

According to the biotech’s lawsuit, the OIG claimed that Vertex’ fertility program “poses more than a low risk of fraud and abuse, and does not promote access to gene therapy care.”

The biotech challenged this allegation, asserting in its lawsuit that “the Fertility Preservation Program would not improperly skew medical decision-making or provide an improper inducement to prescribe,” nor would it persuade patients to “undergo treatment with Casgevy in exchange for the Fertility Preservation Program.”

The HHS does not appear to be convinced. In its filing on Monday, the department’s lawyers laid out several counter arguments, claiming that Vertex’s arguments “twist the statute’s meaning” and that the biotech is “grasping at straws” with its interpretations of precedent rulings and “attempts to shoehorn” different statutes to the anti-kickback policy.

The HHS maintained its prior determination that Vertex’s fertility preservation program “would obviously constitute an ‘independent benefit’” for patients, and in turn carry the risk of skewing both medical and patient decision-making.

“Vertex is not offering $70,000 to any sickle cell patient who undergoes myeloablative conditioning to prepare for treatment, regardless whether that patient elects to purchase Vertex’s Product, or its competitor’s similar gene-therapy product, or a bone- and blood-marrow transplant,” the HHS wrote. “Vertex is only offering payments on behalf of patients who select its own Product.”

“More importantly, the statute Congress wrote prohibits offering or paying ‘any remuneration … directly or indirectly, overtly or covertly, in cash or in kind,’ if made with the relevant purpose,” the document reads. Of note, the anti-kickback statute “contains no exception for remuneration with arguable social merit,” the HHS emphasized.

https://www.biospace.com/policy/hhs-says-vertex-is-grasping-at-straws-with-casgevy-fertility-suit