HHS Challenges Vertex Over Fertility Services Program Tied To Casgevy Gene Therapy, Says Company Is 'Grasping at Straws'

In a court filing on Monday, the Department of Health and Human Services (HHS) challenged Vertex Pharmaceuticals Inc VRTX, defending its stance that the company’s proposed fertility services program would breach anti-kickback laws. The program is tied to Vertex’s gene-editing therapy Casgevy for sickle cell disease and transfusion-dependent beta-thalassemia.

Vertex sued the HHS in July 2024.

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The gene-editing treatment requires high-dose chemotherapy to clear stem cells from the bone marrow, often causing severe side effects, including infertility. To support patients, Vertex provides financial assistance for fertility preservation options like freezing eggs, embryos or reproductive tissues.

Last year, the HHS Office of Inspector General (OIG) confirmed its decision that it could not issue a favorable advisory opinion. According to OIG, the program implicates the anti-kickback statute, poses more than a low risk of fraud and abuse, and does not promote access to gene therapy care.

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The biotech challenged this allegation, "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."

Endpoints published a copy of the lawsuit online Wednesday.

HHS laid out several arguments, claiming Vertex's attempts to “twist the statute's meaning” and that the biotech is "grasping at straws…"

"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. That is a quintessential quid pro quo," the HHS said.

"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."

“Vertex then posits that its $70,000 offer will not interfere with or skew clinical decisionmaking because fertility services "benefit a patient's quality of life," HHS noted.

“This is nonsensical. Many offers of remuneration would enhance patient quality of life, but that doesn't render them lawful," the HHS added.

VRTX Price Action: Vertex stock is down 1.41% at $418.29 at publication Thursday.

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Photo: Courtesy Vertex Pharmaceuticals