In a courtroom submitting on Monday, the Division of Well being and Human Providers (HHS) challenged Vertex Prescription drugs Inc VRTX, defending its stance that the corporate’s proposed fertility providers program would breach anti-kickback legal guidelines. This system is tied to Vertex’s gene-editing remedy Casgevy for sickle cell illness and transfusion-dependent beta-thalassemia.
Vertex sued the HHS in July 2024.
Additionally Learn: FDA-Authorised Sickle Cell Therapies From Bluebird Bio And Vertex Be part of Medicaid Innovation Program
The gene-editing remedy requires high-dose chemotherapy to clear stem cells from the bone marrow, typically inflicting extreme unwanted effects, together with infertility. To assist sufferers, Vertex offers monetary help for fertility preservation choices like freezing eggs, embryos or reproductive tissues.
Final 12 months, the HHS Workplace of Inspector Basic (OIG) confirmed its choice that it couldn’t problem a positive advisory opinion. In line with OIG, this system implicates the anti-kickback statute, poses greater than a low threat of fraud and abuse, and doesn’t promote entry to gene remedy care.
Additionally Learn: Vertex Prescription drugs Units Sight on Increasing Portfolio with Alyftrek Approval, Ache Remedy Progress, and Diabetes Trials
The biotech challenged this allegation, “the Fertility Preservation Program wouldn’t improperly skew medical decision-making or present an improper inducement to prescribe,” nor would it not persuade sufferers to “endure remedy with Casgevy in alternate for the Fertility Preservation Program.”
Endpoints published a duplicate of the lawsuit on-line Wednesday.
HHS laid out a number of arguments, claiming Vertex’s makes an attempt to “twist the statute’s that means” and that the biotech is “greedy at straws…”
“The purpose is that Vertex’s supply of fertility remedy in alternate for buying its product, and solely its product, is supposed to induce sufferers to decide on that product once they in any other case may not. That may be a quintessential quid professional quo,” the HHS mentioned.
“Vertex just isn’t providing $70,000 to any sickle cell affected person who undergoes myeloablative conditioning to arrange for remedy, regardless whether or not that affected person elects to buy Vertex’s product, or its competitor’s comparable gene-therapy product, or a bone- and blood-marrow transplant,” the HHS wrote. “Vertex is simply providing funds on behalf of sufferers who choose its personal product.”
“Vertex then posits that its $70,000 supply won’t intervene with or skew medical decisionmaking as a result of fertility providers “profit a affected person’s high quality of life,” HHS famous.
“That is nonsensical. Many presents of remuneration would improve affected person high quality of life, however that does not render them lawful,” the HHS added.
VRTX Value Motion: Vertex inventory is down 1.41% at $418.29 at publication Thursday.
Learn Subsequent:
Photograph: Courtesy Vertex Prescription drugs
This content material was partially produced with the assistance of AI instruments and was reviewed and printed by Benzinga editors.
Market Information and Information delivered to you by Benzinga APIs
© 2025 Benzinga.com. Benzinga doesn’t present funding recommendation. All rights reserved.
