By Victor Swezey

Vertex Pharmaceuticals sued the U.S. government for the right to pay for the fertility treatments of certain patients who receive a sickle-cell gene therapy that can affect reproduction.

The Boston-based biotechnology company said in a lawsuit filed on Monday that it's prohibited from funding fertility treatments to patients in federal health insurance programs who use its Casgevy gene therapy, due to current rules issued by the Health and Human Services Department's office of inspector general.

Vertex said in the lawsuit, filed in U.S. District Court in the District of Columbia, that it plans to offer the fertility treatment to patients with commercial insurance. The inspector general determined that giving the treatment to patients with federal insurance may violate parts of the 1935 Social Security Act, including the Anti-Kickback Statute and the Beneficiary Inducement Statute, the company said.

Casgevy was approved by the Food and Drug Administration in December and is designed for patients with sickle cell disease and transfusion-dependent beta-thalassemia. In the U.S., sickle cell affects about 100,000 people and transfusion-dependent beta-thalassemia about 2,000 people.

In order to function, Vertex's gene therapy requires high doses of chemotherapy to destroy blood stem cells in bone marrow, a process whose side effects include infertility.

Write to Victor Swezey at victor.swezey@wsj.com; @vicswezey


(END) Dow Jones Newswires

07-15-24 1705ET