To receive Vertex and CRISPR Therapeutics’ $2.2 million gene therapy Casgevy for sickle cell disease (SCD) and transfusion dependent beta thalassemia (TDT), patients must first undergo chemotherapy to eliminate stem cells in the blood marrow that will be replaced by treated cells.
For patients who want to retain their reproductive ability, however, additional procedures are needed to overcome the effects of the chemotherapy. While Vertex is offering to foot the bill for the fertility treatments for patients who have commercial insurance, it can’t do the same for those who are on government programs as the U.S. considers it an illegal inducement to use Casgevy.
On Monday, Vertex filed a lawsuit in federal court in Washington, D.C. against the U.S. Department of Health and Human Services (HHS) seeking to overturn the “erroneous legal positions” of the agency’s Office of the Inspector General (OIG).
“Without this relief from the court, thousands of Americans with SCD or TDT will be forced to choose between a potential cure for their debilitating, ultimately fatal disease and the dream of becoming biological parents,” Vertex wrote in its complaint.
Of the approximately 100,000 in the U.S. who suffer from SCD, 90% are Black and 50% are covered by Medicaid, according to Vertex. Additionally, 45% of the 2,000 in the U.S. with TDT are covered by government programs.
Vertex said its fertility preservation program provides financial support of up to $70,000 for those who have private insurance and have an annual income threshold that does not exceed 670% of the federal poverty level.
In the lawsuit, Vertex said that it sought an “advisory opinion” from the OIG in June of last year on whether its fertility program would violate federal kickback or inducement statutes. In November, when the OIG responded that it was prepared to provide an unfavorable opinion, Vertex offered its program only to those with commercial insurance.
Thirteen months later, Vertex said it still has not received the final advisory opinion—which is required to be answered in 60 days. In the suit, Vertex asked the court to compel the OIG to provide the ruling “without further delay.”
Bluebird Bio—which markets Lyfgenia and Zynteglo, gene therapies for SCD and TDT which also require chemotherapy conditioning—has tried unsuccessfully for more than two years to gain a government go-ahead for a similar fertility program.
“(A) patients’ ability to access fertility preservation services should not be decided by their state of residence or type of insurance,” Bluebird said in a statement. “We are committed to continuing our work with patients, patient advocates, and others to seek a path forward, including the legislative or policy changes that are needed for manufacturers to set up a compliant fertility preservation offering for individuals covered under a federal healthcare program.”