HHS’ Office of the Inspector General has issued a negative advisory opinion for a fertility support program proposed by bluebird bio, less than a week after Vertex sued the federal government over similar comments.
Bluebird’s gene therapies Zynteglo and Lyfgenia are approved to treat two life-threatening blood disorders and have list prices of more than $2.5 million each. Its third gene therapy, Skysona, is for a rare neurological disorder called cerebral adrenoleukodystrophy and priced at $3 million. However, they each require initial treatment with chemotherapy, which can affect fertility.
The company created a support program to help patients access fertility preservation services, and sought guidance from OIG around extending that support to eligible patients insured under a federal healthcare program.
In an opinion posted on Monday, OIG said it doesn’t have enough data to determine that the fertility services would “pose a sufficiently low risk of fraud and abuse” under a federal anti-kickback law. OIG added that bluebird’s fertility support may constitute remuneration to patients “that may induce them to purchase the Drugs,” as well as to treatment centers and physicians who stand to earn fees related to treatment.
“This conclusion also is not a determination by OIG that the Fertility Support would violate the Federal anti-kickback statute; it simply means that, in an exercise of its enforcement discretion, OIG declines to offer prospective immunity — through a favorable advisory opinion — to the Fertility Support offered under the Proposed Arrangement,” OIG wrote.
Bluebird argued that the program would assist patients who may otherwise decline treatment because of the infertility risk. A company spokesperson told Endpoints News on Monday that the company is “extremely disappointed,” and will “continue to advocate until individuals insured under Medicaid have access to the same fertility preservation services as those who are commercially insured.”
Vertex sued the federal government last week over a similar fertility support program for its gene therapy Casgevy, which OIG said poses “more than a low risk of fraud and abuse.” Bluebird declined to comment on whether it also plans to file suit, noting that “we can’t comment on legal strategy.”
“No patient should have to choose between a potentially lifechanging or lifesaving therapy and the chance to have a child,” bluebird said in a statement on Monday.