The Department of Health and Human Services’ Office of the Inspector General found that bluebird bio’s fertility support program for its gene therapies could potentially violate federal anti-kickback statutes.
The Department of Health and Human Services’ Office of the Inspector General on Monday issued a negative advisory opinion against bluebird bio’s proposed fertility support program for patients receiving its gene therapies.
The Office of the Inspector General (OIG) in a 16-page advisory said it “cannot conclude at this time that the Fertility Support would pose a sufficiently low risk of fraud and abuse” and that it would not violate federal anti-kickback statutes.
Bluebird bio markets Zynteglo (betibeglogene autotemcel) for the treatment of beta-thalassemia, and the recently approved Lyfgenia (lovotibeglogene autotemcel), for sickle cell disease. Both are gene therapies that involve a conditioning regimen of high-dose chemotherapy, depleting blood stem cells in the bone marrow.
Because of the strong chemotherapeutic drugs it uses, conditioning carries heavy side effects such as infertility. For patients who want to have children, this can often force them to delay treatment or forgo it completely.
To address the problem, bluebird is proposing a fertility support program which would include $22,500 in assistance “to cover some or all costs of specified fertility preservation procedures and storage” and “would assist patients who may otherwise forgo treatment to avoid the risk of infertility,” according to the OIG.
Fertility preservation interventions can include harvesting and freezing reproductive tissues such as eggs, embryos and sperm for future use.
However, the OIG found that bluebird’s proposed program would run afoul of federal anti-kickback policies in two ways. First, it could be seen as “remuneration to patients,” which in turn could encourage them to choose the company’s therapies over potential competitors. “The Fertility Support would be designed to remove a financial barrier so that eligible patients would purchase” bluebird’s therapies, the OIG contends.
The OIG also argues that bluebird’s fertility program would “constitute remuneration to the Treatment Centers and the treating physicians.” Specifically, this remuneration refers to earnings associated with providing bluebird’s gene therapies to patients who would have otherwise not pushed through with treatment if not for the fertility program.
This could encourage these providers to preferentially dispense and prescribe bluebird’s therapies, according to the OIG.
At the same time, the OIG stated that its opinion is advisory and “does not impose any obligations” on bluebird, nor does it mean that the program would definitively “violate the Federal anti-kickback statute.” The OIG’s opinion only means that it will not provide prospective immunity to bluebird’s fertility program.
Monday’s negative opinion comes after Vertex Pharmaceuticals last week sued the same office over a similarly unfavorable opinion over the biotech’s fertility support program for Casgevy (exagamglogene autotemcel), its CRISPR-based gene editing therapy for sickle-cell disease.
