bluebird bio's fertility support programme associated with its gene therapy has received a rejection from the US Department of Health and Human Services' (HHS) Office of Inspector General (OIG). 

Last year, bluebird won an approval from the US Food and Drug Administration (FDA) for its gene therapy Zynteglo (betibeglogene autotemcel) to treat beta thalassaemia. The therapy comes with a price tag of $2.8m. However, any eligible patients are required to have chemotherapy first before receiving the therapy, which can carry a risk of infertility.  

Bluebird bio had requested an advisory review of the programme that would enable assistance for travel and associated expenses to receive the treatment and fertility perseveration services. The proposed support could cost up to $22,500 per patient. The company was aiming to get guidance on whether these expenses would violate the federal Anti-Kickback Statute.  

The HHS OIG has said any payments made under bluebird bio’s fertility support program would invite sanctions described under Social Security Act in relation to the Anti-Kickback Statue. This would pertain to patients covered by federal insurance programmes like Medicaid, who are undergoing treatment with Zynteglo.

This news comes a week after Vertex Pharmaceuticals sued the federal government over a similar fertility support program for its gene therapy Casgevy (exagamglogene autotemcel), which treats beta thalassemia. Vertex had created a programme that provides patients who need to access fertility services on Medicaid, but the OIG said even that programme would violate anti-kickback laws. 

In its opinion on bluebird’s program, the HHS said it did not have enough data on costs and access to healthcare services to be able to say that the programme presents a “low risk” of fraud and abuse under federal anti-kickback rules. 

The federal Anti-Kickback Statute is a law designed to prevent fraud and abuse in the healthcare system. As per the Statute it is illegal for anyone to offer, pay, solicit, or receive anything of value to get referrals for services covered by federal healthcare programmes like Medicare or Medicaid. 

In the advisory opinion, the OIG added that, "In an exercise of its enforcement discretion, OIG declines to offer prospective immunity—through a favourable advisory opinion—to the Fertility Support offered under the Proposed Arrangement.”