shapes our actions and intentions.
Accessing approved therapies
bluebird bio therapies that are currently approved for use by the U.S. Food and Drug Administration (FDA) are only available in the U.S. through a network of Qualified Treatment Centers—specialized hospitals that are trained to administer gene therapy.
Patients who reside outside of the U.S. and are seeking treatment with a bluebird gene therapy will need to be treated through a U.S.-based Qualified Treatment Center (QTC). Patients or their caregivers or healthcare providers must reach out to a QTC directly to discuss the possibility of treatment.
bluebird is unable to provide financial support or other services to patients who are traveling to the U.S. from outside of the country for treatment.
Accessing investigational therapies
Participating in a clinical study is the most appropriate way to access our investigational therapies. Patients or caregivers who are interested in learning more should speak with their physician or contact firstname.lastname@example.org. We anticipate acknowledging receipt of requests sent to this email within five business days.
When participating in a clinical study is not possible, bluebird bio may consider requests for expanded access on a case-by-case basis for patients with a serious or life-threatening disease or condition when no comparable or satisfactory alternative therapy options are available. At this time, requests for expanded access must come from a qualified treatment center in the United States.
In line with the 21st Century Cures Act, bluebird bio may revise this policy at any time. This website and policy will be updated with a hyperlink or other reference to the expanded access record on clinicaltrials.gov after such record becomes active.