The U.S. Department of Health and Human Services (HHS) will allow Novartis to cover travel, lodging, and meal expenses for Medicaid and Medicare beneficiaries who are receiving the chimeric antigen receptor T-cell therapy tisagenlecleucel but live far from treatment centers.
Tisagenlecleucel was first approved in 2017 to treat children and young adult patients with acute lymphocytic leukemia, then later extended to adult patients with relapsed/refractory large B-cell lymphoma. After receiving the one-time infusion, patients must remain near the treatment center for at least 4 weeks to be monitored and treated for any potential side effects.
The therapy was approved with a Risk Evaluation and Management Strategy (REMS), which requires treatment centers and physicians that administer tisagenlecleucel to be certified and trained in a protocol known as Elements To Assure Safe Use (ETASU).
The HHS Office of Inspector General has agreed to grant Novartis’s request to provide financial assistance to low-income patients living far from treatment centers. In order to be eligible, patients must live at least 100 miles or 2 hours’ driving distance from the nearest center and must not have insurance for non-emergency medical travel.
This decision comes during a federal government crackdown on pharmaceutical companies enticing Medicare beneficiaries to use their medicines. Over the past 2 years, eight drug companies have paid more than $840 million in settlements with the U.S. Department of Justice over accusations that donations paid to patient charities were kickbacks to cover Medicare patients’ out-of-pocket costs.
“Due to the nature of the patient population and the serious safety risks associated with [tisagenlecleucel] therapy, financially needy patients may need enhanced support to access their prescribed treatment. … We believe this program is critical to helping address the unique needs of [tisagenlecleucel] patients,” a Novartis spokesman told STAT.