HHS inspector general signs off on Novartis paying for pricey Kymriah
The Office of Inspector General (OIG) of HHS recently told Novartis that it can pay for low-income patients to access its $475,000 CAR-T therapy Kymriah and that those payments are not illegal.
While acknowledging that the payments might induce certain treatment centers and physicians to use the one-time gene therapy, or push eligible patients to select federally reimbursed items and services related to the treatment, the OIG praises the effectiveness of Kymriah and explains how access to it is available in every care setting, which means the payments won’t inappropriately steer a patient to one center over another.
OIG also said it recognizes that the treatment centers and physicians may receive a financial benefit under this arrangement due to professional service fees and facility fees in connection with administering the free Kymriah.
But the risk of overutilizing Kymriah is reduced here, OIG says, because the CAR-T is generally curative (recent data showed complete remissions in almost half of those with advanced, treatment resistant non-Hodgkin lymphoma), only administered once, and generally only for those not responding to other therapies.
Novartis, which brought in $474 million in Kymriah sales in 2020, told Endpoints News in a statement that its access program for the CAR-T provides it for free to eligible, low-income patients who do not have insurance coverage or have been denied coverage.
“Due to the nature of the patient population, financially needy patients may need enhanced support to access their prescribed treatment. We are pleased with this outcome, as we believe this program is critical to helping address the unique needs of Kymriah patients,” the company added, noting that as of January 2021, Novartis has manufactured CAR-T cells for more than 4,200 patients worldwide, including commercial and clinical product.
OIG previously gave Novartis the go-ahead to continue with its travel assistance program for Kymriah too. That program helps eligible low-income patients with certain travel and lodging costs and provides reimbursement for other related expenses for the patient to stay near a certified treatment center after the infusion of Kymriah.