ICER: CAR T THERAPIES ARE PRICED RIGHT
BY MARY ROMEO
December 21, 2017
The Institute for Clinical and Economic Review (ICER) believes the first two FDA-approved chimeric antigen receptor (CAR) T cell therapies — Kymriah tisagenlecleucel and Yescarta axicabtagene ciloleucel — are priced in-line with their clinical benefits over a lifetime, given currently available evidence. ICER noted "the findings are sensitive to the [life] time horizon and long-term benefit forecasting of the therapies."
In a draft evidence report released Wednesday, the committee said that compared to chemotherapy, Kymriah and Yescarta each provide significant gains in overall survival (OS) and in survival adjusted for potential reduction in quality of life due to pretreatment regimens for CAR T therapies. ICER said Kymriah's estimated incremental cost-effectiveness ratio is $1.2 million per quality-adjusted life year (QALY) gained at one year post-treatment, but that ratio falls to $57,093 per QALY gained when projected over a lifetime. Yescarta's estimated ratio is $5.1 million per QALY gained at one year post-treatment and $145,158 per QALY gained over a lifetime.
ICER based its estimates on wholesale acquisition costs (WAC) as of Oct. 8 — $475,000 for Kymriah and $373,000 for Yescarta — plus about $100,000 added to each WAC for estimated hospital mark-up. Kymriah's WAC includes the leukapheresis process used to extract patients’ T cells, while Yescarta's does not.
FDA approved Kymriah from Novartis AG (NYSE:NVS; SIX:NOVN) in August to treat patients up to 25 years old with B cell precursor acute lymphoblastic leukemia (ALL) that is refractory or in second or later relapse. Novartis has an outcomes-based arrangement with the U.S. Centers for Medicare & Medicaid Services (CMS) for the therapy. Kymriah comprises autologous T cells loaded with a lentiviral vector expressing CART-19, which consists of a cancer antigen-binding domain targeting CD19 linked to CD3zeta/CD137 immunostimulatory domains.
The agency approved Yescarta from the Kite Pharma Inc. unit of Gilead Sciences Inc. (NASDAQ:GILD) in October to treat relapsed or refractory large B cell lymphoma after two or more lines of systemic therapy. The therapy comprises autologous T cells genetically modified to express a CAR targeting CD19
Public comments on the draft evidence report are due Jan. 24, 2018. ICER's California Technology Assessment Forum (CTAF) will hold a public meeting on March 2 and a final report is slated for release on March 16.
