CAR-Ts have been hailed as game-changers for patients with relapsed/refractory blood cancers that are resistant to standard treatments.

2017 saw the approval of two CAR-T therapies: Novartis’ Kymriah and KITE/Gilead’s Yescarta. However, lack of access and continued safety concerns are two factors limiting the commercial potential of approved CAR-T treatments.

Commercial barriers: Two months after KITE/Gilead’s Yescarta gained FDA approval, only five patients had been treated with the drug outside of clinical trials.

Delays in access have been blamed on lack of insurance coverage, particularly with Medicare and Medicaid, due to absence of reimbursement infrastructure as well as payer pushback at the high cost of these treatments (Kymriah costs $475,000 per patient while Yescarta costs $373,000 per patient).

Adding to the discussion on whether the cost of these drugs are justified, there is lack of mature clinical data showing these treatments to be curative. Cytokine release syndrome continues to be a safety concern when administering CAR-T treatments.

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By GlobalData

Looking ahead: Despite lingering safety and pricing concerns, developers are forging ahead with the next generation of CAR-T drugs using novel targeting approaches (bispecific CAR-T) and production strategies (“off-the-shelf” CAR-T).