Interventions of Interest:

  • tisagenlecleucel (KymriahTM , Novartis)
  • axicabtagene ciloleucel (YescartaTM, Kite Pharma)

ICER developed a report on chimeric antigen receptor t-cell (CAR-T) therapies for treatment of B-cell malignancies.

The policy recommendations highlight that even though the pricing of current CAR-T therapies aligns with patient benefit there will be changes needed in future pricing, payment, and delivery mechanisms to ensure patient access without threatening health system affordability.

Both agents were approved in 2017. Tisagenlecleucel is approved for treatment of relapsed or refractory B-cell acute lymphoblastic leukemia in pediatric and young adult patients. Axicabtagene ciloleucel is approved for the treatment of relapsed or refractory aggressive non-Hodgkin’s lymphoma in adult patients.

Date of Review: March 2018

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Final Documents

Below you will find the final documents from the assessment review process:

ICER’s Chief Scientific Officer Dan Ollendorf, PhD stated:

“Given the currently available evidence, these therapies appear to be effective options for those with B-ALL or NHL, though uncertainty in the evidence raised questions around the long-term value for money. Based on current evidence, both therapies appear to be priced in alignment with their clinical value, but there are potential short-term affordability concerns – for axicabtagene ciloleucel under its current indication, and for both treatments should they receive future approvals for broader patient populations. With many other potentially transformative therapies in the pipeline, stakeholders must collaborate now to develop payment and delivery systems that can ensure timely patient access, manage short-term affordability for expensive one-time treatments, and continue to reward the innovation that brings these new treatments to market.”