UK’s NICE recommends Novartis CAR-T Kymriah for lymphoma

The agency is recommending that the CAR-T be covered under the Cancer Drugs Fund while more data are collected. The recommendation was issued in return for a confidential discount from Novartis.

The UK’s drug-pricing watchdog has moved to recommend that a second CAR-T therapy become available for adults with lymphoma, following negotiations that initially saw the therapy rejected.

The National Institute for Health and Care Excellence, or NICE, said Friday that it would recommend that Novartis’s Kymriah (tisagenlecleucel) for adults with diffuse large B-cell lymphoma receive coverage under the Cancer Drugs Fund. NICE issued a similar recommendation in December for a competitor, Gilead Sciences’ Yescarta (axicabtagene ciloleucel), also in DLBCL. In November, it recommended Kymriah for acute lymphoblastic leukemia in children and young adults, also under the CDF.

NICE had initially turned down both CAR-Ts for DLBCL, which is a common occurrence when pricing negotiations between the body and drug manufacturers are in their early stages. However, it said Friday, Kymriah – whose UK list price is 282,000 pounds, or $369,138 – was recommended in exchange for confidential discounts. Yescarta was recommended in exchange for a commercial access agreement, though the details of that are also confidential.

The agency’s recommendation of Kymriah to the CDF for ALL was due to some uncertainties used in the evidence to support it. However, NICE said it recognized the CAR-T as highly innovative, and allowing access to it under the CDF would enable patients to receive it while more evidence is collected to support its use. The recommendation issued Friday followed along similar lines. “CAR-T cell therapy is expensive, however the treatment is specific to each individual and could be a potential cure for some, although it is early days,” NICE Centre for Health Technology Evaluation Director Meindert Boysen said in a statement. “Our recommendation for tisagenlecleucel on the Cancer Drugs Fund means people can benefit while more data is collected.”

Ordinarily, NICE considers new treatments cost-effective if their cost per quality-adjusted life year, or QALY, gained is between 20,000-30,000 pounds ($26,268-39,402), meaning the cost to the NHS for a year of good health does not exceed that threshold.

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