Just the day after the good news of EMA marketing authorisation to Yescarta and Kymriah, NICE posted the Yescarta Draft Guidance for consultation, and it is a No. Here the link to the draft recommendation: NICE draft guidance

These news come as a surprise and apparently in contradiction with previous NICE work on CAR-Ts, the so-called CAR-T mock appraisal.

The NICE committee motivates this initial no with the lack of comparative data vs. chemotherapy and therefore on the uncertainty about size of benefit. Here below the excerpt from the NICE document:

“Evidence from a small, single-arm study suggests that people having axicabtagene ciloleucel have good response rates, overall survival and progression-free survival. But, there are no direct data comparing axicabtagene ciloleucel with salvage chemotherapy (referred to as best supportive care by the company). This means that the exact size of the benefit of axicabtagene ciloleucel compared with salvage chemotherapy is unknown.”

 

And now what?  – Yescarta’s draft guidance is currently undergoing a consultation process, and Gilead/Kite will have the opportunity to complement the submission with more relevant chemotherapy data. NICE has suggested to use subpopulation data from the ORCHARRD study or from the UK Haematological Malignancy Research Network. The NICE Committee will meet again on September 27th and a final decision is expected for December 17th.

Our guess: at NICE, an initial no does not mean no. There are good reasons to think that Gilead/Kite have the opportunity to turn it into a yes for Yescarta.

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