NICE has approved the CAR T-cell therapy axicabtagene ciloleucel (Yescarta) under the Cancer Drugs Fund (CDF) for adults with relapsed or refractory diffuse large B-cell lymphoma or primary mediastinal large B-cell lymphoma who have had two or more systemic therapies.
The new draft guidance follows the initial decision not to recommend the therapy because of uncertainty about clinical benefit and cost-effectiveness. However, after negotiations between NHS England and the company, a commercial agreement was agreed for axicabtagene ciloleucel at a lower cost.
While NICE agrees that the clinical evidence from the small, single-arm, phase I/II ZUMA-1 trial is promising, it says the evidence is uncertain because of limited follow-up and no direct comparison between axicabtagene ciloleucel and salvage chemotherapy.
However, the treatment does meet NICE for a life-extending treatment at the end of life and has plausible potential to be cost effective, and is recommended for use within the CDF.
The treatment will be available at seven hospitals – University College London Hospital, King’s College Hospital, University Hospitals Bristol NHS Trust, The Christie NHS Foundation Trust, Manchester Royal Infirmary, Queen Elizabeth Hospital Birmingham and Newcastle upon Tyne NHS Foundation Trust. It is estimated that approximately 200 people per year in England will be eligible for the therapy.
The draft guidance is open to appeal until 5pm on Friday 21 December 2018.