NICE is inviting feedback on its decision not to recommend tisagenlecleucel (Kymriah) for the treatment of diffuse large B-cell lymphoma in adults.
The draft guidance, issued this week, recommends against the use of tisagenlecleucel for adults with relapsed or refractory diffuse large B-cell lymphoma who have received at least two lines of systemic therapy.
The clinical evidence for tisagenlecleucel came from the phase II, open-label single-arm study JULIET study and a small observational study (Schuster 2017), which included 111 and 14 patients, respectively.
Although the treatment showed significant clinical benefits for adults with lymphoma, the NICE appraisal committee noted that there is no data comparing tisagenlecleucel to salvage chemotherapy, which makes it difficult to determine the exact benefits of the treatment.
The drug’s toxicity profile was also noted. Results from JULIET showed that all patients receiving tisagenlecleucel experienced an adverse event (AE), with most patients experiencing a grade ≥3 AE. Given the need for intensive care, with AEs such as cytokine release syndrome, the committee advised that the costs associated with managing and treating these events should be reflected in the cost-effectiveness modelling.
The committee concluded that, based on available evidence, tisagenlecleucel is not cost-effective for routine funding or use within the Cancer Drugs Fund (CDF).
NICE is now inviting feedback on the draft guidance. The closing date for receipt of comments is 10 October 2018. The committee will consider the comments received on the draft guidance, together with any new evidence, at the next meeting on 23 October 2018.