The UK’s National Institute for Health and Care Excellence (NICE) has recommended use of tisagenlecleucel, an anti-CD19 chimeric antigen receptor T-cell (CAR-T) therapy, as a therapeutic option for the treatment of adults with relapsed/refractory diffuse large B-cell lymphoma (R/R DLBCL) following 2 or more systemic therapies.1
Tisagenlecleucel for the treatment of adults with R/R DLBCL received approval from the US Food and Drug Administration (FDA) and the European Medicines Agency (EMA) in May 2018 and August 2018, respectively, 2,3 on the basis of results from the phase 2, multicenter JULIET trial (ClinicalTrials.gov Number: NCT02445248). In that trial, the drug demonstrated a high rate of durable, ongoing responses in this patient population, with adverse effects that were determined by researchers to be manageable. 2–4
Multiple factors are weighed when a particular therapeutic intervention is evaluated by NICE; these include the evidence related to its efficacy, safety, and cost effectiveness, as well as considerations regarding the equitable distribution of health resources.5
The NICE recommendation for use of tisagenlecleucel in adults with R/R DLBCL follows 2 prior NICE CAR-T therapy recommendations: tisagenlecleucel for patients up to age 25 years with relapsed/refractory B-cell acute lymphoblastic leukemia (ALL), and axicabtagene ciloleucel for the treatment of DLBCL and primary mediastinal large B-cell lymphoma after 2 or more systemic therapies.1
According to a statement from NICE’s director of the Centre for Health Technology Evaluation, “Recommending another revolutionary CAR T-cell therapy for adults with lymphoma represents a step forward for personalized medicine. We are pleased that patients are set to benefit from such an innovative therapy so rapidly because of joint working between NICE, NHS England and the company.”1
- NICE recommends another revolutionary CAR T-cell therapy for adults with lymphoma [press release] . Accessed February 6, 2019.
- Tisagenlecleucel (Kymriah™) [package insert]. East Hanover, NJ: Novartis Pharmaceuticals Corp.; 2018.
- European Medicines Agency. Kymriah. https://www.ema.europa.eu/en/medicines/human/EPAR/kymriah. Updated September 19, 2018. Accessed February 6, 2019.
- Schuster SJ, Bishop MR, Tam CD, et al. Tisagenleuleucel I adult relapsed or refractory diffuse large B-cell lymphoma. N Engl J Med. 2019;380:45-56.
- Drummond M. Clinical guidelines: A NICE way to introduce cost-effectiveness considerations? Value Health. 2016;19(5):525-530.