NICE advice and quality standards Interventional procedures guidance for Tafasitamab with lenalidomide for treating relapsed or refractory diffuse large B-cell lymphoma

1.1 Tafasitamab with lenalidomide is not recommended, within its marketing authorisation, for treating relapsed or refractory diffuse large B‑cell lymphoma in adults who cannot have an autologous stem cell transplant.

1.2 This recommendation is not intended to affect treatment with tafasitamab with lenalidomide that was started in the NHS before this guidance was published. People having treatment outside this recommendation may continue without change to the funding arrangements in place for them before this guidance was published, until they and their NHS clinician consider it appropriate to stop.

Why the committee made these recommendations

People with relapsed or refractory diffuse large B‑cell lymphoma who cannot have an autologous stem cell transplant usually have polatuzumab vedotin plus rituximab and bendamustine.

The clinical evidence is from a small study that did not directly compare tafasitamab plus lenalidomide with any other treatment. The committee considered that the study results were promising because they show that some people's disease responds to tafasitamab plus lenalidomide. Indirect evidence suggests that people who have tafasitamab plus lenalidomide have more time before their disease gets worse than people who have polatuzumab vedotin plus rituximab and bendamustine. It also suggests that they live longer. But there is uncertainty about these results because the survival times for people having polatuzumab vedotin plus rituximab and bendamustine used in the modelling do not reflect the real-world survival times of the treatment in clinical practice, compared with bendamustine and rituximab alone. The methods used for the indirect comparisons are also not clear.

Tafasitamab plus lenalidomide meets NICE's criteria to be considered a life-extending treatment at the end of life. This is because people on standard treatment (polatuzumab vedotin plus rituximab and bendamustine) for relapsed or refractory diffuse large B‑cell lymphoma are likely to live on average less than 2 years. But all the cost-effectiveness estimates for tafasitamab plus lenalidomide are above the range that NICE normally considers to be an acceptable use of NHS resources for end of life treatments. Therefore, it cannot be recommended for routine use in the NHS.

Because the cost-effectiveness estimates are high and uncertain, and further evidence is unlikely to resolve this uncertainty, it also cannot be recommended for use in the Cancer Drugs Fund.