NICE released on 3 September 2018 Technology appraisal guidance [TA540] on pembrolizumab (Keytruda) for treating relapsed or refractory classical Hodgkin lymphoma with next recommendations
Pembrolizumab is not recommended for treating relapsed or refractory classical Hodgkin lymphoma in adults who have had autologous stem cell transplant and brentuximab vedotin.
Pembrolizumab is recommended for use within the Cancer Drugs Fund as an option for treating relapsed or refractory classical Hodgkin lymphoma in adults who have had brentuximab vedotin and cannot have autologous stem cell transplant, only if:
- pembrolizumab is stopped after 2 years of treatment or earlier if the patient has a stem cell transplant or the disease progresses and
- the conditions in the managed access agreement for pembrolizumab are followed.
These recommendations are not intended to affect treatment with pembrolizumab that was started in the NHS before this guidance was published. Patients having treatment outside these recommendations 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 appraisal committee made these recommendations?
The marketing authorisation for pembrolizumab includes 2 subpopulations of patients with relapsed or refractory classical Hodgkin lymphoma: patients who have had brentuximab vedotin and autologous stem cell transplant and those who have had brentuximab vedotin but cannot have autologous stem cell transplant.
There is no evidence directly comparing pembrolizumab with current standard care in either of the subpopulations. Indirect analyses suggest that having pembrolizumab after brentuximab vedotin may lead to longer progression-free survival than current treatment. This would increase the number of patients who can have curative allogeneic stem cell transplant. It is uncertain how many patients having pembrolizumab will be able to have allogeneic stem cell transplant and their long-term outcomes compared with those having standard care and this is a key driver of cost effectiveness.
NICE recommends nivolumab for treating relapsed or refractory classical Hodgkin lymphoma in adults after autologous stem cell transplant and brentuximab vedotin. The committee heard from clinical experts that the clinical effectiveness of pembrolizumab and nivolumab are likely to be similar in this population. The company did not provide a cost-comparison between pembrolizumab and nivolumab and so the committee based its decision on the cost effectiveness of pembrolizumab compared with standard care before the introduction of nivolumab.
Pembrolizumab meets NICE's criteria to be considered a life-extending treatment at the end of life.
Because of uncertainties in the clinical effectiveness and the modelling, the cost-effectiveness estimates are uncertain. Because of this, pembrolizumab cannot be recommended for routine use in the NHS.
There is an unmet treatment need for patients who have had brentuximab vedotin and cannot have autologous stem cell transplant. There are no licensed immunotherapies for this subpopulation. Pembrolizumab has plausible potential to be cost effective for patients who cannot have autologous stem cell transplant. Further data collection may reduce the uncertainty about the cost effectiveness. Therefore, pembrolizumab is recommended for use in the Cancer Drugs Fund for patients who have classical Hodgkin lymphoma that has relapsed after, or not responded to, brentuximab vedotin and who cannot have autologous stem cell transplant.
More evidence on pembrolizumab is being collected, until July 2022. After this NICE will decide whether or not to recommend it for use on the NHS and update the guidance. It will be available through the Cancer Drugs Fund until then.