1.1 Daratumumab monotherapy is recommended as an option for treating relapsed and refractory multiple myeloma in adults who have had a proteasome inhibitor and an immunomodulator, and whose disease progressed on the last treatment, only if:
they have daratumumab after 3 treatments and
the company provides daratumumab according to the commercial arrangement.
Why the committee made this recommendation
This appraisal reviews the additional evidence collected as part of the Cancer Drugs Fund managed access agreement for daratumumab monotherapy for relapsed and refractory multiple myeloma in adults who have already had 3 treatments, including a proteasome inhibitor and an immunomodulator, and whose disease progressed on the last treatment.
Usual treatment for relapsed and refractory multiple myeloma in people who have already had 3 treatments is pomalidomide plus dexamethasone.
The new clinical evidence shows that daratumumab monotherapy increases how long people live compared with pomalidomide plus dexamethasone, but by how much is still uncertain.
Because of this uncertainty, the cost-effectiveness estimates vary. But the most likely estimates are within what NICE considers an acceptable use of NHS resources. Therefore, daratumumab is recommended for routine use.