NICE (UK) managed access for Elrexfio (elranatamab) for treating relapsed and refractory multiple myeloma after 3 or more treatments – Pfizer

NICE (UK) 1.1 Elranatamab is recommended with managed access as an option for treating relapsed and refractory multiple myeloma in adults, only after 3 or more lines of treatment (including an immunomodulatory drug, a proteasome inhibitor and an anti‑CD38 antibody) when the multiple myeloma has progressed on the last treatment. It is only recommended if the conditions in the managed access agreement for elranatamab are followed. 1.2 This recommendation is not intended to affect treatment with elranatamab 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 healthcare professional consider it appropriate to stop. Why the committee made these recommendations: The main treatment that is used for multiple myeloma that has relapsed (come back) and is refractory (has stopped responding to treatment) after 3 or more lines of treatment is pomalidomide plus dexamethasone. If pomalidomide plus dexamethasone is not suitable, panobinostat plus bortezomib and dexamethasone can be used. If the multiple myeloma is refractory to 5 or more treatments, selinexor plus dexamethasone can be used. For this evaluation, the company only compared elranatamab with treatments that are used after 3 or more lines of therapy. This does not include everyone who elranatamab is licensed for.

Elranatamab has not been directly compared in a clinical trial with pomalidomide plus dexamethasone, panobinostat plus bortezomib plus dexamethasone, or selinexor plus dexamethasone. Indirect comparisons with these treatments suggest that elranatamab could increase how long people have before their cancer gets worse. Indirect comparisons with pomalidomide plus dexamethasone and selinexor plus dexamethasone suggest that elranatamab could also increase how long people live. But elranatamab was not directly compared with any of these treatments and the clinical trial of elranatamab is still ongoing. So, the long-term benefits are unknown. To prevent or treat infections, people having elranatamab can have intravenous immunoglobulin, but it is uncertain how many people might have this in NHS clinical practice, and for how long. Because of this, and because of the uncertainty in the long-term benefits of elranatamab, the cost-effectiveness estimates are also uncertain. Even when considering the condition’s severity, and its effect on quality and length of life, the most likely cost-effectiveness estimates are above what NICE considers an acceptable use of NHS resources. So, elranatamab cannot be recommended for routine use in the NHS. Elranatamab could be cost effective if further evidence shows that people live longer with this treatment. Longer-term evidence from the trial and NHS clinical practice could help address the remaining uncertainties. So, elranatamab is recommended for use with managed access only after 3 or more lines of treatment (including an immunomodulatory drug, a proteasome inhibitor and an anti‑CD38 antibody) when the multiple myeloma has progressed on the last treatment.