NICE positive for Darzalex combination in newly diagnosed, transplant-eligible myeloma – Johnson & Johnson

NICE(UK): Daratumumab plus bortezomib, lenalidomide and dexamethasone as induction and consolidation treatment, followed by daratumumab plus lenalidomide as maintenance treatment, can be used as an option for untreated multiple myeloma in adults when an autologous stem cell transplant (ASCT) is suitable.

It can only be used if the company provides daratumumab according to the commercial arrangement. Daratumumab plus lenalidomide maintenance treatment can be used as an option after daratumumab plus bortezomib, thalidomide and dexamethasone induction and consolidation treatment if the person with multiple myeloma has not yet started maintenance treatment with lenalidomide alone. It can only be used if the company provides daratumumab according to the commercial arrangement.

Test for minimal residual disease (MRD) using a bone marrow sample during maintenance treatment with daratumumab plus lenalidomide. Stop daratumumab after at least 24 months of maintenance treatment if MRD has remained negative for 12 months. When MRD negativity is confirmed and daratumumab is stopped, lenalidomide maintenance treatment may continue.

Stop daratumumab plus lenalidomide maintenance treatment if the condition has progressed.

These recommendations are not intended to affect treatment with daratumumab plus bortezomib, lenalidomide and dexamethasone 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: NICE has published guidance on daratumumab with bortezomib, lenalidomide and dexamethasone for untreated multiple myeloma when a stem cell transplant is unsuitable. Usual treatment for untreated multiple myeloma when an ASCT is suitable is: i) daratumumab plus bortezomib, thalidomide and dexamethasone as induction and consolidation treatment, then ii) lenalidomide alone as maintenance treatment.

This evaluation considers: i) daratumumab plus bortezomib, lenalidomide and dexamethasone as induction and consolidation treatment, then ii) daratumumab plus lenalidomide as maintenance treatment. In a clinical trial of daratumumab plus bortezomib, lenalidomide and dexamethasone as induction and consolidation treatment, then daratumumab plus lenalidomide as maintenance treatment, people could stop daratumumab maintenance treatment if they had been having it for at least 24 months and MRD had remained negative for 12 months, or their condition got worse (progressed).

Full treatment sequence – Daratumumab plus bortezomib, lenalidomide and dexamethasone as induction and consolidation treatment, then daratumumab plus lenalidomide as maintenance treatment, has not been directly compared with usual treatment. There is no clinical trial evidence for usual treatment that includes its full treatment sequence of induction, consolidation and maintenance. There are uncertainties in the economic model, including how long people have treatment for and how subsequent treatments are modelled. But even when these uncertainties are taken into account, the likely cost-effectiveness estimates are within the range that NICE considers an acceptable use of NHS resources.

So, daratumumab plus bortezomib, lenalidomide and dexamethasone as induction and consolidation treatment, then daratumumab plus lenalidomide as maintenance treatment, can be used for untreated multiple myeloma when an ASCT is suitable.

Maintenance treatment only – Clinical trial evidence shows that daratumumab plus lenalidomide as maintenance treatment increases how long people live and how long they have before their condition gets worse compared with lenalidomide alone. But this is uncertain because people having lenalidomide alone did not have usual induction and consolidation treatment. Daratumumab plus bortezomib, lenalidomide and dexamethasone as induction and consolidation treatment has not been directly compared with daratumumab plus bortezomib, thalidomide and dexamethasone. But results from indirect comparisons suggest that the lenalidomide combination induction and consolidation treatment may have similar clinical effectiveness to usual induction and consolidation treatment.

So, daratumumab plus lenalidomide maintenance treatment can be used for people who have had daratumumab plus bortezomib, thalidomide and dexamethasone induction and consolidation treatment and who have not yet started maintenance treatment.