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Daratumumab in combination for untreated multiple myeloma when a stem cell transplant is suitable

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1 Recommendations

1.1 Daratumumab plus bortezomib, thalidomide and dexamethasone is not recommended, within its marketing authorisation, as induction and consolidation treatment for untreated multiple myeloma in adults, when an autologous stem cell transplant is suitable.

1.2 This recommendation is not intended to affect treatment with daratumumab plus bortezomib, thalidomide 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 clinician consider it appropriate to stop.

Why the committee made these recommendations

Before having an autologous stem cell transplant, most people with untreated multiple myeloma have bortezomib plus thalidomide and dexamethasone as the first (induction) treatment. This appraisal looks at adding daratumumab (daratumumab in combination). This treatment would also continue for a short time after transplant (consolidation).

Clinical trial results show that, compared with bortezomib plus thalidomide and dexamethasone, adding daratumumab increases how long people live and extends the time before the condition gets worse.

The company's economic model made assumptions around how long the effect of daratumumab lasts and how long people live which are uncertain. Also, there is some uncertainty around how the company modelled treatment after daratumumab.

The cost-effectiveness estimates are likely to be higher than what NICE considers acceptable. So, daratumumab plus bortezomib, thalidomide and dexamethasone cannot be recommended for use in the NHS.