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1 Recommendations

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1 Recommendations

1.1

Daratumumab with bortezomib, lenalidomide and dexamethasone should not be used for untreated multiple myeloma in adults when an autologous stem cell transplant (ASCT) is unsuitable.

1.2

This recommendation is not intended to affect treatment with daratumumab with 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.

What this means in practice

Daratumumab with bortezomib, lenalidomide and dexamethasone is not required to be funded and should not be used routinely in the NHS in England for the condition and population in the recommendations.

This is because there is not enough evidence to determine whether daratumumab with bortezomib, lenalidomide and dexamethasone is value for money in this population.

Why the committee made these recommendations

NICE is evaluating daratumumab with bortezomib, lenalidomide and dexamethasone for untreated multiple myeloma when an autologous stem cell transplant is suitable separately.

Usual treatment for adults with untreated multiple myeloma when an ASCT is unsuitable includes:

  • daratumumab plus lenalidomide and dexamethasone

  • isatuximab plus bortezomib, lenalidomide and dexamethasone.

Daratumumab plus bortezomib, lenalidomide and dexamethasone has not been directly compared in a clinical trial with the usual treatments, but indirect comparisons suggest that it is likely to work as well as these.

Clinical trial evidence shows that daratumumab plus bortezomib, lenalidomide and dexamethasone increases how long people have before their condition gets worse and how long they live compared with bortezomib, lenalidomide and dexamethasone.

There are uncertainties in the economic model, including:

  • the estimates of how long people live and how long they have before their condition gets worse, because the trial data is immature

  • how the indirect comparisons with usual treatment have been undertaken

  • the proportion of subsequent treatments offered in the NHS.

Also, the cost-effectiveness estimates are above the range that NICE considers an acceptable use of NHS resources. So, daratumumab with bortezomib, lenalidomide and dexamethasone should not be used.