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  • Question on Consultation

    Has all of the relevant evidence been taken into account?

  • Question on Consultation

    Are the summaries of clinical and cost effectiveness reasonable interpretations of the evidence?

  • Question on Consultation

    Are the recommendations sound and a suitable basis for guidance to the NHS?

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    Are there any aspects of the recommendations that need particular consideration to ensure we avoid unlawful discrimination against any group of people on the grounds of age, disability, gender reassignment, pregnancy and maternity, race, religion or belief, sex or sexual orientation?

1 Recommendations

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1 Recommendations

1.1

Daratumumab plus bortezomib, lenalidomide and dexamethasone followed by daratumumab plus lenalidomide maintenance
should not be used 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 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 plus bortezomib, lenalidomide and dexamethasone followed by daratumumab plus lenalidomide maintenance
is not required to be funded and should not be used routinely in the NHS in England for untreated multiple myeloma when an autologous stem cell transplant is suitable.

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

Why the committee made these recommendations

Usual treatment for untreated multiple myeloma when an autologous stem cell transplant is suitable is daratumumab plus bortezomib, thalidomide and dexamethasone induction and consolidation therapy followed by lenalidomide maintenance therapy.

Daratumumab plus bortezomib, lenalidomide and dexamethasone induction and consolidation therapy followed by daratumumab and lenalidomide maintenance has not been directly compared in a clinical trial with daratumumab plus bortezomib, thalidomide and dexamethasone followed by lenalidomide maintenance. The results of indirect comparisons of these combinations suggest the efficacy is similar in induction and consolidation phases of treatment. But the long-term benefits of daratumumab, bortezomib, lenalidomide and dexamethasone induction and consolidation followed by daratumumab and lenalidomide maintenance treatment were uncertain because there was no clinical trial data comparing this with daratumumab plus bortezomib, thalidomide and dexamethasone induction and consolidation followed by lenalidomide maintenance.

There are also uncertainties in the economic model, including the modelling of subsequent treatments and time to stopping treatment.

There is considerable uncertainty in the long-term benefits of daratumumab plus bortezomib, lenalidomide, and dexamethasone combination followed by daratumumab and lenalidomide maintenance. When the long-term benefits are incorporated in the economic model it is not possible to determine the most likely cost-effectiveness estimates. However, the cost-effectiveness estimates are likely to be higher than the range that NICE considers an acceptable use of NHS resources. So, daratumumab plus bortezomib, lenalidomide, and dexamethasone combination followed by daratumumab and lenalidomide maintenance should not be used.