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Draft guidance consultation

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1 Recommendations

1.1

Isatuximab plus bortezomib, lenalidomide and dexamethasone should not be used for untreated multiple myeloma in adults when an autologous stem cell transplant is unsuitable.

1.2

This recommendation is not intended to affect treatment with isatuximab 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.

What this means in practice

Isatuximab plus bortezomib, lenalidomide and dexamethasone is not required to be funded in the NHS in England for untreated multiple myeloma in adults when an autologous stem cell transplant is unsuitable. It should not be used routinely in the NHS in England.

This is because the available evidence does not suggest that isatuximab plus bortezomib, lenalidomide and dexamethasone 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 unsuitable is 1 of several combination treatments, most commonly daratumumab, lenalidomide and dexamethasone.

Clinical trial evidence suggests that, compared with bortezomib, lenalidomide and dexamethasone alone, adding isatuximab increases how long people live before their condition gets worse. But the bortezomib, lenalidomide and dexamethasone combination is not used in the NHS. Also, the trial is ongoing so there is not enough evidence to tell whether adding isatuximab increases how long people live.

Isatuximab plus bortezomib, lenalidomide and dexamethasone has not been directly compared in a clinical trial with combinations used in the NHS, including daratumumab, lenalidomide and dexamethasone. The results of an indirect comparison suggest that it is likely to work as well as these combinations, but this is uncertain because of limitations in the analysis.

There are also uncertainties in the economic model, including the modelling of:

  • time to stopping treatment

  • how quality of life changes after treatment is stopped

  • how long people with multiple myeloma live.

The cost-effectiveness estimates for isatuximab plus bortezomib, lenalidomide and dexamethasone are substantially higher than what NICE considers an acceptable use of NHS resources. So, it should not be used.