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Draft guidance consultation

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1 Recommendations

1.1

Belantamab mafodotin plus bortezomib and dexamethasone can be used as an option to treat multiple myeloma in adults if they have had 1 previous line of treatment only, which contained lenalidomide, and:

  • their condition is refractory to lenalidomide, or

  • they cannot tolerate lenalidomide.

    Belantamab mafodotin can only be used if the company provides it according to the commercial arrangement (see section 2).

1.2

This recommendation is not intended to affect treatment with belantamab mafodotin plus bortezomib 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

Belantamab mafodotin plus bortezomib and dexamethasone must be funded in the NHS in England if it is considered the most suitable treatment option to treat multiple myeloma. It must be funded for adults who have had 1 previous line of treatment only, which contained lenalidomide, and whose condition is refractory to or who cannot tolerate lenalidomide.

Belantamab mafodotin plus bortezomib and dexamethasone must be funded in England within 90 days of final publication of this guidance.

There is enough evidence to show that belantamab mafodotin plus bortezomib and dexamethasone provides benefits and value for money, so it can be used routinely across the NHS in this population.

Why the committee made these recommendations

Belantamab mafodotin plus bortezomib and dexamethasone is licensed for use at second line and beyond. But for this evaluation, the company asked for it to be considered as a treatment at second line.

Usual treatment for multiple myeloma at second line includes:

  • daratumumab plus bortezomib and dexamethasone, if lenalidomide is unsuitable or was taken at first line

  • selinexor plus bortezomib and dexamethasone, if the multiple myeloma is refractory to daratumumab and lenalidomide

  • carfilzomib plus dexamethasone

  • carfilzomib plus lenalidomide and dexamethasone.

Evidence from a clinical trial shows that belantamab mafodotin plus bortezomib and dexamethasone increases how long people have before their condition gets worse compared with daratumumab plus bortezomib and dexamethasone. The evidence also suggests that people live longer. But the trial is ongoing, so this is uncertain.

Belantamab mafodotin plus bortezomib and dexamethasone has not been directly compared in a clinical trial with any of the other usual second-line treatments. Indirect comparisons suggest that it is likely to work as well as these, but this is uncertain.

When lenalidomide is not an option at second line, the cost-effectiveness estimates for belantamab mafodotin plus bortezomib and dexamethasone compared with daratumumab plus bortezomib and dexamethasone are within the range that NICE considers an acceptable use of NHS resources.

So, belantamab mafodotin plus bortezomib and dexamethasone can only be used in this population.