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    Has all of the relevant evidence been taken into account?
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    Are the summaries of clinical and cost effectiveness reasonable interpretations of the evidence?
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    Are the recommendations sound and a suitable basis for guidance to the NHS?
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The content on this page is not current guidance and is only for the purposes of the consultation process.

1 Recommendations

1.1

Selinexor with bortezomib and dexamethasone is recommended as an option for treating multiple myeloma in adults, only if:

  • they have only had 1 previous line of treatment, and

  • their condition is refractory to both daratumumab and lenalidomide, and

  • the company provides selinexor according to the commercial arrangement (see section 2).

1.2

These recommendations are not intended to affect treatment with selinexor 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 clinician consider it appropriate to stop.

Why the committee made these recommendations

For this evaluation, the company asked for selinexor with bortezomib and dexamethasone (selinexor combination) to be considered only as a:

  • second-line treatment for multiple myeloma that is refractory (has not responded) to both daratumumab and lenalidomide, and

  • third-line treatment.

This does not include everyone for whom the selinexor combination is licensed.

Carfilzomib with dexamethasone was the relevant second-line comparator for selinexor combination for the treatment of multiple myeloma that is refractory to daratumumab and lenalidomide. At third line, preferred treatments for multiple myeloma that is still sensitive to lenalidomide include ixazomib with lenalidomide and dexamethasone (ixazomib combination). For multiple myeloma that is refractory to lenalidomide, third-line treatments include panobinostat with bortezomib and dexamethasone (panobinostat combination).

Selinexor combination has been directly compared in a clinical trial with bortezomib plus dexamethasone, which is not considered a relevant treatment at second or third line. This clinical trial evidence shows that second-line treatment with selinexor combination increases how long people have before their condition gets worse compared with bortezomib plus dexamethasone. Selinexor combination has only been indirectly compared with carfilzomib plus dexamethasone at second line, or with ixazomib combination or panobinostat combination at third line. These indirect comparisons suggest that there are no statistically significant differences between selinexor combination and these treatments at second and third line on how long people have before their condition gets worse or how long they survive. But, these indirect comparison results are highly uncertain.

The cost-effectiveness estimates for selinexor combination compared with carfilzomib plus dexamethasone at second line are within the range that NICE considers an acceptable use of NHS resources. The cost-effectiveness estimates for selinexor combination compared with ixazomib combination, and panobinostat combination at third line are above what NICE normally considers an acceptable use of NHS resources. So, selinexor combination is only recommended as a second-line treatment for multiple myeloma that is refractory to both daratumumab and lenalidomide.