Review decision
Decision to conduct a part review of the guidance for the triple combination of carfilzomib with lenalidomide and dexamethasone within its marketing authorisation for people who have had at least 1 prior therapy
We would like to update you on the decision made regarding the review of the existing guidance on carfilzomib for previously treated multiple myeloma.
The recommendations in the guidance are only for the combination of carfilzomib with dexamethasone and only for people who have had only 1 previous therapy (second line), which did not include bortezomib. The recommendations were for a population narrower than that covered by the carfilzomib marketing authorisation.
The company have requested a part review of carfilzomib in combination with lenalidomide and dexamethasone:
- At the time of the publication of the guidance, the committee did not recommend the triple combination of carfilzomib with dexamethasone and lenalidomide at third line because the overall survival data was immature, the life expectancy criterion for the end of life consideration was not met and the incremental cost-effectiveness ratios were higher than normally accepted as a cost-effective use of NHS resources. The overall survival trial data for this triple combination versus lenalidomide plus dexamethasone was immature.
- There is more mature overall survival data now available from the clinical trial, for this triple combination at third line position, to allow a part review of the guidance for carfilzomib with lenalidomide and dexamethasone in people who have had 2 previous treatments (that is, third line) compared with lenalidomide plus dexamethasone (as recommended in NICE's technology appraisal guidance on lenalidomide for the treatment of multiple myeloma in people who have received at least 2 prior therapies) where carfilzomib is currently not recommended.
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