thalidomide is contraindicated (including for pre-existing conditions that it may aggravate) or
the person cannot tolerate thalidomide, and
the company provides lenalidomide according to the commercial arrangement.
1.2 This recommendation is not intended to affect treatment with lenalidomide 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
Previously untreated multiple myeloma is normally treated with thalidomide-based therapy. If people cannot take thalidomide, bortezomib-based therapy is used. There is a high unmet need for new treatment options for people who cannot take thalidomide, so that they can have newer treatments later.
Evidence from an indirect comparison suggests that lenalidomide plus dexamethasone substantially improves the length of time people live compared with bortezomib-based therapy.
The most plausible cost-effectiveness estimate for lenalidomide plus dexamethasone for people unable to take thalidomide is within the range that NICE normally considers a cost-effective use of NHS resources. Because of this and the high unmet need, lenalidomide plus dexamethasone can be recommended for people unable to take thalidomide.
Lenalidomide plus dexamethasone cannot be recommended for untreated multiple myeloma in people who could take thalidomide because this would not be cost effective. Because the definition of thalidomide intolerance in clinical practice varies, it is appropriate that NHS England clearly defines who would be eligible for treatment with lenalidomide plus dexamethasone (see section 3.2).