A review of the NICE decision on the approval of lenalidomide is published in a special report Online First and in the July edition of The Lancet Oncology. About 2,000 multiple myeloma sufferers in the UK could benefit from the drug and improve their life expectancy pending a decision by The UK National Institute for Health and Clinical Excellence (NICE). Patients who have received two or more previous therapies could receive lenalidomide, and the cost of cycles beyond the twenty-sixth cycle of treatment would be met by the drug manufacturer.

The treatment for multiple myeloma is focused on disease containment and suppression since it is a cancer of blood cells that form part of the immune system, and is presently incurable.

Initially the manufacturer of lenalidomide (Celgene, in the UK and in Ireland) submitted a proposal to NICE containing evidence on the clinical and cost effectiveness of the drug. On the basis that it was not cost effective, the proposal was rejected. However, the company then agreed to fund treatment beyond the twenty-sixth cycle for patients that required it. NICE's independent evidence review group (ERG) determined that this brought the treatment into acceptable parameters of cost-effectiveness. The committee also considered recent supplementary guidance from NICE to be "taken into account when appraising treatments that might be life-extending for patients with short life-expectancy, and which are licensed for indications that affect a small proportion of patients with incurable illnesses".

In reaching its final decision, "the committee noted that, in patients with multiple myeloma who have received two or more previous therapies, life-expectancy without lenalidomide was unlikely to be greater than 24 months, and that lenalidomide could, plausibly, increase survival by more than 3 months compared with dexamethasone. The Committee considered that the possible alternatives to lenalidomide (thalidomide and bortezomib) were unlikely to be routinely available from the NHS. Additionally, it was estimated that around 2000 patients were eligible for lenalidomide treatment under the terms of the appraisal guidance. Therefore, the Committee accepted that the criteria for an appraisal of a life-extending, end-of-life treatment had been met, and that this conclusion was supported by robust data".

In the end, the committee recommended lenalidomide. The approval of the drug was within its licensed indication and as an option for the treatment of multiple myeloma in people who have received two or more previous therapies and when the cost of lenalidomide is covered by the manufacturer beyond twenty-six cycles.

"Lenalidomide for the treatment of relapsed multiple myeloma"
Elangovan Gajraj, Helen Chung, Meindert Boysen, David B Barnett, Carole Longson
National Institute for Health and Clinical Excellence, MidCity Place, London, UK
The Lancet / Oncology

Stephanie Brunner (B.A.)