NICE Approves Use Of Lenalidomide In Patients With Multiple Myeloma Who Have Received Two Or More Previous Therapies

Main Category: Lymphoma / Leukemia / Myeloma
Also Included In: Regulatory Affairs / Drug Approvals
Article Date: 19 Jun 2009 - 2:00 PDT

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Around 2000 multiple myeloma sufferers in the UK could have their lives extended by around three months after a decision by The UK National Institute for Health and Clinical Excellence (NICE) to approve lenalidomide in those patients who have received two or more previous therapies-provided that the cost of cycles beyond the 26th cycle of treatment are met by the drug manufacturer. A summary of the NICE decision is published in a Special Report Online First and in the July edition of The Lancet Oncology.

Multiple myeloma is a cancer of the blood cells that form part of the immune system, and is currently incurable. As such, treatment for multiple myeloma is focused on disease containment and suppression.

When the manufacturer of lenalidomide (Celgene, UK and Ireland) originally submitted a proposal to NICE containing evidence on the clinical and cost effectiveness of the drug, it was rejected on the basis that is was not cost effective. However, once the company agreed that they would fund treatment beyond the 26th cycle for patients that required it, NICE's independent evidence review group (ERG) decided 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 coming to 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'.

The Committee therefore recommended lenalidomide, within its licensed indication, as an option for the treatment of multiple myeloma in people who have received two or more previous therapies-when the drug cost of lenalidomide beyond 26 cycles is met by the manufacturer.

Source
The Lancet Oncology

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