2 The technology
2.1 Lenalidomide (Revlimid, Celgene) is an immunomodulating agent. It belongs to a class of agents often referred to as immunomodulatory derivatives, which are all structural derivatives of thalidomide. The exact mechanism of action of lenalidomide is not understood but it has anti-neoplastic, anti-angiogenic and pro-erythropoietic properties. Lenalidomide in combination with dexamethasone is licensed for the treatment of multiple myeloma in patients who have received at least one prior therapy. The recommended starting dose of lenalidomide for adults over 18 years is 25 mg orally once daily on days 1 to 21 of repeated 28-day cycles. Treatment with lenalidomide is continued until disease progression or unacceptable adverse effects occur. For full details, see the summary of product characteristics.
2.2 The most serious adverse effects of lenalidomide treatment are grade 4 neutropenia and venous thromboembolism. The most frequently observed adverse effects, which occurred significantly more frequently in the lenalidomide/dexamethasone group compared with the placebo/dexamethasone group in clinical trials (see section 3), were neutropenia, fatigue, asthenia, constipation, muscle cramp, thrombocytopenia, anaemia, diarrhoea and rash. Lenalidomide is structurally related to thalidomide and there is a risk of teratogenesis. Pregnancy must be ruled out before starting treatment in women of child-bearing age, and these women must use effective contraception while on lenalidomide. For full details of adverse effects and contraindications, see the summary of product characteristics.
2.3 Lenalidomide 25 mg capsules cost £4368 per 21 capsules (excluding VAT; 'British national formulary' [BNF] edition 55). Dosage is continued or modified based upon clinical and laboratory findings. For example, if lenalidomide is continued for ten 28-day cycles without dose reduction, the cost would be £43,680. The pricing arrangement considered during guidance development was that the manufacturer (Celgene) had agreed a complex patient access scheme with the Department of Health, in which the cost of lenalidomide for people who remain on treatment for more than 26 cycles would be met by the manufacturer. A commercial arrangement has now been agreed. This makes lenalidomide available to the NHS with a discount. The size of the discount is commercial in confidence. It is the manufacturer's responsibility to let relevant NHS organisations know details of the discount.