2 The technology
2.1 Lenalidomide (Revlimid, Celgene) is a structural analogue of thalidomide. It has anti‑neoplastic, anti‑angiogenic, pro‑erythropoeitic and immunomodulatory properties. Lenalidomide inhibits the proliferation of certain haematopoietic tumour cells, enhances T cell- and natural killer cell‑mediated immunity, increases fetal haemoglobin production by CD34+ haematopoietic stem cells and inhibits production of pro‑inflammatory cytokines. Lenalidomide has a marketing authorisation 'for the treatment of patients with transfusion‑dependent anaemia due to low- or intermediate-1-risk myelodysplastic syndromes associated with an isolated deletion 5q cytogenetic abnormality when other therapeutic options are insufficient or inadequate'.
2.2 The summary of product characteristics lists the following adverse reactions for lenalidomide: fatigue, neutropenia, constipation, diarrhoea, muscle cramp, anaemia, thrombocytopenia and rash. The summary of product characteristics recommends a starting dose of 10 mg orally, once daily, on days 1 to 21 of repeated 28 day cycles, with dose reductions (5.0 mg, 2.5 mg or 2.5 mg every other day) to manage adverse events. Dosage is continued or modified based on clinical and laboratory findings. Lenalidomide is structurally similar to thalidomide, which causes severe birth defects, so a risk minimisation plan has been developed and agreed with the Medicines and Healthcare products Regulatory Agency to avoid fetal exposure to lenalidomide. For full details of adverse reactions and contraindications, see the summary of product characteristics.
2.3 Lenalidomide is available in 21‑day packs of 10 mg and 5 mg capsules at net prices of £3780 and £3570 respectively (excluding VAT; 'British national formulary' [BNF] edition 67). The cost of a 28‑day cycle of treatment with 10 mg of lenalidomide (excluding VAT) is £3780. The pricing arrangement considered during guidance development was that the company (Celgene) had agreed a complex patient access scheme with the Department of Health, in which the NHS paid for lenalidomide treatment for up to 26 monthly cycles. The company subsequently provided free of charge lenalidomide for those people who had more than 26 monthly cycles. 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 company's responsibility to let relevant NHS organisations know details of the discount.