Lenalidomide receives preliminary positive recommendation from NICE for NHS use

The National Institute of Clinical Excellence has today announced that it deems the benefits provided by revlimid to be life-extending and a cost-effective use of NHS resources. The NHS will fully fund the use of oral revlimid for 26 treatment cycles of 28 days per cycle (normally two years) for patients with previously treated multiple myeloma. Celgene will fully fund the use of oral revlimid for these patients who continue to benefit and remain on this innovative outpatient therapy longer than 26 cycles.

NICE's recommendation specifies the use of revlimid, in combination with dexamethasone, as an option for the treatment of patients with multiple myeloma who have received two or more prior therapies.

"This recommendation from NICE is a welcome recognition of the increasing value innovative medicines provide to patients and healthcare systems," said Sol Barer, Chairman of manufacturers Celgene. "In particular, revlimid offers patients a convenient, long-term, continuous therapy that suppresses their disease and enables them to live longer, more productive lives."

According to new evaluation criteria for innovative, life-extending therapies recently adopted by NICE, revlimid is considered a cost-effective use of NHS resources. This evaluation considered peer-reviewed clinical studies that demonstrated revlimid offers unsurpassed survival, deep and durable responses that improve over time and a manageable side-effect profile that is acceptable for long-term use.

"The preliminary recommendation to make revlimid available on the NHS is fantastic news for patients. Revlimid produces a remarkable effect on survival in this difficult-to-treat and cruel cancer and this action is an excellent example of industry, NICE and the NHS working together for the benefit of patients," said Gareth Morgan, Professor of Haematology, Royal Marsden NHS Foundation Trust.

The preliminary recommendation will now undergo consultation, leading to a third appraisal committee meeting, scheduled to take place near the end of the first quarter of 2009. A final recommendation and final guidance are expected during the second quarter of 2009.

Revlimid is currently approved in the European Union, United States, Canada, Argentina, Peru and Switzerland in combination with dexamethasone for the treatment of patients with multiple myeloma who have received at least one prior therapy and in Australia and New Zealand in combination with dexamethasone for the treatment of patients whose disease has progressed after one therapy. Revlimid is also approved in Canada, the United States, Peru and Argentina for transfusion-dependent anaemia due to low- or intermediate-1-risk MDS associated with a deletion 5q cytogenetic abnormality with or without additional cytogenetic abnormalities. Revlimid has obtained Orphan Drug designations for a variety of haematologic indications in the EU, U.S., Switzerland and Australia and Japan.

Almost 3,800 people are newly-diagnosed with multiple myeloma in the UK each year and more than 2,400 die from it annually.

Rachel Rowson, policy manager at Macmillan Cancer Support, said: "We are delighted that the manufacturer of revlimid has decided to put patients before costs and will be making this treatment more affordable to the NHS. revlimid can give some myeloma patients extra time which can be extremely valuable to them and their families."