The National Institute for Health and Clinical Excellence is consulting once again on the use of Celgene’s Revlimid (lenalidomide) in the treatment of multiple myeloma following one prior treatment with Johnson & Johnson’s Velcade (bortezomib), as it issued a second draft guidance not recommending it in this use.

Multiple myeloma is a blood cancer for which there is currently no cure. For most patients, a thalidomide regimen would be most suitable as a first-line treatment to stop the condition’s progress and relieve symptoms. NICE also recommends Velcade as an option for people who cannot take thalidomide and for whom bone marrow transplantation is not appropriate. This appraisal considers the use of Revlimid for such patients who have therefore received first-line treatment with Velcade and whose disease has subsequently relapsed.

“Since 2009, no clinical studies have been undertaken specifically looking at how well lenalidomide works compared with other treatments for these patients,” said NICE chief executive Sir Andrew Dillon. Evidence and analyses presented by Celgene following NICE’s draft recommendations published earlier this year “did not lessen the uncertainty in the results presented because there is very little evidence in the population we are currently assessing this drug for, and the analyses indicate that [Revlimid] is not good use of NHS resources,” he added.

In 2009, NICE published guidance which recommended Revlimid as a treatment option for people with multiple myeloma who have received two or more prior therapies. For this appraisal, Celgene had submitted a patient access scheme (PAS) under which it bears the costs of the drug beyond 26 cycles, and this had enabled the Institute’s appraisal committee to recommend its use on the NHS. However, no PAS has been submitted for this new patient group in this current appraisal, NICE points out.

Responding to the new draft decision, patient organisation Myeloma UK said it was “obviously very disappointed” at this second negative appraisal for Revlimid in this use.

“While there may be a lack of clinical trial evidence and uncertainty around its cost-effectiveness, there is no question about its role in clinical practice in this setting,” said the group’s chief executive, Eric Low. “We strongly feel that it is now up to NICE and Celgene to come up with a solution and to make [Revlimid] available to the myeloma patients who need it, as a matter of urgency,” Mr Low added