Cost regulators for the NHS in England and Wales have ruled that Celgene's Revlimid (lenalidomide) is not a cost-effective option for treating certain patients with multiple myeloma.

The National Institute for Health and Care Excellence (NICE) has published draft guidance this morning rejecting Revlimid for people whose disease has relapsed once after receiving one treatment with Janssen Cilag's Velcade (bortezomib), and are unable to receive thalidomide and for whom bone marrow transplantation is not appropriate.

This is because, from the information provided, it is unclear whether Revlimid is as effective as re-treatment with bortezomib, and the manufacturer’s own economic model showed that it would not be cost effective at this stage, the Institute said, explaining the decision. 

"We hope that the manufacturer, Celgene, will look again at their submission," said NICE chief executive Sir Andrew Dillon, given that, since the drug was recommended for a different subset of patients in 2009, no clinical studies have been undertaken specifically looking at how well Revlimid works compared to other treatments for these patients. 

"Celgene only presented robust trial data comparing lenalidomide to a placebo, not to other chemotherapies and there is very little evidence in the population we are currently appraising this drug for," Dillon added.

In 2009 NICE issued a green light for use of Revlimid in patients who have received two or more prior therapies, and this guidance still stands.

The recommendation was contingent on the provision of a landmark Patient Access Scheme, under which Celgene picks up the cost of the drug beyond 26 cycles (normally two years), but no PAS has been submitted for the current appraisal, it noted.