NICE says better information needed on Celgene’s MM drug

The UK drugs watchdog, the National Institute for Health and care Excellence (NICE) says that, based on the current information available of US biotech major Celgene’s (Nasdaq: CELG) Revlimid (lenalidomide) for treating the blood cancer multiple myeloma after one prior treatment with bortezomib, it does not recommend this drug for this indication.

Commenting on the draft guidance, NICE chief executive Sir Andrew Dillon said: “In the original guidance published in 2009, NICE recommended lenalidomide as treatment option for multiple myeloma in people who have received two or more prior therapies. This recommendation has not changed and patients at that stage in the treatment pathway will still be able to receive lenalidomide through the NHS [National Health Service]. Since then, NICE has also recommended bortezomib as a first line treatment. We are now looking specifically at how well lenalidomide works after someone has received bortezomib, and whether it provides value for money. However, from the information provided by the manufacturer it was unclear if lenalidomide was as effective as re-treatment with bortezomib and the manufacturer’s own economic model showed that the drug would not be cost effective at this stage – because of this we are unable to recommend the drug in preliminary recommendations. We hope that the manufacturer, Celgene, will look again at their submission.”

Sir Andrew added: “Since we recommended lenalidomide in 2009, no clinical studies have been undertaken specifically looking at how well lenalidomide 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.”

In the guidance published in 2009 the manufacturer of lenalidomide submitted a patient access scheme, where they bear the costs of the drug beyond 26 cycles (normally for a period of two years) which enabled the NICE Appraisal Committee to be able to recommend the drug. No patient access scheme has been submitted for this new patient group in this current appraisal.

Cost per QALY more than £30,000