Final NICE 'No' for Novartis' Lucentis in diabetic macular edema treatment

The National Institute for Health and Clinical Excellence (NICE), in final guidance issued today (November 30), the UK drug watchdog, confirmed its previous negative guidance and has not recommended Swiss drug major Novartis’ Lucentis (ranibizumab) for the treatment of diabetic macular edema (DMO: The Pharma Letter November 24).The drug retains its NICE backing for use in the National Health Service for the treatment of neovascular (wet) age-related macular degeneration (AMD),

The NICE’s independent Appraisal Committee concluded that the evidence presented by Novartis did not provide a true reflection of the cost-effectiveness for ranibizumab monotherapy compared with the current standard treatment for people with DMO, laser photocoagulation, which uses heat to seal ocular blood vessels. It concluded that a model that relied on a combined set of plausible assumptions would be certain to produce an incremental cost-effectiveness ratio (ICER) that substantially exceeded the range that NICE considers to represent an effective use of NHS resources.

Sir Andrew Dillon, chief executive of the NICE said that Novartis significantly underestimated the cost of treatment by not accounting in its submission the need to treat both eyes in a proportion of people with DMO. The Committee was also concerned that glycemic control was much better in the trial population than it is in clinical practice, and that the evidence presented by the manufacturer suggested that the ICER would be higher in people with less well controlled glycemic control than observed in the trial, Sir Andrew said.