UK's NICE unable to recommend Novartis Lucentis for diabetic macular edema; Fluvirin shipments begin in USA

The UK’s drug watchdog the National Institute for Health and Clinical Excellence (NICE) has issued a final draft guidance saying it cannot recommend approval for National Health Service use of Swiss drug major Novartis’ (NOVN: VX) Lucentis (ranibizumab) for the treatment of diabetic macular edema (DMO). This follows a previous negative opinion (The Pharma Letter March 7). However, the NICE has previously approved use of Lucentis, which is sold in the USA by fellow Swiss drugmaker Roche, for macular degeneration.

The NICE’s independent Appraisal Committee considered that Novartis’ model underestimated the incremental cost-effectiveness ratio (ICER) 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 ICER that substantially exceeded the range that the NICE considers represents an effective use of NHS resources.

The UK cost of Lucentis is £742.17 ($1,190) per injection. It is designed to be given monthly and continued until vision is stable over three consecutive monthly assessments.