Novartis appeals UK NICE negative decision on Lucentis in DME

The UK subsidiary of Swiss drug major Novartis (NOVN: VX) has lodged an appeal against the decision last month by the UK drug watchdog the National Institute for Health and Clinical Excellence (NICE) to not approve Lucentis (ranibizumab) for use within the National Health Service, in England and Wales, for the treatment of visual impairment due to diabetic macular edema (DME; The Pharma Letter July 18).

This recommendation means patients are being denied an important, licensed treatment option,  says Novartis, which, in clinical trials, has been shown to double the likelihood of gaining vision and reduce the chance of losing vision by up to three-fold compared to laser treatment. The drug, which is sold in the USA by fellow Swiss drug major Roche, is approved for NHS use in the treatment of macular degeneration. Lucentis generated second-quarter 2011 sales of $541 million for Novartis (TPL July 19).

Novartis says it had submitted a patient access scheme to the NICE and the Department of Health to attempt to ensure ranibizumab was deemed cost-effective for the treatment of visual impairment due to DME. The company is continuing negotiations with the NICE and the DoH to achieve a mutually agreeable solution, which will ultimately benefit patients.