UK drugs watchdog the National Institute for Health and Clinical Excellence (NICE), in new draft guidance issued this morning (October 5) has recommended Swiss drug major Novartis’ (NOVN: VX) Lucentis (ranibizumab) as a National Health Service option for treating visual impairment caused by diabetic macular edema (DME).
The NICE says it conducted a rapid review of the original guidance, published in November 2011, because the manufacturer submitted a revised Patient Access Scheme, together with updated analyses including the drug’s superior relative effect among a sub-group of people with DME. The NICE says it has not yet issued final guidance to the NHS and notes that these decisions may change after consultation. Final guidance is expected to be published in February 2013.
Ranibizumab is recommended as an option for treating diabetic macular edema only if: people have a central retinal thickness of 400 micrometres or more; and the manufacturer provides ranibizumab with the discount agreed as part of the patient access scheme (as revised in 2012). People currently receiving ranibizumab whose disease does not meet these criteria should be able to continue therapy until they and their clinician consider it appropriate to stop.
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