Novartis battles with German health funds over use of AMD drug Lucentis

Novartis, which has the worldwide licence to market fellow Swiss drug major Roche majority-owned subsidiary Genentech's Lucentis (ranibizumab) outside the USA, has become immersed in a dispute between its German subsidiary and the country's health funds over the use and cost of the drug. The development echoes the situation faced in the UK for the product, where its use has been blocked by negative guidance from the National Institute for Health and Clinical Excellence (NICE), which provides recommendations for therapeutics in the National Health Service in England and Wales. There, although the agency has indicated it will likely approve the product, no final decision has been announced (Marketletters passim).

Off-label use of Avastin

Lucentis is used to treat age-related macular degeneration (AMD). Last year, the group posted sales of 430.0 million Swiss francs ($394.9 million). Before its introduction, doctors had been using another Genentech agent, the cancer drug Avastin (bevacizumab), as an eye-spray, with good results. However, an indication for this purpose had not received regulatory approval and patients were agreeing to this off-label use at their own risk.