Reuters: Regulatory News: Novartis challenges UK Avastin use in eye disease

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Novartis challenges UK Avastin use in eye disease Apr 24th 2012, 10:32 Tue Apr 24, 2012 6:32am EDT * Seeks judicial review over Avastin use in parts of UK * Low doses of cancer drug cheap alternative to Lucentis * Novartis says use of unlicensed drug a safety risk * Lucentis sales $567 million in first quarter By Caroline Copley and Ben Hirschler ZURICH/LONDON, April 24 (Reuters) - Swiss drugmaker Novartis is challenging the use of a cheap alternative to its eye drug Lucentis in parts of Britain, sparking a row over cost versus safety in treating a common cause of blindness. Lucentis, with annualised sales for Novartis of some $2 billion, is licensed for wet age-related macular degeneration (AMD) and is also recommended by Britain's health cost watchdog, the National Institute for Health and Clinical Excellence. But some local health authorities in the south of England are using low doses of Roche's cancer drug Avastin as a cheaper alternative, even though this product is not licensed for eye use. The tiny amount needed for an eye injection means that Avastin costs less than a tenth of the 742 pounds ($1,200) charged for Lucentis. Novartis is seeking a judicial review of the policy being pursued in Southampton, Hampshire, Isle of Wight and Portsmouth of paying for Avastin on the British National Health Service. "It is unacceptable to put the safety of patients at risk through the widespread use of an unlicensed treatment when a licensed medicine is available," Novartis said in a statement. "It undermines the regulatory process that was introduced to safeguard patients." Although Avastin is not licensed for AMD, it works in a similar way to Lucentis and is widely prescribed on a so-called "off label" basis, not only in Britain but also in the United States. Such off-label treatment is allowed because doctors have the discretion to treat patients as they best see fit. A closely watched U.S. clinical trial concluded last year that Avastin worked as well as Lucentis in treating vision loss from AMD but that it had more adverse side effects. Based on the higher risks associated with Avastin, Novartis said the policy being pursued in parts of Britain was putting cost-savings ahead of patient needs. That charge will resonate with other major drug companies which are increasingly concerned that cash-strapped European governments have taken the axe to healthcare spending and restricted access to newer medicines as they seek to plug budget deficits. Industry critics, however, said it was not for Novartis to dictate how medicines were used by British health authorities. "Companies like Novartis should not be in the position to block moves to more cost-effective treatments in order to maximise their profits," said John Harris of the Institute for Science Ethics and Innovation at the University of Manchester. Lucentis is an important seller for Novartis, with sales rising 30 percent in the first quarter to $567 million. Novartis is banking on such relatively new products as it braces for a wave of patent expiries on its best-selling drugs. Link this Share this Digg this Email Reprints

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