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A Swiss drug company has launched legal action to block National Health Service advice to doctors to use an unauthorised treatment for eye problems that is cheaper than its own drug.
Novartis applied for judicial review against primary care trusts in the south of England, which last year recommended small injected doses of Avastin, the cancer medicine, in place of its drug Lucentis, the only one licensed by regulators for wet age-related macular degeneration (AMD).
Its action triggered fresh calls by patient and medical groups on Tuesday for the government to formally request a detailed review comparing the two drugs and ending uncertainties, forcing prescribers to give advice to patients based on cost.
The latest legal move marks a sharp escalation in a long-running international battle which has forced healthcare systems in Europe and the US to balance very different costs of the two drugs against potential safety concerns.
Cathy Yelf, head of external relations at the Macular Disease Society, a patient organisation, said it favoured Lucentis to treat AMD but that a growing number of primary care trusts seeking to cut costs were “inching” towards Avastin.
“At the moment we can’t get a consensus from the medical or healthcare professionals on safety so prescribers tell the patient to decide,” she said. “We think that it is wholly inadequate, an abnegation of responsibility.”
She said the government should mandate the National Institute for Health and Clinical Excellence (Nice) and the Medicines and Healthcare Products Regulatory Agency to jointly examine Avastin for AMD, as well as several other eye conditions for which Nice has already rejected Lucentis because of its cost.
Lucentis and Avastin were both developed by Genentech, now part of Roche, which in turn licensed the European rights to Lucentis to Novartis. Small US and UK trials comparing the two drugs are under way, with some results expected this month.
The NHS Ship cluster of primary care trusts, which covers Southampton, the Isle of Wight, Portsmouth and Hampshire, said in September it would offer patients the prospect of treatment with Avastin, which it argued could be just as safe and effective while considerably cheaper.
Novartis said in a statement: “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. It undermines the regulatory process that was introduced to safeguard patients.”
But the Ship group expressed “regrets” at the litigation and said in a statement: “The PCTs consider that, in a time of substantial financial pressure on the NHS, this is a responsible as well as lawful approach.”