ZURICH/LONDON Swiss drugmaker Novartis (NOVN.VX) is challenging the use of a cheap alternative to its eye drug Lucentis in Britain, sparking a row over cost versus safety in treating a common cause of blindness.
Lucentis, with annualised sales for Novartis of $2 billion (1 billion pounds), is licensed for wet age-related macular degeneration (AMD) and recommended by Britain's health cost watchdog, the National Institute for Health and Clinical Excellence (NICE).
But some hospitals in southern England are using low doses of Roche's (ROG.VX) cancer drug Avastin as a cheaper alternative, even though it is not licensed for treating eye conditions.
The tiny amount needed for an eye injection means Avastin costs less than 10 percent of the 742 pounds ($1,200) charged for an injection of Lucentis.
Novartis is seeking a judicial review of the policy being pursued by the Southampton, Hampshire, Isle of Wight and Portsmouth Primary Care Trust Cluster of paying for Avastin on the state-run 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 on Tuesday.
"It undermines the regulatory process that was introduced to safeguard patients."
A spokeswoman for the regional healthcare authority said it had taken legal advice and believed its policy of letting doctors choose between Avastin and Lucentis was legal.
"The PCTs (primary care trusts) have reached the view that the published evidence suggests that Avastin is as clinically effective as Lucentis and is far more cost effective," she said.
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 while Avastin worked as well as Lucentis in treating vision loss from AMD, 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 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 expires on best-selling drugs.
Helen Jackman, chief executive of the Macular Disease Society, a patient charity, said patients needed clarity and urged the government to instruct NICE to carry out an assessment of Avastin's use in a range of eye diseases.
"If Avastin is not as safe as Lucentis no-one should be using is. If it is as good perhaps everyone should be using it," she said.
NICE is hampered in its ability to review Avastin for AMD as the drug has not been approved for that use and Roche, which also sells Lucentis in North America, has chosen not to apply for an AMD licence.
Roche has always discouraged treating AMD patients with Avastin, saying Avastin was never tested for such use.
($1 = 0.6213 pound)
(Editing by Mark Potter and Dan Lalor)
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