Wednesday, July 25, 2012

Reuters: Regulatory News: UK authority backs down in Novartis eye drug dispute

Reuters: Regulatory News
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UK authority backs down in Novartis eye drug dispute
Jul 25th 2012, 19:47

LONDON, July 25 | Wed Jul 25, 2012 3:47pm EDT

LONDON, July 25 (Reuters) - A regional British health authority said on Wednesday it had decided to stop using the cancer drug Avastin as a cheap alternative to eye medicine Lucentis following a legal challenge from Novartis, which sells Lucentis in Europe.

Lucentis, with annualized sales for Novartis of more than $2 billion, 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 have been using low doses of Roche's cancer drug Avastin as a cheaper option, even though it is not licensed for treating eye conditions.

In April, Novartis sought 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.

The Swiss drugmaker argued that the use of Avastin could put the safety of patients at risk.

At the time, the health authority said it would fight the case - but it has now decided to back down and discontinue its policy of offering Avastin. Officials said new price discounts for Lucentis would help soften the financial impact.

The Association of the British Pharmaceutical Industry, which had lined up behind Novartis in the case, said it welcomed the change of heart by the health authority.

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.

A closely watched U.S. clinical trial concluded last year that while Avastin works as well as Lucentis in treating vision loss from AMD, it has more adverse side effects.

Lucentis is an important seller for Novartis, with sales rising 20 percent in the second quarter to $604 million. Novartis is banking on such relatively new products as it braces for patent expiries on several current top-selling drugs.

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