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Novartis mounting legal challenge to PCTs’ off-label Avastin policy

By News team

Novartis has gone to court to challenge the decision by a group of primary care trusts to allow bevacizumab to be prescribed off-label for patients with wet age-related macular degeneration (AMD).

The company is seeking a judicial review of the action, taken by the Southampton City, Hampshire, Isle of Wight and Portsmouth City (SHIP) PCT cluster last September, on the basis that it is putting patient safety at risk.

However, the PCTs claim their decision is lawful. They also argue that, at a time of financial pressures in the NHS, endorsing the use bevacizumab (Avastin; Roche) — which is ten times cheaper than the licensed alternative, Novartis’s ranibizumab (Lucentis) — is a responsible approach.

Ranibizumab, which is licensed as well as endorsed by the National Institute for Health and Clinical Excellence for treating wet AMD, costs over £700 per injection. Bevacizumab costs around £70 per injection. It is not licensed for the treatment of wet AMD, but the Department of Health is considering whether to refer the drug to NICE to be appraised for this unlicensed but widely used indication (see Panel).

The PCTs said bevacizumab is internationally recognised as an effective treatment for wet AMD and is prescribed for more than half of patients with the condition in the USA.

In a statement, they said they regret Novartis’s court action: "We have taken legal advice and consider that the policy to allow clinicians the choice between Avastin and Lucentis for the NHS’s AMD patients is a lawful policy.

"If clinicians choose to prescribe Avastin for wet AMD patients, the cost savings will result in the PCTs being able to fund other eye-related treatments for NHS patients."

Novartis confirmed it has filed for a judicial review. In a statement, it said: "Novartis is worried that the principle of patient safety is being undermined by the current SHIP policy.

"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."

Avastin’s UK patent expires at the end of 2019 and Roche currently has no plans to apply for a patent extension or to licence the drug for use in the treatment of wet AMD, a Roche spokeswoman told PJ Online. The Lucentis patent runs until 2018 but is extended in Europe until January 2022 by means of a supplementary protection certificate, Novartis confirmed.

Appraising bevacizumab for wet AMD

In 2010, the Department of Health asked the National Institute for Health and Clinical Excellence to explore the possibility of appraising bevacizumab for treating wet age-related macular degeneration. NICE concluded that there was enough support for such an appraisal, but can only go ahead with DoH approval.

A DoH spokesman said: "We have no immediate plans to refer Avastin for the treatment of AMD to NICE for appraisal, but will keep this position under review."

Citation: The Pharmaceutical Journal URI: 11100128

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