24 Apr 2012

Health trusts face legal action over ‘cheap’ drug

An international drugs giant is taking legal action against four NHS trusts over their use of a cheaper, but “riskier” alternative treatment for a serious eye disease.

Novartis is seeking a judicial review of a decision by Southampton, Hampshire, Isle of Wight and Portsmouth PCT cluster (Ship) to prescribe cancer drug Avastin on the NHS instead of Lucentis, which is recommended by drugs watchdog Nice.

Novartis manufactures both medications but argues that health trusts are putting patients at risk by funding Avastin to treat wet age-related macular degeneration (AMD) when Lucentis is licensed specifically for that purpose.

The health trusts argue that Avastin, which is approved for a totally different use, is widely used in the United States to treat AMD – and at less than a tenth of the cost of Lucentis, could save them around £5m a year.

They also say they are continuing to pay for Lucentis when doctors prescribe it.

AMD is a common cause of loss of vision in older people and leads to severe loss of sight within two years of diagnosis in around 70 per cent of cases, according to the NHS.

Lucentis costs around £740 per injection, whereas Avastin – approved to treat some colorectal and kidney cancers – costs around £60.

Wet age-related macular disease

One of two forms of age-related macular degeneration, caused by the leaking of blood or fluid from vessels behind the retina.

The resultant damage to the macula (a small area in the centre of the retina) causes a rapid loss of vision, which needs to be treated urgently.

‘Patient safety at risk’

Novartis is challenging Ship’s decision to pay for Avastin (the trade name for bevacizumab) to treat AMD when it is prescribed.

A spokesman said: “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.

It is unacceptable to put the safety of patients at risk through the widespread use of an unlicensed treatment. Novartis spokesman

“This is also despite the fact that there is emerging evidence of potential safety concerns with the use of unlicensed bevacizumab when used to treat eye conditions.”

The PCTs say: “Avastin is internationally recognised as an effective treatment for AMD and, for example, over 50 per cent of AMD patients in the United States are treated with Avastin.

“This was an option for clinicians in addition to the option of prescribing a drug marketed by Novartis, called Lucentis. The PCTs have always made it clear that if NHS ophthalmologists prescribed Lucentis in clinically appropriate cases, this drug would be funded by the NHS.”

And they added: “The PCTs have reached the view that the published evidence suggests that Avastin is as clinically effective as Lucentis and is far more cost-effective.

“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.”

National solution

Nice says it cannot investigate the effectiveness of Avastin for the eye treatment unless either the Medicines and Healthcare Products Regulatory Agency (MHRA) licenses it for that purpose or it is asked by the Department of Health to treat it as a special case.

A spokeswoman said Nice had begun preliminary research, but even if given the go-ahead by the DoH, it would take at least 18 months to issue official guidance.

Chief executive of the Macular Disease Society Helen Jackman said: “There needs to be a national solution to these uncertainties. If Avastin is not as safe as Lucentis no-one should be using it. If it is as good, perhaps everyone should be using it.

“If doctors and other experts cannot agree on which drug to use it is not reasonable to expect a patient to decide, and we have doubts patients would have the issues properly explained to them.”

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