A pharmaceutical company is taking a primary care trust cluster to court over its decision to encourage the use of a cheaper, unlicensed drug in a case that could be worth millions to the NHS.
Novartis claims the Southampton, Hampshire, Isle of Wight and Portsmouth (SHIP) cluster’s decision to encourage the prescription of Avastin for patients suffering from the eye disease wet age-related macular degeneration (AMD) is unsafe and is seeking a judicial review, HSJ has learnt.
Lucentis is the only drug approved by the National Institute for Health and Clinical Excellence to treat the condition. Marketed in the UK by Novartis, it costs £890 a dose.
However, Avastin, which can be obtained for between £50 and £100, has been found to be as effective and is widely used in the US and Europe.
The cluster estimates using Avastin could save it between £4m and £5m a year.
If replicated across England this would release savings of up to £134m.
Novartis argues the policy is unsafe as Avastin has not been tested for use in the eye. However, the patents for both drugs are owned by Roche which has not sought to have Avastin licensed to treat wet AMD. This means NICE cannot consider it and although clinicians working in the NHS are free to prescribe off label drugs most tend to follow NICE recommendations.
A spokesman for Novartis said the cluster’s policy undermined the principle of patient safety.
He added: “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.”
Shailen Rao, former chairman of the Primary Care Pharmacists’ Association, told HSJ if the case went in the cluster’s favour it was likely other areas of the country would follow suit. East and Central Cheshire Primary Care Trust has also implemented a similar policy.
He said: “The commissioners are trying to direct clinicians to prescribe an off label product and giving them the back up to do it. As long as the NHS have followed the due process it’s their right to make that judgement call, as long as there is clinical justification and there is no blanket ban.”
A cluster spokesman said clinicians would still be free to prescribe Lucentis if they felt it was more clinically appropriate.
“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,” he said.
“The PCTs consider that, in a time of substantial financial pressure on the NHS, this is a responsible as well as lawful approach.”