Charity challenges government on Avastin for wet AMD
pharmafile | April 24, 2012 | News story | Sales and Marketing | Lucentis, Novartis, Roche, avastin, off label, off-label, wet AMD
A leading patient group has called on the government to get to grips with the issue of off-label prescribing, as Novartis seeks a judicial review of the use of an unlicensed rival treatment on the NHS.
Roche’s Avastin (bevacizumab) is being used by four PCTs in England to treat the eye disease wet age-related macular oedema – despite not being licensed for that purpose.
Chemically similar, Novartis’ Lucentis (ranibizumab) has a European licence for wet AMD, but its price tag is £740 per injection – versus Avastin’s £60.
“There should be a national decision on this,” Cathy Yelf of the Macular Disease Society told Pharmafocus. “The concern is that an unregulated, unlicensed drug is being used.”
Off-label prescribing happens when a drug is used for a disease outside its indication, often because there are no existing treatments – but is also used as a cost-cutting measure.
“We want ministers to instruct NICE to hold an appraisal of Avastin,” says Yelf. “We don’t think it’s right for PCTs to put pressure on doctors to use an unlicensed drug or fair for patients to make the decision.”
Yet the charity also has sympathy with Southampton, Hampshire, The Isle of Wight and Portsmouth PCTs, which are using both drugs to treat wet AMD.
“We would prefer the licensed drug to be used,” says Yelf. “However, the disparity in cost is so great that we understand why the NHS is looking at this.”
The judicial review will seek to establish whether the process of offering Avastin can continue but it will not examine the safety of the drug.
In a statement, Novartis told Pharmafocus: “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.”
Novartis also suggested “there is emerging evidence of potential safety concerns with the use of unlicensed bevacizumab when used to treat eye conditions”.
This is currently a hot topic: last month NICE announced a review of the use of off-label and unlicensed medicines across the NHS in England.
The Department of Health asked the watchdog to look at drugs including Avastin and produce guidance on their use, in order to create a more uniform approach to the practice.
Prescribing drugs off-label to cut costs has been roundly criticised by the pharma industry, and the General Medical Council is soon to clarify its ethical guidelines on the issue with new guidance.
Adam Hill
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