Report sounds off-label prescribing warning
pharmafile | April 21, 2011 | News story | Sales and Marketing | EAASM, off label
A pharma-backed group has warned that some ‘off-label’ prescribing is dangerous for patients.
A report by the European Alliance for Access to Safe Medicines (EAASM) has said allowing doctors to cut costs by prescribing drugs outside their licensed indications will have “very serious consequences”.
The EAASM believes ‘regulatory vagaries and loopholes’ are allowing these practices to continue, which they say will be to the detriment of patients.
Its report alludes to – but doesn’t mention by name – the use of Avastin to treat the eye condition wet AMD. Avastin is virtually the same molecule as licensed wet AMD drug Lucentis, and is now frequently used in its place off-label because of its much lower cost.
Lucentis costs around £10,000 per eye, per patient, but Roche/Genentech’s Avastin costs just £250 per eye.
Alluding to this practice, the report says this will produce ‘horrifying adverse events’. It points to a number of newspaper reports of adverse reactions, but these have so far not been corroborated by clinical studies.
There are currently a number of trials ongoing in the US and the UK to determine whether Avastin can be used safely and effectively for use in wet AMD, but neither Roche nor Novartis wish to submit a new licence for this indication.
The EAASM was originally set up to combat drug counterfeiting in the EU with the financial backing of pharma firms such as Pfizer, Novartis and Lilly.
The group has now turned its attentions to off-label prescribing to combat the ‘institutional malpractice’ it feels is in governments allowing the practice.
It also points out that any EU Member State encouraging such practices is in breach of EU legislation.
The EAASM recommends that any therapeutic decision should be made with the ‘full involvement of the patient’.
“Specifically”, it says, “if a licensed medicine is available, then the patient should be told, enabling that patient to make a fully informed choice.”
The warning comes in the same month the GMC released its consultation on off-label prescribing. The doctors’ regulator has proposed allowing doctors to prescribe an off-label medicine that is cheaper, provided there are authoritative clinical guidelines to support its use and it is just as safe and effective for the patient.
Ben Adams
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