GMC won’t relax off-label prescribing guidelines
pharmafile | April 25, 2012 | News story | Sales and Marketing | GMC, Lucentis, Novartis, Roche, avastin, off label, off-label
The GMC has decided not to relax guidelines on off-label prescribing when a licensed alternative exists.
The GMC’s current rules say off-label prescribing is only acceptable when a doctor judges that such a medicine would better serve the patient’s needs than a licensed alternative.
But prescribing medicines off-label because they are a cheaper alternative to licenced drugs is seen as a growing trend, and is highly controversial.
The doctors’ regulator has been consulting on off-label prescribing for the past year, with the use of Roche’s Avastin (bevacizumab) for wet AMD the most high profile case.
This is being used by some ophthalmologists instead of Novartis’ licensed Lucentis (ranibizumab), which is chemically similar to Avastin, but far more expensive.
The GMC said that despite the high level of concern, at the time of drafting its new guidance there were no authorative clinical guidelines to support using Avastin in this way. The regulator concluded: “This particular issue [using Avastin off-label for wet AMD] has not been resolved by our advice.”
The decision will be welcomed by the pharma industry, as doctors will continue to have a limited scope to prescribe drugs off-label where a licensed treatment is already on the market.
This comes in the same week that Novartis has succeeded in gaining a judicial review against a primary care trust in the south of England, which last year recommended using Avastin ahead of Lucentis for wet AMD.
GMC blocked
The GMC had considered easing rules on off-label prescribing in the UK, but has been advised not to by the MHRA, the drugs regulator for the UK.
New board papers from the GMC reveal that both the MHRA and the ABPI opposed the proposed changes to the GMC’s guidance. But this contrasts with the 70% of respondents to the consultation who supported the proposed changes to off-label prescribing (with 20% disagreeing, and 10% not sure).
The GMC has received many enquiries from doctors prescribing drugs off-label where licensed alternatives exist. These doctors were concerned that they could be reprimanded for the practice, and has looked to the GMC to clarify its position on the practice.
As a result of these concerns the regulator sought its own clarification from European law, but found none.
It said as there are no clear legal guidelines on the issue, it was ‘still exploring’ the issue and for the time being, has decided not to change its rules on off-label drug use.
Ben Adams
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