GMC responds to new NICE guidance
New guidance from the National Institute for Health and Care Excellence (NICE) on the treatment of wet age related macular degeneration (AMD) has been published.
The guidance clarifies that there are no clinically significant differences in the effectiveness and safety of anti-VEGF medications that are licensed for treating AMD and those that are not licensed, such as Avastin. Doctors have expressed concerns that prescribing the licensed versions costs significantly more than the unlicensed version, Avastin.
In light of NICE’s new guidance our Chief Executive, Charlie Massey, has clarified what doctors need to consider when prescribing Avastin for the treatment of AMD.
Charlie Massey, Chief Executive of the General Medical Council said:
‘In an ideal world a licensing solution for using Avastin would be found as the rigours of the licensing regime provide important assurances of patient safety. However, in the absence of this and given the clinical support for using Avastin, including from the Royal College of Ophthalmologists, we want to reassure doctors that this prescribing decision alone would not raise fitness to practise concerns, providing doctors are applying the broader principles of our guidance.
‘We expect doctors to make good use of the resources available to them and sympathise with the concerns of ophthalmologists making decisions between using a cheaper product outside the terms of its license or a more expensive licensed alternative. We cannot of course give specific clinical or legal advice. But we can say that where doctors are working in partnership with patients, following clinical guidance and making prescribing decisions in good faith on the basis of evidence and experience, the use of Avastin would not cause us any concerns.’
GMC prescribing guidance
Our prescribing guidance states that doctors should usually prescribe licensed medicines in accordance with the terms of their licence. The use of the words ‘should’ and ‘usually’ are significant and indicate that we expect doctors to use their judgment to apply the principles in the guidance to the specific situations they face. We say that when prescribing an unlicensed medicine or using a product ‘off-label’ (beyond the terms of its license) doctors must be satisfied that there is sufficient evidence or experience of using the medicine to demonstrate its safety and efficacy. We are also clear that doctors ‘must give patients (or their parents or carers) sufficient information about the medicines you propose to prescribe to allow them to make an informed decision.’