Future of off-label prescribing: wet AMD and the regulatory bodies

The General Medical Council (GMC) is halting plans to loosen its guidance on doctors prescribing off-label and unlicensed medicines, and is seeking further legal advice, according to papers of a recent Council meeting. This follows a legal challenge by Novartis, which manufactures ranibizumab (Lucentis) over the off-label prescribing in some areas of the country of the cheaper drug, bevacizumab (Avastin), for wet age-related macular degeneration (AMD). Bevacizumab is licensed as a cancer drug but not for the treatment of wet AMD.

The Nursing and Midwifery Council (NMC) is planning to review prescribing standards, although it announced recently that the review of medicines management standards would not be going ahead, so this issue may face the nursing regulatory body very soon.

Press coverage has talked about far-reaching consequences, depending on what legal advice is forthcoming: current GMC guidance allows off-label prescribing where the medicine will “better serve” the patient than the appropriately licensed alternative. The proposed change would have also allowed unlicensed or off-label prescribing where the medicine was “as safe and effective” as the appropriately licensed alternative, on the basis of authoritative clinical guidelines. The proposal was in response to the very high costs of licensed drugs for rare conditions, and to avoid doctors being unable to follow both GMC guidance and NICE/employer guidance simultaneously.

The difference in costs can be dramatic – the BMJ reported recently that using bevacizumab instead of ranibizumab for wet AMD could save the NHS £84 million annually, and that new data suggest similar performance.

Nurse prescribers can prescribe unlicensed medicines following a change in the law in 2010 and the NMC has set out certain conditions, one of which is that an alternative, licensed medication would not meet the patient’s needs. For off-label prescribing, the medicine must “better serve” the patient’s needs than the appropriately licensed alternative.