Legal threat against NHS drug plan

Currently, Lucentis, which is marketed in the UK by Bayer and Novartis, is mostly used to treat wet age-related macular degeneration – despite off-label alternative Avastin offering equal performance and safety at one-tenth of the price.However, 12 NHS clinical commission groups in England’s north-east have requested the ability to offer Avastin to patients first.{{quote-A:R-W:450-I:2-Q: The time to take action on the use of this drug at a national level, to release cost-savings to use in other priority areas, is now. -WHO:Dr David Hambleton, Chief officer of the South Tyneside Clinical Commissioning Group}}Dr David Hambleton, chief officer of the South Tyneside Clinical Commissioning Group, estimated the move could save the region up to £13.5m (AU$23.25 m) a year – the equivalent of an extra 270 nurses or 266 heart transplants.“Every patient who chooses the cheaper alternative drug will help the NHS to fund important medical treatment in other areas. We want to have informed conversations with our patients so that they understand the wider effects of the choices we collectively make,” Hambleton wrote in an article for the British Medical Journal advocating the change.According to a statent published in The Guardian, the NHS Clinical Commissioners, the umbrella body for the CCGs, also strongly backs the use of the cheaper drug.“Where cheaper medicines that are equally clinically effective as a more expensive alternative are available, we call on the Department of Health to ensure that every possible avenue is explored to enable these savings to be realised,” the statent read.“The time to take action on the use of this drug at a national level, to release cost-savings to use in other priority areas, is now.”It is not the first time Avastin has been proposed as an inexpensive treatment alternative – the NHS funded a 2012 study that found it could save £84 million (AU$144.6 m) a year if adopted uniformly – but so far the manufacturer, Genentech, has refused to apply for a licence for it to be used on eyes.This is an issue because while doctors can use any drug to treat their patients, the General Medical Council says they should choose a licensed over an unlicensed medicine if they are equally effective.It also forms part of Bayer’s argument against its use, with the pharmaceutical giant releasing a statent that said splitting doses of Avastin into tiny injectable amounts created a different and unlicensed medicine.{{quote-A:L-W:450-Q: Avastin is 10x cheaper than Lucentis }}“The principle of using unlicensed medicines when licensed and NICE [National Institute for Health and Care Excellence]-approved options are available runs the risk of setting a precedent that undermines the regulatory framework and NHS constitution,” the statent read.Bayer is currently considering its position, including the possibility of legal proceedings against the CCGs that have implented the policy, while Novartis has said the new policy of the 12 CCGs “is not in line with the current UK and EU legal and regulatory framework, the purpose of which is, among others, to protect patients and monitor the safe, appropriate use of medicines.“The framework provides that unlicensed medicines can only be used where there is an unmet medical need. That is not the case here,” the statent continued.Both companies have warned the NHS commissioners they will seek a judicial review if they proceed with their plan.