Two multinational drug companies are threatening legal action to prevent patients being offered a cheap version of an effective drug against blindness which could save the NHS millions of pounds.
Twelve NHS clinical commissioning groups (CCGs) in the north-east of England say that saving money by buying a safe and effective – but 10 times cheaper – version of the licensed drug for wet macular degeneration is far preferable to cutting costs in other ways, for instance by rationing fertility treatment or cataract operations.
The licensed drug for the condition, which is the commonest cause of blindness in older age, is Lucentis (known generically as ranibizumab). But more than a decade ago, doctors discovered that an anti-cancer drug, Avastin (bevacizumab), gives results that are just as good – and when it is split into the tiny doses needed to inject into the back of the eye, it is a fraction of the price.
Genentech, the manufacturer of Avastin, refused to apply for a licence for it to be used in eyes. But in 2012, the IVAN trial, funded by the NHS, showed that the two drugs were equally safe and effective and that its widespread use could potentially save the NHS more than £84m a year. Avastin is widely used in the United States and other countries around the world to treat macular degeneration.
It is not much used in the UK, however, and now the two drug giants that market Lucentis, Novartis and Bayer, have warned the NHS commissioners that they will seek a judicial review if they go ahead with their plans to offer Avastin.
Dr David Hambleton, chief officer of the South Tyneside Clinical Commissioning Group, one of the 12, said that offering Avastin first to patients, but with the option to choose Lucentis if they preferred, had the potential to save significant amounts of money without sacrificing safety or efficacy.
“Lots of the decisions and choices we are potentially facing are much less palatable than this one,” he told the Guardian. “This seems to most people to be an absolute no-brainer.”
Explaining the new policy in the British Medical Journal, he writes: “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.”
Choosing Avastin could save the region up to £13.5m a year, which could pay for an extra 270 nurses or 266 heart transplants, says the BMJ.
In the UK, he said, “legal technicalities” stand in the way of more general use. Doctors are entitled to use any drug in their patients that they consider they need, but the General Medical Council, which regulates the profession, says they should choose a licensed over an unlicensed medicine if they are equally good. Avastin is not licensed for macular degeneration, but it is licensed for cancer treatment. Hambleton observes that a licence is simply a “market authorisation”, entitling a drug company to sell a product.
The National Institute for Health and Care Excellence (Nice) has produced draft guidelines for the NHS on the treatment of macular degeneration which endorse the safety and effectiveness of Avastin, but reflect the GMC’s position that it is not licensed for the condition.
NHS Clinical Commissioners, the umbrella body for the CCGs, 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 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 said in a statement.
In a statement, Bayer said that splitting doses of Avastin into tiny injectable amounts created a different and unlicensed medicine. “The principle of using unlicensed medicines when licensed and Nice-approved options are available runs the risk of setting a precedent that undermines the regulatory framework and NHS constitution. Bayer is currently considering its position including the possibility of legal proceedings against the CCGs who have implemented the policy,” it said.
Novartis 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 as there are two licensed products available in the UK, both of which have been approved by Nice as clinically and cost effective.”
The 12 CCGs are Northumberland; Newcastle Gateshead; North Tyneside; South Tyneside; Darlington; Durham Dales, Easington and Sedgefield; North Durham; Hartlepool and Stockton-on-Tees; Cumbria; Sunderland; Hambleton, Richmondshire and Whitby; and South Tees.