Thousands of people with a devastating eye condition could be offered a potentially sight-saving treatment following a U-turn by Nice, the health watchdog.
The National Institute for Health and Clinical Excellence (Nice) provoked a storm last year when it refused to make Lucentis available on the NHS for the treatment of diabetic macular oedema (DMO) on the grounds that it was too expensive.
The move came as a major blow to those afflicted by the condition, which affects around 50,000 people with diabetes in the UK.
But the watchdog has reversed its decision and recommends Lucentis – which has already been approved for restricted use in Scotland – in specific circumstances in England, Wales and Northern Ireland.
The drug, also called ranibizumab, is injected into the eye and is said to be the first licensed treatment to improve vision and quality of life for those with DMO, which occurs when fluid leaks from small blood vessels in the eye.
It costs £742.17 per injection, excluding VAT, and treatment is given monthly.
This is a case of slowly but surely, writes Channel 4 News Health and Social Care Correspondent Victoria Macdonald.
First there was the battle to have NICE recommend Lucentis for wet age-related macular degeneration. That finally happened in 2008, although not before some people had gone blind in at least one eye. Then there was the outcry last year when it did not recommend it for diabetic macular oedema, a smiliar condition.
This latest guidance is only draft and it will be another month before it is finalised but it has been widely welcomed by a variety of organisations who support patients with diabetes and macular degeneration. And it adds on to the list at least another 50,000 people who could benefit from it.
The Macular Society warned, though, that a recent survey found that more than half the specialist clinics in the UK were already struggling to meet the recommended treatment targets for age-related macular degeneration, let alone a new group of patients. Yet without a doubt it saves the NHS money by sheer dint of saving someone's sight.
DMO occurs when fluid leaks from small blood vessels in the eye. This gathers in the central part of the retina – the macular area which is responsible for colour vision and perception of fine detail – and can lead to severe sight problems.
Laser treatment has been offered on the NHS but this only prevents further deterioration of vision.
Professor Carole Longson, director of the centre for health technology evaluation at Nice, said fresh analysis showed Lucentis had a “superior relative effect” if a patient’s eye had a central retinal thickness of 400 micrometres or more.
It will be recommended if the manufacturer, Novartis, provides the drug with a discount agreed in a patient access scheme which would bring down the cost of the drug to the NHS.
Prof Longson said: “Nice is pleased to recommend ranibizumab as a treatment option for some people with visual impairment caused by diabetic macular oedema in new draft guidance.
“In November 2011, Nice published guidance which did not recommend the drug as an effective use of NHS resources.
“However, following the submission of a revised patient access scheme, we have conducted a rapid review of the original guidance.
“The manufacturer also included updated analyses showing that ranibizumab could be expected to have a superior relative effect among people with central retinal thickness greater than 400 micrometres.”
Registered stakeholders now have the opportunity to appeal against the draft recommendations.
NHS bodies have been advised to make decisions locally on the funding of specific treatments until Nice has issued final guidance which is expected to be published next month.