Novartis’ Lucentis has received final approval from the National Institute for Health and Clinical Excellence as a treatment for wet age-related macular degeneration (AMD), but the company will pick up the bill if the treatment goes beyond 14 injections.

“The National Health Service should cover the drug cost of Lucentis (ranibizumab) for the first 14 injections in each eye being treated. If people need more than 14 injections per eye, the manufacturer of ranibizumab has agreed to take over the drug cost from the NHS,” says NICE, in its final guidance published yesterday.

Welcoming the decision, Novartis described the first-of-a-kind cost-capping scheme as “an important collaboration that will ensure patients living with wet AMD in England and Wales receive the best possible care.”

“We are committed to working in partnership with health authorities to ensure that as many patients as possible with wet AMD can benefit from treatment with Lucentis,” said Trevor Mundel, the company’s head of global development functions.

NICE’s chief executive, Andrew Dillon, pointed out that while Lucentis is an expensive drug, costing more than £10,000 for each eye treated, that cost needs to be balanced against the likely cost savings. “It has been estimated that the costs related to sight impairment for patients treated with Lucentis are around £8,000 cheaper than for patients who receive best supportive care over a 10-year period. Our guidance means that patients who are suitable for this treatment will have the same access to it, irrespective of where they live,” he said.

In June 2007, NICE caused a public storm by issuing draft guidance recommending that Lucentis should be made available to just 20% of patients with wet AMD, and rejecting outright the use of Pfizer’s Macugen (pegaptanib) for the condition. Following a massive campaign led by the Royal National Institute of Blind People (RNIB), it agreed to reconsider the evidence on the drugs, and yesterday produced what many observers see as a massive U-turn, although the final guidance also confirms NICE’s recommendation that Macugen should not be available on the NHS.

Yesterday the RNIB described the final backing for Lucentis as “a victory for thousands, bringing overwhelming relief to desperate people across the country.”

“We’ve been waiting for this for over two years,” said the group’s head of campaigns, Steve Winyard. “Finally the torment faced by elderly people forced to either spend their life savings on private treatment or go blind, is over,” he added.

The Macular Disease Society also said it was “very pleased and relieved” with the guidance, "following two years of unnecessary delay.” However, its chief executive Tom Bremridge added that “those responsible for NICE should be aware that during the cumbersome two-year review process, 152 Primary Care Trusts have individually had the power to decide whether to let patients go blind or to save their sight. The resulting stress and suffering has been cruel and unnecessary. Many hundreds of vulnerable patients have been subjected to an appalling emotional rollercoaster ride for the past two years – during which many of them have lost their remaining sight.”

Around 40% of PCTs have been refusing to fund Lucentis but, said RNIB’s Steve Winyard: “there is now nowhere left for PCTs to hide - we want them to implement NICE guidance immediately. RNIB is also calling on hospitals to ensure they build capacity as a matter of urgency, so they can save the sight of patients without further delay."

- Wet AMD is the leading cause of blindness in people aged over 50, with about 26,000 new cases being diagnosed in the UK each year. More women than men are affected, and the risk for developing the condition, which rises significantly with age, is more than three times greater for current and former smokers than for people who have never smoked.