'U-turn' over sight-saving drugs

12.00.00am UTC (GMT +0000) Sat 15th Dec 2007

A controversial decision to limit drugs for a major cause of blindness has been reversed by the NHS drug watchdog in England and Wales. The National Institute for Health and Clinical Excellence (NICE) reconsidered its guidance after 13,000 complaints.

It is now recommending that NHS patients with wet age-related macular degeneration should be eligible for 14 injections of Lucentis per eye. But a second drug, Macugen, is still not recommended for use on the NHS. Campaigners welcomed the decision, which comes after NICE carried out further "economic modelling" of the treatments.

Wet AMD, which affects the central part of the retina, is the leading cause of sight loss in the UK, and affects around a quarter of a million people, with 26,000 new cases each year. Both Macugen and Lucentis are from a class known as anti-VEGF drugs, which work by targeting a protein that protects against damage to the retina.

Both drugs have already been made widely available in Scotland. In the first round of recommendations NICE said that Lucentis (ranibizumab) should be made available only to patients in England and Wales with a particular type of wet AMD, which is responsible for about a fifth of all cases.

Even then, it said the drug should be funded by the NHS only when both eyes were affected - and used only to treat the eye affected the least by the condition. Under the latest proposals, which will undergo consultation, patients would be able to receive treatment when only one eye was affected.

NICE stated a maximum of 14 Lucentis injections per eye should be available - enough to treat most patients - but the manufacturer has agreed to pay for additional doses if needed. Also, the drug will no longer be limited to those with just one form of wet-AMD, although patients will become eligible only once their sight has deteriorated by a certain extent.

The final guidance is due to be published in 2008.

NICE Chief Executive Andrew Dillon said the new proposals with the manufacturer funding additional injections were a good use of NHS resources. Winfried Amoaku, chairman of the Royal College of Ophthalmologists' Scientific Committee, said he was relieved NICE had taken a fresh look at the recommendations.

But he added that Macugen should also be available when treatment with Lucentis is problematic. "Clinicians should be free to choose the most suitable treatment for their patients." He added: "We think that the threshold at which treatment would start has been set too high."

RNIB's head of campaigns Steve Winyard also said they would like to see the eligibility threshold lowered. But he added: "NICE has given thousands of people the best Christmas present they could wish for - hope that their sight might be saved."