The National Institute for Health and Clinical Excellence will reconsider its position on the use of sight-saving anti-VEGF drugs in the UK, following an unprecedented public outcry at its preliminary decision to reject their use on the National Health Service.

In June, NICE issued draft guidance recommending Novartis’ Lucentis (ranibizumab) for treating 20% of patients with wet age-related macular degeneration and rejected Pfizer’s Macugen (pegaptanib) outright, igniting outrage from all sides of the industry and a record-breaking 20,000 responses from the public and health campaigners.

Now the Institute has agreed to reconsider the evidence and issue a new set of preliminary guidelines later this year, but this has further angered patients groups, as final guidance is now not expected until 2008.

The Royal National Institute of Blind People has accused the Institute of “massive incompetence” which may result in 10,000 UK patients losing their sight unnecessarily. "By going back to the drawing board to issue a second set of draft guidelines, NICE is in effect admitting that it got its preliminary recommendations badly wrong. This incompetence means that every day it reconsiders and delays, 50 people could lose their sight,” said Steve Winyard, RNIB’s Head of Campaigns.

“Given the wealth of evidence that NICE received at the start of this process, how could it have got its initial guidance so wrong? This must call into question NICE’s ability to make a decision about who should and who should not, keep their sight,” he added.

Wet AMD is the leading cause of sight loss in the UK and can lead to sight loss in just three months, and prompt treatment is crucial in attempting to save sight, the RNIB points out. "Anti-VEGF drugs have the potential to halve the number of people going blind each year and patients in the UK who can benefit from them must all have them – and quickly,” Winyard stressed.

SMC approvals

Earlier this year, Lucentis became the second anti-VEGF medicine to get the thumbs up from the Scottish Medicines Consortium for use on the NHS in Scotland, after Macugen was given a green light in 2006. Winyard has called on NICE “to now look properly at the overwhelming evidence, follow the example of the SMC, and quickly come to a decision to give everyone who needs it immediate and unquestionable access to these sight-saving treatments."

Tom Brembridge, Chief Executive of the Macular Degeneration Society, told PharmaTimes UK News that the u-turn “is very good news in that NICE has been forced by the strength of submissions from the Royal College of Ophthalmologists, Macular Disease Society and RNIB jointly and over 13,000 letters from the public to have serious second thoughts about its appalling Appraisal Consultation Document.”

He went on to point out that “The Scottish Medicines Consortium approved unrestricted use of Macugen and Lucentis in 18 weeks. NICE will have taken nearly 18 months by the time they have finished muddling through this process.”