The National Institute for Health and Clinical Excellence could be taking a U-turn on its initial stance of rejecting the use of drugs for the treatment of age-related macular degeneration on the National Health Service.

The Institute’s draft guidance earlier this year rejecting Pfizer’s Macugen (pegaptanib) outright and recommending that Novartis’ Lucentis (ranibizumab) only be used for treating around 20% of patients with a certain type of wet AMD in which both eyes are affected, and even then only treating the eye worst affected, sent all sides of the industry into a frenzy and led to a record-breaking 20,000 responses from the public and health campaigners.

NICE bowed to pressure and agreed to reconsider all the evidence on the use of Lucentis and Macugen to set a new set of preliminary guidelines. Although Macugen has been turned away again, the new draft guidance recommends a ground-breaking dose-capping scheme for Lucentis, whereby the NHS pays for a maximum of 14 injections, which should be effective in most cases, and Novartis reimburses the cost if the patients needs any more. “This”, said, NICE chief executive Andrew Dillon, would “represent a good use of NHS resources”.

Furthermore, the Institute has stepped back from its two-eye policy, now recommending treatment for the “first eye to come to clinical attention”, and thereby throwing open the doors to the approximate 26,000 new patients presenting with wet AMD every year.

Explaining the turnaround, Dillon said that two major issues came up in the response to its first guidance: “first, that allowing the first eye to deteriorate would cause anxiety and depression; and two, that treating only the second eye could mean losing the chance to preserve vision if it was affected by untreatable vision loss or didn’t respond to treatment.”

“NICE has taken these concerns on board, and now recommends treating the first eye to come to clinical attention,” he said.

RNIB welcome
The news has certainly pleased patient groups, with The Royal National Institute of Blind People’s Steve Winyard commenting: “This is a tremendous victory for the thousands of people who demanded of NICE that they save sight, not money. After an overwhelming public outcry, NICE have finally thrown a lifeline to the thousands of patients who are routinely refused the sight-saving treatments they desperately need."

“NICE has given thousands of people the best Christmas present they could wish for - hope that their sight might be saved,” he said, but added: “While we broadly welcome these recommendations, we will be asking NICE to revise some of the detail in their guidance. For example, we'd like to see the threshold for eligibility lowered even more, so that everyone who can benefit from treatment can have it."

Furthermore, the RNIB will be calling on NICE to also make Macugen available in its final guidance, to give consultants the choice of offering treatment to patients for whom Lucentis may not be an option.

A new precedent?
If approved, the new dose-capping scheme for Lucents could set a new precedent in the type of agreements drawn up between drug manufacturers as NICE, as companies are becoming more inventive in trying to ensure that their products get onto the NHS’ treatment menu.

Back in October, the Institute gave its seal of approval to a landmark money-back scheme under which the manufacturers of the cancer drug Veclade (bortezomib) will reimburse the NHS for patients not responding to treatment.