All patients in England and Wales with wet age-related macular degeneration could soon get unrestricted access to Novartis’ sight-saving drug Lucentis on the National Health Service, after the National Institute for Health and Clinical Excellence published a Final Appraisal Document yesterday recommending its use.

Wet AMD is the leading cause of sight loss in the UK and can lead to blindness in as little as three months, but last year the Institute sparked outrage from many sides of the industry when it initially rejected Pfizer’s Macugen (pegaptanib) outright and recommended 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.

Its initial stance on access to these potentially sight-saving drugs led to a record-breaking 13,000 responses from the public and health campaigners following a campaign spear-headed by the Royal National Institute for the Blind, causing NICE to reconsider all the evidence and rethink its preliminary guidelines.

In December, it published new draft guidance that again rejected Pfizer’s Macugen but this time recommended the use of Lucentis on the NHS for the “first eye to come to clinical attention”, thereby stepping back from its earlier two-eye policy and throwing open the door to all patients with the condition.

Furthermore, the Institute agreed to a new ground-breaking dose-capping scheme whereby the NHS pays for a maximum of 14 injections of the drug, which should be effective in most cases, and its manufacturer Novartis reimburses the cost if the patients needs any more. The two-year cost of Lucentis is about £10,700 assuming eight injections in the first year and six in the second, and about £18,300 if 12 injections are given in the first year and another 12 second, as per the clinical trial regimen, which particularly with the dose-capping scheme in place, has been deemed by the Institute a cost-effective use of NHS resources.

Ending a ‘national scandal’
Commenting on the guidelines, Steve Winyard, Head of Campaigns at RNIB said the move is “a step closer to achieving justice for the 19,000 patients in England and Wales who develop wet AMD each year,” and he stressed that primary care trusts do not need to wait for final guidance before providing treatment to patients urgently needing therapy. “By acting now, they can play a vital part in ending a national scandal that has seen thousands needlessly robbed of their sight.”

“Countless patients have already been either robbed of their sight, or stripped of their life savings, to pay for private treatment,” he added, and called on NICE to “stay on track and carry these proposals through into final guidance in June”.