The National Institute for Health and Clinical Excellence is once again facing the wrath of UK patients after announcing that it is only partially backing the blindness treatment Lucentis while a competing drug, Macugen, has been rejected outright.
In a draft guidance, NICE recommended the use on the National Health Service of Lucentis (ranibizumab), developed by Genentech and sold by Novartis in Europe, for treating 20% of patients with wet age-related macular degeneration (AMD), the leading cause of blindness and sight loss in the elderly. Specifically, it is recommending the drug for people with predominantly classic subfoveal choroidal neovascularisation (CNV) wet AMD, saying that it should be used when both eyes are affected, and then in the better-seeing eye.
As for Pfizer and OSI Pharmaceuticals' AMD product Macugen (pegaptanib), NICE is not recommending its use at all on the NHS. Explaining the decision, Andrew Dillon, the agency’s chief executive, said “when treatments are very expensive, we have to use them where they give most benefit to patients. Most people with AMD only seek help once the disease is beginning to affect their second eye.” Because of this, “’our independent advisory committee believes the right thing to do is to treat and try to save as much sight as possible in the better-seeing eye,” he added.
He then adopted a more conciliatory tone however, saying that “we’re very keen to hear from people with AMD and those who care for them, and as always, our committee will take these views into account when making their final recommendations. We are particularly interested to hear from them and from the manufacturer about the effect on an individual’s quality of life as the disease affects the first eye.” The consultation on the draft guidance closes on July 5 and, subject to any appeals, a final decision is expected in September.
RNIB 'outraged' by recommendation
The announcement led to a barrage of criticism from health campaigners. The Royal National Institute of Blind People said that the decision will condemn 20,000 people each year in the UK to blindness, saying it is “outraged” at the recommendations to “offer treatment to just one in five 'lucky' patients - but only after they've gone blind in one eye”.
The RNIB's head of campaigns, Steve Winyard, said: "This preliminary guidance is worse than we ever imagined it could be. Anti- vascular endothelial growth factor 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.” He noted that the NHS is currently in surplus, “yet England and Wales are now two of the only countries in Europe to deny its citizens sight-saving treatments.”
Just days ago, Lucentis became the second anti-VEGF drug to receive approval from the Scottish Medicines Consortium with Macugen having been approved in 2006, but Mr Winyard said that negative NICE guidance could however see these positive decisions in Scotland reversed. "NICE must re-consider and show that it makes its decisions based on cost-effectiveness rather than simply cost-containment," he concluded.
Tom Bremridge, chief executive of the Macular Disease Society, said his organisation is “appalled” by the consultation document, noting that “allowing one eye to go blind before treating the second eye is cruel and totally unacceptable. Along with the RNIB, we will be submitting a response to NICE to encourage a re-analysis".
Clearly there is much support for Lucentis among patients and charities. However it has been linked to health problems and Genentech warned doctors in January of a possible increased risk of stroke.