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NICE says macular degeneration drugs ìtoo expensiveî

NICE has released its Appraisal Consultation Document (ACD) for the use of medicines in patients with wet age-related macular degeneration, which says the treatments are too expensive

The UK's National Institute of Clinical Excellence (NICE) has released its Appraisal Consultation Document (ACD) for the use of licensed antiñVEGF medicines in patients with wet age-related macular degeneration (AMD), a progressive ocular disease which leads to blindness.

The preliminary guidance states that OSI Pharmaceuticals and Pfizer's Macugen (pegaptanib), a selective-VEGF inhibitor, is not recommended for the treatment of wet-AMD. NICE added that Macugen should not be used as it costs GBP 8,900 for a two-year course per patient, while Genentech's Lucentis (ranibizumab), which costs GBP 12,000 a year per patient, should only be used on the 20 per cent of people with the worst type of age-related AMD.

A study published in the New England Journal of Medicine back in October 2006 which showed that Lucentis can prevent vision loss in about nine out of ten patients.

The PR war has started in earnest, with Pfizer providing data that there are around 26,000 new annual cases of wet AMD in the UK, with AMD the leading cause of sight-loss for people over the age of 50 in the Western world. The company added that, based on NICE's provisional recommendation, 80 per cent, or over 20,000, of these patients will be left to go blind, with the 20 per cent who are eligible for treatment having been left to go blind in their first eye.

Pfizer's medical director, Dr David Gillen, said of NICE's guidelines: "From a cost perspective, it has been convincingly demonstrated that Macugen's cost-effectiveness can be enhanced when treatment is started at an early stage before too much vision is lost. The NICE economic model did not appropriately address this important issue and therefore underestimated the cost-effectiveness of Macugen."

Head of campaigns at the Royal National Institute of Blind (RNIB), Steve Winyard, stated: "It is simply unacceptable that only a small minority of patients within England and Wales will have access to these ground-breaking drugs. NICE must re-consider and show that it makes its decisions based on cost-effectiveness rather than simply cost containment."

In November 2006, OSI announced it would divest its eye disease business because US net sales of Macugen in FY06 were impacted by the launch of Lucentis. OSI negotiated with its partner, Pfizer, for the return of US marketing rights to Macugen in exchange for a royalty-free license to Pfizer to commercialise it in the rest of the world to facilitate the divestiture of the eye business expected in Q4 2007. OSI says it will concentrate on its oncology franchise, which includes Tarceva, its treatment for non-small cell lung and pancreatic cancers.

FY06 sales for Lucentis were USD 380m. Genentech expects Lucentis sales to reach USD 900m in FY07.

NICE is expected to provide a final ruling in September 2007, but the institute normally sticks to its initial guidance.

14th June 2007

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