The National Institute for Health and Clinical Excellence issued final guidance Wednesday, recommending against NHS reimbursement of Novartis' Lucentis (ranibizumab) for the treatment of diabetic macular oedema (DMO).

The drugmaker said it would "continue to work with NICE and the UK department of health toward a solution that will allow patients access" to the treatment.

The decision, which confirmed a preliminary recommendation from the agency in July, was made after NICE's appraisal committee concluded that evidence presented by Novartis "did not provide a true reflection of the cost-effectiveness" of Lucentis compared to standard therapy of laser photocoagulation.

Andrew Dillon, the agency's chief executive, remarked that the drug "has been shown in some clinical trials to be an effective treatment for DMO."

However, Dillon added that Novartis' cost analysis was "based on implausible assumptions," and the company "significantly underestimated the cost of treatment by not accounting in its submission the need to treat both eyes in a proportion of people with DMO."

Lucentis costs approximately 742 pounds ($1159) per monthly injection and Novartis had offered to pay for the drug in patients who need more than 12 doses.

A Novartis spokeswoman noted that in clinical trials, Lucentis "has been shown to double the likelihood of gaining vision and reduce the chance of losing vision by up to three-fold compared to laser treatment." The company suggested that NICE did not consult sufficiently with clinical and patient experts on the data it submitted to the appraisal committee, adding that the decision was "made despite four independent appeals."

NICE already recommends Lucentis for wet age-related macular degeneration, but last week rejected use of the agent in draft guidance for the treatment of visual impairment caused by macular oedema secondary to central or branch retinal vein occlusion.

(Ref: BBC News, Bloomberg, NICE, The Wall Street Journal, FinanzNachrichten)