Cost regulators for the National Health Service in England and Wales say they are minded not to recommend Novartis' Lucentis as a treatment for diabetic macular oedema (DMO).

The condition, which frequently develops in patients with diabetes, is caused by a build up of fluid in the eye which can severely impair vision and, if left untreated, eventually cause blindness. 

Laser therapy - which involves the use of laser burns to stop capillary leakage and reduce swelling in the eye - is currently the standard option for NHS patients with the condition. 

But there was hope for a more effective method after European regulators issued a green light for Novartis' Lucentis (ranibizumab) to treat DMO in October last year, on the back of clinical trials which showed that the drug is better than laser therapy at improving gains in visual acuity.

Lucentis is an antibody fragment injected into the eye once a month to neutralise vascular endothelial growth factor (VEGF), a protein that increases vascular permeability, and thereby works by a different method to prevent capillary leakage into the eye.

According to data from the RESOLVE study, patients given Novartis' drug recorded an average 11.7 letters gain in visual acuity after a year compared to sham-treated patients, some of whom were given laser treatment, while an independent US study by the Diabetic Retinopathy Clinical Research Network showed that after 12 months nearly 50% of patients' eyes treated with Lucentis and laser therapy achieved an improvement of 10 letters or more, compared to 28% with laser alone, Novartis said.

But following a review of the evidence available, the National Institute for Health and Clinical Excellence's Appraisal Committee has not been persuaded of the drug's cost effectiveness. 

While conceding that Lucentis has been shown to be an effective treatment for DMO, the Committee felt that the economic analysis provided by Novartis did not reflect clinical practice in a number of respects. 

The analysis failed to account for the need to treat both eyes in a significant number of patients with the condition, "substantially overestimated" the life expectancy of diabetics, and underestimated the amount of Lucentis needed to achieve the benefits assumed in the analysis, said NICE chief executive Andrew Dillon. 

Failed on value for money

"In order to recommend any drug or technology, we need to be sure it represents good value for money; unfortunately in this case the Committee agreed that the evidence did not support a positive recommendation of ranibizumab," he added, further explaining the decision.

According to the Committee, using "more plausible" assumptions than those put forward by the Swiss drugmaker, several analyses produced incremental cost effectiveness ratios for Lucentis monotherapy of over £30,000 per QALY when compared with laser therapy, and therefore it could not recommend the drug as a value for money option for the NHS. 

NICE has previously recommended Lucentis - a monthly injection of which costs £742.17 - for wet age-related macular degeneration, and stakeholders now have until March 24 to comment on its preliminary rejection of the drug for DMO.