Lucentis DMO appeals fail

 NICE has rejected a host of appeals and decided to not recommend the use of Lucentis (ranibizumab) in final guidance for the treatment of diabetic macular oedema (DMO).

Its independent Appraisal Committee concluded evidence provided by Novartis did not reflect accurately the cost effectiveness of the injection compared with the current standard treatment.

Novartis says it is “extremely disappointed” with the decision and that patients are being “denied an important treatment”.

Appeals to the FAD decision from Novartis, Royal College of Nursing, Royal College of Ophthalmologists, Royal National Institute of Blind People, Macular Disease Society, Juvenile Diabetes Research Foundation and Diabetes UK were all rejected.

DMO occurs when retinal blood vessels change in people with diabetes. It may lead to severe visual impairment.

Sir Andrew Dillon, Chief Executive at NICE, said the Appraisal Committee recognises the effect visual impairment can have on the lives of those affected but questioned the strength of the data supplied by Novartis.

“It was also noted that the manufacturer 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,” he said. “The Committee was also concerned that glycaemic control was much better in the trial population than it is in clinical practice, and that the evidence presented by the manufacturer suggested that the ICER would be higher in people with less well controlled glycaemic control than observed in the trial.”

But Novartis claimed that NICE did not “consult sufficiently” with both clinical and patient experts on the additional data it submitted. However it said it will continue to work with NICE and the DH on a “number of different levels and on a number of different solutions” to try and reverse the decision.