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NICE rejects use of sight-saving drug on NHS

Charities launch campaign for ranibizumab to be made available

Adrian O'Dowd

Wednesday, 30 November 2011

The NHS should not use ranibizumab (Lucentis) for the treatment of diabetic macular oedema (DMO), according to final guidance issued today by the National Institute for Health and Clinical Excellence (NICE).

Four leading charities, however, have launched a joint campaign for the potentially sight-saving drug to be made easily available.

NICE has rejected an appeal from various bodies on its earlier decision to not recommend the drug, saying it was not cost-effective.

Around 50,000 people in the UK are affected by DMO, a serious eye condition that can lead to sight loss as a result of fluid leaking from the small blood vessels in the eye.

Traditionally, laser treatment has been the standard treatment for DMO on the NHS, but this only stops vision from deteriorating further.

NICE’s independent appraisal committee concluded that the evidence presented by the manufacturer Novartis did not provide a true reflection of the cost-effectiveness for ranibizumab monotherapy compared with the current standard treatment for people with DMO – laser photocoagulation.

The committee concluded that a model that relied on a combined set of plausible assumptions would be certain to produce an incremental cost-effectiveness ratio (ICER) that substantially exceeded the range that NICE considers to represent an effective use of NHS resources.

NICE said that people currently receiving ranibizumab for this indication should have the option to continue treatment until they and their clinicians felt it appropriate to stop.

Sir Andrew Dillon, NICE chief executive, said: “The independent appraisal committee recognises the effect that visual impairment can have on day to day life for people with this condition.

“NICE already recommends ranibizumab for wet age-related macular degeneration, and although it has been shown in some clinical trials to be an effective treatment for DMO, we could not recommend the drug as a clinically and cost-effective use of NHS resources compared with laser photocoagulation for this condition.”

Diabetes UK, JDRF (formerly known as the Juvenile Diabetes Research Foundation), the Macular Disease Society and the Royal National Institute of Blind People said they were unhappy with the decision.

Now that their appeal had been rejected, the charities were calling on Novartis, the Department of Health and NICE to agree a patient access scheme, in order to reduce the cost of this treatment to the NHS and ensure patients were able to access the treatment.

The charities said ranibizumab, given in the form of an injection in the eye, was the first licensed treatment to improve vision in people with sight loss due to DMO.

Simon O'Neill, director of care, information and advocacy at Diabetes UK, said: "Naturally we are disappointed that NICE has turned down our appeal as we believe this treatment is vital to prevent people from needlessly losing their sight.

"It is now of upmost importance that the drug manufacturer works with the Department of Health and NICE to negotiate the costs of this treatment so people with diabetes are still able to access it without detracting from other vital NHS services, such as diabetes specialist nurses and eye screening."

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