NICE Provides Final Draft Guidance for Lucentis

UK drugs watchdog, NICE, have endorsed the use of Lucentis on the NHS to treat visual impairment caused by diabetic macular oedema after Novartis submitted a revised patient access scheme (PAS) and new drug data.

The National Institute for Health and Clinical Excellence published the final draft guidance after a rapid review of the original guidance, published in November 2011, which rejected the drug for the NHS.

Within the new guidance, Lucentis (ranibizumab) can be used to treat visual impairment from diabetic macular oedema if the eye has a central retinal thickness of 400 micrometres or more at the start of the treatment.

The guidance was founded on additional new data provided by Novartis that confirmed that the drug could be expected to have a greater relative effect amongst patients in the subgroup.

The recommendation was also centred on a reduced price for the drug as agreed in the patient access scheme.

The British National Formulary confirmed that the list price of Lucentis is £742.17 per vial excluding VAT.  Treatment is given monthly and sustained until a patient reaches maximum vision.

The discount which will be applied to Lucentis under the patient access scheme has not been revealed.  However, Novartis have agreed that the PAS will remain in place until any review of the NICE technology appraisal guidance is published.

The organisation also commented that the implementation of the patient access scheme means that the NHS will benefit from savings across all current and future licensed indications for Lucentis, including wet age-related macular degeneration (AMD) and visual impairment due to macular oedema secondary to retinal vein occlusion.

In a statement, Novartis named the recommendation an “important and long-awaited step forward in improving the standard of care for people with visual impairment due to diabetic macular oedema.”  The company believes that around 25,000 people with the condition could be eligible for the drug.

“Up until now, most patients could only receive laser treatment on the NHS, which usually just stops their vision worsening but does not necessarily improve it,” noted Ben Burton, consultant ophthalmologist at the James Paget University Hospital.

“Granting access to ranibizumab for patients with VI-DMO, who face the very real prospect of permanently losing their vision, is great news,” he added.

Diabetes UK have also welcomed NICE’s decision.  Barbara Young, chief executive, commented that Diabetes UK “are delighted that NICE have reconsidered their previous decision, and that this draft guidance recommends that Lucentis is made available on the NHS, as this would mean more people with diabetes would have a better opportunity to preserve and possibly improve their vision.”

“We have campaigned vigorously alongside the RNIB, JDRF and the Macular Society for this outcome for the past two years and so welcome this result and hope this is reflected in the final guidance when it is issued next month,” Young added.

Final guidance is expected to be published in February 2013.  The new final draft guidance puts Lucentis on course for a second NICE recommendation, having already been deemed a cost-effective treatment for AMD in 2007.


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