The UK’s drugs watchdog has recommended NHS use of Lucentis as a treatment for visual impairment caused by diabetic macular oedema after Novartis submitted a revised patient access scheme and new drug data.
The National Institute for Health and Clinical Excellence published the final draft guidance following a rapid review of the original guidance that was published in November 2011 that rejected the drug for use on the NHS.
Under the new guidance, Lucentis (ranibizumab) can be used to treat visual impairment due to diabetic macular oedema if the eye has a central retinal thickness of 400 micrometres or more at the start of the treatment, which was based on new data provided by Novartis that said Lucentis could be expected to have a superior relative effect among people in this subgroup.
The approval for use on the NHS was also based on a discounted price for the drug as agreed in the patient access scheme.
The British National Formulary states that the list price of Lucentis is £742.17 per vial excluding VAT. Treatment is given monthly and continued until a patient achieves maximum vision.
The discount applied to Lucentis under the patient access scheme has not been disclosed. However, Novartis has agreed the patient access scheme will remain in place until any review of this NICE technology appraisal guidance is published.
The company also said the implementation of the PAS also means the NHS will benefit from savings across all current and future licensed indications for Lucentis, including wet AMD and visual impairment due to macular oedema secondary to retinal vein occlusion.
In a statement, Novartis called 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”. As many as 25,000 people with the condition could be eligible for the drug, Novartis believes.
“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,” said 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.”
Diabetes UK welcomed NICE's decision. Barbara Young, chief executive, said: "We are delighted that NICE have reconsidered their previous decision, and that this draft guidance recommends that Lucentis is made available on the NHS, as this would mean more people with diabetes would have a better opportunity to preserve and possibly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.”
Lucentis has been available to treat wet age-related macular degeneration since 2007.
Final guidance is expected to be published in February 2013.