U-turn on diabetic eyesight drug
In final draft guidance, NICE recommends ranibizumab (Lucentis) for diabetic macular oedema
4th January 2013 - In final draft guidance the National Institute for Health and Clinical Excellence (NICE) has recommended that ranibizumab (Lucentis) is available on the NHS in England and Wales as an option for treating visual impairment caused by diabetic macular oedema (DMO). It follows a rapid review of the original guidance because the manufacturer submitted updated analyses on the drug's effects and agreed a confidential patient access scheme with the Department of Health which makes ranibizumab available with a discount.
Professor Carole Longson, health technology evaluation centre director at NICE says in a press statement: "In November 2011, NICE published guidance which did not recommend the drug as an effective use of NHS resources. However, following the submission of a revised patient access scheme, we have conducted a rapid review of the original guidance. The manufacturer also included updated analyses showing that ranibizumab could be expected to have a superior relative effect among people with central retinal thickness greater than 400 micrometres."
Diabetic macular oedema
According to the International Diabetes Federation approximately 14% of people with diabetes have diabetic macular oedema and prevalence increases to 29% for people with diabetes who use insulin for more than 20 years.
The macula is the central part of the retina responsible for colour vision and perception of fine detail. DMO occurs as a result of swelling in the macula, one of the areas of the retina. It can lead to severe visual impairment in the affected eye.
Ranibizumab, is given by injection into the eye. It works by preventing the production of a protein called vascular endothelial growth factor (VEGF) which causes increased permeability of the blood retinal barrier. By inhibiting VEGF, ranibizumab can decrease the swelling and limit visual loss or improve vision.
According to the manufacturer’s evidence gains in clearness of vision associated with ranibizumab were greatest in participants with thicker retinas and more severe visual impairment.
According to the draft guidance, ranibizumab is now recommended as an option for treating visual impairment due to diabetic macular oedema if:
- The eye has a central retinal thickness of 400 micrometres or more at the start of treatment and
- The manufacturer provides ranibizumab with the discount agreed in the patient access scheme (as revised in 2012).
People currently receiving ranibizumab whose disease does not meet the above criteria should be able to continue treatment until they and their clinician consider it appropriate to stop.
Final NICE guidance is expected to be published in February 2013.
Barbara Young, Chief Executive of Diabetes UK, says in an emailed comment: "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."