Diabetic macular oedema treatment not a good use of NHS resources
In final guidance issued today (30 November), NICE, the healthcare guidance body, has not recommended ranibizumab (Lucentis, Novartis) for the treatment of diabetic macular oedema (DMO).
The independent Appraisal Committee concluded that the evidence presented by the manufacturer 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, which uses heat to seal ocular blood vessels. It 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. Therefore, NICE has not recommended ranibizumab as a treatment for people with DMO. People currently receiving ranibizumab for this indication should have the option to continue treatment until they and their clinicians feel it appropriate to stop.
The macula is the central part of the retina responsible for colour vision and perception of fine detail. DMO occurs as a result of changes in retinal blood vessels in people with diabetes. A reduction in the number of connective tissues around capillaries and an increased amount of a protein called vascular endothelial growth factor (VEGF) causes increased permeability of the blood retinal barrier. This leads to leakage of plasma constituents in the surrounding retina, causing a build-up of excess fluid (oedema) which disrupts the fovea, the area responsible for sharp vision. It can lead to severe visual impairment in the affected eye.
Ranibizumab, which is given by injection into the eye, works by preventing the production of VEGF. By inhibiting VEGF, ranibizumab can decrease the oedema and limit visual loss or improve vision.
Sir Andrew Dillon, Chief Executive at NICE 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. The manufacturer's analysis produced a cost per quality-adjusted life year gained that was at the higher end of what NICE considers to represent an effective use of NHS resources. But the Committee concluded that the manufacturer's analyses were based on implausible assumptions, and that had a more plausible set of assumptions been used, the resulting cost per quality-adjusted life year gained would have exceeded this range.
He continued: "In particular, 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. 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."
NICE has now issued final guidance to the NHS; once NICE issues its guidance on a technology it replaces local recommendations across the country.
Notes to Editors
About the appraisal
1. The final guidance will be available from Wednesday 30 November 2011.
Please contact the press office for an embargoed copy.
2. Ranibizumab costs £742.17 per injection. Treatment is given monthly and continued until a patient achieves maximum vision (visual acuity) - that is, the patient's visual acuity is stable over three consecutive monthly assessments performed while on ranibizumab treatment. Treatment may be resumed when monitoring indicates a loss of visual acuity.
3. The final appraisal determination decision published in July 2011 was appealed by 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. The appeal was heard on Tuesday 4 October 2011 and was rejected on all points.
1. The National Institute for Health and Clinical Excellence (NICE) is the independent organisation responsible for providing national guidance and standards on the promotion of good health and the prevention and treatment of ill health.
2. NICE produces guidance in three areas of health:
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health technologies - guidance on the use of new and existing medicines, treatments, medical technologies (including devices and diagnostics) and procedures within the NHS
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3. NICE produces standards for patient care:
quality standards - these reflect the very best in high quality patient care, to help healthcare practitioners and commissioners of care deliver excellent services
Quality and Outcomes Framework - NICE develops the clinical and health improvement indicators in the QOF, the Department of Health scheme which rewards GPs for how well they care for patients.
4. NICEprovides advice and support on putting NICE guidance and standards into practice through its implementation programme, and it collates and accredits high quality health guidance, research and information to help health professionals deliver the best patient care through NHS Evidence.
This page was last updated: 29 November 2011