National Institute for Health and Clinical Excellence (NICE)
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NICE unable to recommend drug to treat diabetic macular oedema
In final draft guidance issued today (15 July), NICE has not recommended ranibizumab (Lucentis, Novartis) for the treatment of diabetic macular oedema (DMO).
The independent Appraisal Committee considered that the manufacturer's model underestimated the incremental cost-effectiveness ratio (ICER) 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 ICER that substantially exceeded the range that NICE considers represents an effective use of NHS resources. Therefore, ranibizumab could not be recommended as a treatment for people with DMO. People currently receiving ranibizumab for this indication should have the option to continue treatment until they or their doctors feel it is 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.
Commenting on the draft recommendations, Sir Andrew Dillon, Chief Executive at NICE said: "The independent Appraisal Committee was acutely aware that visual impairment can have a substantial negative impact on quality of life and activities of daily living in people with DMO, especially since it can affect people's ability to manage their diabetes. NICE already recommends ranibizumab for wet age-related macular degeneration, and although it has been shown in clinical trials to be an effective treatment for DMO, the Appraisal Committee was unable to recommend the drug as a cost-effective use of NHS resources compared to laser photocoagulation for this condition. The manufacturer's analysis produced a cost per QALY gained that was at the upper limit of the range NICE considers to represent an effective use of NHS resources. However, the Committee found that the manufacturer's analyses were based on implausible assumptions. The Committee considered that, had a more plausible set of assumptions been used, the resulting cost per QALY gained would substantially exceed this range.
He continued: "In particular, the Committee concluded that by not accounting in its submission for the need to treat both eyes in a proportion of people with DMO, the manufacturer significantly underestimated the cost of treatment. One of the other factors that the Committee was concerned about was 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. The Committee also considered that the amount of ranibizumab that people with diabetic macular oedema are likely to need over time was underestimated in the manufacturer's model and that the manufacturer's assumption that the benefits of ranizumab during the treatment phase continued indefinitely were unrealistic."
NICE has not yet issued final guidance to the NHS; registered stakeholders now have the opportunity to appeal against these draft recommendations and consequently they may change in the event of an appeal being received.
Until NICE issues final guidance, NHS bodies should make decisions locally on the funding of specific treatments. Once NICE issues its guidance on a technology it replaces local recommendations across the country.
Final guidance is expected to be published in August 2011.
About the appraisal
1. The final draft guidance will be available from Friday 15 July 2011 at: http://guidance.nice.org.uk/TA/Wave23/30
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.
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. NICE provides advice and support on putting NICE guidance and standards into practice throughits 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.