In new draft guidance issued today (5 October) for consultation, NICE, the healthcare guidance body, has recommended ranibizumab (Lucentis, Novartis) as an option for treating visual impairment caused by diabetic macular oedema (DMO). NICE conducted a rapid review of the original guidance, published in November 2011, because the manufacturer submitted a revised Patient Access Scheme, together with updated analyses including the drug's superior relative effect among a sub-group of people with DMO.

Ranibizumab is recommended as an option for treating diabetic macular oedema only if:

• people have a central retinal thickness of 400 micrometres or more, and
• the manufacturer provides ranibizumab with the discount agreed as part of the patient access scheme (as revised in 2012).

People currently receiving ranibizumab whose disease does not meet these criteria should be able to continue therapy until they and their clinician consider 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.

Professor Carole Longson, Health Technology Evaluation Centre Director at NICE said: "Our current guidance on the use of ranibizumab for treating visual impairment caused by diabetic macular oedema, published in November 2011, does 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 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. This draft guidance recommending ranibizumab for some patients with diabetic macular oedema is now available for consultation."

NICE has not yet issued final guidance to the NHS; these decisions may change after consultation.

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 February 2013.

Ends

Notes to Editors

About the appraisal

1. The draft guidance (appraisal consultation document /ACD) will be available from 00:01hrs, Friday 5 October 2012 at: TA274

Embargoed copies are available on request; please contact the press office.

Closing date for comments is Friday 26 October 2012.

The second appraisal committee meeting will take place in November 2012.

Final guidance is expected to publish inFebruary 2013.

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 manufacturer of ranibizumab, Novartis, has agreed a patient access scheme with the Department of Health which makes ranibizumab available with a discount applied to all invoices. The size of the discount is commercial in confidence. Novartis has agreed that the patient access scheme will remain in place until any review of this NICE technology appraisal guidance is published.

4. NICE published guidance (TA237) in November 2011 not recommending ranibizumab for diabetic macular oedema. Please see link: /Guidance/TA237/firstchapter

5. Further information on the rapid review process is given in the NICE Single Technology Appraisal process guide, sections 5. 11 and 5.12 at: /proxy/?sourceUrl=http%3a%2f%2fwww.nice.org.uk%2fmedia%2f42D%2fB3%2fSTAGuideLrFinal.pdf

Until final guidance is published, the current guidance on ranibizumab, TA237, is applicable.

About NICE

1. The National Institute for Health and Care 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:

• public health - guidance on the promotion of good health and the prevention of ill health for those working in the NHS, local authorities and the wider public and voluntary sector
• health technologies - guidance on the use of new and existing medicines, treatments, medical technologies (including devices and diagnostics) and procedures within the NHS
• clinical practice - guidance on the appropriate treatment and care of people with specific diseases and conditions within the NHS.

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.