In final guidance issued today (27 February), NICE 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 showing the drug's superior relative effect among a sub-group of people with DMOⁱ.

Ranibizumab is now recommended as an option for treating visual impairment due to diabetic macular oedema only 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.

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: "NICE is pleased to recommend ranibizumab as a treatment option for some people with visual impairment caused by diabetic macular oedema. 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."

This is NICE's final guidance on this technology and now replaces local recommendations across the country.

Ends

Notes to editors

References and explanation of terms

i. In people with thicker retinas(greater than 400 micrometres), ranibizumab is more effective when compared with laser photocoagulation treatment in people with thinner retinas.

About the appraisal

1. The final guidance will be available on the NICE website from 00:01 hrs on Wednesday 27 February.

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

2. The British National Formulary (BNF; edition 64) states that the list price of ranibizumab is £742.17 per vial excluding VAT. 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 caused by DMO.

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. The Committee understood from the manufacturer's evidence that gains in visual acuity associated with ranibizumab were greatest in participants with thicker retinas and more severe visual impairment at baseline. In particular, it noted the manufacturer's suggestion that ranibizumab could be expected to have a superior relative effect among people with central retinal thickness greater than 400 micrometres. Therefore, the Committee concluded that ranibizumab has a significantly greater relative effect in this subgroup of people.

5. The Committee concluded that the most plausible ICER for the subgroup of people with thicker retinas was likely to be higher than the manufacturer's estimate, but would be under £25,000 per QALY gained and could, therefore, be considered an effective use of NHS resources in people with a central retinal thickness of 400 micrometres or more at the start of treatment.

6. NICE previously published guidance (TA237) in November 2011 not recommending ranibizumab for diabetic macular oedema.

7. Further information on the rapid review process is given in the NICE Single Technology Appraisal process guide, sections 5. 11 and 5.12.

8. Ranibizumab is accepted for restricted use within NHS Scotland for the treatment of visual impairment due to diabetic macular oedema (DMO) in adults.

9. NICE published guidance (TA271) in January 2013 not recommending fluocinolone acetonide intravitreal implant for the treatment of diabetic macular oedema.

10. NICE technology appraisals apply in England and Wales and are usually disseminated in Northern Ireland after local review.

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
• social care - the Health and Social Care Act (2012) sets out a new responsibility for NICE to develop guidance and quality standards for social care. To reflect this new role, from 1 April 2013 NICE will be called the National Institute for Health and Care Excellence (NICE) and it will become a Non-Departmental Public Body.

3. NICE produces standards for patient care:

• quality standards - these describe high-priority areas for quality improvement in a defined care or service area
• 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
• CCG Outcomes Indicator Set(formerly known as COF) - NICE develops the potential clinical health improvement indicators to ensure quality of care for patients and communities served by the clinical commissioning groups (CCGs).

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.