NICE gives green light to ranibizumab for diabetic macular oedema in final guidance after rapid review
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.
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.
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This page was last updated: 27 February 2013