NICE consults on ranibizumab for macular oedema
In preliminary recommendations published today (24 November) by NICE, ranibizumab (Lucentis, Novartis) is not recommended for the treatment of visual impairment caused by macular oedema secondary to central or branch retinal vein occlusion.
This is the second appraisal of a treatment for this condition that NICE has consulted on this year: In July 2011 NICE published final guidance recommending dexamethasone intravitreal implant for the treatment of macular oedema caused by retinal vein occlusion.
The macula is the central part of the retina responsible for seeing colour and fine detail. Macular oedema occurs when fluid collects in the retina at the macular area, which can lead to severe visual impairment in the affected eye. Straight lines may appear wavy, and people can have blurred central vision or sensitivity to light. A reduction in the number of connective tissues around the capillaries and an increased amount of a protein called vascular endothelial growth factor (VEGF) causes the blood retinal barrier to become porous. This leads to leakage of plasma in the surrounding retina, causing a build-up of excess fluid (oedema) which disrupts the fovea, the area of the eye responsible for sharp vision.
Incidence of RVO increases with age. Other risk factors for RVO include high blood pressure, hyperlipidaemiai, glaucomaii, thrombophiliaiii and diabetes. Macular oedema secondary to RVO is further divided into either branch retinal vein occlusion (BRVO)iv or central retinal vein occlusion (CRVO)v.
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 and/or improve vision.
The independent Appraisal Committee concluded that ranibizumab could not be recommended because of gaps and uncertainties in the evidence on the effectiveness of ranibizumab compared with other treatments currently used in the UK. The Committee also concluded that the analysis provided by the manufacturer was not a true reflection of clinical practice or the efficacy of ranibizumab.
The Committee considered that the manufacturer's model underestimated the incremental cost-effectiveness ratio (ICER) for ranibizumab compared with standard care. It concluded that a model that relied on more plausible assumptions would be certain to produce an ICER that exceeded the range that NICE considers an effective use of NHS resources.
Dr Carole Longson, Health Technology Evaluation Centre Director at NICE said: "The independent Appraisal Committee recognises the profound effect that RVO can have on everyday life. However, in order for NICE to recommend any drug or technology, we have to be sure that it is both clinically effective and good value for money. NICE has recently recommended dexamethasone as a clinically and cost effective treatment for this indication, but the evidence presented for ranibizumab did not support a positive recommendation for this condition. These draft recommendations are now available for public consultation, and the manufacturer and other consultees have the opportunity to respond to concerns and comments made by the Appraisal Committee."
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 likely to be published in March 2012.
Notes to Editors
i. Hyperlipidaemia occurs when there is an excessively high level of lipids / fats in the blood.
ii. Glaucoma is the name given to a group of eye conditions which cause optic nerve damage that affects vision.
iii. Thrombophilia is a condition in which the blood has an increased tendency to form clots.
iv. BRVO is caused by venous thrombosis at an arteriovenous crossing (where an artery and vein share a common lining of connective tissue).
v. CRVO results from thrombosis of the central retinal vein where it passes through the back of the optic nerve through a mesh-like structure called the lamina cribrosa.
About the guidance
1. The appraisal consultation document can be found from Thursday 24 November on the NICE website at: http://guidance.nice.org.uk/TA/Wave23/26
Please contact the press office for an embargoed copy.
Closing date for comments is Thursday 15 December.
2. After consultation the Appraisal Committee will meet again (Tuesday 10 January 2012) to consider the evidence, this appraisal consultation document and comments from the consultees. At that meeting, the Committee will also consider comments made by people who are not consultees.
3. After considering these comments, the Committee will prepare the final appraisal determination (FAD). Subject to any appeal by consultees, NICE will produce final guidance on the use of ranibizumab in the NHS in England and Wales. For further details, see the webpage on developing NICE technology appraisals.
4. Ranibizumab (Lucentis, Novartis) belongs to a class of drugs that block the action of vascular endothelial growth factor A (VEGF-A).
5. Ranibizumab has a marketing authorisation for ‘the treatment of visual impairment due to macular oedema secondary to retinal vein occlusion (branch RVO or central RVO)'. For more details see the summary of product characteristics (SPC).
6. Ranibizumab is administered as a single intravitreal injection of 0.5 mg. Each vial of ranibizumab contains 2.3 mg in 0.23 ml. Ranibizumab costs £742.17 per vial (excluding VAT; this represents a recent reduction from the price of £761.20 listed in the current 'British national formulary' [BNF] edition 61).
7. The manufacturer of ranibizumab has agreed a patient access scheme with the Department of Health, in which a discount on the list price of ranibizumab is offered. The size of the discount is commercial-in-confidence.
8. RVO is a common cause of reduced vision due to retinal vascular disease. It is classified into BRVO and CRVO. Thrombosis of the retinal veins causes an increase in retinal capillary pressure, resulting in the capillaries being more permeable, and the discharge of blood and plasma into the retina. This leads to the development of macular oedema and varying levels of ischaemia (a restriction in blood supply) through non-perfusion of capillaries. These changes trigger an increased amount of vascular endothelial growth factor (VEGF), which increases vascular permeability and new vessels developing.
9. The published NICE guidance on dexamethasone can be found here: http://guidance.nice.org.uk/TA229
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This page was last updated: 23 November 2011