National Institute for Health and Clinical Excellence (NICE)
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NICE gives green light to dexamethasone for the treatment of common eye condition in draft guidance
It is also recommended following branch retinal vein occlusion (BRVO)ii when:
treatment with laser photocoagulationiii has not been beneficial, or
treatment with laser photocoagulation is not considered suitable because of the extent of macular haemorrhage.
The macular is the central part of the retina responsible for colour vision and perception of fine detail. Macular oedema is where fluid collects in the retina at the macular area, which can lead to severe visual impairment. Straight lines may appear wavy, and one may have blurred central vision or sensitivity to light.
Incidence of RVO increases with age. Other risk factors for RVO include high blood pressure, high cholesterol, glaucoma, thrombophiliaiv and diabetes.
The dexamethasone implant is injected into the eye once every six months and works by suppressing inflammation.
In its preliminary draft guidance on this appraisal, the NICE committee asked the manufacturer for additional information on the clinical and cost effectiveness of dexamethasone intravitreal implant compared with bevacizumab (Avastin, Genentech/Roche).
The Committee also asked for the submission of a revised base case for the cost effectiveness of dexamethasone, as well as further detail on the location and extent of macular haemorrhage for the subgroup of patients for whom laser treatment was not considered appropriate.
Professor Peter Littlejohns, Clinical and Public Health Director at NICE said: “After receiving the information requested from the manufacturer following the consultation, we are pleased to be able to recommend dexamethasone intravitreal implant for this condition. RVO can be very debilitating and have a very profound effect on everyday life so this draft decision will be welcome news to all those affected.”
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 likely to be published in July 2011.
Notes to Editors
1. Subject to any appeal by consultees, NICE will publish final guidance on the use of dexamethasone in the NHS in England and Wales. For further details on the development of NICE technology appraisals, see the NICE website at: http://www.nice.org.uk/aboutnice/howwework/devnicetech/developing_nice_technology_appraisals.jsp
2. Dexamethasone intravitreal implant (Ozurdex, Allergan) is a potent corticosteroid (a type of medication that contains steroids) that suppresses inflammation in the eye by inhibiting oedema, fibrinv deposition, capillary leakage and phagocyticvi migration.
3. Dexamethasone intravitreal implant has a marketing authorisation for the treatment of adult patients with macular oedema following either branch retinal vein occlusion (BRVO) or central retinal vein occlusion (CRVO).
4. The cost of a 700-microgram implant and applicator is £870.00 (BNF, edition 61), excluding VAT. One dexamethasone intravitreal implant is administered every 6 months in the affected eye and up to six implants may be given. Costs may vary in different settings because of negotiated procurement discounts.
5. No prevalence or incidence data has been identified for England and Wales; however a recent US study reported a 15 year incidence of 500 new cases per 100,000 population for CRVO and 1800 cases per 100,000 population for BRVO.
6. 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 capillariesvii.
i. 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.
ii. BRVO is caused by venous thrombosis at an arteriovenous crossing (where an artery and vein share a common lining of connective tissue).
iii. Laser photocoagulation is a type of surgery whereby a laser is used to finely cauterize blood vessels in the eye.
iv. Thrombophilia is a condition where the blood has an increased tendency to form clots. Blood clots can cause problems such as deep vein thrombosis (DVT) or pulmonary embolus (PE).
v. A fibrin is a protein that is produced in response to bleeding; it is the major component of the blood clot.
vi. A phagocytic is a white blood cell that protects the body from harmful material or bacteria.
vii. These changes trigger an increased amount of vascular endothelial growth factor (VEGF), which increases vascular permeability and new vessels developing.
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
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