NICE consults on dexamethasone intravitreal implant for the treatment of macular oedema secondary to retinal vein occlusion
In preliminary recommendations published today (8 February) NICE is asking Allergan for more information on its product dexamethasone (Ozurdex) intravitreal implant, for the treatment of macular oedema secondary to retinal vein occlusion (RVO).
The macula is the central part of the retina responsible for colour vision and perception of fine detail. Macular oedema is the collection of fluid in the retina at the macular area, which can lead to severe visual impairment in the affected eye. 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 hypertension, hyperlipidaemia, glaucoma, thrombophilia and diabetes. Macular oedema secondary to RVO is further divided into either branch retinal vein occlusion (BRVO) or central retinal vein occlusion (CRVO).
The dexamethasone implant is injected into the eye once every six months and works by suppressing inflammation.
The independent Appraisal Committee has requested additional information from the manufacturer on the clinical and cost effectiveness of dexamethasone intravitreal implant compared with bevacizumab (Avastin, Genentech/Roche).
The Committee also asks 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.
Dr Carole Longson, Health Technology Evaluation Centre Director at NICE said: "The Appraisal Committee recognises that for people living with RVO, poor vision can have a very significant impact on their everyday lives. From the evidence presented, however, it is not clear how clinically and cost-effective dexamethasone intravitreal implant is for treating this serious condition. The next step is for the manufacturer to respond to our comments and provide the information requested."
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 June 2011.
Notes to Editors
1. The appraisal consultation document can be found from Tuesday 8 February on the NICE website at: http://guidance.nice.org.uk/TA/Wave24/12
Closing date for comments is Tuesday 1 March.
2. After consultation the Appraisal Committee will meet again 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.
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 dexamethasone in the NHS in England and Wales. For further details, see the NICE website at: http://www.nice.org.uk/aboutnice/howwework/devnicetech/developing_nice_technology_appraisals.jsp
3. 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, fibrin deposition, capillary leakage and phagocytic migration.
4. 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).
5. The cost of a 700-microgram implant and applicator is £870.00 (MIMS, December 2010), 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.
6. 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.
7. 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.
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 through its 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.
 BRVO is caused by venous thrombosis at an arteriovenous crossing (where an artery and vein share a common lining of connective tissue).
 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.
 Bevacizumab is currently being used outside its licensed indication as a treatment for eye conditions by some NHS trusts as an alternative to ranibizumab (Lucentis), which is licensed for AMD and which NICE recommended for use in August 2008 (http://guidance.nice.org.uk/TA155).
 A fibrin is a protein that is produced in response to bleeding; it is the major component of the blood clot.
 A phagocytic is a white blood cell that protects the body from harmful material or bacteria.
 These changes trigger an increased amount of vascular endothelial growth factor (VEGF), which increases vascular permeability and new vessels developing.
This page was last updated: 10 February 2011