The National Institute for Health and Care Excellence has preliminary support for two new options for the treatment of diabetic macular oedema.
Diabetic macular oedema is caused when blood vessels abnormally form under the retina and then begin to break down causing plasma to leak into the eye.
The leakage is due to a reduction in the amount of connective tissues around the blood vessels and an increased amount of vascular endothelial growth factor. The resulting oedema can lead to severe visual impairment.
In draft guidance, published today, aflibercept (Eylea) is recommended by NICE where the eye has a central retinal thickness of 400 micrometres or more at the start of treatment.
“Diabetic macular oedema is a common problem among people with diabetes”
It is a vascular endothelial growth factor inhibitor that prevents abnormal new blood vessels from forming under the retina and also helps treat swelling in the retina caused by the oedema.
The drug is administered as a single 2mg intravitreal injection, with each vial containing a single dose. The list price is £816 per vial (excluding VAT).
Its manufacturer, Bayer, has agreed a patient access scheme with the Department of Health. However, the level of the discount is “commercial in confidence”, said NICE.
Dr Carole Longson, director of NICE’s Health Technology Evaluation Centre, said: “The manufacturer has agreed a patient access scheme which reduces the financial burden of aflibercept on the NHS.
“NICE is, therefore, pleased to recommend aflibercept as an additional treatment option for some people with diabetic macular oedema in preliminary guidance,” she said.
The preliminary draft guidance on the drug is published today on the NICE website. Final guidance is expected to be published in June 2015.
NICE has also given its initial backing to dexamethasone (Ozurdex) intravitreal implants for the treatment of the same condition.
The draft guidance recommends dexamethasone as a treatment option in people only where the implant is to be used in an eye with an intraocular (pseudophakic) lens, and the oedema does not respond to non-corticosteroid treatment or such treatment is unsuitable for them.
The dexamethasone intravitreal implant is injected into the eye once every six months, and works by suppressing inflammation and preventing oedema forming in the eye.
It reduces plasma leakage from blood vessels and inhibits the release of inflammatory compounds. The cost of a 700mcg implant and applicator is £870, excluding VAT.
Dr Longson described diabetic macular oedema as a “common problem among people with diabetes”.
It affects around 189,000 people with diabetes in the UK, 39% of whom are eligible for the treatment because they have clinically significant macular oedema.