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NICE approves two new treatments for diabetic macular oedema

NICE has recommended two new treatments for diabetic macular oedema (DMO): Bayer’s Eylea (aflibercept) solution for injection and Allergan’s Ozurdex (dexamethasone) intravitreal implant.

NICE has recommended two new treatments for diabetic macular oedema (DMO): Bayer’s Eylea (aflibercept) solution for injection and Allergan’s Ozurdex (dexamethasone) intravitreal implant.

Aflibercept is a vascular endothelial growth factor (VEGF) inhibitor that prevents abnormal new blood vessels from forming under the retina and helps treat swelling in the retina caused by DMO. It is administered as a single 2-mg intravitreal injection every month for 5 consecutive months, followed by one injection every 2 months, with no requirement for monitoring between injections. After the first year, the treatment interval may be extended based on visual and anatomic outcomes.

Each vial of aflibercept contains a single dose. The list price is £816.00 per vial (excluding VAT). The manufacturer has agreed a patient access scheme with the Department of Health. This scheme provides a simple discount to the list price of aflibercept, with the discount applied at the point of purchase or invoice. NICE has recommended the agent in people with a central retinal thickness of ≥400 μm at the start of treatment, as long as the discount from the patient access scheme is applied.

The dexamethasone implant is injected into the eye, with each implant delivering around 700 μg of dexamethasone over a period of 6 months or more. All patients should be monitored during this time. The implant remains in the vitreous for up to 270 days before fully dissolving. After initial treatment, re-treatment can be performed after approximately 6 months if the patient experiences decreased vision with or without an increase in retinal thickness with recurrent or worsening DMO. There is currently no experience of the efficacy or safety of repeat administrations in DMO beyond seven implants.

Each implant and applicator costs £870.00 (excluding VAT). Costs may vary in different settings because of negotiated procurement discounts. The device has a marketing authorisation in the UK for the treatment of adults with visual impairment due to DMO who are pseudophakic or who are considered insufficiently responsive to, or unsuitable for, non-corticosteroid therapy.

These approvals add two more treatment options to the two that are currently available, ranibizumab (Lucentis, Novartis) and the fluocinolone acetonide implant Retisert (Bausch & Lomb).

The full guidance on Eylea can be read here.

The full guidance on Ozurdex can be read here.

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