1.1 Dexamethasone intravitreal implant is recommended as an option for treating visual impairment caused by diabetic macular oedema in adults only if their condition has not responded well enough to, or if they cannot have non-corticosteroid therapy.
1.2 This recommendation is not intended to affect treatment with dexamethasone intravitreal implant that was started in the NHS before this guidance was published. Adults having treatment outside this recommendation may continue without change to the funding arrangements in place for them before this guidance was published, until they and their NHS clinician consider it appropriate to stop.
This technology appraisal is a partial review of NICE's technology appraisal guidance on dexamethasone intravitreal implant for treating diabetic macular oedema (TA349) which recommended its use for people who have a pseudophakic (intraocular) lens and whose condition did not respond well enough to, or who could not have non-corticosteroid therapy. This partial review specifically considers people with diabetic macular oedema with a phakic (natural) lens and whose condition did not respond well enough to, or who could not have non-corticosteroid therapy. This final draft guidance from NICE means that dexamethasone intravitreal implant is recommended for treating visual impairment due to diabetic macular oedema only if the diabetic macular oedema has not responded well enough to non-corticosteroids, or non-corticosteroids are unsuitable, irrespective of whether they have a phakic or pseudophakic lens. TA349 has been updated and replaced by this guidance at publication. The considerations below refer only to evidence covered by the partial review.
Why the committee made these recommendations
Standard care for people with diabetic macular oedema who still have a natural lens (phakic) is anti-vascular endothelial growth factor (anti-VEGF) treatments (such as ranibizumab or aflibercept), or laser monotherapy. If non-corticosteroids do not work well enough, people can keep having anti-VEGFs or laser monotherapy. In people with a phakic lens and diabetic macular oedema who cannot have non-corticosteroid therapy, watch and wait is the only available treatment option.
Clinical trial evidence shows that dexamethasone intravitreal implant is more effective than a sham (inactive) procedure. The sham procedure may be considered as a proxy for continued anti-VEGF therapies. The resulting cost-effectiveness estimates for dexamethasone intravitreal implant compared with anti-VEGF therapy are likely to be within what NICE normally considers an acceptable use of NHS resources. Although no cost-effectiveness evidence was presented for people for whom non-corticosteroids are unsuitable, the committee considered the equalities issues, the unmet need, and the size of the population, and agreed that the risk to the NHS was low, and therefore it is recommended.