Fluocinolone acetonide intravitreal implant is recommended, within its marketing authorisation, as an option for treating visual impairment caused by chronic diabetic macular oedema that has not responded well enough to available treatments in adults. It is recommended only if the company provides it according to the commercial arrangement.
For people with the condition in an eye with a natural (phakic) lens, if the person and their clinicians consider fluocinolone acetonide intravitreal implant to be 1 of a range of suitable treatments, after discussing the advantages and disadvantages of all the options, use the least expensive. Take account of administration costs, dosage, price per dose, duration of effect and commercial arrangements.
Why these recommendations were made
This evaluation is a review of NICE technology appraisal guidance on fluocinolone acetonide intravitreal implant for treating chronic diabetic macular oedema in phakic eyes after an inadequate response to previous therapy (TA613). The new recommendation merges the outcome of the review for treating chronic diabetic macular oedema in eyes with a phakic (natural) lens, with the recommendation from NICE technology appraisal guidance on fluocinolone acetonide intravitreal implant for treating chronic diabetic macular oedema after an inadequate response to prior therapy in people with a pseudophakic (artificial) lens (TA301).
Usual treatment for visual impairment caused by diabetic macular oedema that has not responded well enough to available treatments in eyes with a phakic lens is dexamethasone intravitreal implant. Fluocinolone acetonide and dexamethasone are both corticosteroid treatments. Fluocinolone acetonide intravitreal implant works in a similar way to dexamethasone intravitreal implant, and would be offered to the same population. Fluocinolone acetonide is released from the implant for up to 36 months, whereas dexamethasone is released over 6 months. So, fluocinolone acetonide intravitreal implant needs to be replaced less frequently than dexamethasone intravitreal implant.
Clinical trial evidence suggests that fluocinolone acetonide intravitreal implant is more effective than a sham (inactive) procedure. Evidence from people having fluocinolone acetonide intravitreal implant in clinical practice supports the trial evidence that it is clinically effective. Fluocinolone acetonide intravitreal implant has not been directly compared in a clinical trial with dexamethasone intravitreal implant. But indirect comparisons suggest that it is likely to work as well as dexamethasone intravitreal implant.
A cost comparison suggests fluocinolone acetonide intravitreal implant has lower costs than dexamethasone intravitreal implant for treating diabetic macular oedema in eyes with a phakic lens. For the evidence for this review, see the TA953 committee papers. To see what NICE did for dexamethasone intravitreal implant see the committee discussion section in NICE's technology appraisal guidance on dexamethasone intravitreal implant for treating diabetic macular oedema.
NICE TA301 recommended fluocinolone acetonide intravitreal implant as an option for treating chronic diabetic macular oedema in eyes with a pseudophakic lens. The cost-effectiveness estimates for eyes with a pseudophakic lens are within the range that NICE considers an acceptable use of NHS resources. For the evidence for TA301, see the TA301 manufacturer's submission and committee papers.
So, fluocinolone acetonide intravitreal implant is recommended for treating visual impairment caused by chronic diabetic macular oedema, irrespective of the type of lens.