1 Recommendations

1 Recommendations

1.1 Fluocinolone acetonide intravitreal implant is not recommended as an option for treating chronic diabetic macular oedema that is insufficiently responsive to available therapies in an eye with a natural lens (phakic eye).

1.2 This recommendation is not intended to affect treatment with fluocinolone acetonide intravitreal implant that was started in the NHS before this guidance was published. People 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.

Why the committee made these recommendations

Treatments for untreated chronic diabetic macular oedema include laser therapy and anti-vascular endothelial growth factors (VEGFs). There are no further treatment options for eyes with a natural lens (phakic eyes).

The company submitted evidence for people with phakic eyes and symptomatic cataracts. Clinical trial evidence compares the effectiveness of fluocinolone acetonide intravitreal implant and sham in people with chronic diabetic macular oedema who already had at least 1 laser treatment. Only very few people had anti‑VEGFs before the trial and few people had phakic eyes with symptomatic cataracts. Also, non-comparative studies used to support the company's submission only include few people with phakic eyes and symptomatic cataract. No other data for this group have been identified. This makes it difficult to establish if fluocinolone acetonide intravitreal implant works better than usual care for these people, especially in the long term.

Because of the lack of clinical evidence, the cost-effectiveness estimates for fluocinolone acetonide intravitreal implant are also uncertain. Even the lowest clinically plausible cost-effectiveness estimates are substantially higher than what NICE normally considers an acceptable use of NHS resources. Therefore, fluocinolone acetonide intravitreal implant is not recommended for treating chronic diabetic macular oedema that is insufficiently responsive to available therapies in an eye with a natural lens (phakic eye).

  • National Institute for Health and Care Excellence (NICE)