Log in or register to see all Alerts
New HTA Decisions in England
June 2020
Drug name
ILUVIEN® (fluocinolone acetonide intravitreal implant)
Company
Alimera Sciences
Decision date
17/10/2019
Therapeutic area
Eye conditions
Therapeutic sub area
Macular oedema and retinal vein occlusion
Decision
Not recommended
Indication
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).
Decision Detail
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.
Summary
The clinical evidence for fluocinolone acetonide intravitreal implant came from 2 phase 3 randomised sham-injection controlled trials that were analysed as 1 trial (FAME). 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. The committee concluded that there were not enough data to establish if fluocinolone acetonide intravitreal implant worked better than usual care in phakic eyes with symptomatic cataract. The committee understood that there is limited non-comparative evidence for phakic eyes with symptomatic cataract therefore it concluded that it is difficult to establish whether fluocinolone acetonide intravitreal implant works better than usual care in this group. The ICERs are therefore highly uncertain, and there is no single most plausible ICER, but all plausible ICERs exceed £30,000 per quality-adjusted life year (QALY) gained. The committee did not recommend fluocinolone acetonide intravitreal implant for treating chronic diabetic macular oedema that is insufficiently responsive to available therapies if the implant is to be used in an eye with a natural lens (phakic eye).