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New HTA Decisions in England
November 2019
Drug name
ILUVIEN (fluocinolone acetonide intravitreal implant)
Alimera Sciences
Decision date
Therapeutic area
Eye conditions
Therapeutic sub area
Eye conditions: general and other
Within its marketing authorisation, as an option for preventing relapse in recurrent non-infectious uveitis affecting the posterior segment of the eye.
Decision Detail
It is recommended only if the company provides it according to the commercial arrangement.
The clinical evidence was presented from the PSV-FAI-001 trial, a multicentre, randomised, double-blind trial in patients with chronic non-infectious uveitis affecting the posterior segment of the eye. It compared the fluocinolone acetonide implant with a sham injection. Patients in both treatment groups could have 'limited current practice': this was the corticosteroids and immunosuppressants that they had been having before enrolling in the trial but tapered off within the first 3 months. Other than treatments that were being tapered off, patients could not have corticosteroids or immunosuppressants until their uveitis recurred. This meant that after 3 months and before recurrence, people in the control group had no treatment. Additionally, before recurrence in the trial, trial investigators were encouraged to use systemic treatment only after local treatment had failed. The committee concluded that treatment in the trial may not fully reflect NHS clinical practice in England, for example clinical experts had confirmed that systemic treatment may be given first for bilateral or systemic disease. Additionally, the trial didn't directly measure health-related quality of life and the number of recurrences reported may be overestimated as recurrence was assumed for patients who had missing data for the required eye examinations, or who had local or systemic treatments that were prohibited as part of the trial. The cost-effectiveness estimates are also uncertain, for example the committee considered that although the company's updated ICERs were within the range normally considered to represent cost-effective technologies, they were associated with a high degree of uncertainty because of the method used to incorporate the dexamethasone implant as a comparator. However, if all the most plausible assumptions had been included in the model, most of the cost-effectiveness estimates would be within the range that NICE normally considers a cost-effective use of NHS resources, so the fluocinolone acetonide implant is recommended.