The UK National Institute for Health and Clinical Excellence (NICE) has not recommended a fluocinolone acetonide intravitreal implant (Illuvien, Alimera Sciences, Alpharetta, Georgia, USA) for individuals with diabetic macular edema who do not respond to existing therapies.
The decision was made on cost implications, with NICE's independent Appraisal Committee concluding that the most plausible incremental cost-effectiveness ratio (ICER) for the implant compared with current available treatments was at least £ 47,600 (US$ 76,350; € 58,677) per quality-adjusted life year (QALY).
QALY's take into account disease burden in addition to the quality and quantity of life lived.
Andrew Dillon (NICE, London, UK) said in a press release that the Committee is aware of the "significant impact" that macular edema can have on those with the condition and their carers.
"However, when NICE recommends any drug or treatment, we have to be sure that it is both clinically and cost effective, because money has to be diverted from elsewhere in the health service to pay for it."
Fluocinolone acetonide intravitreal implant is a corticosteroid with anti-inflammatory and antivascular endothelial growth factor properties, explains the NCIE final appraisal. Only patients with diabetic macular edema who have not responded to laser photocoagulation or other therapies should receive it.
In addition to the cost implications, NICE also maintains that the manufacturer of the implant has not taken into account the potential negative side effects of the treatment, which include cataract, increased intraocular pressure, floaters, retinal detachment, and glaucoma, and the associated costs of these comorbidities.
The manufacturer provided further evidence to the Committee involving a subgroup of individuals who had already undergone operation for cataract removal, and had been fitted with an intraocular lens. The results indicated further benefits of treatment in this population since a known adverse event was in effect, removed, maintained the company.
However, the most plausible ICER for this group was £ 29,700-50,600 (US$ 47,640-81,160; € 36,611-62,375) per QALY gained, and therefore the technology was not recommended in this population either.
"The Committee concluded that the evidence provided did not show that the benefits fluocinolone intravitreal implant provides to patients justify the price the NHS [National Health Service] is being asked to pay," concluded Dillon.
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