Economic evaluation of a fluocinolone acetonide intravitreal implant for patients with DME based on the FAME study.
BACKGROUND
Diabetic macular edema (DME) is the most common cause of visual impairment in patients with diabetes. DME is a complex disease characterized by the deposition of fluid and proteins within the intraretinal layers, and the disease is recognized as being mediated by multiple cytokines, requiring a multifactorial therapeutic approach. Iluvien (fluocinolone acetonide intravitreal implant) 0.19 mg contains a corticosteroid, fluocinolone acetonide [FAc], and is indicated for the treatment of DME in patients who have been previously treated with a course of corticosteroids and did not have a clinically significant rise in intraocular pressure.


METHODS
A Markov model was constructed in Microsoft Excel with a 15-year time horizon comparing the healthcare and productivity costs with health outcomes from treatment. The model was structured around 13 best corrected visual acuity states using Early Treatment Diabetic Retinopathy Study scores. Observations and extrapolations from the Fluocinolone Acetonide for Diabetic Macular Edema study were applied to determine observed and ongoing treatment effects.


RESULTS
The expected incremental cost-effectiveness ratio for treatment with an FAc implant is $38,763, assuming 40% of patients are treated unilaterally; when 100% of patients receive unilateral treatment with an FAc implant, it is cost-saving.


CONCLUSIONS
Administering an FAc implant to patients with DME previously treated with a corticosteroid is a cost-effective treatment option for ophthalmologists.
Antonio
A
Cutino
Kenneth
K
Green
Robyn
R
Kendall
Peter T
PT
Moore
Alimera Sciences, 6120 Windward Parkway, Ste 290, Alpharetta, GA 30005. E-mail: Christopher.Zachary@alimerasciences.com.
Christopher
C
Zachary
D000893:Anti-Inflammatory Agents / Q000191:economics / Q000627:therapeutic use*; D017326:Clinical Trials, Phase III as Topic; D003362:Cost-Benefit Analysis; D003930:Diabetic Retinopathy / Q000150:complications / Q000188:drug therapy* / Q000191:economics; D004343:Drug Implants; D005446:Fluocinolone Acetonide / Q000191:economics / Q000627:therapeutic use*; D006801:Humans; D058449:Intravitreal Injections; D008269:Macular Edema / Q000188:drug therapy* / Q000191:economics / Q000209:etiology; D008390:Markov Chains; D019057:Quality-Adjusted Life Years; D016032:Randomized Controlled Trials as Topic; D014481:United States
D000893:Anti-Inflammatory Agents; D004343:Drug Implants; D005446:Fluocinolone Acetonide