Medical Necessity of Eylea for Diabetic Macular Edema

Diagnosis and Treatment Criteria

The American Academy of Ophthalmology recommends intravitreal anti-VEGF treatment with aflibercept 2 mg for center-involving diabetic macular edema with associated vision loss, as it is considered standard of care 1, 3
Aetna's policy considers Eylea treatment medically necessary for patients with Type 2 diabetes mellitus with mild nonproliferative diabetic retinopathy with macular edema, who have demonstrated positive clinical response to therapy 1
The International Council of Ophthalmology guidelines support treatment interruption and reinitiation based on visual stability and OCT findings, allowing for flexible dosing regimens 4

The standard FDA-approved dosing for Eylea in diabetic retinopathy is 2 mg every 4 weeks for the first 5 injections, followed by 2 mg every 8 weeks, but the International Council of Ophthalmology guidelines acknowledge that different treatment regimens may be necessary 2, 4
The prescribed regimen of 2 mg every 6 weeks represents a modified dosing schedule that falls between the standard initial monthly dosing and the maintenance 8-week dosing, and is supported by the patient's documented clinical improvement 2
Regular monitoring with OCT is essential to evaluate treatment response and determine the need for continued therapy, and follow-up should occur every 1-3 months with consideration of anti-VEGF therapy 1, 4

Aetna considers continuation of aflibercept therapy medically necessary when the member has demonstrated a positive clinical response to therapy, defined as improvement or maintenance in best corrected visual acuity, or a reduction in the rate of vision decline or risk of more severe vision loss 2
The benefits of continuing the current effective regimen likely outweigh the theoretical risks of the non-standard dosing interval, and disrupting a treatment regimen that is showing positive results could potentially lead to disease progression and vision loss 1, 2, 4