Is Eylea (aflibercept) treatment medically necessary and considered standard of care for Diabetic Macular Edema?

Medical Necessity Assessment for Eylea in Non-Center-Involved Diabetic Macular Edema

This treatment is NOT medically necessary at this time, as the patient has non-center-involved diabetic macular edema with stable vision and the clinical documentation explicitly states "no treatment needed at this time, continue observation." 1

Critical Issues with This Authorization Request

1. Clinical Documentation Contradicts Treatment Request

The most recent office visit note directly states: "Non-central DME on exam/OCT OU with no treatment needed at this time. continue observation." This physician documentation contradicts the treatment order and raises serious questions about medical necessity. 1

The treating ophthalmologist's own assessment indicates observation rather than treatment is appropriate. This creates a fundamental conflict that must be resolved before authorization can proceed.

2. Non-Center-Involved DME Does Not Meet Standard Treatment Criteria

• Current guidelines specify that anti-VEGF therapy is indicated for center-involved diabetic macular edema, not non-center-involved DME. 1
• The American Diabetes Association 2023 Standards of Care explicitly state that intravitreal anti-VEGF agents provide effective treatment for "center-involved diabetic macular edema" and that eyes with good vision (20/25 or better) despite DME can be managed with close monitoring, with anti-VEGF therapy initiated only if vision worsens. 1
• The International Council of Ophthalmology guidelines recommend anti-VEGF therapy for center-involving DME with visual acuity 6/9 (20/30) or worse, while non-center-involved DME with better vision can be managed with focal/grid laser photocoagulation or observation with close monitoring. 1

3. Dosing Discrepancy Issue

While the dosing discrepancy (3 loading doses versus FDA-approved 5 loading doses) is noted, this is a secondary concern compared to the fundamental question of whether treatment is indicated at all. 2

• The FDA-approved dosing for diabetic macular edema is 2 mg every 4 weeks for the first 5 injections, followed by 2 mg every 8 weeks. 2
• The ordered regimen of 3 loading doses represents off-label dosing that deviates from the evidence-based protocol established in clinical trials. 2

When Anti-VEGF Treatment IS Medically Necessary for DME

To provide context for appropriate use, anti-VEGF therapy with aflibercept is medically necessary when: 1

• Center-involved diabetic macular edema is present (not documented in this case)
• Visual acuity is threatened or impaired (vision 20/30 or worse with center involvement)
• OCT demonstrates central macular thickening requiring intervention
• The patient has failed or is not a candidate for observation

Severe Nonproliferative Diabetic Retinopathy Consideration

The patient does have severe nonproliferative diabetic retinopathy (NPDR) in both eyes, which warrants discussion: 1

• The American Diabetes Association guidelines recommend prompt referral to an ophthalmologist for moderate or worse NPDR. 1
• Anti-VEGF treatment of eyes with non-proliferative diabetic retinopathy has been shown to reduce subsequent development of neovascularization and DME, but has not been shown to improve visual outcomes over 2 years and therefore is not routinely recommended for this indication. 1
• The appropriate management for severe NPDR without proliferative disease or center-involved DME is close monitoring (typically every 3 months or less), not prophylactic anti-VEGF therapy. 1

Recommendation

Deny authorization with request for clarification from the treating ophthalmologist regarding:

1. Why treatment is being ordered when the clinical note states "no treatment needed at this time"?
2. Is there center-involved macular edema that was not clearly documented in the OCT report?
3. What is the current best-corrected visual acuity in each eye?
4. Has the clinical situation changed since the documented visit?

If the ophthalmologist clarifies that center-involved DME is present with visual impairment, then treatment would be medically necessary, though the dosing regimen should follow FDA-approved protocols (5 loading doses, not 3). 2

The presence of vitreomacular traction in both eyes also warrants consideration of whether vitrectomy might be more appropriate than anti-VEGF monotherapy if treatment becomes necessary. 1