Is Eylea HD (aflibercept) medically necessary and appropriate for the treatment of diabetic macular edema and diabetic retinopathy?

Medical Necessity Assessment for Eylea HD in Diabetic Macular Edema and Diabetic Retinopathy

Eylea HD treatment to the right eye is medically necessary and meets standard of care criteria, while treatment to the left eye requires careful consideration based on disease severity and visual acuity status.

Right Eye (OD) - Treatment is Medically Necessary

Clinical Justification

• The right eye demonstrates clinically significant macular edema with central retinal vein occlusion (CRVO) and cystoid macular edema, with foveal thickness of 208 microns and increased intraretinal cysts 1
• Anti-VEGF therapy is the standard of care for center-involving diabetic macular edema, particularly when associated with vision loss or significant anatomic changes 1
• The International Council of Ophthalmology guidelines establish that intravitreal anti-VEGF agents have been demonstrated as standard of care with favorable outcomes in preventing vision loss in patients with DME 1

FDA-Approved Indication and Dosing

• Eylea HD is FDA-approved for both diabetic macular edema and diabetic retinopathy 2
• The FDA-approved dosing regimen for DME is 8 mg every 4 weeks for the first 3 doses, followed by 8 mg every 8-16 weeks 2
• The FDA-approved dosing for diabetic retinopathy is 8 mg every 4 weeks for the first 3 doses, followed by 8 mg every 8-12 weeks 2

Treatment Response Documentation

• The patient has received Eylea HD 8mg to the right eye and tolerated the injection well [@clinical documentation provided]
• Continuation of therapy is medically necessary when the member demonstrates positive clinical response (improvement or maintenance in visual acuity or reduction in rate of vision decline) [@insurance criteria provided]

Left Eye (OS) - Observation Approach is Clinically Appropriate

Current Clinical Status

• The left eye shows minimal macular edema with foveal thickness of 292 microns, along with an epiretinal membrane [@clinical documentation provided]
• The physician notes this is the patient's better seeing eye, warranting close observation with treatment if/when disease worsens [@clinical documentation provided]

Evidence-Based Rationale for Observation

• For center-involving DME with good visual acuity (better than 20/30), treatment options include careful follow-up with anti-VEGF treatment only for worsening DME 1
• The International Council of Ophthalmology guidelines support observation with close monitoring for mild to moderate non-center-involving DME when visual acuity is better than 20/30 1
• Treatment intervals should be based on disease activity, with monthly OCT monitoring to assess need for intervention 1

When to Initiate Treatment in Left Eye

• Treatment becomes medically necessary if: 1
  • Visual acuity declines to 20/30 or worse
  • OCT demonstrates worsening central macular thickness (>10% increase)
  • Development of center-involving macular edema with vision loss
  • Evidence of disease progression despite observation

Addressing the Insurance Criteria Concern

Positive Clinical Response Assessment

The reviewer notes uncertainty about positive clinical response between June and August visits. This concern requires clarification:

• Stable disease with persistent edema after initial treatment may still warrant continued therapy 1
• The DRCR.net protocol demonstrates that even with excellent visual acuity (20/20), continued anti-VEGF injections were given when OCT central subfield thickness remained abnormally thickened 1
• Anatomic improvement often lags behind visual improvement, and a prolonged course of treatment may be necessary 1
• The presence of increased intraretinal cysts consistent with cystoid macular edema on both visits indicates ongoing disease activity requiring continued treatment 1

Standard Treatment Expectations

• Typically, 6-8 injections are needed in the first year, with 2-3 during the second year 1
• Treatment should continue if retinal thickening persists despite anti-VEGF therapy, with consideration of adjunct laser treatment after 24 weeks if needed 1
• Patients should be monitored almost monthly with OCT to assess treatment need 1

Critical Pitfalls to Avoid

Common Treatment Errors

• Do not discontinue treatment prematurely based solely on stable OCT measurements - anatomic response may require prolonged therapy even with good visual outcomes 1
• Do not treat both eyes simultaneously without clear indication - the left eye observation strategy is appropriate given better visual acuity and minimal edema 1
• Do not extend dosing intervals beyond FDA-approved ranges (8-16 weeks for DME, 8-12 weeks for DR) without documented disease stability 2

Documentation Requirements

• Visual acuity measurements at each visit using standardized testing 1
• OCT central subfield thickness measurements with comparison to baseline 1
• Assessment of disease activity including presence/absence of intraretinal cysts, subretinal fluid 1
• Justification for treatment decisions, particularly when deviating from standard protocols 1

Final Recommendation

The request for Eylea HD to the right eye is medically necessary and appropriate. The treatment plan follows FDA-approved indications and dosing, meets insurance criteria for diabetic macular edema and diabetic retinopathy, and represents standard of care based on International Council of Ophthalmology guidelines 1, 2.

The observation approach for the left eye is clinically appropriate given minimal edema and better visual acuity, with treatment initiation warranted only if disease progression occurs 1.