Is continuation of Eylea (aflibercept) 8mg injections every 8 weeks to both eyes medically indicated for a patient with a history of proliferative diabetic retinopathy, diabetic macular edema, vitreous hemorrhage, hypertensive retinopathy, and nuclear sclerosis?

Medical Necessity Assessment for Eylea HD 8mg Continuation

Direct Recommendation

Yes, continuation of Eylea HD 8mg injections every 8 weeks to both eyes is medically indicated for this patient with proliferative diabetic retinopathy and diabetic macular edema. 1, 2

Treatment Indication and FDA-Approved Dosing

The FDA-approved dosing for Eylea HD 8mg in diabetic macular edema and diabetic retinopathy supports the proposed treatment plan:

• For diabetic macular edema (DME), the FDA label specifies 8mg every 4 weeks for the first three doses, followed by 8mg every 8 to 16 weeks 2
• For diabetic retinopathy (DR), the FDA label specifies 8mg every 4 weeks for the first three doses, followed by 8mg every 8 to 12 weeks 2
• The proposed 8-week interval falls within the FDA-approved maintenance range for both conditions 2

Bilateral Treatment Justification

Bilateral treatment is appropriate even though only one eye currently has macular edema:

• The eye with proliferative diabetic retinopathy without current macular edema still requires anti-VEGF therapy to prevent progression to vision-threatening complications 1
• Severe nonproliferative and proliferative diabetic retinopathy require aggressive anti-VEGF therapy to prevent progression, independent of macular edema status 1
• The American Academy of Ophthalmology recommends prompt treatment for patients at high risk of vision loss, which includes both eyes in this clinical scenario 1

Disease Severity and Risk Assessment

This patient has multiple high-risk features that mandate continued treatment:

• History of vitreous hemorrhage indicates advanced proliferative disease requiring ongoing anti-VEGF suppression 1
• Proliferative diabetic retinopathy with macular edema represents severe disease with significant risk of permanent vision loss if undertreated 1
• Studies demonstrate that 3.2-9.7% of inadequately treated eyes lose ≥15 letters of vision 1
• Premature discontinuation could lead to recurrence of macular edema and subsequent vision loss 1

Treatment Interval Appropriateness

The 8-week maintenance interval is evidence-based and clinically appropriate:

• The American Academy of Ophthalmology supports a "treat and extend" approach with intervals of 10-14 weeks when disease stability is achieved 1
• DRCR.net protocol supports extending intervals up to 16 weeks if edema remains stable 1
• The proposed 8-week interval is conservative and appropriate given the history of vitreous hemorrhage and proliferative disease 1
• Clinical trials demonstrate mean BCVA improvement of 8.8 letters at 48 weeks with extended dosing intervals 1, 3

Standard of Care Alignment

The proposed treatment plan aligns with established standard of care:

• Intravitreal anti-VEGF agents, including aflibercept, are the standard of care for center-involving diabetic macular edema with associated vision loss 1
• The International Council of Ophthalmology guidelines recommend anti-VEGF therapy for diabetic macular edema, resulting in improved visual outcomes 1
• The "treat and extend" protocol minimizes treatment burden while maintaining efficacy, as supported by real-world studies and the American Academy of Ophthalmology 1

Critical Pitfall to Avoid

Discontinuing or undertreating this patient would constitute a deviation from standard of care:

• Premature discontinuation or inadequate treatment frequency can result in significant risk of permanent vision loss 1
• Inconsistent treatment may lead to disease progression and recurrence of complications 1
• The American Academy of Ophthalmology specifically warns against premature discontinuation in patients with diabetic macular edema 1

Treatment Burden Reduction Benefit

Eylea HD 8mg provides therapeutic advantage over standard dosing:

• Eylea HD 8mg reduces treatment burden while maintaining efficacy compared to standard Eylea 2mg 1
• Maintenance intervals of 8-16 weeks reduce annual injection burden compared to more frequent dosing 1
• This formulation allows for extended dosing intervals without compromising visual outcomes 3