Subject: Eylea-Eylea HD 2024-A SGM P2023a
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EYLEA
(aflibercept)
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EYLEA HD
(aflibercept)
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Policy:
I. INDICATIONS
The indications below including FDA-approved indications and
compendial uses are considered a covered benefit provided that
all the approval criteria are met and the member has no
exclusions to the prescribed therapy.
FDA-Approved Indications
Eylea is indicated for the treatment of:
A. Diabetic macular edema
B. Diabetic retinopathy
C. Neovascular (wet) age-related macular degeneration
D. Macular edema following retinal vein occlusion
E. Retinopathy of Prematurity
Eylea HD is indicated for the treatment of:
A. Diabetic macular edema
B. Diabetic retinopathy
C. Neovascular (wet) age-related macular degeneration
All other indications are considered experimental/investigational
and not medically necessary.
II. CRITERIA FOR INITIAL APPROVAL
A. Diabetic Macular Edema
Authorization of 6 months may be granted for treatment of
diabetic macular edema.
B. Diabetic Retinopathy
Authorization of 6 months may be granted for treatment of
diabetic retinopathy.
C. Neovascular (Wet) Age-Related Macular Degeneration
Authorization of 6 months may be granted for treatment of
neovascular (wet) age-related macular degeneration.
D. Macular Edema Following Retinal Vein Occlusion
Authorization of 6 months may be granted for treatment of
macular edema following retinal vein occlusion.
E. Retinopathy of Prematurity
Authorization of 6 months may be granted for treatment of
retinopathy of prematurity.
III. CONTINUATION OF THERAPY
Authorization of 12 months may be granted for continued
treatment of an indication listed in Section II for members who
have demonstrated a positive clinical response to therapy (e.g.,
improvement or maintenance in best corrected visual acuity
[BCVA] or visual field, or a reduction in the rate of vision decline
or the risk of more severe vision loss).
Place of Service:
Outpatient
The above policy is based on the following references:
- Eylea [package insert]. Tarrytown, NY: Regeneron Pharmaceuticals; February 2023.
- Eylea HD [package insert]. Tarrytown, NY: Regeneron Pharmaceuticals; August 2023.
- American Academy of Ophthalmology Retinal/Vitreous Panel. Preferred Practice Pattern® Age-Related Macular Degeneration. San Francisco, CA: American Academy of Ophthalmology; 2019. Available at: https://www.aao.org/preferred-practice-pattern/age-related-macular-degeneration-ppp.
- American Academy of Ophthalmology Retinal/Vitreous Panel. Preferred Practice Pattern® Diabetic Retinopathy. San Francisco, CA: American Academy of Ophthalmology; 2019. Available at: https://www.aao.org/preferred-practice-pattern/diabetic-retinopathy-ppp.
- American Academy of Ophthalmology Retinal/Vitreous Panel. Preferred Practice Pattern® Retinal Vein Occlusions. San Francisco, CA: American Academy of Ophthalmology; 2019. Available at: https://www.aao.org/preferred-practice-pattern/retinal-vein-occlusions-ppp.
Copyright Aetna Inc. All rights reserved. Pharmacy Clinical Policy Bulletins are developed by Aetna to assist in administering plan benefits and constitute neither offers of coverage nor medical advice. This Clinical Policy Bulletin contains only a partial, general description of plan or program benefits and does not constitute a contract. Aetna does not provide health care services and, therefore, cannot guarantee any results or outcomes. Participating providers are independent contractors in private practice and are neither employees nor agents of Aetna or its affiliates. Treating providers are solely responsible for medical advice and treatment of members. This Clinical Policy Bulletin may be updated and therefore is subject to change.
October 07, 2023
