Subject: Lucentis-Byooviz-Cimerli 1976-A SGM P2024
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LUCENTIS
(ranibizumab)
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BYOOVIZ
(ranibizumab-nuna)
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CIMERLI
(ranibizumab-eqrn)
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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
Lucentis, Byooviz and Cimerli are indicated for:
1. Neovascular (wet) age-related macular degeneration
2. Macular edema following retinal vein occlusion
3. Myopic choroidal neovascularization
Lucentis and Cimerli are also indicated for:
1. Diabetic macular edema
2. Diabetic retinopathy
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. Neovascular (Wet) Age-Related Macular Degeneration
Authorization of 6 months may be granted for treatment of neovascular (wet) age-related
macular degeneration.
C. Macular Edema Following Retinal Vein Occlusion
Authorization of 6 months may be granted for treatment of macular edema following retinal
vein occlusion.
D. Diabetic Retinopathy
Authorization of 6 months may be granted for treatment of diabetic retinopathy.
E. Myopic Choroidal Neovascularization
Authorization of 6 months may be granted for treatment of myopic choroidal
neovascularization.
III. CONTINUATION OF THERAPY
Authorization of 12 months may be granted for continued treatment in members requesting
reauthorization for an indication listed in Section II when the member has 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:
- Lucentis [package insert]. South San Francisco, CA: Genentech, Inc.; February 2024.
- 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.
- Byooviz [package insert]. Cambridge, MA: Biogen, Inc.; October 2023.
- Cimerli [package insert]. Redwood City, CA: Coherus BioSciences, Inc.; November 2022.
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.
August 18, 2024
