Aflibercept (Eylea®; Eylea®HD)
Some agents on this policy may require step therapy See “Step Therapy Requirements for Provider Administered Specialty Medications” Document at: https://www.bcbst.com/docs/providers/Comm_BC_PAD_Step_Therapy_Guide.pdf
IMPORTANT REMINDER
We develop Medical Policies to provide guidance to Members and Providers. This Medical Policy relates only to the services or supplies described in it. The existence of a Medical Policy is not an authorization, certification, explanation of benefits or a contract for the service (or supply) that is referenced in the Medical Policy. For a determination of the benefits that a Member is entitled to receive under his or her health plan, the Member's health plan must be reviewed. If there is a conflict between the medical policy and a health plan or government program (e.g., TennCare), the express terms of the health plan or government program will govern.
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).
MEDICATION QUANTITY LIMITS
|
Drug Name |
Diagnosis |
Maximum Dosing Regimen |
|
Eylea (Aflibercept) |
Diabetic Macular Edema |
Route of Administration: Intravitreal Initial: 2mg per affected eye every 4 weeks for 5 doses Maintenance: 2mg per affected eye every 4 weeks (approximately every 25 days, monthly) |
|
Eylea (Aflibercept) |
Diabetic Retinopathy |
Route of Administration: Intravitreal Initial: 2mg per affected eye every 4 weeks for 5 doses Maintenance: 2mg per affected eye every 4 weeks (approximately every 25 days, monthly) |
|
Eylea (Aflibercept) |
Macular Edema following Retinal Vein Occlusion |
Route of Administration: Intravitreal 2mg per affected eye every 4 weeks (approximately every 25 days, monthly) |
|
Eylea (Aflibercept) |
Neovascular (Wet) Age-Related Macular Degeneration |
Route of Administration: Intravitreal Initial: 2mg per affected eye every 4 weeks for the first 3 months Maintenance: 2mg per affected eye every 4 weeks (approximately every 25 days, monthly) |
|
Eylea (Aflibercept) |
Retinopathy of Prematurity |
Route of Administration: Intravitreal 0.4mg per affected eye every 10 days |
|
Eylea HD (Aflibercept) |
Diabetic Macular Edema |
Route of Administration: Intravitreal Initial: 8mg per affected eye every 4 weeks (+/- 7 days) for the first 3 doses, then Maintenance: 8mg per affected eye every 8 to 16 weeks (+/- 1 week) |
|
Eylea HD (Aflibercept) |
Diabetic Retinopathy |
Route of Administration: Intravitreal Initial: 8mg per affected eye every 4 weeks (+/- 7 days) for the first 3 doses, then Maintenance: 8mg per affected eye every 8 to 12 weeks (+/- 1 week) |
|
Eylea HD (Aflibercept) |
Neovascular (Wet) Age-Related Macular Degeneration
|
Route of Administration: Intravitreal Initial: 8mg per affected eye every 4 weeks (+/- 7 days) for the first 3 doses, then Maintenance: 8mg per affected eye every 8 to 16 weeks (+/- 1 week) |
APPLICABLE TENNESSEE STATE MANDATE REQUIREMENTS
BlueCross BlueShield of Tennessee’s Medical Policy complies with Tennessee Code Annotated Section 56-7-2352 regarding coverage of off-label indications of Food and Drug Administration (FDA) approved drugs when the off-label use is recognized in one of the statutorily recognized standard reference compendia or in the published peer-reviewed medical literature.
ADDITIONAL INFORMATION
For appropriate chemotherapy regimens, dosage information, contraindications, precautions, warnings, and monitoring information, please refer to one of the standard reference compendia (e.g., the NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines®) published by the National Comprehensive Cancer Network®, Drugdex Evaluations of Micromedex Solutions at Truven Health, or The American Hospital Formulary Service Drug Information).
REFERENCES
1. Eylea [package insert]. Tarrytown, NY: Regeneron Pharmaceuticals; February 2023.
2. Eylea HD [package insert]. Tarrytown, NY: Regeneron Pharmaceuticals; August 2023.
3. American Academy of Ophthalmology Retinal/Vitreous Panel. Preferred Practice Pattern® Guidelines. 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.
4. American Academy of Ophthalmology Retinal/Vitreous Panel. Preferred Practice Pattern® Guidelines. Diabetic Retinopathy. San Francisco, CA: American Academy of Ophthalmology; 2019. Available at: https://www.aao.org/preferred-practice-pattern/diabetic-retinopathy-ppp.
5. American Academy of Ophthalmology Retinal/Vitreous Panel. Preferred Practice Pattern® Guidelines. Retinal Vein Occlusions. San Francisco, CA: American Academy of Ophthalmology; 2019. Available at: https://www.aao.org/preferred-practice-pattern/retinal-vein-occlusions-ppp.
ORIGINAL EFFECTIVE DATE: 12/1/2016
MOST RECENT REVIEW DATE: 4/1/2024
ID_CHS
Policies included in the Medical Policy Manual are not intended to certify coverage availability. They are medical determinations about a particular technology, service, drug, etc. While a policy or technology may be medically necessary, it could be excluded in a member's benefit plan. Please check with the appropriate claims department to determine if the service in question is a covered service under a particular benefit plan. Use of the Medical Policy Manual is not intended to replace independent medical judgment for treatment of individuals. The content on this Web site is not intended to be a substitute for professional medical advice in any way. Always seek the advice of your physician or other qualified health care provider if you have questions regarding a medical condition or treatment.
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