BlueCross BlueShield of Tennessee Medical Policy Manual

Ranibizumab (Lucentis®; Byooviz™; Cimerli™)

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

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 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

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.     Lucentis [package insert]. South San Francisco, CA: Genentech, Inc.; March 2018. 

2.     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.

3.     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.

4.     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. 

5.     Byooviz [package insert]. Cambridge, MA: Biogen, Inc.; June 2022.

6.     Cimerli [package insert]. Redwood City, CA: Coherus BioSciences, Inc.; November 2022.

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.

This document has been classified as public information.