BlueCross BlueShield of Tennessee Medical Policy Manual

Ranibizumab

NDC CODE(S)

50242-0080-XXLucentis 0.5 MG/0.05ML SOLN (GENENTECH)

50242-0080-XXLucentis 0.5 MG/0.05ML SOSY (GENENTECH)

50242-0082-XXLucentis 0.3 MG/0.05ML SOLN (GENENTECH)

50242-0082-XXLucentis 0.3 MG/0.05ML SOSY (GENENTECH)

DESCRIPTION

Ranibizumab is a vascular endothelial growth factor (VEGF) inhibitor.  It is a fragment of a monoclonal antibody which binds to and inhibits the biologic activity of VEGF-A.  VEGF-A has been shown to cause neovascularization and leakage in models of ocular angiogenesis and vascular occlusion.  It is thought to contribute to the pathophysiology of neovascular age-related macular degeneration, macular edema following retinal vein occlusion, diabetic retinopathy and diabetic macular edema.  The binding of ranibizumab to VEGF-A prevents the interaction of VEGF-A with its receptors on the surface of endothelial cells, reducing endothelial cell proliferation, vascular leakage, and new blood vessel formation.

POLICY

MEDICAL APPROPRIATENESS

INITIAL APPROVAL

RENEWAL CRITERIA

INDICATION(S) DOSAGE & ADMINISTRATION
Diabetic macular edema and Diabetic retinopathy (DR)

0.3 mg intravitreally per affected eye once a month (approximately 28 days)

AMD* and macular edema following RVO

0.5 mg intravitreally per affected eye once a month (approximately 28 days)

Myopic Choroidal Neovascularization (mCNV)

0.5 mg intravitreally per affected eye once a month (approximately 28 days) for up to 3 months

Patients may be retreated if needed.

Individuals with AMD* may be treated with 3 monthly doses followed by less frequent dosing (4-5 doses on average in the following 9 months) or one dose every 3 months after 4 monthly doses. Patients should be assessed regularly.

LENGTH OF AUTHORIZATION

Coverage for myopic choroidal neovascularization (mCNV) will be provided for 3 months and may be renewed

Coverage for all other indications will be provided annually and may be renewed

Refer to DOSAGE LIMITS below

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.

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, the express terms of the health plan will govern.

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).

SOURCES

Lexi-Comp Online. (2018). AHFS DI. Ranibizumab. Retrieved October 31, 2018 from Lexi-Comp Online with AHFS.

MICROMEDEX Healthcare Series. Drugdex Drug Evaluations. (2018, September). Ranibizumab. Retrieved October 31, 2018 from MICROMEDEX Healthcare Series.

U. S. Food and Drug Administration. (2017, April). Center for Drug Evaluation and Research. Lucentis® (ranibizumab). Retrieved October 31, 2018 from https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/125156s114lbl.pdf.

ORIGINAL EFFECTIVE DATE: 12/1/2016

MOST RECENT REVIEW DATE:  3/2/2019

ID_MRx

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.

 

 

DOSAGE LIMITS

Maximum billable units per dose and over time by indication as a Medical Benefit   1 billable unit = 0.1 mg

DIAGNOSIS

MAXIMUM UNITS

Diabetic Macular Edema (DME) or Diabetic Retinopathy (DR)

6 units every 28 days

Neovascular Age-related Macular Degeneration (AMD); Macular Edema following Retinal Vein Occlusion (RVO) or Myopic Choroidal Neovascularization (mCNV)

10 units every 28 days

(Maximum units are based on administration to both eyes)