BlueCross BlueShield of Tennessee Medical Policy Manual

Bevacizumab -awwb

NDC CODE(S)

55513-0206-XX MVASI 100 mg/4mL SOLN (AMGEN)

 

55513-0207-XX MVASI 400 mg/16mL SOLN (AMGEN)

DESCRIPTION

Bevacizumab is a recombinant humanized monoclonal IgG1 antibody which binds to human vascular endothelial growth factor (VEGF).  VEGF normally interacts with receptors (Flt-1 and KDR) on the surface of endothelial cells and leads to endothelial cell proliferation and new blood vessel formation.  By binding to VEGF, bevacizumab halts interaction with these receptors, resulting in reduction of microvascular growth and inhibition of metastatic disease progression.  Bevacizumab-awwb is biosimilar to bevacizumab, the innovator product.

POLICY

MEDICAL APPROPRIATENESS

INITIAL APPROVAL

Genomic Aberration Targeted Therapies (not all inclusive)

  • Sensitizing EGFR mutation-positive tumors

    • Erlotinib

    • Afatinib

    • Gefitinib

    • Dacomitinib

    • Osimertinib

  • ALK rearrangement-positive tumors

    • Crizotinib

    • Ceritinib

    • Brigatinib

    • Alectinib

  • ROS1 rearrangement-positive tumors

    • Crizotinib

  • BRAF V600E-mutation positive tumors

    • Dabrafenib/Trametinib

  • PD-L1 expression-positive tumors (>50%)

    • Pembrolizumab

    • Atezolizumab

RENEWAL CRITERIA

INDICATION(S)

DOSAGE & ADMINISTRATION

Colorectal Cancer

5 to 10 mg/kg every 2 weeks or 7.5 mg/kg every 3 weeks

NSCLC & Cervical Cancer

15 mg/kg every 3 weeks until disease progression or unacceptable toxicity.

CNS Cancers

For disease treatment: 10 mg/kg every 2 weeks until disease progression or unacceptable toxicity.

For symptom management: 5-10 mg/kg every 2 weeks up to 12 weeks duration

Renal Cell Carcinoma

10 mg/kg every 2 weeks until disease progression or unacceptable toxicity.

Malignant Pleural Mesothelioma

15 mg/kg every 3 weeks in combination with chemotherapy for up to 6 cycles followed by single agent use, at the same dose/frequency, until disease progression or unacceptable toxicity.

Ovarian Cancer

Platinum-sensitive:

15 mg/kg every 3 weeks for up to 8 cycles when used with paclitaxel or up to 10 cycles when used with gemcitabine; followed by single-agent bevacizumab 15 mg/kg IV every 3 weeks until disease progression or unacceptable toxicity

Platinum-resistant:

10 mg/kg every 2 weeks or 15 mg/kg every 3 weeks until disease progression or unacceptable toxicity

All Other Oncology Indications

5-10 mg/kg every 2 weeks OR 7.5-15 mg/kg every 3 weeks

LENGTH OF AUTHORIZATION

Coverage will be provided for six months and may be renewed; For CNS cancers (symptom management), coverage will be provided for 12 weeks and may NOT 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

Anandan, S. & Bilodeau, C. C. Acoustic neuroma. In Ferri, F. F.(Ed.), Ferri’s Clinical Advisor 2013 (1st ed. sec.1). Philadelphia, PA: Mosby, Elsevier.

Lexi-Comp Online. (2019, February). AHFS DI. Bevacizumab. Retrieved March 18, 2019 from Lexi-Comp Online with AHFS.

MICROMEDEX Healthcare Series. Drugdex Drug Evaluations. (2019, May). Bevacizumab. Retrieved May 10, 2019 from MICRODEX Healthcare Series.

Mink. J. W. (2011). Congenital, developmental, and neurocutaneous disorders. In Goldman, L. & Schafer, A. I. (Eds.), Goldman’s Cecil medicine (ch. 426). Philadelphia, PA: Saunders, Elsevier.

National Comprehensive Cancer Network. (2019). NCCN Drugs & Biologics Compendium®Bevacizumab. Retrieved March 18, 2019 from the National Comprehensive Cancer Network.

U. S. Food and Drug Administration. (2017, September). Center for Drug Evaluation and Research. MVASI (bevacizumab-awwb) solution for intravenous infusion. Retrieved May 10, 2019 from https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/761028s000lbl.pdf.. 

ORIGINAL EFFECTIVE DATE: 8/30/2019

MOST RECENT REVIEW DATE:  8/30/2019

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 = 10 mg

DIAGNOSIS

MAXIMUM UNITS

Oncology indications

170 billable units per 21 days

120 billable units per 14 days