BlueCross BlueShield of Tennessee Medical Policy Manual

Obinutuzumab

NDC CODE(S)

50242-0070-XX - Gazyva 1000 mg/ 40 ml vial (Genentech)

DESCRIPTION

Obinutuzumab is a monoclonal antibody which targets the CD20 antigen expressed on the surface of B-lymphocytes, both pre B-lymphocytes and mature B-lymphocytes.  When obinutuzumab binds with the CD20 antigen it causes B-cell lysis and cell death likely through three ways.  First, it causes engagement of immune effector cells; second, it directly activates intracellular death signaling pathways; third, activation of the complement cascade.  Once engaged, the immune effector cells mechanisms of cell death include antibody-dependent cellular cytotoxicity and antibody-dependent cellular phagocytosis.

REFER TO DECISION SUPPORT TREE

POLICY

MEDICAL APPROPRIATENESS

INITIAL APPROVAL

RENEWAL CRITERIA

INDICATION(S)

DOSAGE & ADMINISTRATION

CLL

100 mg day 1, 900 mg day 2, 1000 mg days 8 and 15 of Cycle 1 (loading doses)

1000 mg on Day 1 of Cycles 2-6 (cycles are 28 days)

FL

1000 mg days 1, 8, & 15 of cycle 1 (loading doses); given in combination with bendamustine

1000 mg day 1 of cycles 2 – 6; given in combination with bendamustine

1000 mg every 2 months for two years as monotherapy  (cycles are 28 days)

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).

No controlled studies were found in the published literature that validate the use of obinutuzumab for the treatment of other conditions or diseases.

SOURCES

BlueCross BlueShield Association. Medical Policy Reference Manual. (10:2016). Uses of monoclonal antibodies for the treatment of non-Hodgkin lymphoma, including chronic lymphocytic leukemia, and acute myeloid leukemia in the non-hematopoietic stem-cell transplant setting (2.03.05). Retrieved November 14, 2016 from BlueWeb.

Lexicomp Online. (2016). AHFS DI. Obinutuzumab. Retrieved November 14, 2016 from Lexicomp Online with AHFS.

MICROMEDEX Healthcare Series. Drugdex Evaluations. (2016, October). Obinutuzumab. Retrieved November 14, 2016 from MICROMEDEX Healthcare Series.

National Comprehensive Cancer Network. (2016). NCCN Drugs & Biologics Compendium®. Obinutuzumab. Retrieved November 14, 2016 from the National Comprehensive Cancer Network.

U. S. Food and Drug Administration. (2016, February). Center for Drug Evaluation and Research. Gazyva® (obinutuzumab) for injection. Retrieved November 14, 2016 fromhttp://www.accessdata.fda.gov/drugsatfda_docs/label/2016/125486s013lbl.pdf.

ORIGINAL EFFECTIVE DATE:  11/8/2013

MOST RECENT REVIEW DATE:  12/1/2016

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.

Pharmaceutical Decision Support Tree

Obinutuzumab (Gazyva ®)

  1. Is this the initial request for this agent?

If yes, go to question #2

If no, go to question #6

  1. Does the request show individual is/has ALL of the following?

If yes, go to question #3

If no, this does not meet medical necessity and/or medical appropriateness criteria

  1. Does the individual have a diagnosis of chronic lymphocytic leukemia/small lymphocytic lymphoma (CLL/SLL) with ANY ONE of the following?

If yes, go to question #5

If no, go to question #4

  1. Does the individual have a diagnosis of follicular lymphoma if relapsed on or is refractory to a rituximab-containing regimen and therapy is in combination with bendamustine followed by obinutuzumab monotherapy?

If yes, go to question #5

If no, this does not meet medical necessity and/or medical appropriateness criteria

  1. Is the request for ANY ONE of the following?

CLL

10 billable units day 1, 90 billable units day 2, 100 billable units days 8 & 15 of cycle 1

100 billable units every 28 days

100 mg day 1, 900 mg day 2, 1000 mg days 8 and 15 of Cycle 1 (loading doses)

1000 mg on Day 1 of Cycles 2-6 (cycles are 28 days)

FL

100 billable units day 1, day 8 and day 15 cycle 1

100 units every 28 days for 6 cycles then every 2 months for 2 years

1000 mg days 1, 8, & 15 of cycle 1 (loading doses); given in combination with bendamustine

1000 mg day 1 of cycles 2 – 6; with bendamustine

1000 mg every 2 months for two years as monotherapy 

If yes, this satisfies medical necessity and medical appropriateness criteria

If no, this does not meet medical necessity and/or medical appropriateness criteria

  1. Does the individual continue to meet the initial approval criteria for follicular lymphoma ONLY in questions 2, 4 & 5?

If yes, go to question #7

If no, this does not meet medical necessity and/or medical appropriateness criteria

  1. Is response to treatment indicated by stabilization of disease or decrease in size of tumor or tumor spread with absence of unacceptable toxicity from the drug?

If yes, go to question #8

If no, this does not meet medical necessity and/or medical appropriateness criteria

  1. Does length of therapy not exceed two years?

If yes, this satisfies medical necessity and medical appropriateness criteria

If no, this does not meet medical necessity and/or medical appropriateness criteria

This document has been classified as public information.