50242-0070-XX Gazyva 1000 MG/40ML SOLN (GENENTECH)
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.
Obinutuzumab for the treatment of the following is considered medically necessary if the medical appropriateness criteria are met: (See Medical Appropriateness below.)
Chronic lymphocytic leukemia/small lymphocytic lymphoma (CLL/SLL)
Follicular lymphoma (FL)
Non-Hodgkin’s Lymphoma (NHL)
Obinutuzumab for the treatment of other conditions/diseases is considered investigational.
Obinutuzumab is considered medically appropriate if individual is/has ALL of the following:
18 years of age or older
Free from active infection
Has not received live vaccine in preceding 28 days
Negative for hepatitis B or hepatitis C serology
Diagnosis of ANY ONE of the following:
Chronic lymphocytic leukemia/small lymphocytic lymphoma (CLL/SLL) if ANY ONE of the following:
Treatment is first-line therapy and ANY ONE of the following:
Used in combination with chlorambucil
Used as single agent therapy for disease with del(17p)/TP53 mutation
Used in combination with bendamustine for disease without del(17p)/TP53 mutation
Therapy for relapsed or refractory disease if ALL of the following:
Used as single agent therapy
Disease without del(17p)/TP53 mutation
Follicular lymphoma (FL) if ANY ONE of the following:
Used in combination with chemotherapy (e.g. bendamustine or CHOP (cyclophosphamide, doxorubicin, vincristine, prednisone) or CVP (cyclophosphamide, vincristine, prednisone) and ANY ONE of the following:
Used as first-line therapy
Used as second-line or greater therapy, for refractory or have progressive disease
Used as maintenance therapy and ANY ONE of the following:
Used as monotherapy after combination bendamustine use for individuals who are refractory to or relapsed after a rituximab containing regimen
Used as monotherapy after combination initial chemotherapy in patients who have achieved at least a partial remission in stage II bulky, III or IV disease
Used as first-line consolidation therapy or extended dosing
Used as second-line consolidation therapy extended dosing in individuals who are refractory to rituximab
Used in individuals with histologic transformation to diffuse-large B-cell lymphoma with extensive follicular lymphoma
Non-Hodgkin’s Lymphoma (NHL) with a diagnosis of ANY ONE of the following:
MALT Lymphoma (Gastric or Non-Gastric) or Marginal Zone Lymphoma (Splenic or Nodal) and ANY ONE of the following:
Used as maintenance therapy, as second line consolidation or extended dosing, in rituximab refractory individuals treated with obinutuzumab and bendamustine for recurrent disease
Used in combination with bendamustine as second-line or greater therapy for refractory (recurrent for Gastric MALT) or progressive disease
Obinutuzumab is considered medically appropriate for renewal if ALL of the following criteria are met:
Individual continues to meet initial approval criteria for follicular lymphoma, Non-Hodgkin’s Lymphoma diagnosed as Malt Lymphoma (Gastric or Non Gastric) or Marginal Zone Lymphoma (Splenic or Nodal), Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma indication is NOT medically appropriate for renewal)
Response to treatment is indicated by stabilization of disease or decrease in size of tumor or tumor spread
Absence of unacceptable toxicity from the drug. Examples of unacceptable toxicity include the following (e.g. progressive multifocal leukoencephalopathy (PML), hepatitis B reactivation, severe neutropenia/febrile neutropenia, severe thrombocytopenia, severe infusion reactions, hypersensitivity reactions including serum sickness, tumor lysis syndrome, etc)
Length of therapy does not exceed two years
DOSAGE & ADMINISTRATION
100 mg day 1, 900 mg day 2, then 1000 mg days 8 and 15 of Cycle 1 (loading doses)1000 mg on Day 1 of Cycles 2-6 (cycles are 28 days)
All other indications
1000 mg days 1, 8, & 15 of cycle 1 (loading doses); given in combination with chemotherapy
LENGTH OF AUTHORIZATION
Chronic lymphocytic leukemia/Small Lymphocytic Lymphoma (CLL/SLL): Coverage is provided for six months (6 cycles) and may NOT be renewed.
All other indications: Coverage is provided for six months and may be renewed up to a max of two years therapy.
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.
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.
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 or prevention of other conditions or diseases.
BlueCross BlueShield Association. Medical Policy Reference Manual. (10:2017). 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 June 18, 2018 from BlueWeb.
Lexicomp Online. (2018). AHFS DI. Obinutuzumab. Retrieved June 18, 2018 from Lexicomp Online with AHFS.
MICROMEDEX Healthcare Series. Drugdex Evaluations. (2018, May). Obinutuzumab. Retrieved June 18, 2018 from MICROMEDEX Healthcare Series.
National Comprehensive Cancer Network. (2018). NCCN Drugs & Biologics Compendium®. Obinutuzumab. Retrieved June 18, 2018 from the National Comprehensive Cancer Network.
U. S. Food and Drug Administration. (2017, November). Center for Drug Evaluation and Research. Gazyva® (obinutuzumab) for injection. Retrieved June 18, 2018 from http://www.accessdata.fda.gov/drugsatfda_docs/label/2017/125486s013lbl.pdf.
ORIGINAL EFFECTIVE DATE: 11/8/2013
MOST RECENT REVIEW DATE: 8/14/2018
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.
Maximum billable units per dose and over time by indication as a Medical Benefit 1 billable unit = 10 mg