00078-0669-XX Arzerra 100 MG/5ML CONC (NOVARTIS)
00078-0690-XX Arzerra 1000 MG/50ML CONC (NOVARTIS)
Ofatumumab is an IgG1κ human monoclonal antibody which binds specifically to the CD20 molecule. The CD20 molecule is expressed on the surface of B lymphocytes, both of normal cells and on those of B-cell chronic lymphocytic leukemia. After binding with ofatumumab, the CD20 molecule remains on the B-cell surface resulting in cell lysis and destruction of the diseased and normal B-cells. While the exact cause of cell lysis is not known, complement-dependent cytotoxicity and antibody-dependent, cell mediated cytotoxicity are likely mechanisms.
Ofatumumab 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)
Waldenström’s macroglobulinemia/lymphoplasmacytic lymphoma
Ofatumumab for the treatment of other conditions/diseases is considered investigational.
Ofatumumab is considered medically appropriate if ALL of the following:
Individual is 18 years of age or older
Individual must be screened for HBV infection (i.e., HBsAg and anti-HBc) prior to initiating therapy
Not to be administered concurrently with live vaccines
Individual has a diagnosis of ANY ONE of the following:
Chronic lymphocytic leukemia / small lymphocytic lymphoma (CLL/SLL) for ANY ONE of the following:
Used as first-line therapy in combination with chlorambucil
Used for relapsed or refractory disease as ANY ONE of the following:
In combination with fludarabine and cyclophosphamide (FC)
Used as Extended treatment in individuals with ALL of the following:
Complete or partial response after two or more lines of therapy
As single agent for recurrent or progressive disease
Used as first-line therapy in combination with bendamustine and individual does not have del(17p)/TP53 mutation
Waldenström’s macroglobulinemia/lymphoplasmacytic lymphoma if ALL of the following:
Individual is rituximab-intolerant
Individual is/has ANY ONE of the following:
Unresponsive or intolerant to primary therapy
Progressive or relapsed disease
Used as single agent or combination therapy
Ofatumumab is considered medically appropriate for renewal if ALL of the following criteria are met:
Individual continues to meet initial approval criteria
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: progressive multifocal leukoencephalopathy, severe infusion reactions, tumor lysis syndrome, cytopenias (neutropenia, anemia, and thrombocytopenia), etc.
DOSAGE & ADMINISTRATION
CLL/SLL (1st line)
300 mg on Day 1, then 1,000 mg on Day 8, followed by 1,000 mg on Day 1 of subsequent 28-day cycles for a minimum of 3 cycles or a maximum of 12 cycles
300 mg on Day 1, followed 1 wk later by 2,000 mg given weekly x 7 doses, (infusions 2 through 8) followed 4 wks later by 2,000 mg every 4 wks for 4 doses (infusions 9 through 12),for a total of 12 doses
300 mg on Day 1, then 1,000 mg on Day 8, followed by 1,000 mg on Day 1 of subsequent 28 -day cycles for a maximum of 6 cycles
CLL/SLL (extended treatment)
300 mg on Day 1, then 1,000 mg on Day 8, followed by 1,000 mg 7 weeks later and every 8 weeks thereafter for up to a maximum of 2 years
300 mg on day 1, then 1,000 mg weekly for 4 doses
LENGTH OF AUTHORIZATION
Coverage will be provided for 6 months with renewal subject to the following:
CLL/SLL (1st- line) may be renewed to allow for a total of 12 cycles
CLL/SLL (relapsed or refractory) may not be renewed (unless the provisions for extended treatment have been met)
CLL/SLL (extended treatment) may be renewed to provide for a total of 2 years of therapy
Waldenström’s/Lymphoplasmacytic lymphoma 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.
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 ofatumumab for the treatment of other conditions or diseases.
BlueCross BlueShield Association. Medical Policy Reference Manual. (10:2017). 10:2016_061517 Uses of monoclonal antibodies for the treatment of non-Hodgkin lymphoma, (2.03.05). Retrieved February 16, 2018 from BlueWeb.
Lexi-Comp Online. (2017, March). AHFS DI. Ofatumumab. Retrieved February 16, 2018 from Lexi-Comp Online with AHFS.
MICROMEDEX Healthcare Series. Drugdex Drug Evaluations. (2018, February). Ofatumumab. Retrieved February 16, 2018 from MICROMEDEX Healthcare Series.
National Comprehensive Cancer Network. (2018). NCCN Drugs & Biologics Compendium™. Ofatumumab. Retrieved February 16, 2018 from the National Comprehensive Cancer Network.
U. S. Food and Drug Administration. (2016, August). Center for Drug Evaluation and Research. Arzerra® (ofatumumab) injection, for intravenous injection. Retrieved February 16, 2018 from http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/125326s063lbl.pdf.
ORIGINAL EFFECTIVE DATE: 6/12/2010
MOST RECENT REVIEW DATE: 5/8/2018
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