BlueCross BlueShield of Tennessee Medical Policy Manual

Ofatumumab

NDC CODE(S)

00078-0669-XX Arzerra 100 MG/5ML CONC (NOVARTIS)

 

00078-0690-XX Arzerra 1000 MG/50ML CONC (NOVARTIS)

DESCRIPTION

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.

POLICY

MEDICAL APPROPRIATENESS

INITIAL APPROVAL

RENEWAL CRITERIA

INDICATION(S)

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

CLL/SLL (Refractory)

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

CLL/SLL (Relapsed)

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

Waldenström’s/Lymphoplasmacytic lymphoma

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:

Click here to view DOSAGE LIMITS

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 ofatumumab for the treatment of other conditions or diseases.

SOURCES 

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

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

CLL/SLL

1st Line

  • 30 billable units on day 1 and 100 billable units on day 8; then

  • 100 billable units every 28 days for up to 11 doses

Refractory

  • 30 billable units on day 1; then

  • 200 billable units weekly x 7 doses; then

  • 200 billable units every 28 days x 4 doses

Relapsed

  • 30 billable units on day 1 and 100 billable units on day 8; then

  • 100 billable units every 28 days for up to 5 doses

Extended Treatment

  • 30 billable units on day 1 and 100 billable units on day 8; then

  • 100 billable units 7 weeks later and every 8 weeks thereafter

Waldenström’s Macroglobulinemia / Lymphoplasmacytic Lymphoma

  • 30 billable units on day 1; then

  • 100 billable units every 7 days x 4 doses