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.

REFER TO DECISION SUPPORT TREE

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 maximum of 12 cycles

CLL/SLL (2nd line or later)

300 mg on Day 1, followed 1 wk later by 2,000 mg given weekly x 7 doses, followed in 4 wks by 2,000 mg every 4 wks for 4 doses, total of 12 doses

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

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. (10:2016). Uses of monoclonal antibodies for the treatm10:2016_061517ent 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 15, 2017 from BlueWeb.

Lexi-Comp Online. (2017, March). AHFS DI. Ofatumumab. Retrieved June 14, 2017 from Lexi-Comp Online with AHFS.

MICROMEDEX Healthcare Series. Drugdex Drug Evaluations. (2017, January). Ofatumumab. Retrieved June 14, 2017 from MICROMEDEX Healthcare Series. 

National Comprehensive Cancer Network. (2017). NCCN Drugs & Biologics Compendium™. Ofatumumab. Retrieved June 15, 2017 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 June 14, 2017 from http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/125326s063lbl.pdf.

ORIGINAL EFFECTIVE DATE:  6/12/2010

MOST RECENT REVIEW DATE:  8/11/2017

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

Ofatumumab (Arzerra®)

  1. Is this the initial request for this agent?

If yes, go to question #2

If no, go to question #5

  1. Is the individual 18 years of age or older, without a history or Hepatitis B (HBV) but with a diagnosis of chronic lymphocytic leukemia / small lymphocytic lymphoma (CLL/SLL) requesting ANY ONE of the following?

If yes, go to question #4

If no, go to question #3

  1. Is the individual 18 years of age or older, without a history or Hepatitis B (HBV) but with a diagnosis of Waldenström’s macroglobulinemia/lymphoplasmacytic lymphoma and ALL of the following?

If yes, go to question #4

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

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

INDICATION(S)

BILLABLE UNITS

DOSAGE & ADMINISTRATION

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

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 12 cycles

CLL/SLL (2nd line or later)

30 billable units on day 1; then

200 billable units weekly x 7 doses; then

200 billable units monthly x 4 doses

300 mg on Day 1, followed 1 wk later by 2,000 mg given weekly x 7 doses, followed in 4 wks by 2,000 mg every 4 wks for 4 doses, total of 12 doses

CLL/SLL (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

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

30 billable units on day 1; then

100 billable units every 7 days doses

300 mg on day 1 then 1,000 mg weekly for 4 doses

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 meet the initial approval criteria in questions 2 through 4?

If yes, go to question #6

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?

If yes, go to question #7

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

  1. Is there absence of unacceptable toxicity from the drug such as hematological abnormalities (neutropenia, anemia, leucopenia, thrombocytopenia, etc.) and/or new onset of or changes in pre-existing neurological signs or symptoms?

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.