Coverage Policies

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Current policies effective through April 30, 2024.

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Effective Date: 06/01/2023 Title: Arzerra (ofatumumab)
Revision Date: Document: BI713:00
CPT Code(s):
Public Statement

Revision Date:


Annual Review: June

CPT Code(s): J9302

Public Statement:

Effective Date:

a)    This policy will apply to all services performed on or after the above revision date which will become the new effective date.

b)    For all services referred to in this policy that were performed before the revision date, contact customer service for the rules that would apply.

1)    Arzerra (ofatumumab) requires prior authorization.

2)    Arzerra is used to treat chronic lymphocytic leukemia (CLL) and Waldenstrom’s Macroglobulinemia/Lymphoplasmacytic Lympohoma.

Medical Statement

Arzerra (ofatumumab) is considered medically necessary when the following criteria are met:


I.             Initial Approval Criteria

a.    Chronic Lymphocytic Leukemia (must meet all):

                                          i.    Diagnosis of CLL;

                                        ii.    Prescribed by or in consultation with an oncologist or hematologist;

                                       iii.    Age > 18 years;

                                       iv.    Onfe of the following:

1.    Both of the following:

a.    Prescribed as first-line therapy in combination with chlorambucil;

b.    Fludarabine-based therapy is considered inappropriate;

2.    Prescribed in combination with fludarabine and cyclophosphamide for relapsed disease;

3.    Member is in complete or partial response after at least two lines of therapy for recurrent or progressive disease;

4.    Disease is refractory to fludarabine and alemtuzumab

Approval Duration: 6 months


b.    Waldenstrom’s Macrogloubulinemia/Lymphoplasmacytic Lymphoma (off-label) (must meet all):

                                          i.    Diagnosis of Waldenstrom’s macroblobulinemia/lymphoplasmacytic lymphoma (WM/LPL);

                                        ii.    Prescribed by or in consultation with an oncologist or hematologist;

                                       iii.    Age > 18 years;

                                       iv.    Member is reituximab-intoleratnt;

                                        v.    Request is for second-line or subsequent therapy;

Approval Duration: 6 months


II.            Continuation of Therapy

a.    Must be responding positively to therapy and dosing is within FDA approved guidelines or supported by practice guidelines or peer-reviewed literature


Codes Used In This BI:


1)    J9302 – injection, ofatumumab, 10mg


1)    Arzerra Prescribing Information. East Hanover, NJ: Novartis Pharmaceuticals Corporation; August 2016. Available at Accessed January 31, 2023.

2)    National Comprehensive Cancer Network. Waldenstrom’s Macroglobulinemia/ Lymphoplasmacytic Lymphoma Version 1.2023. Available at: Accessed January 31, 2023.

Application to Products
This policy applies to all health plans administered by QualChoice, both those insured by QualChoice and those that are self-funded by the sponsoring employer, unless there is indication in this policy otherwise or a stated exclusion in your medical plan booklet. Consult the individual plan sponsor Summary Plan Description (SPD) for self-insured plans or the specific Evidence of Coverage (EOC) for those plans insured by QualChoice. In the event of a discrepancy between this policy and a self-insured customer’s SPD or the specific QualChoice EOC, the SPD or EOC, as applicable, will prevail. State and federal mandates will be followed as they apply.
Changes: QualChoice reserves the right to alter, amend, change or supplement benefit interpretations as needed.
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