Criteria
Coverage is subject to the specific terms of the member’s benefit plan.
Federal Employee Program members (FEP) should check with their Retail Pharmacy Program to determine if prior approval is required by calling the Retail Pharmacy Program at 1-800-624-5060 (TTY: 1-800-624-5077). FEP members can also obtain the list through the www.fepblue.org website.
Ofatumumab (Arzerra) may be considered medically necessary for individuals 18 years of age or older for the treatment of ANY of the following indications:
Food and Drug and Drug Administration (FDA) Indications
Chronic Lymphocytic Leukemia (CLL)
- Combination therapy with chlorambucil, for the treatment of previously untreated individuals for whom fludarabine-based therapy is considered inappropriate; or
- Combination therapy with fludarabine and cyclophosphamide for the treatment of relapsed disease; or
- Extended treatment of individuals who are in complete or partial response after at least two (2) lines of therapy for recurrent or progressive disease; or
- Treatment of individuals with refractory to fludarabine and alemtuzumab; or
National Comprehensive Cancer Network (NCCN) Indications
B-Cell Lymphomas - AIDS-Related B-Cell Lymphomas, Burkitt Lymphoma, Castleman's Disease Diffuse Large B-Cell Lymphoma, Follicular Lymphoma (grade 1-2), Gastric MALT Lymphoma, High-Grade B-Cell Lymphomas with Translocations of MYC and BCL2 and/or BCL6 (Double/Triple Hit Lymphoma) , High-Grade B-Cell Lymphomas, NOS, Histologic Transformation of Marginal Zone Lymphoma to Diffuse Large B-Cell Lymphoma, Mantle Cell Lymphoma, Nongastric MALT Lymphoma, Nodal Marginal Zone Lymphoma, Post-Transplant Lymphoproliferative Disorders and Splenic Marginal Zone Lymphoma
- Used as a substitute* for rituximab or obinutuzumab in patients experiencing rare complications such as mucocutaneous reactions including paraneoplastic pemphigus, Stevens-Johnson syndrome, lichenoid dermatitis, vesiculobullous dermatitis, and toxic epidermal necrolysis
Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma (CLL/SLL)
- Second-line and subsequent therapy in individuals without del (17p)/TP53 mutation and with indications for retreatment:
- as a single agent; or
- in combination with FC (fludarabine, cyclophosphamide) regimen in individuals age less than 65 years without significant comorbidities; or
- First-line therapy in combination with bendamustine for CLL/SLL without del(17p)/TP53 mutation in individuals greater than or equal to 65 years and younger individuals with or without significant comorbidities who have indications for treatment; or
- Second-line and subsequent single agent therapy in individuals with del(17p)TP53 mutation with lymph nodes less than or equal to 5 cm; or
- Post second-line maintenance therapy for CLL/SLL without del (17p)/TP53 mutation following complete or partial response to treatment for relapsed or refractory disease; or
Waldenström's macroglobulinemia/lymphoplasmacytic lymphoma:
- As single-agent or combination therapy in rituximab-intolerant individuals for disease that does not respond to primary therapy or for progressive or relapsed disease.
All other uses for ofatumumab (Arzerra) are considered experimental/investigational and, therefore, not covered. Scientific evidence does not support its use for any other indication.
Safety and effectiveness in pediatric individuals has not been established.
Procedure Codes
