ModifiedAnthemPolicy CC-0122

Arzerra (ofatumumab) — Coverage Criteria for CLL/SLL

Clinical criteria governing prior authorization and medical necessity determinations for Arzerra (ofatumumab) for treatment of chronic lymphocytic leukemia/small lymphocytic lymphoma (CLL/SLL) under the payer's medical benefit.

Policy Summary

PayerAnthem

PolicyArzerra (ofatumumab) — Coverage Criteria for CLL/SLL

Policy CodePolicy CC-0122

Change TypeRevised criteria and coding adjustments

Effective Date

Next Review Date

Key ActionObtain prior authorization for Arzerra (HCPCS J9302) with documentation of diagnosis and that use meets the specified criteria.

SourceLink

POLICY UPDATE CHANGES

Removed NCCN recommendations from the criteria because NCCN no longer includes Arzerra.

Removed ICD-10-CM C88.0 from coding.

24 monthsMaintenance duration

1Single-agent use limit

J9302HCPCS

C91.10-C91.12ICD-10 range

Black box warningsSafety warnings

Coverage Criteria for Arzerra (ofatumumab)

Approved Uses (Initial/Continuation)

Requests for Arzerra (ofatumumab) may be approved if ALL of the following are met:

Primary diagnosis: Individual has a diagnosis of chronic lymphocytic leukemia/small lymphocytic lymphoma (CLL/SLL)

Label indication

Permitted uses

A: First-line use in combination with chlorambucil
B1: Single-agent use for relapsed or refractory CLL/SLL
Limited to one line of therapy

Policy Summary

PayerAnthem

PolicyArzerra (ofatumumab) — Coverage Criteria for CLL/SLL

Policy CodePolicy CC-0122

Change TypeRevised criteria and coding adjustments

Effective Date

Next Review Date

Key ActionObtain prior authorization for Arzerra (HCPCS J9302) with documentation of diagnosis and that use meets the specified criteria.

SourceLink

On This Page

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Any use of Arzerra (ofatumumab) that is not one of the specified CLL/SLL indications is considered not approved. Specifically, requests are not approved for uses other than: (A) first-line therapy in combination with chlorambucil; (B) treatment of relapsed or refractory CLL/SLL either as a single agent (limited to one line of therapy) or in combination with fludarabine and cyclophosphamide; or (C) maintenance therapy following at least two prior lines of therapy for up to 24 months when a complete or partial response has been achieved. Uses outside these settings are not covered.

Covered Regimens and Eligible Settings

Regimen	Indication / Line of therapy	Coverage status
{"text":"Ofatumumab in combination with chlorambucil","status":""},{"text":"First-line therapy when fludarabine-based therapy is inappropriate (first-line use in combination with chlorambucil)","status":""},{"text":"Covered","status":"covered"}

Regimen	Indication / Line of therapy	Coverage status
{"text":"Ofatumumab in combination with fludarabine and cyclophosphamide","status":""},{"text":"Treatment of relapsed CLL/SLL (relapsed disease)","status":""},{"text":"Covered","status":"covered"}

Regimen	Indication / Line of therapy	Coverage status
{"text":"Ofatumumab as single agent for fludarabine- and alemtuzumab-refractory patients","status":""},{"text":"Relapsed or refractory CLL/SLL — single-agent use limited to one line of therapy","status":""},{"text":"Covered","status":"covered"}

Regimen	Indication / Line of therapy	Coverage status
{"text":"Ofatumumab maintenance","status":""},{"text":"Maintenance therapy following >=2 prior lines for relapsed/progressive disease with documented complete or partial response — up to 24 months","status":""},{"text":"Covered","status":"covered"}

Coding Information

HCPCSHCPCSCovered

J9302

Injection, ofatumumab, 10 mg [Arzerra]

ICD-10 Diagnosis (SLL)ICD-10

C83.00-C83.09

Small cell B-cell lymphoma [specified as small lymphocytic lymphoma]

ICD-10 Diagnosis (CLL)ICD-10

C91.10-C91.12

Chronic lymphocytic leukemia of B-cell type

inv-07: Maintenance duration — up to 24 months

Maintenance durationUp to 24 months

Prerequisite for maintenanceMaintenance only after at least 2 prior lines of therapy for relapsed/progressive disease

Response requirementMaintenance limited to individuals who achieved a complete or partial response

ScopeApplies only to maintenance treatment for CLL/SLL as specified in policy

Provider Actions, Documentation, and Denial Risks

Prior Authorization

Prior Authorization Required

Prior authorization required for Arzerra (HCPCS J9302). Requests must include documentation of diagnosis and that use meets the policy criteria (see coverage criteria for CLL/SLL, line-of-therapy and regimen requirements).

Prior authorization required: Arzerra (ofatumumab) — HCPCS J9302

Denial Risk

Denial Triggers

Requests may be denied when the request does not meet the labeled CLL/SLL indications or the policy’s specified uses. Common denial triggers include: use for multiple sclerosis or other non‑listed indications, lack of documentation that the agent is being used in an approved line of therapy or regimen (e.g., not first‑line with chlorambucil, not single‑agent in the allowed relapsed/refractory setting, or maintenance use not following ≥2 prior lines with documented response), or missing required clinical information.

Denial triggers: use for MS or other non‑listed indications
Denial triggers: indication not CLL/SLL
Denial triggers: maintenance use without documentation of ≥2 prior lines and response

Documentation Required

Required Documentation

Documentation must support the diagnosis of CLL or SLL and the specific therapy intent. Required documentation includes prior treatment history (lines of therapy with agents and dates), regimen details (concurrent drugs such as chlorambucil, fludarabine and cyclophosphamide), response status (complete or partial response when requesting maintenance), and any relevant labs or imaging supporting disease status. Include supporting clinical notes and prior authorization forms as applicable.

Required documentation: diagnosis of CLL or SLL
Required documentation: prior lines of therapy (agents and dates)
Required documentation: regimen details and concurrent medications
Required documentation: response status (CR or PR) for maintenance requests
Required documentation: relevant labs/imaging and clinical notes

Step Therapy

No additional step‑therapy sequence is specified beyond the policy’s line‑of‑therapy definitions; approval depends on meeting the applicable line‑of‑therapy and regimen criteria in the coverage criteria. There is no required prior use of other specific agents before Arzerra except where the indication or line of therapy implies prior therapies (e.g., maintenance requires prior response after ≥2 lines).

Step therapy: no explicit step sequence beyond line‑of‑therapy requirements
Step therapy: maintenance requires prior ≥2 lines of therapy and documented response

Line of Therapy Definitions and Rules

Line of Therapy

First-line: Use as first-line therapy in combination with chlorambucil when fludarabine-based therapy is considered inappropriate.

Label indication

Relapsed/Refractory: Treatment of relapsed or refractory CLL/SLL as either: single-agent (limited to one line of therapy) OR in combination with fludarabine and cyclophosphamide.

See regimen-specific conditions

Maintenance therapy following at least 2 prior lines of therapy for relapsed or progressive disease with achievement of complete response (CR) or partial response (PR)up to 24 months

Maintenance only when both prior-line and response criteria are met

Definitions

inv-13: Complete Response (CR) — disappearance of all signs of cancer as a result of treatment

DefinitionThe disappearance of all signs of cancer as a result of treatment; also called complete remission; does not indicate the cancer has been cured.

SynonymComplete remission

Clinical implicationCR is used as a response milestone to qualify for maintenance therapy per policy

inv-14: Line of Therapy — Definitions for first-, second-, third-line therapy and maintenance as provided in the policy

First-line therapyThe first or primary treatment for the diagnosis (may include surgery, chemotherapy, radiation, or combinations). Policy: Arzerra covered as first-line only in combination with chlorambucil when indicated.

Second-line therapyTreatment given when initial (first-line) therapy is not effective or there is disease progression.

Third-line therapyTreatment given when both first- and second-line therapies are not effective or there is disease progression.

Maintenance therapyTherapy designed to maintain a condition to prevent relapse. Policy: Arzerra maintenance allowed up to 24 months following ≥2 prior lines and achievement of complete or partial response.

OpenPayer