CurrentEmblemHealthPolicy N/A

Drug Policy: Arzerra (ofatumumab) — Coverage Criteria

Defines accepted indications, continuation and exclusion criteria, and utilization management for Arzerra (ofatumumab) for members covered by the payer; applies to providers submitting medication requests processed by Evolent/UM.

Policy Summary

PayerEmblemHealth

PolicyDrug Policy: Arzerra (ofatumumab) — Coverage Criteria

Policy CodePolicy N/A

Change TypeNo material change

Effective DateAug 30, 2024

Next Review DateN/A

Key ActionSubmit medication requests to Evolent (UM) for prior authorization; requests lacking Evolent authorization may be deemed not approvable and not reimbursable.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

12committee review dates listed

2024-08-30effective date

12 dosesmax for previously treated CLL

2 yearsextended treatment max

Coverage Criteria for Arzerra (ofatumumab)

Chronic Lymphocytic Leukemia (CLL)

Arzerra (ofatumumab) may be used in members with ONE of the following criteria:

CLL indications: a) In combination with chlorambucil for newly diagnosed CLL in members with no history of prior CLL treatment; b) In combination with fludarabine + cyclophosphamide for relapsed or refractory CLL; c) As monotherapy following response to prior therapy or as second-line therapy for relapsed or refractory CLL.

Includes FDA-approved and supported uses; patient access program availability noted.

Continuation Requests

Continuation requests for a not-approvable medication shall be exempt from this policy provided ALL of the following are met:

Continuation exemption: 1) Member has not experienced disease progression on the requested medication; 2) The requested medication was used within the last year without a lapse of more than 30 days of having an active authorization; 3) Additional medication(s) are not being added to the continuation request.

Policy Summary

PayerEmblemHealth

PolicyDrug Policy: Arzerra (ofatumumab) — Coverage Criteria

Policy CodePolicy N/A

Change TypeNo material change

Effective DateAug 30, 2024

Next Review DateN/A

Key ActionSubmit medication requests to Evolent (UM) for prior authorization; requests lacking Evolent authorization may be deemed not approvable and not reimbursable.

SourceLink

On This Page

Trek Health ingests and normalizes Transparency in Coverage data and payer policy updates to give provider organizations a clear view of how commercial reimbursement behaves across markets, payers, and services. Our platform transforms raw payer disclosures into structured intelligence that supports contract evaluation, payer negotiations, and service line strategy. By combining market benchmarks with ongoing policy visibility, Trek helps teams identify variability, risk, and opportunity in commercial reimbursement. The result is faster insight, stronger negotiating positions, and more informed financial decisions.

Applies to continuation of therapy even if medication otherwise not approvable.

Requests will be excluded when the member has experienced disease progression while taking Arzerra (ofatumumab). Coverage is also not allowed when dosing exceeds the single dose limit of 1,000 mg. Treatment that exceeds the stated maximum durations is excluded: for previously treated CLL a maximum of 12 doses over 24 weeks, for previously untreated CLL a maximum of 12 cycles, and for extended treatment in CLL a maximum of 2 years. Finally, investigational or off‑label uses lacking sufficient evidence are excluded; insufficient evidence includes inadequate representation of the patient or regimen in the published data, outcomes that are not clinically meaningful, inappropriate study design, reliance on uncontrolled case reports, or abstracts without a full peer‑reviewed article.

Use of Arzerra (ofatumumab) for investigational or off‑label indications is considered not medically necessary unless supported by robust evidence. Acceptable support includes representation of the patient population and regimen in the published evidence, clinically meaningful outcomes (for example ASCO‑recommended thresholds), and study designs appropriate to the question under investigation. Nonrandomized trials with substantial subject numbers may provide supportive evidence, but case reports and meeting abstracts without a full peer‑reviewed article are not considered adequate to establish coverage.

Coding and Dose Limits

inv-05: Single dose limit

Single dose limit1,000 mg

Applies toArzerra (ofatumumab) dosing per administration

Policy locationExclusion criteria — dosing exceeds single dose limit

inv-06: Maximum duration (previously treated CLL)

Maximum duration (previously treated CLL)12 doses over 24 weeks

Applies toPreviously treated (relapsed/refractory) CLL courses

Policy locationExclusion criteria — treatment exceeds maximum duration

inv-07: Maximum duration (previously untreated CLL)

Maximum duration (previously untreated CLL)Maximum 12 cycles

Applies toPreviously untreated (newly diagnosed) CLL courses

Policy locationExclusion criteria — treatment exceeds maximum duration

inv-08: Extended treatment maximum duration

Extended treatment maximum duration2 years

Applies toExtended treatment courses in CLL

Policy locationExclusion criteria — treatment exceeds maximum duration

Requirements and Actions for Providers

Prior Authorization

Prior Authorization Required

Prior authorization is required. Evolent is responsible for processing all medication requests from network ordering providers; medications not authorized by Evolent may be deemed not approvable and therefore not reimbursable.

Evolent (UM) processes medication requests — prior authorization required
Medications not authorized by Evolent may be deemed not approvable and not reimbursable

Note

Provider Actions

None specified.

Initial Therapy — Medical Necessity Criteria

Initial therapy

Initial/first-line use: In combination with chlorambucil for newly diagnosed CLL in members with no prior CLL treatment.

Listed as an accepted indication.

Continuation Therapy Criteria

Continuation Therapy

Continuation requests may be exempt from standard non-approvable medication rules when criteria are met.

Continuation therapy criteria: Member has not experienced disease progression on the requested medication; the requested medication was used within the last year without a lapse of more than 30 days of having an active authorization; no additional medications are being added to the continuation request.

See continuation requests section for requirements and operational details.

Quantity Limits for Arzerra (ofatumumab)

inv-17: Arzerra (ofatumumab) — dose identifier

DrugArzerra (ofatumumab)

Dose identifier for quantity limits1,000 mg

ContextSingle dose limit used in exclusion criteria

inv-18: Arzerra (ofatumumab) — quantity limit detail

DrugArzerra (ofatumumab)

Quantity limit detail12 doses over 24 weeks

Applies toPreviously treated CLL maximum course

Definitions

inv-14: Continuation requests

DefinitionContinuation request — treatment continuation when the member has not experienced disease progression on the requested medication; the requested medication was used within the last year with no lapse of more than 30 days in active authorization; and no additional medications are being added to the continuation request.

When it appliesApplies to continuing an existing authorization even if the medication would otherwise be not approvable under this policy

Prior authorization status carryoverContinuation requires that prior authorization was active within the last year without >30 day lapse

Background

Arzerra (ofatumumab) is an anti‑CD20 monoclonal antibody indicated for use in chronic lymphocytic leukemia (CLL). The policy recognizes Arzerra for CLL treatment in specific settings: in combination with chlorambucil for newly diagnosed patients with no prior CLL therapy; in combination with fludarabine plus cyclophosphamide for relapsed or refractory disease; and as monotherapy following response to prior therapy or as second‑line therapy for relapsed/refractory CLL. The document cites FDA‑approved uses and accepts supporting evidence from recognized compendia and peer‑reviewed literature when determining coverage.