CurrentHealth NetPolicy N/A

Clinical Policy: Chlorambucil (Leukeran)

Defines medical necessity criteria, initial and continued therapy requirements, dosing limits, contraindications, excluded indications, and approval duration for chlorambucil (Leukeran) across HIM and Medicaid lines of business within Centene-affiliated plans.

Policy Summary

PayerHealth Net

PolicyClinical Policy: Chlorambucil (Leukeran)

Policy CodePolicy N/A

Change TypeClarified indications and dosingremoved an excluded indication

Effective DateDec 1, 2021

Next Review Date

Key ActionProvider must submit office chart notes, lab results or other clinical information supporting that member meets all approval criteria.

SourceLink

POLICY UPDATE CHANGES

Clarified follicular lymphoma is classic; added MF/SS requirement for single-agent subsequent treatment; added CLL/SLL requirement for combination use per NCCN.

Removed coverage for primary cutaneous CD30+ T-cell lymphoproliferative disorder as it is no longer NCCN supported.

Clarified continued therapy daily dosing requirements per Prescribing Information.

5Covered Indications Listed

1Excluded Indications Listed

12Approval Duration (months)

Coverage Summary

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Scope: This policy addresses medical necessity, initial and continued therapy, dosing limits, contraindications, and excluded indications for chlorambucil (Leukeran) across HIM and Medicaid lines of business within Centene-affiliated plans. Coverage stance: covered_with_criteria, aligned with FDA-approved indications and NCCN recommendations. Indication alignment: policy generally follows the FDA-approved indications for chronic lymphocytic leukemia and malignant lymphomas and incorporates NCCN guidance for specific use conditions. Specialist requirement: therapy must be prescribed by or in consultation with an oncologist or hematologist. Approval duration: authorization is granted for 12 months.

Dosing thresholds and approval duration

Daily dose limit (initial up to 6 weeks)<= 0.2 mg/kg/day

Daily dose limit (maintenance/after 6 weeks)<= 0.1 mg/kg/day

Intermittent initial dose (CLL/SLL)<= 0.4 mg/kg single dose

Intermittent dose escalation stepincrements <= 0.1 mg/kg until response/toxicity

Minimum prior exposure for continuation>= 30 days

Approval Duration12 months

Provider Actions & Prior Authorization

Prior Authorization

Specialist prescribing requirement

Prescriptions for Leukeran (chlorambucil) must be written by an oncologist or hematologist, or the prescriber must document that the order was made in consultation with an oncologist or hematologist. Include the specialist name or documentation of the consultation when submitting the prior authorization request.

Documentation Required

Submit supporting documentation

Submit office chart notes, relevant laboratory results, and other clinical documentation demonstrating the member meets all approval criteria for the requested indication. For off‑label regimens or dose changes, include supporting evidence from practice guidelines or peer‑reviewed literature as required by the policy.

Billing Rule

Generic required before brand

For requests for brand name Leukeran, members must use available generic chlorambucil unless the member has a documented contraindication or clinically significant adverse reaction to the generic. Billing and coverage will follow this therapeutic substitution requirement.

Prior Authorization

Dose increase documentation

Requests for dose increases or nonstandard/off‑label regimens must document that the new dose meets the policy mg/kg limits or is supported by practice guidelines or peer‑reviewed literature. Provide calculations for mg/kg dosing, prior dosing history, duration of therapy, and cited guideline or literature evidence to justify increases beyond the stated thresholds.

Clinical Evidence & Guidelines

Primary evidence sources referenced include the Leukeran Prescribing Information (Waylis Therapeutics LLC; 2023) and NCCN resources: the Drugs & Biologics Compendium and disease guidelines (e.g., B-Cell Lymphomas V2.2024; CLL/SLL V3.2024; Primary Cutaneous Lymphomas V2.2024). The policy was reviewed and updated during the 4Q 2024 annual review. The policy aligns with FDA labeling and incorporates NCCN recommendations where applicable; no individual trial metrics are provided in this brief summary.

Background

Background: Chlorambucil (Leukeran) is an aromatic nitrogen mustard alkylating agent. It is indicated for chronic lymphocytic (lymphocytic) leukemia and malignant lymphomas (including lymphosarcoma and classic/giant follicular lymphoma) per FDA labeling; treatment is palliative rather than curative. The policy aligns use with FDA indications and NCCN recommendations, requires prescribing or consultation by an oncologist or hematologist, and references dosing limits from the Prescribing Information such as daily and intermittent dosing constraints.

Glossary: CLL = chronic lymphocytic leukemia; MALT = mucosa-associated lymphoid tissues; MZL = marginal zone lymphoma; SLL = small lymphocytic lymphoma.

Revision History

07.15.21policy_creation

Policy created/adapted from prior policies; removed coverage for primary cutaneous CD30+ T-cell lymphoproliferative disorder per NCCN (policy creation/adaptation).

12.15.21P&T_clarification

P&T clarification applied: clarified continued therapy daily dosing requirements per Prescribing Information; annual review notes for 2022–2023 indicated no significant clinical policy changes beyond template and reference updates.

11.24annual_review_updateLatest

4Q 2024 annual review updates: clarified follicular lymphoma is classic; added MF/SS requirement that leukeran be used as a single agent as subsequent treatment; added CLL/SLL requirement for combination use per NCCN; references reviewed and updated (P&T Approval Date = 11.24).