CurrentCentenePolicy N/A

Chlorambucil (Leukeran) coverage

Defines medical necessity criteria, dosing limits, and prior authorization/continuation requirements for chlorambucil (Leukeran) for members of Centene-affiliated health plans (HIM, Medicaid). Applies to prescribing providers and reviewers.

Policy Summary

PayerCentene

PolicyChlorambucil (Leukeran) coverage

Policy CodePolicy N/A

Change TypeRevised indications and dosingremoved unsupported indication

Effective Date12.01.21

Next Review Date

Key ActionSubmit prior authorization with diagnosis documentation, oncologist/hematologist prescribing or consultation, and dosing within policy limits.

SourceLink

POLICY UPDATE CHANGES

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

Clarified continued therapy daily dosing requirements per prescribing information.

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

12 monthsapproval duration for continued therapy

0.1-0.2 mg/kg/dayusual daily dosing range

0.4 mg/kginitial intermittent dose for CLL

Tablet: 2 mgproduct availability

Coverage Criteria

Initial Therapy — Covered when ALL of the following are met for initial approval

Covered when ALL of the following are met for initial approval:

Diagnosis: Member has one of the following diagnoses: marginal zone lymphoma (nodal, splenic, or extranodal MALT including gastric and nongastric), classic follicular lymphoma, mycosis fungoides/Sezary syndrome, or chronic lymphocytic leukemia/small lymphocytic lymphoma (CLL/SLL)

Prescriber: Prescribed by or in consultation with an oncologist or hematologist

Age: Member is >= 18 years

Generic first: For brand name Leukeran requests, member must use generic chlorambucil if available unless contraindicated or clinically significant adverse effects are experienced

Policy Summary

PayerCentene

PolicyChlorambucil (Leukeran) coverage

Policy CodePolicy N/A

Change TypeRevised indications and dosingremoved unsupported indication

Effective Date12.01.21

Next Review Date

Key ActionSubmit prior authorization with diagnosis documentation, oncologist/hematologist prescribing or consultation, and dosing within policy limits.

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.

Continuation Therapy — Covered for continuation when ALL are met

Covered for continuation when ALL are met:

Current therapy: Member is currently receiving Leukeran via Centene benefit and documentation supports that the member has received the medication for at least 30 days

Response: Member is responding positively to therapy

Generic first: For brand name Leukeran requests, member must use generic chlorambucil if available unless contraindicated or clinically significant adverse effects are experienced

Dose increase: If request is for a dose increase, the new dose meets one of the following: (a) Daily dosing — if member has received <6 weeks of therapy: new dose does not exceed 0.2 mg/kg/day for up to a total of 6 weeks; if member has received >6 weeks of therapy: new dose does not exceed 0.1 mg/kg/day; (b) Intermittent dosing (CLL/SLL) — new dose does not exceed a 0.4 mg/kg initial dose or dose increases of 0.1 mg/kg until response/toxicity are observed; (c) New dose is supported by practice guidelines or peer‑reviewed literature (prescriber must submit supporting evidence). Prescribed regimen must be FDA‑approved or recommended by NCCN.

Approval duration: 12 months

Dosing and Regimens

Regimen	Indication	Dose / Schedule	Coverage
Daily regimen
Lymphomas (including malignant lymphomas, lymphosarcoma, and follicular lymphoma) and CLL
Usual oral dosage 0.1–0.2 mg/kg PO daily for 3–6 weeks; if maintenance dosage is used, it should not exceed 0.1 mg/kg/day.
Covered with criteria

Regimen	Indication	Dose / Schedule	Coverage
Intermittent (pulse) regimen
Chronic lymphocytic leukemia / small lymphocytic lymphoma (CLL/SLL)
Initial single dose 0.4 mg/kg; doses may be increased by 0.1 mg/kg until control of lymphocytosis/response or toxicity is observed. Alternate biweekly or once-monthly schedules reported.
Covered with criteria

Daily dosing

Usual daily dosing0.1–0.2 mg/kg PO daily for 3–6 weeks (usual oral dosage)

Maintenance dosing limitMaintenance dosing should not exceed 0.1 mg/kg PO daily

Intermittent (CLL/SLL) initial pulseInitial single dose 0.4 mg/kg for intermittent schedules

Intermittent dose escalationDose increases generally by 0.1 mg/kg until control of lymphocytosis or toxicity is observed

Maximum daily dosing (short course)Do not exceed 0.2 mg/kg/day for up to 6 weeks

Provider Actions & Authorization

Prior Authorization

Prior Authorization Required

Prior authorization is required. Provider must document the diagnosis and that the medication is prescribed by or in consultation with an oncologist or hematologist.

Documentation to submit: office chart notes, lab results, or other clinical information supporting that approval criteria are met.

Billing Rule

Combination Requirement for CLL/SLL

For chronic lymphocytic leukemia/small lymphocytic lymphoma (CLL/SLL), chlorambucil must be prescribed in combination with Gazyva (obinutuzumab) as specified by the policy.

Documentation Required

Required Clinical Documentation

Provider must submit clinical documentation (e.g., office chart notes, laboratory results, or other relevant clinical information) supporting that the member meets all approval criteria. This documentation should include diagnosis, staging or disease details as applicable, prior therapies, dosing rationale, and any supporting guideline or literature for off‑label uses.

Denial Risk

Denial Triggers / Not Authorized Uses

Requests for use of chlorambucil/Leukeran for Hodgkin lymphoma are not authorized. Non‑FDA approved indications not addressed in this policy require sufficient off‑label documentation per applicable off‑label use policies (HIM.PA.154 for Marketplace; CP.PMN.53 for Medicaid) or evidence of coverage documents.

Hodgkin lymphoma: not authorized.
Off‑label uses: require supporting evidence per HIM.PA.154 or CP.PMN.53.

OpenPayer

Chlorambucil (Leukeran) coverage

Coverage Criteria

Dosing and Regimens

Drug Codes & Formulation

Provider Actions & Authorization

Line of Therapy

Background