CurrentNeighborhood Health Plan of Rhode IslandPolicy N/A

Clolar (clofarabine) — Coverage Criteria for Relapsed/Refractory Acute Leukemias

Defines accepted indications, coverage criteria, exclusions, and coding for clofarabine (Clolar) for providers requesting authorization from the payer; applies to members whose requests are processed by Evolent on behalf of the health plan.

Policy Summary

PayerNeighborhood Health Plan of Rhode Island

PolicyClolar (clofarabine) — Coverage Criteria for Relapsed/Refractory Acute Leukemias

Policy CodePolicy N/A

Change TypeTemplate conversion / revision

Effective DateN/A

Next Review DateN/A

Key ActionSubmit prior authorization requests to Evolent for Clolar (clofarabine) for relapsed/refractory ALL or AML with supporting documentation from FDA labeling, CMS compendia, NCCN/ASCO guidelines, or peer-reviewed literature.

SourceLink

POLICY UPDATE CHANGES

Converted to new Evolent guideline template and replaced prior UM ONC_1395 Clolar (clofarabine).

2primary cancer indications listed (ALL, AML)

1 mgunit basis for J9027 billing code

52 mg/m2single dose maximum excluded

Commercial, Exchange/Marketplace, Medicaidapplicable lines of business

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Coverage Criteria for Clofarabine (Clolar)

Acute Lymphoblastic Leukemia (ALL)

Covered when ALL of the following are met

Relapsed/Refractory ALL use: Member has relapsed or refractory Acute Lymphoblastic Leukemia, and Clolar (clofarabine) is being used as a single agent or as part of a multi-agent regimen (e.g., clofarabine + cyclophosphamide + etoposide).

Acute Myeloid Leukemia (AML)

Covered when ALL of the following are met

Relapsed/Refractory AML use: Member has relapsed or refractory Acute Myeloid Leukemia, and Clolar (clofarabine) is being used either as a single agent or as part of a multi-agent regimen (e.g., clofarabine + cytarabine +/- idarubicin).

Requests will be excluded from coverage if any of the following apply: disease progression occurred while the member was receiving Clolar (clofarabine) or a clofarabine-containing regimen; the requested dosing exceeds the single dose limit of 52 mg/m2; or the request is for an off‑label indication considered investigational or lacking sufficient supporting evidence per the policy’s evidence standards. The policy defines insufficient evidence as inadequate representation of the patient or regimen in the published literature, lack of clinically meaningful outcomes (for example, ASCO-recommended thresholds such as a hazard ratio <0.80 and at least a 3‑month survival benefit for OS or PFS), inappropriate study design for the question being asked, reliance solely on uncontrolled case reports or abstracts without a full peer‑reviewed article, or absence of support from CMS‑recognized compendia or acceptable peer‑reviewed literature.

Off‑label requests for Clolar (clofarabine) that do not meet the policy’s evidence requirements are considered not approvable. Specifically, an off‑label indication will be treated as investigational when the available literature does not adequately represent the clinical characteristics of the patient and cancer, does not include the administered regimen, fails to demonstrate clinically meaningful outcomes as defined by the policy (e.g., ASCO thresholds), relies primarily on uncontrolled case reports or meeting abstracts without full peer‑reviewed publication, or lacks support from CMS‑recognized compendia or other acceptable peer‑reviewed sources. Such requests should not be authorized.

Regimen	Indication	Coverage
Clofarabine + cyclophosphamide + etoposide
Relapsed or refractory acute lymphoblastic leukemia (ALL)
Covered when used for relapsed/refractory ALL per policy criteria

Regimen	Indication	Coverage
Clofarabine + cytarabine (with or without idarubicin)
Relapsed or refractory acute myeloid leukemia (AML)
Covered when used for relapsed/refractory AML per policy criteria

Authorization, Documentation, and Continuation Rules

Prior Authorization

Prior Authorization Required

Prior authorization is required for requests for Clolar (clofarabine). Evolent processes all medication requests from network ordering providers; medications not authorized by Evolent may be deemed not approvable and not reimbursable.

Evolent is responsible for processing all medication requests.
Medications not authorized by Evolent may be deemed not approvable and therefore not reimbursable.

Note

Continuation / Re-Authorization Conditions

Continuation (re-authorization) requests may be approved when all of the following are met: the member has not experienced disease progression while on the requested medication; the medication was used within the last year with no lapse of more than 30 days of an active authorization; and no additional medications are being added to the continuation request.

Member has not experienced disease progression on the requested medication.
Requested medication was used within the last year without a lapse > 30 days of having an active authorization.
No additional medication(s) are being added to the continuation request.

Documentation Required

Supporting Documentation Required

Use of Clolar must be supported by one or more of the following sources: FDA-approved product labeling, CMS-recognized compendia, NCCN, ASCO clinical guidelines, or acceptable peer-reviewed literature that meets CMS standards (see Medicare Benefit Policy Manual Chapter 15). Documentation provided with authorization requests should clearly reference and, where applicable, attach excerpts or citations from these sources demonstrating applicability to the patient’s diagnosis and regimen.

Acceptable evidence: FDA labeling, CMS-approved compendia, NCCN, ASCO clinical guidelines, or peer-reviewed literature meeting CMS criteria.
Documentation should demonstrate that the patient and regimen are adequately represented in the cited evidence.
Attach supporting references or excerpts when relying on peer-reviewed literature or guidelines.

Denial Risk

Denial Triggers / Exclusion Conditions

Requests should be denied when any of the following exclusion criteria are present: disease progression while receiving Clolar or a Clolar-containing regimen; dosing requested exceeds the single-dose limit of 52 mg/m2; investigational use for an off-label indication lacking sufficient supporting evidence as defined by CMS compendia or acceptable peer-reviewed literature.

Disease progression while receiving Clolar (clofarabine) or a Clolar-containing regimen.
Requested dosing exceeds single-dose limit of Clolar (clofarabine) 52 mg/m2.
Investigational or off-label indications not supported by CMS-recognized compendia or acceptable peer-reviewed literature.
Insufficient evidence includes: lack of adequate representation of patient/cancer characteristics in the evidence; regimen not represented; outcomes not clinically meaningful per ASCO definitions; inadequate experimental design; reliance on uncontrolled case reports or meeting abstracts without full peer-reviewed publication.

Policy Summary

PayerNeighborhood Health Plan of Rhode Island

PolicyClolar (clofarabine) — Coverage Criteria for Relapsed/Refractory Acute Leukemias

Policy CodePolicy N/A

Change TypeTemplate conversion / revision

Effective DateN/A

Next Review DateN/A

SourceLink

On This Page

OpenPayer

Clolar (clofarabine) — Coverage Criteria for Relapsed/Refractory Acute Leukemias

Coverage Criteria for Clofarabine (Clolar)

Accepted Regimens and Combinations

Billing Codes and Dose Limits

Authorization, Documentation, and Continuation Rules

Line of Therapy Specifications

Accepted Evidence Sources and Definitions

Background on Clofarabine (Clolar)

Policy Revision History