ModifiedNeighborhood Health Plan of Rhode IslandPolicy N/A

Clolar (clofarabine) coverage guideline

Defines accepted indications, continuation and exclusion criteria, supporting evidence sources, applicable billing code, and applicable lines of business for Clolar (clofarabine) medication requests processed by Evolent on behalf of Neighborhood Health Plan of Rhode Island.

Policy Summary

PayerNeighborhood Health Plan of Rhode Island

PolicyClolar (clofarabine) coverage guideline

Policy CodePolicy N/A

Change TypeTemplate/branding updates

Effective Date

Next Review Date

Key ActionProvide documentation showing indication and that use is supported by FDA labeling, CMS‑approved compendia, NCCN, ASCO guidelines, or acceptable peer‑reviewed literature; ensure Evolent authorization for all medication requests.

POLICY UPDATE CHANGES

Converted to new Evolent guideline template in March 2025; replaces prior UM ONC 1395 Clolar (clofarabine).

Updated NCH verbiage to Evolent in March 2024.

2Covered Indications

1HCPCS code listed

52Single‑dose exclusion threshold (mg/m2)

Coverage Summary & Criteria

This guideline defines accepted indications for Clolar (clofarabine), including FDA‑approved and off‑label uses supported by recognized compendia or guidelines, and applies to medication requests for HCPCS code J9027. Evolent processes all medication requests on behalf of the payer and will authorize medications consistent with CMS requirements and the documented supporting literature; medications not authorized by Evolent may be deemed not approvable and not reimbursable.

General coverage condition

Clolar (clofarabine) use must be supported by one of the listed evidence sources and meet indication-specific criteria:

ALL of the following

Evidence source: Use is supported by one of the following: FDA approved product labeling, CMS‑approved compendia, National Comprehensive Cancer Network (NCCN), American Society of Clinical Oncology (ASCO) clinical guidelines, or peer‑reviewed literature that meets CMS Medicare Benefit Policy Manual Chapter 15 requirements.
Indication
- Relapsed/refractory ALL: Relapsed/refractory Acute Lymphoblastic Leukemia (ALL), and clofarabine is being used as a single agent or as part of a multi‑agent regimen (e.g., clofarabine + cyclophosphamide + etoposide).
- Relapsed/refractory AML: Relapsed/refractory Acute Myeloid Leukemia (AML), and clofarabine is being used as a single agent or as part of a multi‑agent regimen (e.g., clofarabine + cytarabine +/‑ idarubicin).

Initial and Continuation Therapy Criteria

Continuation requests (exemption to non‑approvable status)

Continuation requests for a medication that would otherwise be not approvable are allowed if ALL of the following are met:

Continuation requirements

No disease progression: Member has not experienced disease progression on the requested medication.
Recent prior use: The requested medication was used within the last year without a lapse of more than 30 days of having an active authorization.
No additions: Additional medication(s) are not being added to the continuation request.

Exclusion / Not medically acceptable

Clolar (clofarabine) is excluded when ANY of the following are present:

Exclusion criteria

Disease progression on therapy: Disease progression while receiving Clolar (clofarabine) or a Clolar containing regimen.
Single dose limit: Dosing exceeds single dose limit of Clolar (clofarabine) 52 mg/m2.single dose <= 52 mg/m2
Requests exceeding this single dose limit are excluded.
Investigational or insufficient evidence
- Patient representation: Clinical characteristics of the patient and the cancer are not adequately represented in published evidence.
- Regimen representation:

Prior Authorization, Documentation & Denial Risks

Prior Authorization

Evolent authorization required

Evolent authorization required. All medication requests for clofarabine must be processed and authorized by Evolent; medications not authorized by Evolent may be deemed not approvable and not reimbursable. Affected billing code: J9027 (Injection, clofarabine, mg).

Documentation Required

Support with accepted evidence

Provide documentation showing the indication and that use is supported by one of the accepted evidence sources: FDA approved product labeling, CMS‑approved compendia, National Comprehensive Cancer Network (NCCN), American Society of Clinical Oncology (ASCO) clinical guidelines, or peer‑reviewed literature that meets CMS Medicare Benefit Policy Manual Chapter 15 requirements.

FDA product labeling
CMS‑approved compendia
NCCN guidelines/compendia
ASCO clinical guidelines
Acceptable peer‑reviewed literature meeting CMS Medicare Benefit Manual Chapter 15

Denial Risk

Risk of denial for insufficient evidence or investigational/off‑label uses

Requests are at risk for denial when the use is off‑label or investigational without sufficient supporting evidence, when dosing exceeds the single‑dose limit of 52 mg/m2, or when disease progression occurred while receiving clofarabine. Affected billing code: J9027 (Injection, clofarabine, mg).

Off‑label or investigational use without sufficient evidence
Dosing > 52 mg/m2 (single dose limit)
Disease progression while on clofarabine or a clofarabine‑containing regimen

Documentation Required

Continuation request requirements

For continuation requests, document that all of the following are met: no disease progression on the requested medication; the medication was used within the last year without a lapse of more than 30 days of active authorization; and no additional medications are being added to the continuation request.

No disease progression on therapy
Prior use within the last year with ≤30‑day authorization lapse
No additional medications added to the regimen

Background & Definitions

Purpose: To define and describe accepted indications for Clolar (clofarabine) use in cancer treatment, including FDA labeling and off‑label indications when supported by CMS‑approved compendia, NCCN, ASCO guidelines, or peer‑reviewed literature that meets CMS Medicare Benefit Policy Manual Chapter 15. Evolent is responsible for processing all medication requests from network ordering providers and will determine authorization based on these evidence sources; medications not authorized by Evolent may be deemed not approvable and not reimbursable. Continuation requests that would otherwise be not approvable are exempt if the member has not experienced disease progression on the medication, the medication was used within the last year without >30 days lapse in authorization, and no additional medications are being added. This policy was converted to the current Evolent guideline template in March 2025 and replaces the prior UM ONC 1395 Clolar (clofarabine) guideline.

Sufficient evidence: Evidence supported by CMS‑recognized compendia or acceptable peer‑reviewed literature that adequately represents the patient and regimen characteristics, reports clinically meaningful outcomes (ASCO guidance suggests thresholds such as hazard ratio < 0.80 and survival benefit for OS/PFS of at least 3 months), and uses appropriate experimental design; case reports and abstracts without full peer‑reviewed articles are generally inadequate.

Policy Summary

PayerNeighborhood Health Plan of Rhode Island

PolicyClolar (clofarabine) coverage guideline

Policy CodePolicy N/A

Change TypeTemplate/branding updates

Effective Date

Next Review Date

On This Page

OpenPayer

Clolar (clofarabine) coverage guideline

Coverage Summary & Criteria

Initial and Continuation Therapy Criteria

Prior Authorization, Documentation & Denial Risks

Applicable Codes

Background & Definitions

Evidence & References

Thresholds & Quick Facts

Revision History