Arranon (nelarabine) coverage
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Defines medical necessity and prior authorization requirements for Arranon (nelarabine) across Geisinger Health Plan lines of business including Commercial, Medicare, CHIP, and Medicaid. Applies to providers requesting coverage for nelarabine.
No material clinical or coverage changes in this revision.
Coverage Criteria for Arranon (nelarabine)
Initial Therapy — Covered when ALL of the following are met
Covered when ALL of the following are met
Applies when brand is requested
Eligibility and contract-specific benefit limitations and exclusions may apply. Coverage statements contained in the member's line-of-business benefit document take precedence and supersede this policy when there is a conflict.
Arranon (nelarabine) will no longer be covered if the patient experiences treatment-related toxicity or clinical worsening of disease. For Medicaid (GHP Family) members, requests that do not meet the PARP criteria will be evaluated on a case-by-case basis.
Initial Authorization Criteria
Initial Therapy — explicit initial authorization criteria
Initial authorization criteria
Physician-provided documentation required
Physician-provided documentation required
Continuation / Renewal Criteria
Continuation Therapy — criteria for subsequent approvals
Subsequent approvals
Medication will no longer be covered if patient experiences toxicity or worsening of disease
Provider Actions, Prior Authorization, and Documentation
Prior authorization required by Medical Director or designee
Prior authorization is required for Arranon (nelarabine) and must be obtained from the Medical Director or their designee before coverage will be considered.
PA governance and MA UM Committee approvals recorded
Prior authorization requirements in this policy are governed by the policy document and the policy has MA UM Committee approval dates recorded; specific operational PA instructions are not detailed in the cited sections.
Provide documentation when requesting brand over generic
When a brand product is requested while a therapeutically equivalent generic exists, submit medical record documentation showing therapeutic failure of, or intolerance to, the generic formulary agent(s) or intolerance/contraindication to the generic's inactive ingredients.
- Documentation of therapeutic failure on the generic formulary agent(s) OR
- Documentation of intolerance to the generic agent(s) OR
- Documentation of intolerance to or contraindication to the inactive ingredients of the generic agent(s)
No step therapy rules specified
No step therapy (step edits) rules are specified in the cited sections of this policy.
Required physician documentation of diagnosis and prior regimen failures
Provide physician-supplied medical record documentation of the diagnosis (T-ALL or T-LBL) and documentation that the patient failed to respond to, or relapsed following, at least two chemotherapy regimens when requesting authorization.
- Physician documentation of T-cell acute lymphoblastic leukemia (T-ALL) or T-cell lymphoblastic lymphoma (T-LBL)
- Documentation of failure to respond to, or relapse following, a minimum of 2 chemotherapy regimens
Reference policy revision and review history for compliance
The policy includes a revision and review history (devised and multiple revision dates) that should be referenced for administrative compliance and recordkeeping.
- Devised: 10/8/08; multiple revisions listed including 2/2012, 3/24/15, 9/16/22, 9/12/23, 12/31/23, 8/29/24
- Reviewed: entries include 2/2010; 1/2014; 3/2016; and others through 7/22/25
Denial risk for missing diagnosis or prior-regimen documentation
Requests that do not document a diagnosis of T-ALL or T-LBL, or that do not document failure to respond to or relapse after at least two chemotherapy regimens, may be denied.
- Missing documented diagnosis of T-ALL or T-LBL
- Missing documentation of failure to respond to, or relapse following, ≥2 chemotherapy regimens
Risk if administrative or criteria documentation is not present
Absence of documented policy criteria changes or other administrative requirements in the cited sections may increase risk of denial if other parts of the policy are not met; consult the policy history and MA UM approvals as applicable.
Step Therapy / Brand-Over-Generic Requirements
| Requirement | Documentation needed |
|---|---|
| Brand requested when therapeutically equivalent generic exists | |
| Medical record documentation of therapeutic failure on the generic formulary agent(s) | |
| OR medical record documentation of intolerance to the generic formulary agent(s) | |
| OR medical record documentation of therapeutic failure on, intolerance to, or contraindication to the inactive ingredients of the generic formulary agent(s) |
Background on Nelarabine
Nelarabine is a prodrug that is metabolized to ara-GTP, which accumulates in leukemic blasts, incorporates into DNA, inhibits DNA synthesis, and leads to cell death. The policy focuses on nelarabine use in T-cell malignancies (T-ALL and T-LBL) following failure of prior chemotherapy regimens.
Definitions
Revision and Review History
Revised: LOB table and taglines added (document lists 8/29/24 as a revision).
References added to the policy document.
LOB carve out, Medicaid business segment, and generic drug language were added to the policy.
Medicaid PARP statement was added to the policy criteria.
Formatting changes and authorization duration updated.
Criteria revised in February 2012.
Policy devised on 2008-10-08.
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