CurrentAnthemPolicy CC-0280

Grafapex (treosulfan) — Clinical Coverage and Prior Authorization Criteria

Clinical coverage and prior authorization criteria for Grafapex (treosulfan) when used as a preparative regimen with fludarabine for allogeneic hematopoietic stem cell transplantation (HSCT). Applies to members whose benefit requires clinical review for this drug.

Policy Summary

PayerAnthem

PolicyGrafapex (treosulfan) — Clinical Coverage and Prior Authorization Criteria

Policy CodePolicy CC-0280

Change TypeNo material change

Effective Date

Next Review Date

Key ActionObtain prior authorization and document diagnosis of AML or MDS plus planned use as a preparative regimen for allogeneic HSCT in combination with fludarabine.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

Phase 3Efficacy basis

MyelosuppressionBlack box

J0614HCPCS

2 codesICD-10 adds

Coverage Criteria for Grafapex (treosulfan)

Covered when ALL criteria are met

Requests for Grafapex (treosulfan) may be approved if ALL of the following are met:

Grafapex coverage criteria: 1) Individual has a diagnosis of acute myeloid leukemia (AML) or myelodysplastic syndrome (MDS); 2) Individual is using Grafapex as a preparative regimen for allogeneic hematopoietic stem cell transplantation (alloHSCT); 3) Grafapex will be administered in combination with fludarabine.all required

Requests not meeting all criteria may not be approved.

Requests for Grafapex (treosulfan) may not be approved when the coverage criteria are not met. Specifically, authorization will generally be denied if the request does not document that the patient has a diagnosis of acute myeloid leukemia (AML) or myelodysplastic syndrome (MDS), that Grafapex is being used as a preparative regimen for allogeneic hematopoietic stem cell transplantation (alloHSCT), and that it will be administered in combination with fludarabine. Requests for any other indications are also not covered.

Initial Therapy Coverage Criteria

Policy Summary

PayerAnthem

PolicyGrafapex (treosulfan) — Clinical Coverage and Prior Authorization Criteria

Policy CodePolicy CC-0280

Change TypeNo material change

Effective Date

Next Review Date

Key ActionObtain prior authorization and document diagnosis of AML or MDS plus planned use as a preparative regimen for allogeneic HSCT in combination with fludarabine.

SourceLink

On This Page

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Initial therapy coverage criteria

Initial therapy criteria: Patient has AML or MDS; Grafapex is being used as a preparative regimen for alloHSCT; Grafapex will be administered in combination with fludarabine.all required

Matches prior authorization criteria.

Coding — HCPCS, ICD-10 Procedure, ICD-10 Diagnosis

HCPCSHCPCS

J0614

Injection, treosulfan 50 mg [Grafapex]

ICD-10 ProcedureICD-10

XW03388	Introduction of treosulfan into peripheral vein, percutaneous approach, new technology group 8
XW04388	Introduction of treosulfan into central vein, percutaneous approach, new technology group 8

ICD-10 DiagnosisICD-10

C92.00	Acute myeloblastic leukemia, not having achieved remission
D46.9	Myelodysplastic syndrome, unspecified
Z94.81	Bone marrow transplant status
Z94.84	Stem cells transplant status

Provider Actions, Prior Authorization, and Documentation

Prior Authorization

Prior Authorization Required

Prior authorization is required. Requests for Grafapex (treosulfan) will be approved only when documentation shows the patient has acute myeloid leukemia (AML) or myelodysplastic syndrome (MDS) and Grafapex is being used as part of a preparative regimen for allogeneic hematopoietic stem cell transplantation (alloHSCT).

Prior authorization must be obtained before service.
Approval requires documentation of AML or MDS and intent to use Grafapex with fludarabine as conditioning for alloHSCT.

Note

Additional Provider Actions

Providers should submit a complete prior authorization request that includes the diagnosis, treatment intent (preparative regimen for alloHSCT), and the planned combination with fludarabine.

Include patient diagnosis (AML or MDS) and supporting pathology/lab reports.
Specify that Grafapex will be given as conditioning for allogeneic HSCT and will be combined with fludarabine.
Provide transplant plan and treating physician contact information as available.

Documentation Required

Required Documentation

Required documentation must support the diagnosis of AML or MDS, show that Grafapex is planned as part of a preparative regimen for allogeneic HSCT, and indicate concomitant use with fludarabine. Documentation should also address patient eligibility for reduced-intensity conditioning (for example age, HSCT-specific comorbidity index, performance status) and include relevant laboratory data given the drug's risk of severe prolonged myelosuppression.

Diagnosis documentation: pathology reports, bone marrow blast counts (AML <5% in marrow for remission; MDS blast counts as applicable).
Treatment plan: explicit statement that Grafapex is being used as preparative regimen for alloHSCT and will be administered with fludarabine.
Eligibility/supporting clinical information: age, Karnofsky performance status, HSCT-specific comorbidity index, and rationale for reduced-intensity conditioning if applicable.
Safety monitoring plan: hematologic labs and transplant arrangements given risk of severe/prolonged myelosuppression.

Denial Risk

Denial Triggers

Requests may be denied when the clinical criteria or required documentation are not met.

Denial likely if diagnosis is not AML or MDS.
Denial if Grafapex is not being used as a preparative regimen for allogeneic HSCT.
Denial if Grafapex is not planned in combination with fludarabine.
Denial if required supporting documentation (diagnostic reports, transplant plan, concomitant therapy) is incomplete or absent.

Site of Care and Administration

Billing Rule

Infusion center administration and billing guidance

Administration procedures for Grafapex include introduction into a peripheral or central vein (ICD-10-PCS codes XW03388, XW04388); facility billing should follow the clinical setting (outpatient vs inpatient) and applicable coding conventions.

Peripheral venous introduction: XW03388
Central venous introduction: XW04388
Drug HCPCS code: J0614 — Injection, treosulfan 50 mg [Grafapex]

Background

Grafapex (treosulfan) is an alkylating agent used in combination with fludarabine as a conditioning or preparative regimen prior to allogeneic hematopoietic stem cell transplantation (HSCT). The agent is intended for use in patients with AML or MDS as part of the transplant conditioning strategy and must be given with fludarabine to meet coverage criteria.

Definitions

Hematopoietic stem cells — definition

TermHematopoietic stem cells

DefinitionPrimitive cells capable of replication and formation into mature blood cells to repopulate the bone marrow.

Clinical relevanceSource of all mature blood cell lineages used to reconstitute hematopoiesis after conditioning and transplantation.