CurrentCignaPolicy IP0727

Grafapex (treosulfan) for allogeneic HSCT conditioning

This policy governs prior-authorization medical benefit coverage for Grafapex (treosulfan IV) used as part of conditioning in allogeneic hematopoietic stem cell transplantation for eligible pediatric and adult patients under Cigna-administered plans.

Policy Summary

PayerCigna

PolicyGrafapex (treosulfan) for allogeneic HSCT conditioning

Policy CodePolicy IP0727

Change TypeNew policy + coding updates

Effective DateOct 1, 2025

Next Review Date

Key ActionObtain prior authorization and document that Grafapex will be used in combination with fludarabine for allogeneic HSCT to qualify for a 30-day approval.

SourceLink

POLICY UPDATE CHANGES

New policy established for Grafapex (treosulfan) with indications, dosing, and coding.

HCPCS/CPT/HCPCS coding entries added/updated: C9175 added (effective 7/1/2025); J0614 added (effective 10/1/2025); J9999 description updated with effective date note.

≥1 yrmin age

10 g/m2/day x3dosing

30 daysapproval duration

2indications

Boxed Warningsafety

Coverage Criteria for Grafapex (treosulfan)

inv-01: Initial therapy — Acute Myeloid Leukemia

Approve for 30 days if ALL of the following are met:

Acute Myeloid Leukemia (AML) indication: A) Patient is ≥ 1 year of age; AND B) Patient is using Grafapex in combination with fludarabine; AND C) Patient is undergoing allogeneic hematopoietic stem cell transplantation; AND D) The medication is prescribed by or in consultation with a hematologist, oncologist, transplant specialist physician, or a physician associated with a transplant center.dose <= 10 g/m2/day for up to 3 consecutive days

Approval duration: 30 days.

inv-02: Initial therapy — Myelodysplastic Syndrome

Approve for 30 days if ALL of the following are met:

Myelodysplastic Syndrome (MDS) indication: A) Patient is ≥ 1 year of age; AND B) Patient is using Grafapex in combination with fludarabine; AND C) Patient is undergoing allogeneic hematopoietic stem cell transplantation; AND D) The medication is prescribed by or in consultation with a hematologist, oncologist, transplant specialist physician, or a physician associated with a transplant center.

Policy Summary

PayerCigna

PolicyGrafapex (treosulfan) for allogeneic HSCT conditioning

Policy CodePolicy IP0727

Change TypeNew policy + coding updates

Effective DateOct 1, 2025

Next Review Date

Key ActionObtain prior authorization and document that Grafapex will be used in combination with fludarabine for allogeneic HSCT to qualify for a 30-day approval.

SourceLink

On This Page

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dose <= 10 g/m2/day for up to 3 consecutive days

Approval duration: 30 days.

inv-03: Not Medically Necessary — Other uses

Other uses: Grafapex for any other use is considered not medically necessary.

Criteria will be updated as new published data are available.

Grafapex (treosulfan) is considered not medically necessary for any use that does not meet the specific, listed indications in this policy. The policy’s FDA‑approved indications are limited to Acute Myeloid Leukemia (AML) and Myelodysplastic Syndrome (MDS) when used as part of a conditioning regimen for allogeneic hematopoietic stem cell transplantation in patients meeting the stated criteria; uses outside those indications will be denied as not covered.

Grafapex is covered only when used in combination with fludarabine as part of the preparative (conditioning) regimen for allogeneic hematopoietic stem cell transplantation in eligible patients with AML or MDS. Approval is contingent on meeting the policy’s age, setting, specialist prescribing/consultation, and dosing criteria.

Coding and Dosing

Considered medically necessary / billing codesHCPCSCovered

C9175	Injection, treosulfan, 50 mg (Code effective until 09/30/2025)
J0614	Injection, treosulfan, 50 mg (Code effective date 10/1/2025)
J9999	Not otherwise classified, antineoplastic drugs (Code effective until 6/30/2025)

Grafapex dosing (inv-07)

Recommended dose10 g/m2 per day as a 2-hour IV infusion

Course lengthAdministered on up to 3 consecutive days (Day -4, -3, -2)

Timing relative to transplantGiven in combination with fludarabine prior to HSCT (before Day 0)

Provider Actions and Authorization

Prior Authorization

Prior Authorization Required

Prior authorization is required for medical benefit coverage of Grafapex. Approvals are provided when indication-specific criteria and dosing in this policy are met. All approvals are provided for 30 days to allow an adequate time frame to administer the doses. Requests for doses outside the established dosing documented in this policy will be considered on a case-by-case basis by a clinician (Medical Director or Pharmacist).

Prior authorization required for medical benefit coverage
Approvals granted for 30 days
Dose exceptions reviewed case-by-case by clinician

Step Therapy

Step Therapy / Regimen Context

Grafapex has no step therapy requirements under this policy. Use is limited to administration in combination with fludarabine as part of a preparatory conditioning regimen for allogeneic hematopoietic stem cell transplantation (HSCT) in patients ≥ 1 year of age for AML or MDS per the coverage criteria.

No step therapy required
Must be used in combination with fludarabine as preparatory regimen for allogeneic HSCT

Documentation Required

Prescriber and Authorization Documentation

Because of the specialized skills required for evaluation, diagnosis, and monitoring of patients receiving Grafapex, the medication must be prescribed by or in consultation with a hematologist, oncologist, transplant specialist physician, or a physician associated with a transplant center. Providers should include documentation supporting the indication, combination use with fludarabine, transplant intent, and relevant clinical notes with prior authorization requests. Documentation supporting dosing, body surface area calculations, and anticipated dates of administration should also be provided.

Prescriber specialty required: hematologist, oncologist, transplant specialist, or physician associated with a transplant center
Include indication, confirmation of combination with fludarabine, and transplant plan in authorization request
Provide dosing rationale, BSA calculation, and planned administration dates

Billing Rule

Coding and Billing Compliance

Claims must be submitted with the appropriate covered diagnosis and procedure codes that reflect the indications and services described in this policy. Claims submitted without covered diagnosis/procedure codes or for services not consistent with the Coverage Policy will be denied as not covered. Providers must use the most appropriate and current codes as of the date of service.

Claims without covered diagnosis/procedure codes will be denied as not covered
Use most appropriate and current codes as of the date of service
Ensure billing reflects combination use with fludarabine and allogeneic HSCT conditioning when applicable

Background

Grafapex (treosulfan) is an alkylating chemotherapeutic agent used as part of conditioning prior to allogeneic hematopoietic stem cell transplantation. In this policy the drug is described in the context of conditioning regimens where it is administered intravenously with fludarabine to achieve cytoreduction and immunosuppression before donor cell infusion. The FDA‑approved indications covered here are for AML and MDS in patients aged ≥ 1 year who meet the stated transplant and prescribing criteria.

Definitions

Conditioning (inv-13)

DefinitionConditioning regimen: treatments given before allogeneic HSCT to eradicate malignant marrow cells (myeloablative regimens) and to immunosuppress the recipient to promote donor engraftment

PurposeEradicate malignant hematopoietic cells and immunosuppress the recipient to allow donor cell engraftment

Common use caseUsed as part of preparatory regimens (e.g., treosulfan plus fludarabine) for patients with AML or MDS undergoing allogeneic HSCT

TimingAdministered prior to donor cell infusion (Day 0) as part of the transplant preparative phase

Transplant Candidate Eligibility

inv-14: Transplant candidate eligibility

Candidates for Grafapex must be undergoing allogeneic HSCT and meet indication-specific criteria.

Eligibility for Grafapex in HSCT candidates: Patient is ≥ 1 year of age; AND Patient has a planned allogeneic hematopoietic stem cell transplantation; AND Grafapex will be used in combination with fludarabine as the conditioning regimen; AND The medication is prescribed by or in consultation with a hematologist, oncologist, transplant specialist physician, or a physician associated with a transplant center.

Contraindications and Safety

The policy does not list formal absolute contraindications. However, the product safety information includes a Boxed Warning for myelosuppression, and patients receiving Grafapex require appropriate monitoring and management for bone marrow suppression and related complications per usual clinical practice.

Evaluation Requirements

Documentation Required

Document Grafapex as part of conditioning and specialist involvement

No specific pre‑approval diagnostic testing or workup is listed; providers must document that Grafapex is being used as part of the conditioning regimen for allogeneic HSCT and that appropriate specialist involvement is present.

Documentation should indicate Grafapex use in combination with fludarabine for conditioning and planned allogeneic HSCT.
Specialist prescribing or documented consultation should be included in the submission.

Center and Prescriber Requirements

Note

Specialist prescribing or consultation required

Grafapex must be prescribed by or in consultation with a hematologist, oncologist, transplant specialist physician, or a physician associated with a transplant center due to the specialized evaluation and monitoring required.

Specialist requirement applies to approval of Grafapex for AML and MDS indications.
This implies involvement of a specialized transplant center physician when applicable.

Administration and Authorization Duration

Grafapex administration — authorization period (inv-18)

Authorization durationApprovals are provided for 30 days to allow for administration of Grafapex dosing

Dosing window allowed by authorizationAuthorization timeframe covers administration of up to 3 consecutive days of Grafapex (10 g/m2/day)

Prior authorization requirementPrior authorization is required for medical benefit coverage of Grafapex; approvals recommended when criteria and dosing are met

Prescriber requirementApproval requires Grafapex to be prescribed by or in consultation with a hematologist, oncologist, transplant specialist, or physician associated with a transplant center