Cigna Grafapex Prior Auth Coverage Update

Coverage Criteria for Grafapex (treosulfan)

inv-01: Acute Myeloid Leukemia (FDA-approved)

Covered when ALL of the following are met

Indication Criteria (AML): 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.Up to 10 mg/m2 body surface area per day IV for up to 3 consecutive days.

Approve for 30 days.

inv-02: Myelodysplastic Syndrome (FDA-approved)

Covered when ALL of the following are met

Indication Criteria (MDS): 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.Up to 10 mg/m2 body surface area per day IV for up to 3 consecutive days.

Approve for 30 days.

Grafapex for any use other than the FDA-approved indications specified in this policy is considered not medically necessary. This policy will be updated if new published data expand approved or supported uses.

Use of Grafapex outside the listed FDA-approved indications — specifically acute myeloid leukemia (AML) and myelodysplastic syndrome (MDS) when administered in combination with fludarabine as conditioning for allogeneic hematopoietic stem cell transplantation in patients aged ≥ 1 year — is considered not medically necessary. Requests for coverage for other indications will be denied unless and until the policy criteria are revised based on new published evidence or regulatory approval.

Coding and Dosing

Covered HCPCS CodesHCPCSCovered

C9175

Injection, treosulfan, 50 mg (Code effective until 09/30/2025)

Covered HCPCS Codes (future effective)HCPCSCovered

J0614

Injection, treosulfan, 50 mg (Code effective date 10/1/2025)

Grafapex dosing — key thresholds

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

DurationAdministered on 3 consecutive days (Day -4, -3, -2)

Maximum per-day dosing noted in policyApprove a dose of up to 10 mg/m2 per day IV for up to 3 consecutive days

BSA-based dosingDose calculated by body surface area (g/m2)

Provider Actions, Authorization and Documentation

Prior Authorization

Prior Authorization Required

Prior Authorization is required for benefit coverage of Grafapex. Approval is required for patients who meet ALL specified criteria in the policy (see FDA-Approved Indications and Dosing). All approvals are provided for 30 days. Requests for doses outside the established dosing will be considered on a case-by-case basis by a clinician (Medical Director or Pharmacist). Grafapex must be prescribed by or in consultation with a physician who specializes in the condition being treated (hematologist, oncologist, transplant specialist, or physician associated with a transplant center).

Approvals are valid for 30 days when patient meets ALL specified criteria.
Grafapex must be prescribed by or in consultation with an appropriate specialist.
Requests for non-standard dosing reviewed case-by-case by clinician.

Documentation Required

Background and Indication Summary

Grafapex (treosulfan) is an alkylating agent indicated, in combination with fludarabine, as a preparatory conditioning regimen prior to allogeneic hematopoietic stem cell transplantation (HSCT) for patients with hematologic malignancies such as acute myeloid leukemia (AML) and myelodysplastic syndrome (MDS). Conditioning regimens are given to eradicate malignant marrow cells and immunosuppress the recipient to permit donor cell engraftment.

Key Definitions

conditioning regimen / allogeneic HSCT

DefinitionConditioning regimen: treatment given prior to allogeneic HSCT to eradicate malignant cells and immunosuppress the recipient to allow donor cell engraftment.

PurposeEradicate malignant marrow cells (when myeloablative) and immunosuppress the recipient to promote engraftment of donor hematopoietic cells.

TimingAdministered before hematopoietic stem cell infusion (e.g., Grafapex on Days -4 to -2 with infusion on Day 0).

ContextUsed in allogeneic HSCT for hematologic malignancies such as AML and MDS.

Transplant Candidate Criteria

inv-15: Transplant candidate criteria

Candidate must meet the following prior to approval for Grafapex as conditioning for HSCT

Transplant Candidate Criteria: Patient undergoing allogeneic hematopoietic stem cell transplantation and receiving Grafapex in combination with fludarabine; patient age ≥ 1 year; prescribed by or in consultation with a hematologist, oncologist, transplant specialist physician, or a physician associated with a transplant center.

Approvals provided for 30 days to allow administration of doses.

Contraindications and Warnings

The policy notes a Boxed Warning for myelosuppression associated with Grafapex. No absolute contraindications are listed in the policy text; clinicians should exercise caution and monitor blood counts closely given the drug’s myelosuppressive potential.

Evaluation and Specialist Involvement

Note

Evaluation requirements — documentation only

No additional pre-approval evaluation steps are specified beyond documenting that the patient meets the indication criteria and that the medication is prescribed by or in consultation with an appropriate specialist.

Ensure all indication criteria and specialist prescribing/consultation are documented with the prior authorization request.

Center and Prescriber Requirements

Step Therapy

Center/specialist requirement — specialist prescribing or consultation

Grafapex must be prescribed by or in consultation with a hematologist, oncologist, transplant specialist physician, or a physician associated with a transplant center; approvals require specialist involvement.

Document the prescribing clinician's specialty or evidence of consultation with an appropriate transplant specialist.

Post-Transplant Coverage Notes

Grafapex administration — authorization duration and scope

Approval durationApprovals are provided for 30 days to allow an adequate time frame to administer Grafapex doses.

Scope of approvalTime-limited approval covers dosing administration (up to the 3-day conditioning course); no longer-term post-transplant services are specified in this policy.

Prior authorization requirementPrior Authorization is required and approval is contingent on meeting criteria and dosing in the policy.

Specialist prescribingApproval requires Grafapex to be prescribed by or in consultation with a specialist (hematologist, oncologist, transplant physician, or physician associated with a transplant center).

OpenPayer

Transplantation - Grafapex