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Prior Authorization Criteria for Treosulfan (Grafapex) Effective August 1, 2025

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Note: Texas Medicaid managed care organizations (MCOs) must provide all medically necessary, Medicaid-covered services to Medicaid members who are enrolled in their MCO. Administrative procedures, such as prior authorization, precertification, referrals, and claims and encounter data filing, may differ from traditional Medicaid (fee-for-service) and from MCO to MCO. Providers should contact the member’s specific MCO for details.

Effective for dates of service on or after August 1, 2025, prior authorization will be required for treosulfan (Grafapex), procedure code C9175.

Treosulfan (Grafapex) is an alkylating drug that is administered through intravenous infusion in combination with fludarabine over three consecutive days before hematopoietic stem cell infusion.

Prior Authorization Requirements for Treosulfan (Grafapex)

Prior authorization requests for treosulfan (Grafapex) must be submitted with a Special Medical Prior Authorization (SMPA) Request Form.

Treosulfan (Grafapex) must be used in combination with fludarabine as a preparative regimen for allogeneic hematopoietic stem cell transplantation (HSCT). It is indicated for clients who meet the following requirements:

  • The client is 1 year of age or older.
  • The client has a confirmed diagnosis of acute myeloid leukemia (diagnosis code C9200) or myelodysplastic syndrome (diagnosis code D469).
  • The client is undergoing allogeneic HSCT.

The prescriber must attest that female clients of childbearing age were counseled on the use of an effective method of contraception to prevent pregnancy during treatment and up to six months after the last dose of therapy. Male clients with female partners of reproductive potential should also be counseled.

Required Monitoring Parameters

After administering treosulfan (Grafapex) infusion, the provider must monitor the client for all the following:

  • Hematologic laboratory parameters, due to the risk of severe and prolonged myelosuppression.
  • Neurological adverse reactions, such as seizures.
  • Signs of extravasation and tissue necrosis.
  • Infections, anemia, thrombocytopenia, and secondary malignancies.

For more information, call the TMHP Contact Center at 800-925-9126.