Prior Authorization Criteria for Grafapex and Niktimvo

Date: June 27, 2025

Attention: Providers

Effective date: July 1, 2025

Call to action: Texas Children’s Health Plan (TCHP) would like to make providers aware of updates to the prior authorization criteria for Grafapex and Niktimvo pharmaceuticals.

Grafapex

On July 1, 2025, Grafapex, will become a benefit of Medicaid and CHIP. Health and Human Services (HHSC) requires prior authorization for Grafapex (procedure code C9175) for Medicaid and CHIP, effective for dates of service on or after August 1, 2025.
Grafapex (treosulfan) is an alkylating drug indicated for use in combination with fludarabine as a preparative regimen for allogeneic hematopoietic stem cell transplantation (HSCT) in adult and pediatric clients 1 year or older with acute myeloid leukemia (AML) or myelodysplastic syndrome (MDS).

Niktimvo

On July 1, 2025, Niktimvo, will become a benefit of Medicaid and CHIP. HHSC requires prior authorization for Niktimvo (procedure code J9038) for Medicaid and CHIP, effective for dates of service on or after August 1, 2025.
Niktimvo (axatilimab-csfr) is a colony stimulating factor-1 receptor (CSF-1R)-blocking antibody indicated for the treatment of chronic graft-versus-host disease (cGVHD) after failure of at least two prior lines of systemic therapy in adult and pediatric patients weighing at least 40 kg.

Grafapex Prior Authorization Requirements

Prior authorization approval for Grafapex (treosulfan) C9175 infusion therapy will be considered when all the following criteria are met:

Client is 1 year or older;
Client has a confirmed diagnosis of one of the following:
Acute myeloid leukemia (diagnosis code: C92.00) or
Myelodysplastic syndrome (diagnosis code D46.9);
Client is undergoing allogeneic hematopoietic stem cell transplantation;
Fludarabine must be administered in conjunction with Grafapex as a preparative regimen for allogeneic HSCT; and
The prescriber attests to counseling female clients of childbearing age regarding 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

MCOs must require providers to monitor the client for the parameters listed below following Grafapex (treosulfan):

Monitor hematologic laboratory parameters, as Grafapex can cause severe and prolonged myelosuppression;
Monitor for signs of neurological adverse reactions (e.g., seizures);
Monitor for extravasation and tissue necrosis; and
Monitor for infections, anemia, thrombocytopenia, and secondary malignancies.

Resource:Outpatient Drug Services Handbook Chapter of the Texas Medicaid Provider Procedure Manual

Niktimvo Prior Authorization Requirements

Prior authorization approval for Niktimvo (axatilimab-csfr) J9038 infusion therapy will be considered when the following criteria are met:

Client weighs at least 40 kg (88 lbs);
Client has a confirmed diagnosis of cGVHD (diagnosis code: D89.811 or D89.812);
Client has undergone allogenic stem cell transplantation;
Client has a failure history with at least two prior systemic therapies for cGVHD; and
The prescriber attests to counseling female clients of childbearing age regarding the use of an effective method of contraception to prevent pregnancy during treatment of Niktimvo and 30 days after the last dose of therapy.

Required Monitoring Parameters

MCOs must require providers to monitor the client’s aspartate aminotransferase (AST), alanine aminotransferase (ALT), alkaline phosphatase (ALP), creatine phosphokinase (CPK), amylase, and lipase prior to starting therapy, every 2 weeks for the first month, and one or two months after Niktimvo treatment.

Continuation Therapy

For continuation of Niktimvo therapy, MCOs must require providers to monitor the client for the parameters listed below:

Client met initial requirements to prior authorization and is currently treated with Niktimvo with absence of unacceptable toxicity (e.g., severe infusion related reactions); and
Client experienced positive clinical response to therapy.

Next step for Providers: Providers should share this information with their staff.

If you have any questions, please email Provider Relations at:providerrelations@texaschildrens.org.

For access to all provider alerts:www.texaschildrenshealthplan.org/provideralerts.