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Prior Authorization Criteria for Axatilimab-csfr (Niktimvo) Effective July 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 July 1, 2025, providers must receive prior authorization for axatilimab-csfr (Niktimvo), procedure code J9038. Providers must also include a Special Medical Prior Authorization (SMPA) Request Form when submitting prior authorization requests for axatilimab-csfr (Niktimvo).

Prior Authorization Requirements for Axatilimab-csfr (Niktimvo)

Axatilimab-csfr (Niktimvo) is an intravenous infusion and a colony-stimulating factor-1 receptor (CSF-1R)-blocking antibody that is indicated for clients who meet the following requirements:

  • The client weighs at least 40 kilograms (88 pounds).
  • The client has a confirmed diagnosis of chronic graft-versus-host disease (cGVHD) (diagnosis codes D89811 and D89812).
  • The client has undergone allogenic stem cell transplantation.
  • The client has previously had at least two failed systemic therapies for cGVHD.
  • The prescribing provider attests to counseling female clients of childbearing age regarding the use of an effective method of contraception to prevent pregnancy during treatment with axatilimab-csfr (Niktimvo) and for 30 days after the last dose of therapy.

Requests for Renewal or Continuation of Therapy

To renew or continue with axatilimab-csfr (Niktimvo) therapy:

  • The client must meet the initial requirements for prior authorization.
  • The client must be undergoing treatment with axatilimab-csfr (Niktimvo) with the absence of unacceptable toxicity (such as severe infusion-related reactions).
  • The client must experience a positive clinical response to therapy.

Required Monitoring Parameters

Clients who take axatilimab-csfr (Niktimvo) must be monitored:

  • Before starting axatilimab-csfr (Niktimvo) therapy.
  • Every two weeks for the first month of axatilimab-csfr (Niktimvo) therapy.
  • One to two months after completing axatilimab-csfr (Niktimvo) therapy.

Providers will monitor the client for the following:

  • Aspartate aminotransferase (AST)
  • Alanine aminotransferase (ALT)
  • Alkaline phosphatase (ALP)
  • Creatine phosphokinase (CPK)
  • Amylase
  • Lipase

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