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Prior Authorization Criteria for Imetelstat (Rytelo) Effective February 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 February 1, 2025, prior authorization will be required for imetelstat (Rytelo), procedure code J0870.

Imetelstat (Rytelo) is an oligonucleotide telomerase inhibitor indicated for the treatment of adult clients meeting both of the following criteria:

  • The client has low- to intermediate-1 risk myelodysplastic syndromes (MDS) with transfusion-dependent anemia requiring four or more red blood cell (RBC) units over eight weeks.
  • The client has not responded to, has lost response to, or is ineligible for erythropoiesis-stimulating agents (ESA).

Prior Authorization Requirements for Imetelstat (Rytelo)

Imetelstat (Rytelo) is an intravenous infusion indicated for the treatment of a client who is 18 years of age or older.

Prior authorization requests for imetelstat (Rytelo) must be submitted with a Special Medical Prior Authorization (SMPA) Request Form and documentation of all the following:

  • The client is 18 years of age or older.
  • The client has a confirmed diagnosis of low- to intermediate-1 risk MDS (diagnosis code D460, D461, D464, D469, D46A, D46B, D46C, or D46Z).
  • The client has transfusion-dependent anemia requiring regular RBC transfusions, defined as more than four RBC units over eight weeks.
  • The prescriber has ruled out or addressed other causes of anemia (such as abnormal bleeding, hemolysis, nutritional deficiency, or renal disease).
  • The prescriber attests that the client has not responded to, has lost response to, or is ineligible for ESAs.
  • The client does not have deletion 5q cytogenic abnormalities.
  • Imetelstat (Rytelo) will not be prescribed concomitantly with other erythropoiesis-stimulating agents.
  • The prescriber attests to counseling female clients of childbearing age regarding the use of an effective method of contraception to prevent pregnancy during treatment with imetelstat (Rytelo).

Required Monitoring Parameters

Liver function tests must be monitored before imetelstat (Rytelo) administration, then weekly for the first cycle, and before each cycle thereafter.

Thrombocytopenia and neutropenia must be monitored after imetelstat (Rytelo) infusion.

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