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Prior Authorization Criteria for Rytelo Effective February 1, 2025
Date: December 24, 2024
Attention: All Providers
Prior authorization effective date: February 1, 2025
Call to action: The purpose of this communication is to inform providers that on January 1, 2025, Rytelo will become a benefit of Medicaid and CHIP. The Texas Health and Human Services Commission (HHSC) requires prior authorization for Rytelo (procedure code J0870) for Medicaid and CHIP, effective February 1, 2025.
Rytelo (Imetelstat) is an oligonucleotide telomerase inhibitor indicated for the treatment of adult clients with low- to intermediate-1 risk myelodysplastic syndromes (MDS) with transfusion-dependent anemia requiring four or more red blood cell (RBC) units over eight weeks who have not responded to, have lost response to, or are ineligible for erythropoiesis-stimulating agents (ESA).
Rytelo (Imetelstat) IV infusion Criteria:
- Patient is at least is 18 years or older; AND
- Patient has confirmed diagnosis of low- to intermediate-1 risk MDS (diagnosis code D460, D461, D464, D469, D46A, D46B, D46C, or D46Z); AND
- Patient has transfusion-dependent anemia requiring regular RBC transfusions, defined as more than four RBC units over eight weeks; AND
- Patient does not have deletion 5q cytogenic abnormalities; AND
- Patient is not concomitantly taking any other erythropoiesis-stimulating agents.
Provider Attestation Requirements:
- Provider should attest to the patient not responding or has lost response or is ineligible for ESA; AND
- Provider should attest to counseling female clients of childbearing age regarding the use of an effective method of contraception to prevent pregnancy during treatment with Rytelo (Imetelstat); AND
- Provider should attest to ruling and or addressing other causes of anemia (such as such as abnormal bleeding, hemolysis, nutritional deficiency, or renal disease).
Monitoring Parameters
- Provider should monitor the following
- Liver function test before initial administration, then weekly for the first cycle, and before each cycle thereafter.
- Thrombocytopenia and neutropenia after infusion.
Next step for providers: Providers should refer to the Texas Medicaid Provider Procedures Manual (TMPPM), Outpatient Drug Services Handbook for more details on the clinical policy and prior authorization requirements.
Note: If request is for a non-FDA approved dose, indication, or age medical rational must be submitted in support of therapy (such as high-quality peer reviewed literature, acceptable compendia or evidence based practice guidelines) and exceptions will be considered on a case-by-case basis.
If and when there any updates or changes related to the coverage for Rytelo, we will promptly communicate those changes to you.
If you have any questions, please email Provider Relations at: providerrelations@texaschildrens.org.
For access to all provider alerts, log into: www.texaschildrenshealthplan.org/provideralerts.