Pharmacy Prior Authorization Criteria

Rytelo (imetelstat)

Indications for Prior Authorization

Rytelo (imetelstat)

• For diagnosis of Anemia Associated with Myelodysplastic Syndrome (MDS)
  Indicated for the treatment of adult patients with low- to intermediate-1 risk myelodysplastic syndromes (MDS) with transfusion-dependent anemia requiring 4 or more red blood cell units over 8 weeks who have not responded to or have lost response to or are ineligible for erythropoiesis-stimulating agents (ESA).

Criteria

Rytelo

Prior Authorization (Initial Authorization)

Length of Approval: 6 Month(s)

• Diagnosis of myelodysplastic syndrome
AND
• Disease is low to intermediate-1 risk [A]
AND
• All of the following:
• Hemoglobin less than 10 g/dL
• Baseline absolute neutrophil count of 1.5 x 10^9 /L or greater
• Baseline platelet count of 75 x 10^9 /L or greater
AND
• Both of the following:
• Patient does not have a confirmed mutation with deletion 5q [del(5q)]
• Patient has not received prior treatment with Revlimid (lenalidomide) or hypomethylating agents (e.g., azacitidine, decitabine)
AND
• Patient requires 4 or more red blood cell units over 8 weeks
AND
• One of the following:
• Previous treatment with an erythropoiesis stimulating agent shows no response
• Previous treatment with an erythropoiesis stimulating agent shows loss of response
• Patient is ineligible for treatment with an erythropoiesis stimulating agent

Rytelo

Prior Authorization (Reauthorization)

Length of Approval: 12 Month(s)

• Patient does not show evidence of progressive disease while on therapy

P & T Revisions

2024-08-16

References

1. Rytelo Prescribing Information. Catalent Indiana, LLC. Bloomington, IN. June 2024.
2. ClinicalTrials.gov. Study to Evaluate Imetelstat (GRN163L) in Subjects With International Prognostic Scoring System (IPSS) Low or Intermediate-1 Risk Myelodysplastic Syndrome (MDS). Available at: https://www.clinicaltrials.gov/study/NCT02598661?cond=NCT02598661&rank=1. Accessed July 28, 2024.
3. ICER: Anemia in Myelodysplastic Syndrome. Available at: https://icer.org/assessment/myelodysplastic-syndrome-2024. Accessed July 28, 2024.
4. Leukemia and Lymphoma Society: The International Prognostic Scoring System. Available at: https://www.lls.org/myelodysplastic-syndromes/diagnosis/international-prognostic-scoring-system. Accessed July 28, 2024.
5. NCCN Clinical Practice Guidelines in Oncology: Myelodysplastic Syndromes v3.2024. Available at: https://www.nccn.org/professionals/physician_gls/pdf/mds.pdf. Accessed July 29, 2024.

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End Notes

1. Disease was determined as low to intermediate-1 risk based on the The International Prognostic Scoring System (IPSS). [1,4]

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Revision History

• 2024-08-16: New UM PA Criteria

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