RYTELO (imetelstat) 

Office-Administration- intravenous (IV) infusion

Diagnosis considered for coverage:

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).

Coverage Criteria:

For diagnosis of anemia associated with MDS:

  • Diagnosis of MDS; AND

  • Disease is low to intermediate-1 risk; 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

Reauthorization Criteria:

For diagnosis of anemia associated with MDS:

  • Patient does not show evidence of progressive disease while on therapy (e.g. baseline lab values do not worsen or transfusion requirements do not increase).

Coverage Duration:
  • Initial: 6 months

  • Reauthorization: 1 year

Dosing:

For diagnosis of anemia associated with MDS:

  • The recommended dosage of RYTELO is 7.1 mg/kg administered as an intravenous infusion over 2 hours every 4 weeks. 

  • Premedicate prior to dosing with RYTELO for potential infusion-related reactions.

  • Obtain complete blood cell counts prior to initiation of RYTELO, weekly for the first two cycles, and prior to each cycle thereafter to monitor.

    • Delay or dose reduce as recommended

  • Discontinue RYTELO if a patient does not experience a decrease in red blood cell (RBC) transfusion burden after 24 weeks of treatment (administration of 6 doses) or if unacceptable toxicity occurs at any time.

  • RYTELO treatment should be permanently discontinued if the patient cannot tolerate the lowest dose level of 4.4 mg/kg.

Authorization is not covered for the following:
  • The use of this drug for indications not listed in this policy does not meet the coverage criteria established by the Western Health Advantage (WHA) Pharmacy and Therapeutics (P&T) Committee.

Additional Information: 
  • Anemia (low red blood cell counts), thrombocytopenia (low platelet counts), and leukopenia (low white blood cell counts) are common among patients with MDS.

  • Patients with serum EPO concentrations > 500 mU/mL are unlikely to respond to ESAs and are considered ineligible for ESA therapy.

  • Disease was determined as low to intermediate-1 risk based on the International Prognostic Scoring System (IPSS).

  • IPSS uses three "prognostic indicators" to predict the course of the patient's disease: 

    • The percentage of leukemic blast cells in the marrow 

    • The type of chromosomal changes, if any, in the marrow cells (cytogenetics) 

    • The presence of one or more low blood cell counts (cytopenias) 

  • These 3 prognostic indicators are then assigned a total risk score from low, intermediate risk-1, intermediate risk -2, or high. 

Policy Updates:
  • 12/01/2024 – New policy for Rytelo approved by WHA P&T Committee. (P&T, 11/20/2024)

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.

Last review date: December 9, 2024

Rite Aid Pharmacy Patients: All Rite Aid pharmacies nationwide are closing! Please be on the lookout for information from Rite Aid pharmacies about their bankruptcy and store closures. Call your Rite Aid pharmacy for questions about your prescriptions and new pharmacy options. WHA is here to help as well. Contact Us via Phone