RYTELO (imetelstat)

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.