WHA
 

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: [2]
    • 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: [2, 3]
    • 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

  • Guideline ID
    GL-648194

  • Formulary
    Premium

  • Effective date
    Oct 1, 2026

  • P&T approval date
    Aug 15, 2024

P & T Revisions

2026-07-08, 2025-08-05, 2024-08-16

  1. Rytelo Prescribing Information. Geron Corporation. Foster City, CA. April 2026.
  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 8, 2026.
  3. National Comprehensive Cancer (NCCN) Drugs & Biologics Compendium [internet database]. National Comprehensive Cancer Network, Inc. Updated periodically. Available at: http://www.nccn.org/professionals/drug_compendium/content/contents.asp. Accessed July 8, 2026.
  4. Sekeres MA, Larson RA, Rosmarin AG. Myelodysplastic syndromes/neoplasms (MDS): Overview of diagnosis and management. Wolters Kluwer. Updated July 26, 2024 (review current through June 2026). Available at: https://www.uptodate.com. Accessed July 8, 2026.
  1. Disease was determined as low to intermediate-1 risk based on International Prognostic Scoring System (IPSS) in the pivotal study. The IPSS model has been replaced by the IPSS-Molecular (IPSS-M) and IPSS-Revised (IPSS-R), which are more widely accepted due to their updated diagnostic criteria and higher prognostic accuracy. The National Comprehensive Cancer Network (NCCN) recommends Rytelo as a preferred treatment of lower risk disease, defined as IPSS-Revised [very low, low, intermediate] associated with symptomatic anemia with no del(5q). [3, 4]
  • 2026-07-08: Annual Review 2026 - No criteria changes. Background updates
  • 2025-08-05: 2025 Annual Review. No criteria changes.
  • 2024-08-16: New UM PA Criteria