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Imetelstat (Rytelo™)
Commercial Utilization Management Policy
Version Date: September 2024

Restricted Product(s):

  • imetelstat (Rytelo™) intravenous infusion for administration by a healthcare professional

FDA Approved Use:

  • For treatment of adults 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 (ESAs)

Criteria for Medical Necessity:

The restricted product(s) may be considered medically necessary when the following criteria are met:

Initial Criteria for Approval:

  1. The patient is 18 years of age or older; AND
  2. The patient has a diagnosis of symptomatic low- to intermediate-1 risk myelodysplastic syndrome (MDS) based on prognostic risk stratification [medical record documentation required]; AND
  3. The patient has red blood cell (RBC) transfusion-dependent anemia, defined as requiring at least 4 RBC units transfused over an 8-week period in the last 16 weeks prior to initiation of treatment with the requested agent [medical record documentation required]; AND
  4. ONE of the following:
    1. The patient has tried and had an inadequate response to or lost response to prior treatment with an erythropoiesis stimulating agent (ESA) [medical record documentation required]; OR
    2. The patient has an intolerance, FDA labeled contraindication, or hypersensitivity to ESAs [medical record documentation required]; OR
    3. The patient is unable to receive ESA treatment, defined by a serum erythropoietin level > 500 mU/mL [medical record documentation required]; AND
  5. If the patient has ring sideroblasts ≥ 15% OR ring sideroblasts ≥ 5% with an SF3B1 genetic mutation, then ONE of the following:
    1. The patient has tried and had an inadequate response to luspatercept-aamt (Reblozyl®) [medical record documentation required]; OR
    2. The patient has an intolerance, FDA labeled contraindication, or hypersensitivity to luspatercept-aamt (Reblozyl®) [medical record documentation required]; AND
  6. The patient does NOT have deletion 5q [del(5q)] cytogenetic abnormalities [medical record documentation required]; AND
  7. The prescriber is a specialist in the area of the patient’s diagnosis (e.g., hematologist, oncologist, specialist in treating myelodysplastic syndromes) or has consulted with a specialist in the area of the patient’s diagnosis [medical record documentation required]; AND
  8. The requested quantity does NOT exceed the maximum units allowed for the duration of approval (see table below); AND
  9. For requests for injection or infusion administration of the requested medication in an inpatient or outpatient hospital setting, Site of Care Criteria applies (outlined below)*

Duration of Approval: 180 days (6 months)

Continuation Criteria for Approval:

  1. The patient was approved through Blue Cross NC initial criteria for approval; OR
  2. The patient would have met initial criteria for approval at the time they started therapy [medical record documentation required]; AND
  3. The patient has demonstrated a reduction in red blood cell (RBC) transfusion burden from baseline following imetelstat treatment [medical record documentation required]; AND
  4. The patient does NOT have deletion 5q [del(5q)] cytogenetic abnormalities [medical record documentation required]; AND
  5. The prescriber is a specialist in the area of the patient’s diagnosis (e.g., hematologist, oncologist, specialist in treating myelodysplastic syndromes) or has consulted with a specialist in the area of the patient’s diagnosis [medical record documentation required]; AND
  6. The requested quantity does NOT exceed the maximum units allowed for the duration of approval (see table below); AND
  7. For requests for injection or infusion administration of the requested medication in an inpatient or outpatient hospital setting, Site of Care Criteria applies (outlined below)*

Duration of Approval: 365 days (1 year)
FDA Label Reference 
MedicationIndicationDosingHCPCS Maximum Units*

imetelstat (Rytelo™)

intravenous (IV) infusion

Low- to intermediate-1 risk MDS with transfusion-dependent anemia in adult patients who have not responded to or have lost response to or are ineligible for ESAs

7.1 mg/kg IV every 4 weeks

Discontinue treatment if the patient does not experience a decrease in RBC transfusion burden after 24 weeks of treatment (6 doses) or if unacceptable toxicity occurs at any time

C9399**
J3490**
J3590**
J9999**		Initial: 4,260 Continuation: 9,230

*Maximum units allowed for duration of approval
**Non-specific assigned HCPCS codes, must submit requested product NDC

*Site of Care Medical Necessity Criteria

  1. For requests for injection or infusion administration in an inpatient setting, the injection or infusion may be given if the above medical necessity criteria are met AND the inpatient admission is NOT for the sole purpose of administering the injection or infusion; OR
  2. For requests for injection or infusion administration in an outpatient hospital setting, the injection or infusion may be given if the above medical necessity criteria are met AND ONE of the following must be met:
    1. History of mild adverse events that have not been successfully managed through mild pre-medication (e.g., diphenhydramine, acetaminophen, steroids, fluids, etc.); OR
    2. Inability to physically and cognitively adhere to the treatment schedule and regimen complexity; OR
    3. New to therapy, defined as initial injection or infusion OR less than 3 months since initial injection or infusion; OR
    4. Re-initiation of therapy, defined as ONE of the following:
      1. First injection or infusion after 6 months of no injections or infusions for drugs with an approved dosing interval less than 6 months duration; OR
      2. First injection or infusion after at least a 1-month gap in therapy outside of the approved dosing interval for drugs requiring every 6 months dosing duration; OR
    5. Requirement of a change in the requested restricted product formulation; AND
  3. If the Site of Care Medical Necessity Criteria in #1 or #2 above are not met, the injection or infusion will be administered in a home-based infusion or physician office setting with or without supervision by a certified healthcare professional.

References:

All information referenced is from FDA package insert unless otherwise noted below.

  1. Platzbecker U, Santini V, Fenaux P, et al. Imetelstat in patients with lower-risk myelodysplastic syndromes who have relapsed or are refractory to erythropoiesis-stimulating agents (IMerge): a multinational, randomised, double-blind, placebo-controlled, phase 3 trial. Lancet. 2024;403(10423):249-260.
  2. National Comprehensive Cancer Network (NCCN) Clinical Practice Guidelines in Oncology. Myelodysplastic Syndromes, version 3.2024. Revised July 25, 2024. Available at: https://www.nccn.org/professionals/physician_gls/pdf/mds.pdf. Last accessed September 2024.

Policy Implementation/Update Information:

Criteria and treatment protocols are reviewed annually by the Blue Cross NC P&T Committee, regardless of change. This policy is reviewed in Q2 annually.

September 2024: Original medical policy criteria issued.
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