CurrentEmblemHealthPolicy MG.MM.PH.422

Rytelo (imetelstat) Intravenous

Covers medical necessity criteria, dosing, and authorization requirements for Rytelo (imetelstat) IV in adults with low- to intermediate-1 risk myelodysplastic syndromes (MDS) with transfusion-dependent anemia for EmblemHealth members.

Policy Summary

PayerEmblemHealth

PolicyRytelo (imetelstat) Intravenous

Policy CodePolicy MG.MM.PH.422

Change TypeICD-10 additions and dosing limit update

Effective DateSep 9, 2024

Next Review DateFeb 19, 2025

Key ActionSubmit prior authorization with clinical documentation; initial authorization provided for 6 months and continuation for 1 year.

SourceLink

POLICY UPDATE CHANGES

Added ICD-10 codes D46.20, D46.21, D46.22, D46.C, and D46.Z and dosing limits.

≥4 RBC / 8wTransfusion threshold

7.1 mg/kgDose per administration

940 mgMax per 4 weeks

6 monthsInitial auth

1 yearContinuation auth

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Coverage Criteria for Rytelo (imetelstat)

Myelodysplastic Syndrome

Approve for Myelodysplastic Syndrome when ONE of the following (A OR B) is met:

Overall

A. Initial Therapy
- Age: Patient is ≥ 18 years of age>=18
- Risk category: Prescriber states patient has low- to intermediate-1 risk MDS determined using IPSSIPSS low- to intermediate-1
- Transfusion dependence: Patient has transfusion-dependent anemia, defined as requiring transfusion of ≥ 4 red blood cell units over an 8-week period>=4 units / 8 weeks
- ESA failure/ineligibility: Prescriber states patient has not responded to, lost response to, or is ineligible for erythropoiesis-stimulating agentsESA trial failed or ineligible
- Cytogenetics: Patient does NOT have deletion 5q [del(5q)] cytogenetic abnormalitiesno del(5q)
- Monotherapy: Rytelo will NOT be used in combination with an erythropoiesis-stimulating agentno ESA combination
- Prescriber specialty: Prescribed by or in consultation with an oncologist or hematologistoncologist or hematologist involvement
B. Currently Receiving Rytelo: Patient is currently receiving Rytelo and, according to the prescriber, has experienced a clinically meaningful decrease in transfusion burdenclinical improvement in transfusion burden
Approve for 1 year

Patients with the deletion 5q cytogenetic abnormality (del(5q)) are excluded from approval under the Initial Therapy criteria for Rytelo (imetelstat). The Initial Therapy pathway requires that the patient does NOT have deletion 5q [del(5q)] cytogenic abnormalities as a condition of coverage.

Initial therapy approval requires that all Initial Therapy conditions be met: patient is ≥ 18 years of age; prescriber documents low- to intermediate-1 risk MDS (IPSS); the patient has transfusion-dependent anemia defined as requiring ≥ 4 RBC units over an 8-week period; the patient has not responded to, lost response to, or is ineligible for erythropoiesis-stimulating agents; Rytelo will not be used in combination with an ESA; and the medication is prescribed by or in consultation with an oncologist or hematologist. Alternatively, patients currently receiving Rytelo who have experienced a clinically meaningful decrease in transfusion burden may be approved for 1 year.

Regimen	Dose / Schedule	Maximum per 4 weeks
Rytelo (imetelstat) — treatment of transfusion‑dependent anemia in low- to intermediate-1 risk myelodysplastic syndromes as per policy criteria	7.1 mg/kg intravenous infusion over 2 hours once every 4 weeks (do not more frequently than once every 4 weeks)	Maximum 940 mg every 4 weeks

Coding and Diagnosis Codes

Applicable HCPCS/CPT CodesHCPCSCovered

J0870

Injection, imetelstat, 1 mg

Applicable NDCsNDC

82959-0112-01	One 47-mg single-dose vial of Rytelo
82959-0111-01	One 188-mg single-dose vial of Rytelo

Applicable ICD-10 DiagnosesICD-10Covered

D46.0	Refractory Anemia Without Ring Sideroblasts, So Stated
D46.1	Refractory Anemia With Ring Sideroblasts
D46.20	Refractory anemia with excess of blasts, unspecified
D46.21	Refractory anemia with excess of blasts 1
D46.22	Refractory anemia with excess of blasts 2
D46.4	Refractory Anemia, Unspecified
D46.9	Myelodysplastic Syndrome, Unspecified
D46.A	Refractory Cytopenia With Multilineage Dysplasia
D46.B	Refractory Cytopenia With Multilineage Dysplasia And Ring Sideroblasts
D46.C	Myelodysplastic syndrome with isolated del(5q) chromosomal abnormality

1–10 of 11

1/2

inv-07: Transfusion-dependence threshold — ≥ 4 RBC units over an 8-week period

Threshold≥ 4 red blood cell (RBC) units over an 8-week period

ContextUsed to define transfusion-dependent anemia for eligibility under Initial Therapy (must meet this and other criteria)

Measurement period8-week (56-day) interval

Provider Actions, Prior Authorization, and Documentation

Prior Authorization

Prior Authorization Required

Prior authorization is required for Rytelo. Initial authorizations will be approved for 6 months; continuation authorizations may be approved for 1 year.

Initial authorization: 6 months
Continuation authorization: 1 year

Documentation Required

Documentation Requirement

Requests must include sufficient clinical documentation from the treating physician or primary care provider so EmblemHealth can review the request. Lack of required documentation may delay review or result in denial.

Incomplete requests may be denied or delayed
Submit all relevant clinical records, transfusion history, and prescriber statements

Definitions Relevant to Policy

inv-13: Definition — Transfusion-dependent anemia defined as requiring ≥ 4 red blood cell units over an 8-week period

DefinitionTransfusion-dependent anemia defined as requiring transfusion of ≥ 4 red blood cell units over an 8-week period

RelevanceRequired criterion for Initial Therapy approval for Rytelo in low- to intermediate-1 risk MDS

DocumentationPrescriber must attest to transfusion history when submitting prior authorization documentation

inv-14: Definition — Rytelo (imetelstat) described as oligonucleotide telomerase inhibitor indicated for specified MDS patients

Drug classOligonucleotide telomerase inhibitor

Indication (per document)Treatment of low- to intermediate-1 risk myelodysplastic syndromes (MDS) in adults with transfusion-dependent anemia who have not responded to, lost response to, or are ineligible for erythropoiesis-stimulating agents

Initial and Continuation Therapy Criteria

Initial Therapy (not specified)

Initial therapy — patient must meet ALL of the following:

Initial Therapy (line unspecified): Patient is adult with low- to intermediate-1 risk MDS, transfusion-dependent, and failed/ineligible for ESA prior to initiation

Continuation Therapy

Continuation therapy — approve when the following is met:

Continuation Therapy: Patient is currently receiving Rytelo and, according to the prescriber, has experienced a clinically meaningful decrease in transfusion burden

Approve for 1 year

Biomarker and Cytogenetic Requirements

inv-17: del(5q) — absence required for initial approval

BiomarkerDeletion 5q [del(5q)] cytogenetic abnormality

RequirementAbsence of del(5q) is required for Initial Therapy approval

ScopeApplies to Initial Therapy criteria only (patients with del(5q) are excluded from initial approval)

Background

Rytelo (imetelstat) is an oligonucleotide telomerase inhibitor indicated for adults with low- to intermediate-1 risk myelodysplastic syndromes (MDS) who have transfusion-dependent anemia. The policy requires use in adults (≥ 18 years) with transfusion-dependent anemia (≥ 4 RBC units per 8 weeks) and prior failure, loss of response to, or ineligibility for erythropoiesis-stimulating agents for initial therapy. Dosing for treatment is 7.1 mg/kg administered by intravenous infusion not more frequently than once every 4 weeks.

Policy Revision History

2025-02-19annual_reviewLatest

Annual review expanded ICD-10 diagnosis list (added D46.20, D46.21, D46.22, D46.C, D46.Z) and added dosing limits (maximum 940 mg every 4 weeks).

2024-09-09policy_created

Policy created (New Policy effective 2024-09-09).