CurrentViva Health PlanPolicy IC-0761

Rytelo (imetelstat) Intravenous Therapy

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This policy governs prior authorization, dosing, renewal, and coverage criteria for intravenous Rytelo (imetelstat) for adult members with myelodysplastic syndromes. It applies to providers requesting coverage under the Viva Health Plan medical benefit.

Policy Summary

PayerViva Health Plan

PolicyRytelo (imetelstat) Intravenous Therapy

Policy CodePolicy IC-0761

Change TypeRoutine reviewno material changes

Effective DateN/A

Last ReviewSep 1, 2026

Next Review DateN/A

Key ActionObtain prior authorization before treatment; initial authorization is valid for 6 months and renewal may be requested every 6 months when criteria are met.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

18 yearsMinimum member age

6 monthsInitial authorization

6 monthsRenewal interval

940 unitsMaximum units every 4 weeks

7.1 mg/kg

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CurrentViva Health PlanPolicy IC-0761

Rytelo (imetelstat) Intravenous Therapy

Customize your policy alerts

Sign up for vivahealthplan Policy IC-0761 alerts

Get alerted when Policy IC-0761 changes without checking for updates manually.

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Policy Summary

PayerViva Health Plan

PolicyRytelo (imetelstat) Intravenous Therapy

Policy CodePolicy IC-0761

Change TypeRoutine reviewno material changes

Effective DateN/A

Last ReviewSep 1, 2026

Next Review DateN/A

Key ActionObtain prior authorization before treatment; initial authorization is valid for 6 months and renewal may be requested every 6 months when criteria are met.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

18 yearsMinimum member age

6 monthsInitial authorization

6 monthsRenewal interval

940 unitsMaximum units every 4 weeks

7.1 mg/kg

IV dose every 4 weeks

4 RBC unitsTransfusion threshold

Coverage Criteria

Initial Therapy

Covered for initial therapy when both the general requirements and at least one qualifying clinical pathway are met.

General requirements

Age and diagnosis: Member is at least 18 years of age and has myelodysplastic syndrome (MDS) with symptomatic anemia.
ONE qualifying clinical pathway
- IPSS lower-risk pathway
  - Disease is lower risk, defined as IPSS low to intermediate-1.
  - ESA treatment status
    ONE of
    Member is relapsed or refractory to erythropoiesis-stimulating agent (ESA) therapy.
    Member is ESA-ineligible because serum erythropoietin is greater than 500 mU/mL.
  - Member is red blood cell (RBC) transfusion dependent.At least 4 RBC units transfused over an 8-week period
- IPSS-R lower-risk pathway
  - Disease is lower risk, defined as IPSS-R Very Low, Low, or Intermediate.
  - Member does not have a del(5q) mutation.
  - Ring sideroblasts are less than 15%, or less than 5% with an SF3B1 mutation.
  - Serum erythropoietin is 500 mU/mL or less.
  - ONE applicable prior-treatment route
    Treatment follows no response to or relapse after an ESA, despite adequate iron stores, or luspatercept.
    Treatment follows no response to or relapse after an ESA alone or luspatercept, followed by no response or relapse after an ESA, with or without lenalidomide or G-CSF, or luspatercept alone if not previously used.
- Higher EPO pathway
  - Serum erythropoietin is greater than 500 mU/mL.
  - Member has no response, intolerance, relapse, or a poor probability of response to immunosuppressive therapy (IST).
- Higher ring-sideroblast pathway
  - Ring sideroblasts are at least 15%, or at least 5% with an SF3B1 mutation.
  - Treatment follows no response to or relapse after luspatercept.
- Initial ESA-ineligible pathway
  - Ring sideroblasts are at least 15%, or at least 5% with an SF3B1 mutation.
  - Treatment is being used as initial treatment because the member is ineligible for ESAs.
  - Serum erythropoietin is greater than 500 mU/mL.

Continuation Therapy

Covered for continuation therapy when all of the following are met.

Continuation requirements

Member continues to meet the relevant indication-specific criteria, including applicable concomitant-therapy and performance-status requirements identified in the initial approval criteria.
Member has no unacceptable toxicity from Rytelo.
Examples include severe thrombocytopenia, neutropenia, and severe infusion-related reactions.
For MDS, member demonstrates disease response by at least one of the following: increased platelets, increased hemoglobin, increased WBC/ANC over pretreatment values, or decreased RBC transfusions.

Billing and Coding

HCPCS CodeHCPCS

J0870

Injection, imetelstat, 1 mg; 1 billable unit = 1 mg

NDC(s)NDC

82959-0112-xx	Rytelo 47 mg powder in a single-dose vial
82959-0111-xx	Rytelo 188 mg powder in a single-dose vial

Covered Diagnosis CodesICD-10Covered

C93.10	Chronic myelomonocytic leukemia not having achieved remission
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
D46.4	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

Maximum Billable Units

Maximum quantity940 billable units

Time periodEvery 4 weeks

Billing basisHCPCS units

RBC Transfusion Dependence

Minimum transfusionsAt least 4 red blood cell (RBC) units

Measurement periodOver an 8-week period

Policy definition

Provider Actions and Authorization Rules

Prior Authorization

Prior Authorization and Authorization Term

Prior authorization is required for Rytelo® (imetelstat). Initial authorization is valid for 6 months (180 days) and may be renewed every 6 months (180 days) thereafter.

Obtain prior authorization before treatment.
Initial authorization term: 6 months (180 days).
Renewal interval: every 6 months (180 days).

Step Therapy

Required Prior Therapy and Clinical Prerequisites

Before requesting initial authorization, document that the member meets the applicable MDS clinical pathway and required prior-therapy conditions. The applicable prerequisite depends on disease risk, EPO level, ring sideroblast status, and prior treatment response or eligibility.

Member must be at least 18 years old and have symptomatic anemia.

Clinical Background

Rytelo (imetelstat) is an intravenous therapy covered under this policy for adults with symptomatic anemia associated with lower-risk myelodysplastic syndromes (MDS). Coverage depends on the member’s disease-risk classification, ring sideroblast status, serum erythropoietin level, transfusion dependence, and response or eligibility for applicable prior therapies.

Policy Definitions

Lower-Risk MDS (IPSS)

Risk classificationInternational Prognostic Scoring System (IPSS)

Lower-risk rangeIPSS low to intermediate-1

Clinical contextUsed for lower-risk myelodysplastic syndrome (MDS)

Lower-Risk MDS (IPSS-R)

Risk classificationIPSS-R

Lower-risk categoriesVery Low, Low, or Intermediate

Clinical contextUsed to define lower-risk myelodysplastic syndrome (MDS)

Initial Approval Criteria

Initial authorization requires age 18 or older, symptomatic MDS, and at least one qualifying disease-risk, laboratory, transfusion, or prior-treatment pathway.

Initial approval requirements

Member is at least 18 years of age.Age >= 18 years
Member has MDS with symptomatic anemia.
ONE qualifying approval pathway
- IPSS low- to intermediate-1 pathway
  - Disease is lower risk, defined as IPSS low to intermediate-1.

Renewal Criteria

Renewal requires continued indication-specific eligibility, absence of unacceptable toxicity, and evidence of disease response.

Renewal requirements

Member continues to meet the relevant indication-specific criteria from the initial approval section, including applicable concomitant-therapy and performance-status requirements.
Member has no unacceptable toxicity from Rytelo.
Examples of unacceptable toxicity include severe thrombocytopenia, neutropenia, and severe infusion-related reactions.
Member demonstrates disease response by at least one of the following: increased platelets, increased hemoglobin, increased WBC/ANC over pretreatment values, or decreased RBC transfusions.At least 1 response measure

Step-Therapy Requirements

Clinical pathway	Required prior therapy or treatment sequence	Qualifying outcome or condition
IPSS low- to intermediate-1 lower-risk MDS	ESA therapy	Relapsed or refractory to ESA therapy, or ESA-ineligible with erythropoietin >500 mU/mL
IPSS-R Very Low, Low, or Intermediate lower-risk MDS with ring sideroblasts <15% (or <5% with an SF3B1 mutation) and serum EPO ≤500 mU/mL	ESA or luspatercept	No response to or relapse after either therapy; specified sequential ESA/luspatercept treatment pathways may also qualify
Serum EPO >500 mU/mL pathway	Immunosuppressive therapy	No response, intolerance, relapse, or poor probability of response
Ring sideroblasts ≥15% (or ≥5% with an SF3B1 mutation)	Luspatercept	No response to or relapse after luspatercept
Ring sideroblasts ≥15% (or ≥5% with an SF3B1 mutation), initial treatment pathway	No prior ESA required when the member is ESA-ineligible	ESA ineligibility with serum EPO >500 mU/mL

Quantity Limits

Rytelo (imetelstat)

ProductRytelo (imetelstat)

Maximum quantity940 billable units

FrequencyEvery 4 weeks

Administration Site and Infusion Requirements

Note

Follow infusion-center administration and monitoring requirements

Administer Rytelo in an infusion center as an intravenous infusion over 2 hours. Administer pretreatment medications at least 30 minutes before dosing and monitor the member for adverse reactions for at least 1 hour after the infusion.

Recommended dosage: 7.1 mg/kg every 4 weeks.
Use pretreatment medications to prevent or reduce potential infusion-related reactions.
Monitor for adverse reactions for at least 1 hour after infusion.

Policy Summary

PayerViva Health Plan

PolicyRytelo (imetelstat) Intravenous Therapy

Policy CodePolicy IC-0761

Change TypeRoutine reviewno material changes

Effective DateN/A

Last ReviewSep 1, 2026

Next Review DateN/A

Key ActionObtain prior authorization before treatment; initial authorization is valid for 6 months and renewal may be requested every 6 months when criteria are met.

SourceLink

On This Page

RBC transfusion dependent means requiring at least 4 RBC units transfused over an 8-week period

Serum Erythropoietin

Lower-EPO pathwaySerum EPO ≤ 500 mU/mL

Higher-EPO pathwaySerum EPO > 500 mU/mL

ESA-ineligible definitionErythropoietin >500 mU/mL in the applicable pathway

Ring Sideroblasts

Lower ring-sideroblast pathwayRing sideroblasts <15%, or <5% with an SF3B1 mutation

Higher ring-sideroblast pathwayRing sideroblasts ≥15%, or ≥5% with an SF3B1 mutation

Mutation criterionSF3B1 mutation is recognized with the <5% or ≥5% ring-sideroblast thresholds

For lower-risk disease defined as IPSS low to intermediate-1: member must be relapsed or refractory to ESA therapy or ESA-ineligible (EPO >500 mU/mL), and RBC transfusion-dependent, defined as at least 4 RBC units transfused over 8 weeks.

For lower-risk disease defined as IPSS-R Very Low, Low, or Intermediate: member must not have a del(5q) mutation, must have ring sideroblasts <15% (or <5% with an SF3B1 mutation), and must have serum EPO ≤500 mU/mL; treatment must follow no response to or relapse after an ESA or luspatercept, or the specified sequential ESA/luspatercept treatment pathways.

When serum EPO is >500 mU/mL, document no response, intolerance, relapse, or poor probability of response to immunosuppressive therapy (IST).

When ring sideroblasts are ≥15% (or ≥5% with an SF3B1 mutation), treatment must follow no response to or relapse after luspatercept.

Initial treatment may be used when the member is ESA-ineligible and has serum EPO >500 mU/mL.

Denial Risk

Initial Criteria Not Met

Initial coverage may be denied when the submitted documentation does not establish every applicable initial approval requirement or the required treatment sequence for the member’s MDS pathway.

Deny when the member is younger than 18 years or does not have symptomatic anemia.
Deny when the applicable lower-risk disease definition, transfusion-dependence requirement, del(5q) status, ring sideroblast threshold, or serum EPO requirement is not met.
Deny when the required ESA, luspatercept, or IST prerequisite is absent, unsuccessful, not tolerated, or otherwise not documented as required by the applicable pathway.
Deny when the required prior-treatment sequence is not met, including required ESA/luspatercept failure or relapse, or required IST nonresponse, intolerance, relapse, or poor probability of response.

Denial Risk

Renewal Criteria Not Met

Renewal requires continued eligibility under the relevant indication-specific criteria and evidence that treatment remains safe and effective. Renewal may be denied if the required criteria, response, or safety conditions are not documented.

Member must continue to meet the relevant indication-specific criteria from the initial approval section, including applicable concomitant-therapy requirements and performance-status requirements; prerequisite therapy is not required again for renewal.
Document absence of unacceptable toxicity, including severe thrombocytopenia, neutropenia, or severe infusion-related reactions.
Document disease response by at least one of the following: increased platelets, increased hemoglobin, increased WBC/ANC over pretreatment values, or decreased RBC transfusions.
Deny renewal when ongoing indication-specific criteria are not met, unacceptable toxicity is present, or disease response is not demonstrated.

Billing Rule

Dosing Limit Exceeded

Do not submit claims above the plan’s billable-unit limit for Rytelo® (imetelstat).

Maximum: 940 HCPCS billable units every 4 weeks per dose and over time.
Claims exceeding 940 billable units in a 4-week period may be denied or require correction.

RBC Transfusion Dependent

Minimum RBC unitsAt least 4 red blood cell units

Time periodOver an 8-week period

DefinitionRequiring at least 4 RBC units transfused over an 8-week period

ESA Ineligible

Erythropoietin thresholdSerum erythropoietin >500 mU/mL

Applicable useIdentifies ESA ineligibility in the applicable approval pathway

Related lower thresholdSerum EPO ≤500 mU/mL applies in another approval pathway

Ring Sideroblast Threshold

Lower thresholdRing sideroblasts <15%, or <5% with an SF3B1 mutation

Higher thresholdRing sideroblasts ≥15%, or ≥5% with an SF3B1 mutation

SF3B1 mutationThe policy specifies separate <5% and ≥5% thresholds when an SF3B1 mutation is present

ONE ESA status

Member is relapsed or refractory to ESA therapy.
Member is ESA-ineligible, with serum erythropoietin greater than 500 mU/mL.EPO > 500 mU/mL

Member is RBC transfusion dependent.At least 4 RBC units transfused over an 8-week period

IPSS-R lower-risk, low ring-sideroblast pathway

Disease is lower risk, defined as IPSS-R Very Low, Low, or Intermediate.
Member does not have a del(5q) mutation.
Ring sideroblasts are less than 15%, or less than 5% with an SF3B1 mutation.< 15%; or < 5% with SF3B1 mutation
Serum erythropoietin is 500 mU/mL or less.EPO <= 500 mU/mL
ONE applicable prior-treatment route
- Treatment follows no response to or relapse after an ESA, despite adequate iron stores, or luspatercept.
- Treatment follows no response to or relapse after an ESA alone or luspatercept, followed by no response or relapse after an ESA, with or without lenalidomide or G-CSF, or luspatercept alone if not previously used.

Higher EPO pathway

Serum erythropoietin is greater than 500 mU/mL.EPO > 500 mU/mL
Member has no response, intolerance, relapse, or a poor probability of response to IST.

Higher ring-sideroblast pathway

Ring sideroblasts are at least 15%, or at least 5% with an SF3B1 mutation.>= 15%; or >= 5% with SF3B1 mutation
Treatment follows no response to or relapse after luspatercept.

Initial-treatment ESA-ineligible pathway

Ring sideroblasts are at least 15%, or at least 5% with an SF3B1 mutation.>= 15%; or >= 5% with SF3B1 mutation
Treatment is being used as initial treatment because the member is ineligible for ESAs.
Serum erythropoietin is greater than 500 mU/mL.EPO > 500 mU/mL