CurrentAmerihealth Caritas Vip CarePolicy MA08.177

Imetelstat (Rytelo) Policy

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Medical-benefit coverage and prior authorization for imetelstat (Rytelo) in adult members with low- to intermediate-1-risk myelodysplastic syndromes and transfusion-dependent anemia, subject to clinical, treatment-history, dosing, continuation, Evidence of Coverage, and benefit-contract requirements.

Policy Summary

PayerAmerihealth Caritas Vip Care

PolicyImetelstat (Rytelo) Policy

Policy CodePolicy MA08.177

Change TypeNew policy

Effective DateMar 20, 2026

Next Review DateNot specified

Key ActionObtain prior authorization and submit accurate member and regimen information, including dose and frequency, before requesting imetelstat coverage.

SourceLink

POLICY UPDATE CHANGES

A new policy was developed to communicate the company's coverage criteria for imetelstat (Rytelo).

7.1 mg/kgInitial dose

Every 4 weeksTreatment interval

4+ RBC unitsTransfusion threshold

24 weeks / 6 dosesContinuation review

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CurrentAmerihealth Caritas Vip CarePolicy MA08.177

Imetelstat (Rytelo) Policy

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Policy Summary

PayerAmerihealth Caritas Vip Care

PolicyImetelstat (Rytelo) Policy

Policy CodePolicy MA08.177

Change TypeNew policy

Effective DateMar 20, 2026

Next Review DateNot specified

Key ActionObtain prior authorization and submit accurate member and regimen information, including dose and frequency, before requesting imetelstat coverage.

SourceLink

POLICY UPDATE CHANGES

A new policy was developed to communicate the company's coverage criteria for imetelstat (Rytelo).

7.1 mg/kgInitial dose

Every 4 weeksTreatment interval

4+ RBC unitsTransfusion threshold

24 weeks / 6 dosesContinuation review

Decreased burdenContinuation response

Not coveredOther uses

Coverage Criteria

Initial Therapy Criteria

Covered when all required criteria are met.

Initial therapy

Base requirements
- Adult individual with low- to intermediate-1-risk myelodysplastic syndromes (MDS) with transfusion-dependent anemia.
- Diagnosis of MDS is confirmed by bone marrow aspirate and/or biopsy.
- The individual has required transfusion of 4 or more red blood cell (RBC) units over 8 weeks, and pretransfusion hemoglobin is 9.0 g/dL or less.4 or more RBC units over 8 weeks; pretransfusion hemoglobin <= 9.0 g/dL
- The individual has lower-risk disease—very low, low, or intermediate—assessed using a validated rating index or scale, such as the International Prognostic Scoring System-Revised (IPSS-R).
ONE qualifying disease and treatment pathway
- Symptomatic anemia with del(5q)
  - Disease-associated symptomatic anemia with del(5q), with or without one other cytogenetic abnormality except abnormalities involving chromosome 7, and one of the following: no response to or relapse after lenalidomide with poor probability of response to immunosuppressive therapy (IST); no response to or relapse after an erythropoiesis-stimulating agent (ESA) with poor probability of response to IST; no response to or relapse after lenalidomide followed by no response to, intolerance of, or relapse after IST; or no response to or relapse after an ESA with serum erythropoietin 500 mU/mL or less followed by no response to, intolerance of, or relapse after IST.Serum erythropoietin <= 500 mU/mL where specified
    Poor probability of response to IST may include older age or high-risk mutations.
- Symptomatic anemia without del(5q); ring sideroblasts below threshold
  - Disease-associated symptomatic anemia without del(5q), with or without other cytogenetic abnormalities, with ring sideroblasts less than 15% or less than 5% with an SF3B1 mutation, and one of the following: serum erythropoietin 500 mU/mL or less after no response to or relapse after an ESA alone followed by no response to or relapse after an ESA with or without G-CSF or lenalidomide; serum erythropoietin 500 mU/mL or less after an ESA followed by no response to or relapse after luspatercept-aamt; no response to or relapse after luspatercept-aamt followed by no response to or relapse after an ESA with or without G-CSF or lenalidomide; serum erythropoietin greater than 500 mU/mL with poor probability of response to IST; or serum erythropoietin greater than 500 mU/mL after no response to, intolerance of, or relapse after IST.
Dosing
- Imetelstat is administered at 7.1 mg/kg as an intravenous infusion over 2 hours every 4 weeks.7.1 mg/kg IV over 2 hours every 4 weeks

Continuation Therapy Criteria

Continuation is covered when both criteria are met compared with baseline.

Continuation therapy

Transfusion response: The individual experiences a decrease in RBC transfusion burden after 24 weeks of treatment, defined as administration of six doses, compared with baseline.Decrease after 24 weeks / 6 doses
Safety: No unacceptable toxicity occurs at any time.No unacceptable toxicity

All other uses of imetelstat (Rytelo) are considered experimental/investigational and are not covered unless the indication is supported as an accepted off-label use under the Company’s medical policy for off-label coverage of prescription drugs and biologics.

Coding and Clinical Thresholds

HCPCS Level II Code Number(s)HCPCS

J0870

Injection, imetelstat, 1 mg

HCPCS Level II Code Number(s)HCPCS

J0870

Injection, imetelstat, 1 mg

Revenue Code Number(s)Revenue

N/A

RBC transfusion burden

Minimum transfusion burdenFour or more red blood cell (RBC) units

Assessment periodOver an 8-week period

Initial-therapy requirementThe transfusion burden must be met together with a pretransfusion hemoglobin of 9.0 g/dL or less

Pretransfusion hemoglobin

Required threshold9.0 g/dL or less

MeasurementPretransfusion hemoglobin

Provider Requirements and Authorization Actions

Prior Authorization

Precertification Required

Precertification is required for imetelstat (Rytelo). Submit accurate member information, the requested regimen, dose, and frequency so the Company can evaluate and approve treatment.

Include the member's current dose, frequency, and treatment regimen.
Dosing and frequency requirements may be modified to remain consistent with FDA recommendations, recognized pharmacology compendia, and published clinical research.

Documentation Required

Medical Necessity Records

The professional provider must maintain and submit records demonstrating the medical necessity of imetelstat across applicable care settings when requested.

Records may include documentation from the professional provider's office, hospital, nursing home, home health agency, therapy providers, and test reports.

Clinical Background

Myelodysplastic syndromes (MDS) are disorders in which abnormal bone marrow cells produce defective or insufficient blood cells, commonly causing anemia and other cytopenias. MDS is a type of cancer that may progress to acute myeloid leukemia or bone marrow failure. Under this policy, imetelstat is considered for adults with lower-risk MDS and transfusion-dependent anemia who meet the specified disease-risk and prior-treatment criteria.

Definitions

International Prognostic Scoring System-Revised (IPSS-R)

PurposeValidated prognostic scoring system for myelodysplastic syndromes

ComponentsCytogenetics, bone marrow blasts, hemoglobin, platelets, and absolute neutrophil count

Risk categoriesVery low, low, intermediate, high, and very high

Risk-score rangesVery low: 1.5 or less; low: greater than 1.5 to 3; intermediate: greater than 3 to 4.5; high: greater than 4.5 to 6; very high: greater than 6

Lower-risk MDS

DefinitionMDS categorized as very low, low, or intermediate risk

Assessment method

Initial Therapy

Initial Therapy Criteria

Initial therapy is medically necessary and covered when all base, disease-pathway, and dosing requirements are met.

Initial therapy

Base requirements
- Adult individual with low- to intermediate-1-risk myelodysplastic syndromes (MDS) with transfusion-dependent anemia.
- Diagnosis of MDS is confirmed by bone marrow aspirate and/or biopsy.
- The individual has required transfusion of 4 or more red blood cell (RBC) units over 8 weeks, and pretransfusion hemoglobin is 9.0 g/dL or less.4 or more RBC units over 8 weeks; pretransfusion hemoglobin <= 9.0 g/dL

Continuation After Initial Therapy

Continuation is medically necessary and covered when both requirements are met compared with baseline.

Continuation after initial therapy

Transfusion response: The individual experiences a decrease in RBC transfusion burden after 24 weeks of treatment, defined as administration of six doses, compared with baseline.Decrease after 24 weeks / 6 doses
Safety: No unacceptable toxicity occurs at any time.No unacceptable toxicity

Required Prior Treatment Sequence

Step	MDS subtype and laboratory pathway	Required prior-treatment sequence
1	Symptomatic anemia with del(5q), with or without one other cytogenetic abnormality except abnormalities involving chromosome 7.	One qualifying sequence: (1) no response to or relapse after lenalidomide when there is a poor probability of response to immunosuppressive therapy (IST); (2) no response to or relapse after an erythropoiesis-stimulating agent (ESA) when there is a poor probability of response to IST; (3) no response to or relapse after lenalidomide, followed by no response to, intolerance of, or relapse after IST; or (4) no response to or relapse after an ESA with serum erythropoietin 500 mU/mL or less, followed by no response to, intolerance of, or relapse after IST.
1	Symptomatic anemia without del(5q), with or without other cytogenetic abnormalities; ring sideroblasts less than 15% (or less than 5% with an SF3B1 mutation).	One qualifying sequence: (1) serum erythropoietin 500 mU/mL or less after no response to or relapse after an ESA alone, followed by no response to or relapse after an ESA with or without G-CSF or lenalidomide; (2) serum erythropoietin 500 mU/mL or less after an ESA, followed by no response to or relapse after luspatercept-aamt; (3) no response to or relapse after luspatercept-aamt, followed by no response to or relapse after an ESA with or without G-CSF or lenalidomide; (4) serum erythropoietin greater than 500 mU/mL with a poor probability of response to IST; or (5) serum erythropoietin greater than 500 mU/mL after no response to, intolerance of, or relapse after IST.
1	Symptomatic anemia without del(5q), with or without other cytogenetic abnormalities; ring sideroblasts 15% or greater (or 5% or greater with an SF3B1 mutation).	One qualifying sequence: (1) no response to or relapse after luspatercept-aamt; (2) serum erythropoietin 500 mU/mL or less after luspatercept-aamt, followed by no response to or relapse after an ESA with or without G-CSF when there is a poor probability of response to IST; (3) serum erythropoietin 500 mU/mL or less after luspatercept-aamt, followed by no response to or relapse after an ESA with or without G-CSF, and then no response to, intolerance of, or relapse after IST; (4) initial treatment when serum erythropoietin is greater than 500 mU/mL and the individual is ineligible for ESAs; or (5) serum erythropoietin greater than 500 mU/mL after luspatercept-aamt, followed by no response to or relapse after lenalidomide when there is a poor probability of response to IST.

Dose and Quantity Limits

Imetelstat (Rytelo)

Maximum dose per administration7.1 mg/kg

Route and infusion timeAdministered by intravenous infusion over 2 hours

FrequencyEvery 4 weeks

Policy Summary

PayerAmerihealth Caritas Vip Care

PolicyImetelstat (Rytelo) Policy

Policy CodePolicy MA08.177

Change TypeNew policy

Effective DateMar 20, 2026

Next Review DateNot specified

Key ActionObtain prior authorization and submit accurate member and regimen information, including dose and frequency, before requesting imetelstat coverage.

SourceLink

On This Page

Ring sideroblasts <15% or <5% with an SF3B1 mutation; serum erythropoietin <=500 or >500 mU/mL as specified

Poor probability of response to IST may include older age or high-risk mutations.

Symptomatic anemia without del(5q); ring sideroblasts at or above threshold

Disease-associated symptomatic anemia without del(5q), with or without other cytogenetic abnormalities, with ring sideroblasts 15% or greater or 5% or greater with an SF3B1 mutation, and one of the following: no response to or relapse after luspatercept-aamt; serum erythropoietin 500 mU/mL or less after luspatercept-aamt followed by no response to or relapse after an ESA with or without G-CSF when there is poor probability of response to IST; serum erythropoietin 500 mU/mL or less after luspatercept-aamt followed by no response to or relapse after an ESA with or without G-CSF and then no response to, intolerance of, or relapse after IST; initial treatment when serum erythropoietin is greater than 500 mU/mL and the individual is ineligible for ESAs; serum erythropoietin greater than 500 mU/mL after luspatercept-aamt followed by no response to or relapse after lenalidomide when there is poor probability of response to IST; or serum erythropoietin greater than 500 mU/mL after luspatercept-aamt followed by no response to or relapse after lenalidomide and then no response to, intolerance of, or relapse after IST.Ring sideroblasts >=15% or >=5% with an SF3B1 mutation; serum erythropoietin >500 mU/mL where specified
Luspatercept-aamt is identified as preferred in one pathway; poor probability of response to IST may include older age or high-risk mutations.

The threshold applies with transfusion of four or more RBC units over 8 weeks

Serum erythropoietin

Lower threshold500 mU/mL or less

Higher thresholdGreater than 500 mU/mL

ApplicationThe applicable serum erythropoietin threshold depends on the disease and treatment pathway

Ring sideroblasts

Lower ring-sideroblast pathwayLess than 15% ring sideroblasts, or less than 5% when an SF3B1 mutation is present

Higher ring-sideroblast pathway15% or greater ring sideroblasts, or 5% or greater when an SF3B1 mutation is present

SF3B1-specific thresholdsThe SF3B1 mutation thresholds are less than 5% versus 5% or greater

Continuation response

Response requirementDecrease in RBC transfusion burden compared with baseline

Assessment pointAfter 24 weeks of treatment

Dose equivalentTwenty-four weeks is defined as administration of six doses

Red blood cell transfusion burden

Required burdenAt least four RBC units

Time frameOver an 8-week period

Covered-indication contextThe threshold applies to transfusion-dependent adults with low- to intermediate-1-risk MDS

Pretransfusion hemoglobin

Required threshold9.0 g/dL or less

Use in trial definitionA pretransfusion hemoglobin of 9.0 g/dL or less counted toward the four-unit RBC total

Measurement timingHemoglobin is measured before transfusion

The Company may review or audit services regardless of the provider's participation status.

Documentation Required

Initial Therapy Clinical Documentation

For initial therapy, submit clinical documentation confirming the diagnosis, transfusion burden, hemoglobin level, lower-risk disease status, and the applicable treatment pathway.

Confirm MDS by bone marrow aspirate and/or biopsy.
Document at least 4 RBC units transfused over 8 weeks and pretransfusion hemoglobin of 9.0 g/dL or less.
Document very low, low, or intermediate-risk disease using a validated index or scale, such as IPSS-R.
For symptomatic anemia with del(5q), document the applicable prior lenalidomide, ESA, and/or IST response or intolerance pathway, including poor probability of response to IST when required.
For symptomatic anemia without del(5q), document ring-sideroblast status, SF3B1 mutation status when applicable, serum erythropoietin level, and the applicable prior ESA, luspatercept-aamt, lenalidomide, G-CSF, and/or IST treatment pathway.
Document the applicable pathway for ring sideroblasts below 15% (or below 5% with an SF3B1 mutation), including serum erythropoietin at or below or above 500 mU/mL.
Document the applicable pathway for ring sideroblasts of 15% or greater (or 5% or greater with an SF3B1 mutation), including luspatercept-aamt use, ESA eligibility or failure, IST response or intolerance, and lenalidomide history when required.

Documentation Required

Continuation Documentation

Continuation therapy requires documentation that the individual has demonstrated both a reduction in RBC transfusion burden after 24 weeks of treatment (six doses) and no unacceptable toxicity at any time.

Compare the post-treatment RBC transfusion burden with baseline.
Document the response after 24 weeks or six administered doses.
Document that no unacceptable toxicity has occurred.

Prior Authorization

Out-of-Guideline Dosing Support

Requests for an amount of imetelstat outside the policy's dosing or frequency requirements must include supporting published peer-reviewed literature.

Submit the literature supporting the requested dose, frequency, or amount.
The Company may use FDA recommendations, recognized pharmacology compendia, and published peer-reviewed clinical research when updating dosing and frequency requirements.

Denial Risk

Noncovered Indication

All other uses of imetelstat (Rytelo) are considered experimental/investigational and are not covered unless the indication is supported as an accepted off-label use under the Company's policy for off-label coverage of prescription drugs and biologics.

Do not assume coverage for an indication outside the covered MDS criteria.
Submit documentation supporting an accepted off-label use when applicable.

Denial Risk

Continuation Criteria Not Met

Continuation coverage is at risk of denial when the required response after 24 weeks or six doses is not demonstrated or when unacceptable toxicity occurs.

Required response: a decrease in RBC transfusion burden compared with baseline.
Required safety condition: no unacceptable toxicity at any time.

Unsupported block type: prior_auth

Denial Risk

Records Unavailable

All requested documentation must be available to the Company upon request. Failure to produce medical records or other supporting information may result in denial of the drug.

Maintain records demonstrating medical necessity and the applicable clinical criteria.
Respond to Company requests for records during review or audit.
The documentation requirement applies regardless of the provider's participation status.

Risk must be assessed using a validated rating index or scale

ExampleThe International Prognostic Scoring System-Revised (IPSS-R) is an example of an accepted scale

FDA indication

Approval dateJune 6, 2024

Approved populationAdults with low- to intermediate-1-risk myelodysplastic syndromes

Anemia indicationTransfusion-dependent anemia requiring four or more RBC units over 8 weeks

Prior-treatment statusPatients who are ineligible for ESAs or have not responded to, or lost response to, ESAs

Myelodysplastic syndromes (MDS)

Disease descriptionConditions characterized by abnormal, dysplastic cells in the bone marrow

Blood-cell effectProduction of defective blood cells and/or low levels of one or more blood-cell types

Common abnormalityLaboratory tests may show low levels of red blood cells, white blood cells, and/or platelets

Disease classificationMDS is considered a type of cancer

Acute myeloid leukemia (AML)

Relationship to MDSAML may develop as a long-term progression of MDS

Estimated occurrenceApproximately one in three individuals with MDS may be affected

Disease typeAML is a form of leukemia

Transfusion dependence

Minimum RBC unitsAt least four units of RBCs

Required periodAn 8-week period during the 16 weeks before study entry

Hemoglobin conditionPretransfusion hemoglobin had to be 9.0 g/dL or less for the unit to count toward the four-unit total

The individual has lower-risk disease—very low, low, or intermediate—assessed using a validated rating index or scale, such as the International Prognostic Scoring System-Revised (IPSS-R).

ONE qualifying disease and treatment pathway

Symptomatic anemia with del(5q)
- Disease-associated symptomatic anemia with del(5q), with or without one other cytogenetic abnormality except abnormalities involving chromosome 7, and one of the following: no response to or relapse after lenalidomide with poor probability of response to immunosuppressive therapy (IST); no response to or relapse after an erythropoiesis-stimulating agent (ESA) with poor probability of response to IST; no response to or relapse after lenalidomide followed by no response to, intolerance of, or relapse after IST; or no response to or relapse after an ESA with serum erythropoietin 500 mU/mL or less followed by no response to, intolerance of, or relapse after IST.Serum erythropoietin <= 500 mU/mL where specified
  Poor probability of response to IST may include older age or high-risk mutations.
Symptomatic anemia without del(5q); ring sideroblasts below threshold
- Disease-associated symptomatic anemia without del(5q), with or without other cytogenetic abnormalities, with ring sideroblasts less than 15% or less than 5% with an SF3B1 mutation, and one of the following: serum erythropoietin 500 mU/mL or less after no response to or relapse after an ESA alone followed by no response to or relapse after an ESA with or without G-CSF or lenalidomide; serum erythropoietin 500 mU/mL or less after an ESA followed by no response to or relapse after luspatercept-aamt; no response to or relapse after luspatercept-aamt followed by no response to or relapse after an ESA with or without G-CSF or lenalidomide; serum erythropoietin greater than 500 mU/mL with poor probability of response to IST; or serum erythropoietin greater than 500 mU/mL after no response to, intolerance of, or relapse after IST.Ring sideroblasts <15% or <5% with an SF3B1 mutation; serum erythropoietin <=500 or >500 mU/mL as specified
  Poor probability of response to IST may include older age or high-risk mutations.
Symptomatic anemia without del(5q); ring sideroblasts at or above threshold
- Disease-associated symptomatic anemia without del(5q), with or without other cytogenetic abnormalities, with ring sideroblasts 15% or greater or 5% or greater with an SF3B1 mutation, and one of the following: no response to or relapse after luspatercept-aamt; serum erythropoietin 500 mU/mL or less after luspatercept-aamt followed by no response to or relapse after an ESA with or without G-CSF when there is poor probability of response to IST; serum erythropoietin 500 mU/mL or less after luspatercept-aamt followed by no response to or relapse after an ESA with or without G-CSF and then no response to, intolerance of, or relapse after IST; initial treatment when serum erythropoietin is greater than 500 mU/mL and the individual is ineligible for ESAs; serum erythropoietin greater than 500 mU/mL after luspatercept-aamt followed by no response to or relapse after lenalidomide when there is poor probability of response to IST; or serum erythropoietin greater than 500 mU/mL after luspatercept-aamt followed by no response to or relapse after lenalidomide and then no response to, intolerance of, or relapse after IST.Ring sideroblasts >=15% or >=5% with an SF3B1 mutation; serum erythropoietin >500 mU/mL where specified
  Luspatercept-aamt is identified as preferred in one pathway; poor probability of response to IST may include older age or high-risk mutations.

Dosing

Imetelstat is administered at 7.1 mg/kg as an intravenous infusion over 2 hours every 4 weeks.7.1 mg/kg IV over 2 hours every 4 weeks