ModifiedCentenePolicy CP.PHAR.690

Imetelstat (Rytelo) for lower-risk myelodysplastic syndromes

Defines medical necessity and prior authorization criteria for imetelstat (Rytelo) for adults with low- to intermediate-1 risk myelodysplastic syndromes (MDS) with transfusion-dependent anemia; applies to Centene-affiliated health plans across listed lines of business.

Policy Summary

PayerCentene

PolicyImetelstat (Rytelo) for lower-risk myelodysplastic syndromes

Policy CodePolicy CP.PHAR.690

Change TypeHCPCS code J0870 addedIL step therapy bypass added (material changes)

Effective DateSep 1, 2024

Next Review Date

Key ActionSubmit prior authorization with diagnosis, transfusion history, ESA trial history or ineligibility, absence of del(5q), prescriber specialty, and planned dosing (≤7.1 mg/kg q4w).

SourceLink

POLICY UPDATE CHANGES

HCPCS code J0870 (Injection, imetelstat, 1 mg) was added and C9399/J9999 removed.

Step therapy bypass for Illinois HIM requests per Illinois HB 5395 was added.

7.1 mg/kg q4wmax dose

≥4 RBC/8wktransfusion requirement

J0870billing code

6 monthsapproval length

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Coverage Criteria for Imetelstat (Rytelo)

Initial Therapy

Covered when ALL of the following are met:

Initial MDS criteria: 1) Diagnosis of myelodysplastic syndromes (MDS) with transfusion-dependent anemia; 2) Prescribed by or in consultation with a hematologist or oncologist; 3) Age ≥ 18 years; 4) Low or intermediate-1 risk MDS by IPSS; 5) Documentation of at least 4 RBC units transfused over 8 weeks; 6) No del(5q) cytogenetic abnormality; 7) Member meets one of the following (a or b): a. Inadequate response to or ineligible for erythropoiesis-stimulating agent (ESA) therapy (e.g., epoetin alfa, darbepoetin); b. One of the following: i. Failure of Retacrit unless contraindicated or clinically significant adverse effects are experienced (prior authorization may be required for Retacrit); ii. If Retacrit is unavailable due to shortage, member must use Epogen unless contraindicated or clinically significant adverse effects are experienced (prior authorization may be required for Epogen). Note: For Illinois HIM requests, the step therapy requirements do not apply per IL HB 5395 effective 1/1/2026; 8) Imetelstat (Rytelo) is not prescribed concurrently with luspatercept-aamt (Reblozyl); 9) Request meets one of the following (a or b): a. Dose does not exceed 7.1 mg/kg every 4 weeks; b. Dose is supported by practice guidelines or peer-reviewed literature for the relevant off-label use (prescriber must submit supporting evidence).see individual node texts

Prescribed regimen must be FDA-approved or recommended by NCCN

Continuation Therapy

Continued therapy covered when ALL of the following are met:

Continuation MDS criteria: 1) Member meets one of the following (a or b): a. Currently receiving medication via Centene benefit or previously met initial approval criteria; b. Member is currently receiving medication and is enrolled in a state/product with continuity of care regulations; 2) Member is responding positively to therapy as evidenced by a decrease in RBC transfusion requirement; 3) Imetelstat (Rytelo) is not prescribed concurrently with luspatercept-aamt (Reblozyl); 4) If request is for a dose increase, request meets one of the following (a or b): a. Dose does not exceed 7.1 mg/kg every 4 weeks; b. Dose is supported by practice guidelines or peer-reviewed literature for the relevant off-label use (prescriber must submit supporting evidence).see individual node texts

Prescribed regimen must be FDA-approved or recommended by NCCN

This policy addresses coverage for imetelstat (Rytelo) for specified indications only. Non‑FDA approved indications that are not addressed in this policy are not authorized unless the provider supplies sufficient documentation of efficacy and safety in accordance with the applicable off‑label use policies: CP.CPA.09 (Commercial), HIM.PA.154 (Health Insurance Marketplace), or CP.PMN.53 (Medicaid). Providers requesting coverage for an off‑label use must include supporting evidence per those referenced off‑label policies to allow consideration.

Coverage under this clinical policy is subject to the terms, conditions, exclusions, and limitations of the member’s coverage documents (for example, Evidence of Coverage, certificate of coverage, policy, or contract of insurance) and to applicable state and federal requirements. This policy is a guide to medical necessity and does not guarantee payment; if there is any conflict between this policy and a member’s coverage documents or applicable law, the coverage documents or law will govern.

Imetelstat must not be prescribed concurrently with Reblozyl®; concurrent use is a criterion for denial. Additionally, uses outside the FDA‑approved indication described in this policy are generally not authorized unless the provider submits appropriate off‑label justification and supporting evidence per the referenced off‑label policies.

Approved Dosing Regimens

Regimen	Dose / Schedule	Maximum dose
Imetelstat (Rytelo)
7.1 mg/kg intravenous infusion over 2 hours every 4 weeks
Maximum 7.1 mg/kg per 4 weeks

Billing and Coding

HCPCS CodesHCPCSCovered

J0870

Injection, imetelstat, 1 mg

Transfusion requirement and dosing

Transfusion requirementAt least 4 RBC units transfused over an 8-week period

Maximum dose7.1 mg/kg per 4 weeks (maximum 7.1 mg/kg/4 weeks)

Dosing regimen7.1 mg/kg intravenous infusion over 2 hours every 4 weeks

Provider Actions and Prior Authorization

Prior Authorization

Prior Authorization Required

Prior authorization is required for Rytelo (imetelstat). Providers must obtain prior authorization before initiation of therapy. Requests should document diagnosis, transfusion history, prior ESA use or ineligibility, absence of del(5q) cytogenetic abnormality, performance status, prescribing specialist consultation, and that dosing meets policy limits or is supported by guidelines/literature for off‑label uses.

Affected HCPCS: J0870

Documentation Required

Documentation and Indication

Provider must submit clinical documentation to support the indication and medical necessity. Acceptable documentation includes office chart notes, hematology/oncology consult notes, laboratory results (e.g., CBC, iron studies), transfusion records documenting at least 4 RBC units over 8 weeks, cytogenetic testing demonstrating absence of del(5q), ESA trial records or documentation of ineligibility, and any supporting literature for off‑label dosing.

Line of Therapy

Second-line designation

Second-line requirement: Indication-specific line: Adult patients with lower-risk (low or intermediate-1 IPSS) MDS with transfusion-dependent anemia who have not responded to, lost response to, or are ineligible for erythropoiesis-stimulating agents (ESA); typically after an ESA trial per step therapy rules (exceptions per state-specific provisions, e.g., Illinois HIM).N/A

Definitions

erythropoiesis-stimulating agent (ESA)

AbbreviationESA

Definition (shorthand)erythropoiesis-stimulating agent

Examples (Appendix B)epoetin alfa (Procrit, Epogen, Retacrit), darbepoetin alfa (Aranesp)

IPSS risk category definitions

LowIPSS score = 0

Intermediate-1IPSS score = 0.5 – 1

Intermediate-2IPSS score = 1.5 – 2

Background

Imetelstat (Rytelo) is an oligonucleotide telomerase inhibitor indicated for adult patients with low‑ to intermediate‑1 risk myelodysplastic syndromes (MDS) with transfusion‑dependent anemia who have not responded to, lost response to, or are ineligible for erythropoiesis‑stimulating agents (ESAs). The policy requires management by or in consultation with a hematologist/oncologist and documents specific eligibility criteria including Age ≥ 18, low or intermediate‑1 IPSS risk, and a transfusion requirement of ≥4 RBC units over 8 weeks. Dosing for the FDA‑approved MDS indication is 7.1 mg/kg IV infusion over 2 hours every 4 weeks (maximum 7.1 mg/kg/4 weeks).

Revision History

2024-11-07coding_update

HCPCS code J0870 (Injection, imetelstat, 1 mg) was added and codes C9399 and J9999 were removed.

2025-06-30policy_changeLatest

Added step therapy bypass for Illinois Health Insurance Marketplace (HIM) requests per Illinois HB 5395 effective 01/01/2026.