CurrentMass General Brigham Health PlanPolicy N/A

Beta Thalassemia; Myelodysplastic Syndrome and Sickle Cell Disease Agents Rytelo (imetelstat)

Pharmacy prior authorization policy governing coverage and quantity/step/authorization rules for Rytelo (imetelstat) for treatment of transfusion-dependent anemia in lower-risk MDS patients on the Mass General Brigham Health Plan (MassHealth UPPL / Commercial/Exchange). Includes initial and continuation criteria, provider requirements, and authorization duration.

Policy Summary

PayerMass General Brigham Health Plan

PolicyBeta Thalassemia; Myelodysplastic Syndrome and Sickle Cell Disease Agents Rytelo (imetelstat)

Policy CodePolicy N/A

Change TypeMinor formatting updates; earlier creation/adoption

Effective DateSep 1, 2025

Next Review Date

Key ActionPrior authorization is required; prescriber must be a hematologist or provide specialist consult notes and documentation of response is required for continuation.

SourceLink

POLICY UPDATE CHANGES

Created for P&T. Adopted MH criteria for Rytelo available through MBO: Effective 1/6/25

Reviewed and updated for P&T. Minor formatting updates only. Effective 9/1/25

1Covered Indication (MDS lower-risk transfusion-dependent anemia)

6 monthsAuthorization Duration

Coverage Summary

Coverage stance: covered_with_criteria. This is a pharmacy prior authorization policy for Rytelo (imetelstat) governing coverage, quantity/step, and authorization rules for treatment of transfusion-dependent anemia in lower-risk myelodysplastic syndromes (MDS) on the Mass General Brigham Health Plan (MassHealth UPPL / Commercial/Exchange).

Initial Therapy Criteria

Initial Authorization

Authorization may be granted when ALL of the following criteria are met:

ALL of the following

Diagnosis of low-to intermediate-1 risk myelodysplastic syndromes (MDS)
Member is ≥ 18 years of age
Prescriber is a hematologist or consult notes from specialist are provided
Member has required ≥ 4 RBC transfusions in the last 8 weeks
Erythropoiesis-stimulating agent (ESA) failure or contraindication
- Inadequate response or adverse reaction to ONE erythropoiesis-stimulating agent (e.g., epoetin, darbepoetin)
- Contraindication to ALL erythropoiesis-stimulating agents
If MDS with del(5q) cytogenetic abnormality
- Inadequate response to lenalidomide
- Adverse reaction to lenalidomide
- Contraindication to lenalidomide
If MDS with ring sideroblasts (RS)
- Inadequate response to Reblozyl (luspatercept)
- Adverse reaction to Reblozyl (luspatercept)
- Contraindication to Reblozyl (luspatercept)
Dosing is appropriate per FDA labeling

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Provider Actions & Requirements

Prior Authorization

Prior authorization required

Prior authorization is required. Requests for members who are new to the plan and currently receiving the medication may be reviewed on a case-by-case basis. Authorizations are granted for 6 months.

Authorizations granted for 6 months
Case-by-case review for members new to the plan currently receiving treatment

Documentation Required

Specialist prescriber or consult notes required

Prescriber must be a hematologist or provide consult notes from a specialist to support the diagnosis and treatment.

Documentation Required

Document response for continuation

For continuation of therapy, the prescriber must provide documentation of a positive clinical response to treatment (for example, a decrease in transfusion requirements).

Documentation Required

Dosing requirement

Dosing must be appropriate per FDA labeling.

Background

Rytelo (imetelstat) is described as an oligonucleotide telomerase inhibitor that blocks telomerase–telomere interaction, leading to increased destruction of malignant cells with high telomerase activity and potential improvement in bone marrow hematopoiesis.

Indication: imetelstat is indicated for the treatment of transfusion-dependent anemia in lower‑risk MDS patients who have not responded to, lost response to, or are ineligible for erythropoiesis‑stimulating agents (ESAs).

Policy intent and requirements: the policy adopts criteria to ensure specialist involvement (prescriber must be a hematologist or provide specialist consult notes), documentation of prior inadequate response or contraindication to ESAs, and when applicable prior treatment or contraindication to alternatives — lenalidomide for MDS with del(5q) and luspatercept (Reblozyl) for MDS with ring sideroblasts — plus dosing must be appropriate per FDA labeling. For continuation, prescribers must provide documentation of clinical benefit (e.g., decreased transfusion requirements). Authorizations are granted for 6 months.

Threshold detail / note

Threshold (RBC transfusions in prior 8 weeks)Policy text: 'required 24 RBC transfusions in the last eight weeks (document text; likely intended ≥4 transfusions)'

Policy Summary

PayerMass General Brigham Health Plan

PolicyBeta Thalassemia; Myelodysplastic Syndrome and Sickle Cell Disease Agents Rytelo (imetelstat)

Policy CodePolicy N/A

Change TypeMinor formatting updates; earlier creation/adoption

Effective DateSep 1, 2025

Next Review Date

Key ActionPrior authorization is required; prescriber must be a hematologist or provide specialist consult notes and documentation of response is required for continuation.

SourceLink

On This Page

OpenPayer

Beta Thalassemia; Myelodysplastic Syndrome and Sickle Cell Disease Agents Rytelo (imetelstat)

Coverage Summary

Initial Therapy Criteria

Continuation Therapy Criteria

Provider Actions & Requirements

Applicable Codes

Clinical Evidence & References

Background

Revision History