CurrentMass General Brigham Health PlanPolicy N/A

Rytelo (imetelstat) — Medical‑benefit prior authorization for transfusion‑dependent anemia in lower‑risk MDS

Medical-benefit prior authorization criteria for Rytelo (imetelstat) to treat transfusion‑dependent anemia in adults with low‑to‑intermediate‑1 risk MDS; applies to MassHealth members under Mass General Brigham Health Plan.

Policy Summary

PayerMass General Brigham Health Plan

PolicyRytelo (imetelstat) — coverage criteria for lower‑risk MDS

Policy CodePolicy N/A

Change TypeMinor — no material clinical changes

Effective DateSep 1, 2025

Next Review DateSep 1, 2025

Key ActionObtain prior authorization and provide documentation of positive response for continuation (e.g., decreased transfusion requirements).

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

≥18minimum member age

≥4required RBC transfusions in prior 8 weeks

6 moauthorization duration

Hematologistspecialist requirement

Coverage Criteria for Rytelo (imetelstat)

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Initial authorization criteria

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

Primary criteria: 1. Diagnosis of low-to intermediate-1 risk myelodysplastic syndromes (MDS); 2. Member is ≥ 18 years of age; 3. Prescriber is a hematologist or consult notes from specialist are provided; 4. Member has required ≥4 RBC transfusions in the last eight weeks; 5. Inadequate response or adverse reaction to ONE or contraindication to ALL erythropoiesis stimulating agents (e.g. epoetin, darbepoetin); 6. If member has MDS with ring sideroblasts (RS), inadequate response, adverse reaction or contraindication to Reblozyl (luspatercept); 7. If member has MDS associated with a del 5q cytogenic abnormality, inadequate response, adverse reaction or contraindication to lenalidomide; 8. Dosing is appropriate per FDA labeling

Continuation Therapy

Continuation of therapy

Continuation: Prescriber must provide documentation of positive response to therapy (e.g., decrease in transfusion requirements).

Requests for products provided as samples or obtained through a manufacturer's patient assistance program are excluded from case‑by‑case authorization review. Authorization may be reviewed on a case‑by‑case basis for members who are new to the plan and currently receiving the requested medication, but coverage will not be granted for therapies supplied only as samples or via patient assistance programs.

Regimen	Indication	Coverage status
Rytelo (imetelstat) dosed per FDA labeling	Transfusion‑dependent anemia in low‑to intermediate‑1 risk myelodysplastic syndromes (MDS) when all prior treatment and clinical criteria are met (see coverage criteria): age ≥18 years; prescriber is a hematologist or specialist consult provided; ≥4 RBC transfusions in the last 8 weeks; inadequate response/adverse reaction/contraindication to erythropoiesis‑stimulating agents; if ring sideroblasts, inadequate response/adverse reaction/contraindication to luspatercept; if del(5q), inadequate response/adverse reaction/contraindication to lenalidomide; dosing per FDA labeling.	Covered

Provider Actions and Documentation Requirements

Prior Authorization

Prior Authorization Required

Prior authorization is required for this medical benefit. Requests may be reviewed on a case-by-case basis for members who are new to the plan and currently receiving the requested medication. Case-by-case review does not apply when the product was obtained as samples or through a manufacturer's patient assistance program.

Medical benefit prior authorization required
Case-by-case review available for members new to plan currently receiving therapy
Samples and manufacturer patient-assistance program supplies are excluded from case-by-case consideration

Step Therapy

Prior Treatment Requirements

Prior treatment requirements must be met before authorization is approved. The prescriber must document prior therapies, responses, or contraindications as specified below.

Member must have had inadequate response or adverse reaction to ONE erythropoiesis-stimulating agent (e.g., epoetin, darbepoetin) or have a documented contraindication to all ESAs
For MDS with ring sideroblasts (RS): inadequate response, adverse reaction, or contraindication to luspatercept (Reblozyl) is required
For MDS with del(5q): inadequate response, adverse reaction, or contraindication to lenalidomide is required
Member must have required ≥4 RBC transfusions in the last 8 weeks

Documentation Required

Required Clinical Documentation

Required clinical documentation must be submitted with the authorization request to support initial and continuation approvals.

Prescriber specialty: hematologist or submission of specialist consult notes when prescriber is not a hematologist
Documentation of diagnosis: low- to intermediate-1 risk myelodysplastic syndromes (MDS)
Age: member is ≥ 18 years
Documentation of transfusion history: ≥4 RBC transfusions in the prior 8 weeks
Documentation of prior therapies and reasons for failure or contraindication (ESAs, luspatercept, lenalidomide as applicable)
For continuation: documentation of positive clinical response (e.g., decrease in transfusion requirements)
Dosing must be appropriate per FDA labeling

Note

Case-by-Case Review Notes

Case-by-case review may be granted for members new to the plan who are currently receiving the requested medication; however, prior authorization is still required. Authorizations will not be granted for products obtained as samples or through manufacturer patient assistance programs.

Case-by-case reviews apply only to members actively receiving therapy at plan entry
Exclude supply obtained as samples or via manufacturer's assistance programs from coverage consideration
Providers should submit current treatment records and rationale to support continuation at plan enrollment

Biomarker and Specific Subgroup Requirements

del(5q) — lenalidomide requirement prior to approval

Requirement before approvalIf MDS associated with del(5q), inadequate response, adverse reaction, or contraindication to lenalidomide is required prior to approval

Biomarker contextApplies when del(5q) cytogenetic abnormality is present

Actionable documentationProvider must document prior lenalidomide trial or reason for ineligibility/contraindication

Ring sideroblasts (RS) — luspatercept requirement prior to approval

Requirement before approvalIf MDS with ring sideroblasts (RS), inadequate response, adverse reaction, or contraindication to Reblozyl (luspatercept) is required prior to approval

Biomarker contextApplies when ring sideroblasts (RS) are present

Actionable documentationProvider must document prior luspatercept trial or reason for ineligibility/contraindication

Background

Imetelstat (Rytelo) is an oligonucleotide telomerase inhibitor that disrupts the interaction between telomerase and telomeres, a mechanism that can restore or improve hematopoiesis in certain patients with myelodysplastic syndromes. The policy applies to adults (≥18 years) with transfusion‑dependent anemia due to low‑to‑intermediate‑1 risk MDS who have not responded to, have lost response to, or are ineligible for erythropoiesis‑stimulating agents. Use is intended for patients meeting specified prior therapy and biomarker requirements (for example, prior luspatercept for ring sideroblasts or lenalidomide for del(5q) disease) and dosed per FDA labeling.