CurrentNeighborhood Health Plan of Rhode IslandPolicy UM ONC_1506

Drug Policy: Rytelo (imetelstat)

Defines clinical indications, inclusion and exclusion criteria, and utilization management requirements for coverage of Rytelo (imetelstat) for Neighborhood Health Plan of Rhode Island members; applies to providers requesting medication authorizations processed by UM/Evolent.

Policy Summary

PayerNeighborhood Health Plan of Rhode Island

PolicyDrug Policy: Rytelo (imetelstat)

Policy CodePolicy UM ONC_1506

Change TypeNo material changes

Effective DateAug 30, 2024

Next Review Date

Key ActionPrior authorization is required for Rytelo requests processed by Evolent/UM; continuation requests may be exempt when continuation criteria are met.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

6maximum number of treatment doses allowed

7.1 mg/kgsingle dose maximum

4+ RBC/8wtransfusion dependence threshold

FDA + CMS/NCCN/ASCOacceptable evidence sources

08/14/24committee approval date

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Coverage Criteria for Rytelo (imetelstat)

MDS — Initial coverage

Covered when ALL of the following are met

Rytelo coverage for lower‑risk MDS: Patient is an adult with low‑ or intermediate‑1‑risk myelodysplastic syndromes (MDS) with transfusion‑dependent anemia (>=4 RBC units over 8 weeks) AND patient has not responded to, has lost response to, or is ineligible for erythropoiesis‑stimulating agents (ESAs).

Supported by FDA labeling and published evidence per policy

Coverage excludes members who experience disease progression while taking Rytelo (imetelstat). Requests will also be excluded for concurrent use with other anticancer therapies. Dosing that exceeds the policy limits is not approvable: the maximum single dose is 7.1 mg/kg and therapy that exceeds 6 total doses will be denied. Additionally, investigational or off‑label uses that do not meet the policy's evidence standards are excluded.

Off‑label use of Rytelo (imetelstat) is considered investigational and not approvable unless supported by acceptable evidence. Per policy, acceptable sources include FDA‑approved product labeling, CMS‑recognized compendia, NCCN or ASCO clinical guidelines, or peer‑reviewed literature that meets the standards of the CMS Medicare Benefit Policy Manual Chapter 15. The policy further requires that published evidence adequately represent the clinical characteristics and treatment regimens of the patient population and demonstrate clinically meaningful outcomes.

Coding and Clinical Thresholds

inv-04: Transfusion dependence — threshold definition

Transfusion-dependence threshold>= 4 red blood cell (RBC) units over an 8-week period

Clinical contextApplies to adults with low- to intermediate-1–risk myelodysplastic syndromes (MDS) with transfusion-dependent anemia

Policy usageRequired as part of initial coverage criteria for Rytelo (imetelstat) in MDS

inv-05: Maximum single dose — 7.1 mg/kg

Maximum single dose7.1 mg/kg per single dose

Consequence of exceedanceDosing that exceeds 7.1 mg/kg is listed as an exclusion and may lead to denial

Applies to

Provider Requirements and Authorization Process

Prior Authorization

Prior Authorization Required

Prior authorization is required for Rytelo (imetelstat) requests and shall be processed by UM/Evolent. Requests not authorized by Evolent may be deemed not approvable and therefore not reimbursable.

All medication requests must be submitted to Evolent for prior authorization processing.
Continuation exceptions (see continuation requirements) apply when criteria are met.

Documentation Required

Continuation Request Requirements

Continuation requests may be approved without a new full review when all continuation conditions below are met. The use must be supported by acceptable evidence sources (FDA labeling, CMS-recognized compendia, NCCN, ASCO guidelines, or peer-reviewed literature meeting CMS Medicare Benefit Policy Manual Chapter 15 standards).

Member has not experienced disease progression while taking the requested medication.

Background

Rytelo (imetelstat) is an antineoplastic agent indicated in this policy for use in adults with lower‑risk myelodysplastic syndromes (low to intermediate‑1 risk) with transfusion‑dependent anemia. The policy focuses on patients who have not responded to, lost response to, or are ineligible for erythropoiesis‑stimulating agents. Clinical context and eligibility thresholds used by the policy (for example transfusion dependence and dosing limits) are drawn from the product labeling and the evidence base referenced in the policy.

Policy Definitions

inv-12: Transfusion-dependent anemia (policy definition)

Definition termTransfusion-dependent anemia (policy definition)

Operational definitionRequirement for four or more red blood cell units over 8 weeks

Intended populationAdults with low- to intermediate-1–risk myelodysplastic syndromes (MDS) considered for Rytelo

Initial Therapy

Initial therapy

Initial therapy coverage requirements and limits

Initial therapy limits and exclusions: Covered for adult patients meeting MDS transfusion‑dependence and ESA failure/ineligibility criteria. Not covered if dosing >7.1 mg/kg single dose or treatment >6 doses. Concurrent anticancer therapy precludes coverage.single dose <=7.1 mg/kg; total doses <=6

Per policy exclusions and dosing limits

Continuation Therapy

Continuation therapy

Continuation requests may be approved without reapplying policy if continuation conditions met

Continuation exemption: Member has not experienced disease progression on imetelstat AND the medication was used within the last year without a lapse of more than 30 days of an active authorization AND no additional medications are added to the continuation request.

Applies to continuation requests per policy

Quantity Limits for Rytelo (imetelstat)

inv-15: Rytelo (imetelstat) — maximum number of treatment doses (6)

Maximum treatment doses (Rytelo)6 doses total

Policy placementListed as a quantity limit and an exclusion if exceeded

Applies toRytelo (imetelstat) requests processed under this policy

inv-16: Rytelo (imetelstat) — maximum single dose (7.1 mg/kg)

Maximum single dose (Rytelo)7.1 mg/kg per single dose

Policy consequenceDosing above this single-dose limit is an exclusion and may result in denial

Referenced in

Policy Summary

PayerNeighborhood Health Plan of Rhode Island

PolicyDrug Policy: Rytelo (imetelstat)

Policy CodePolicy UM ONC_1506

Change TypeNo material changes

Effective DateAug 30, 2024

Next Review Date

Key ActionPrior authorization is required for Rytelo requests processed by Evolent/UM; continuation requests may be exempt when continuation criteria are met.

SourceLink

On This Page

All Rytelo (imetelstat) treatment requests under this policy

inv-06: Maximum number of doses — 6 doses

Maximum number of doses6 total treatment doses

Consequence of exceedanceTreatment exceeding 6 doses is an exclusion and may be denied

Quantity limitPolicy quantity limit: 6 doses per course

Requested medication was used within the last year and there has been no lapse >30 days without an active authorization.

No additional medications are being added to the continuation request.

Documentation Required

Required Supporting Documentation

Providers must submit supporting documentation to demonstrate that use is consistent with accepted evidence sources. Evolent will consider documentation from the listed sources when evaluating medical necessity.

Acceptable evidence sources: FDA approved product labeling; CMS-recognized compendia; National Comprehensive Cancer Network (NCCN) guidelines; American Society of Clinical Oncology (ASCO) clinical guidelines; peer-reviewed literature that meets CMS Medicare Benefit Policy Manual Chapter 15 requirements.
For off-label indications, provide peer-reviewed literature demonstrating that the patient and disease characteristics, therapy regimen, and clinically meaningful outcomes are adequately represented (see exclusion criteria for insufficient evidence considerations).
Include relevant clinical records: diagnosis, prior lines of therapy, response to therapy, dates of treatment, dosing, and any imaging or laboratory results supporting continued benefit.

Denial Risk

Denial Triggers and Exclusion Criteria

Requests may be denied if exclusion criteria are met. Submit clear documentation addressing these denial triggers when requesting approval or continuation.

Documented disease progression while on Rytelo (imetelstat) — denial trigger.
Concurrent use with other anticancer therapies — unless explicitly allowed and documented.
Dosing that exceeds the single dose limit of 7.1 mg/kg or treatment exceeding 6 doses.
Use for investigational or off-label indications lacking sufficient evidence as defined (insufficient representation of patient/cancer characteristics, inadequate regimen representation, outcomes not clinically meaningful, reliance on uncontrolled case reports or meeting abstracts without full peer-reviewed publication).

Exclusion criteria and quantity limits for Rytelo (imetelstat)