CurrentNeighborhood Health Plan of Rhode IslandPolicy N/A

Um Onc_1405 Retevmo Selpercatinib_11292024

Defines clinical inclusion and exclusion criteria, treatment limits, and utilization management requirements for coverage of Retevmo (selpercatinib) for members (including pediatrics ≥2 years) across indicated RET-altered cancers; references FDA label, CMS compendia, NCCN/ASCO guidance and peer-reviewed literature for supporting evidence.

Policy Summary

PayerNeighborhood Health Plan of Rhode Island

PolicyUm Onc_1405 Retevmo Selpercatinib_11292024

Policy CodePolicy N/A

Change TypeClarified committee approval/effective dates

Effective DateNov 29, 2024

Next Review Date

Key ActionProvide documentation of a positive RET genomic alteration (fusion or mutation) confirmed by genomic testing (FDA-approved test preferred).

SourceLink

POLICY UPDATE CHANGES

Policy committee approval and effective date updated to November 13, 2024 and effective date November 29, 2024.

3Covered Indications (NSCLC, RET-fusion solid tumors, Thyroid cancer)

7Exclusion criteria items

4Monthly dosing limits specified

Coverage Summary

This policy defines coverage for Retevmo (selpercatinib) as covered with criteria for specific RET-altered cancers: advanced/recurrent/metastatic Non‑Small Cell Lung Cancer (NSCLC) with a confirmed RET genomic alteration; recurrent unresectable or metastatic solid tumors with a RET gene fusion (adult and pediatric members ≥ 2 years) after progression on prior systemic therapy; and advanced/metastatic RET‑mutation or RET‑fusion positive thyroid cancers (including pediatric ≥ 2 years and non‑medullary histologies) when used as single‑agent therapy. The policy implements clinical inclusion and exclusion rules, dosing and monthly quantity thresholds, and utilization management requirements for these indications.

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Initial Therapy Criteria

Non-Small Cell Lung Cancer (NSCLC) - Approved use

Covered when ALL of the following are met:

ALL of the following

Member has advanced/recurrent/metastatic Non-Small Cell Lung Cancer
Tumor is positive for a RET-genomic alteration confirmed by a gene sequencing test
Retevmo (selpercatinib) will be used as a single agent as first or subsequent line of therapy

Solid tumors with RET gene fusion - Approved use

Covered when ALL of the following are met for adult and pediatric members 63 2 years:

ALL of the following

Member has recurrent unresectable or metastatic solid tumor
Tumor is positive for RET gene fusion detected by an FDA-approved test
Disease has progressed following one or more prior systemic therapies
Retevmo (selpercatinib) will be used as monotherapy

Thyroid cancer - Approved use

Covered when ANY of the following scenarios are met for adult and pediatric members 63 2 years (AND Retevmo used as single agent):

Continuation Therapy Criteria

Continuation requests exemption

Continuation requests for a not-approvable medication shall be exempt provided ALL of the following are met:

ALL of the following

The requested medication was used within the last year
The member has not experienced disease progression and/or no intolerance to the requested medication
Additional medication(s) are not being added to the continuation request

Continuation requests are exempt from full review only when ALL of the following are met: the medication was used within the last year; the member has not experienced disease progression or intolerance to the medication; and no additional medications are being added to the continuation request. Requests will be excluded (denied) if there is disease progression while receiving Retevmo or another RET inhibitor (e.g., pralsetinib), or if other exclusion criteria apply.

Provider Actions & Utilization Management

Prior Authorization

Prior authorization required

Prior authorization is required for Retevmo (selpercatinib). Evolent UM processes all medication requests from network ordering providers; medications not authorized by Evolent may be deemed not approvable and not reimbursable. Requests should be supported by one or more of the following evidence sources: FDA product labeling, CMS‑recognized compendia, NCCN or ASCO clinical guidelines, or peer‑reviewed literature that meets CMS Medicare Benefit Policy Manual Chapter 15 requirements.

Evolent UM processes prior authorization requests
Acceptable evidence: FDA label, CMS compendia, NCCN, ASCO, or acceptable peer‑reviewed literature

Documentation Required

Confirm RET genomic alteration

Confirm documentation of a RET genomic alteration (fusion or mutation) prior to approval. Genomic testing should be performed and documented; use of an FDA‑approved test is preferred when available.

Positive RET genomic alteration must be documented (fusion or mutation)
Genomic testing documentation required; FDA‑approved test preferred

Documentation Required

Pediatric dosing documentation

For pediatric patients aged 2 to <12 years, document body surface area (BSA) and provide dosing calculations. Therapy is not appropriate for pediatric patients with BSA < 0.33 m2.

Pediatric BSA must be ≥ 0.33 m2
Include BSA value and dosing calculation used to derive mg dose

Billing Rule

Adhere to monthly quantity limits

Adhere to monthly quantity limits. Claims exceeding the specified monthly maximums may be denied at claim adjudication.

Maximums: 90 (40 mg) capsules/month or 60 (80 mg) capsules/month
Maximums: 60 (120 mg) tablets/month or 60 (160 mg) tablets/month
Claims exceeding monthly limits may be denied

Denial Risk

Exclusion — disease progression on RET inhibitors

Denial risk: therapy is excluded if there is documented disease progression while receiving Retevmo or another RET inhibitor (e.g., pralsetinib).

Documented progression on Retevmo or another RET inhibitor = exclusion

Denial Risk

Denial risk — lack of confirming documentation

Denial risk: lack of confirming documentation of a positive RET genomic alteration (fusion or mutation) will result in denial.

Missing or insufficient genomic test documentation = exclusion

Denial Risk

Denial risk — concurrent therapy exclusion

Denial risk: concurrent use with other anti‑cancer therapy (targeted therapy, immunotherapy, and/or chemotherapy) is not permitted and may result in denial.

Concurrent use with other systemic anti‑cancer therapies is excluded

Clinical Evidence & Guidelines

Key evidence sources referenced by this policy include the pivotal trial by Drilon et al. (N Engl J Med. 2020) demonstrating efficacy of selpercatinib in RET fusion–positive NSCLC; updated pediatric results from LIBRETTO‑121 (Morgenstern et al., J Clin Oncol. 2024); the Retevmo prescribing information (Lilly, 2024); and guideline/compendia sources such as NCCN (2024), ASCO guidance, and CMS materials. These trials, prescribing information, and compendia form the evidentiary basis for the covered indications and utilization rules in the policy.

Drilon 2020Key NSCLC trial: Selpercatinib efficacy in RET‑fusion NSCLC reported by Drilon et al., N Engl J Med 2020

LIBRETTO‑121 2024Pediatric data: Updated safety and efficacy results from LIBRETTO‑121 (Morgenstern et al., J Clin Onc. 2024)

NCCN/ASCO/CMSGuideline endorsements: Supported by FDA label, NCCN 2024, ASCO guidance and CMS compendia/manual referenced as accepted evidence sources

Background

Background: This policy establishes the accepted indications for selpercatinib, covering FDA‑approved uses and certain off‑label indications when supported by recognized compendia or peer‑reviewed literature. Evolent is responsible for processing medication requests from network providers; requests lacking support from the FDA label, CMS‑approved compendia, NCCN/ASCO guidelines, or acceptable peer‑reviewed literature may be deemed not approvable and not reimbursable.

RET genomic alterationRET fusion or RET mutation detected by genomic testing (FDA-approved test preferred)

Continuation request exemptionContinuation of a previously used not-approvable medication within last year provided the member has not progressed or had intolerance and no additional medications are being added

OpenPayer

Um Onc_1405 Retevmo Selpercatinib_11292024

Coverage Summary

Initial Therapy Criteria

Continuation Therapy Criteria

Provider Actions & Utilization Management

Applicable Codes

Clinical Evidence & Guidelines

Background

Revision History