CurrentNeighborhood Health Plan of Rhode IslandPolicy N/A

Retevmo

Defines accepted indications, exclusion criteria, coding, and requirements for coverage and continuation of Retevmo (selpercatinib) for commercial, exchange/marketplace and Medicaid lines of business; includes FDA-approved and select off-label uses supported by compendia or peer-reviewed literature.

Policy Summary

PayerNeighborhood Health Plan of Rhode Island

PolicyRetevmo

Policy CodePolicy N/A

Change TypeTemplate conversion; indication and dosing updates

Effective Date

Next Review Date

Key ActionProvider must supply confirming documentation of a positive RET-genomic alteration (fusion or mutation) by genomic testing to support authorization.

SourceLink

POLICY UPDATE CHANGES

Converted to new Evolent guideline template and replaced prior guideline UM ONC_1405; indication section updated.

Added new tablet strengths to exclusion criteria and updated maximum dosage form quantities.

3Primary covered indications (NSCLC, solid tumors with RET fusion, thyroid cancer)

1J-code listed

3Applicable lines of business

Coverage Summary

Background: Retevmo (selpercatinib) is indicated for multiple RET-altered cancers per this policy, including FDA‑approved uses and selected off‑label indications supported by compendia or peer‑reviewed literature. Applicable lines of business: Commercial, Exchange/Marketplace, and Medicaid. Coverage stance: covered_with_criteria. Note: Continuation rules provide an exemption that may allow renewal of therapy for certain medications that would otherwise be not‑approvable when strict conditions are met.

General coverage preface

Coverage requires FDA labeling, CMS-approved compendia, NCCN/ASCO guidelines, or peer-reviewed literature that meets CMS Medicare Benefit Policy Manual Chapter 15 requirements; continuation exemptions apply when specified.

Use is supported by FDA approved product labeling, CMS-approved compendia, NCCN, ASCO clinical guidelines, or peer-reviewed literature that meets CMS Medicare Benefit Policy Manual Chapter 15 requirements

Initial Therapy Criteria (Covered Indications)

Non-Small Cell Lung Cancer (NSCLC) - Covered indication

Retevmo may be used when ALL of the following are met:

Adult member with locally advanced, recurrent, or metastatic Non-Small Cell Lung Cancer (NSCLC)

Tumor is positive for a RET-genomic alteration confirmed by a gene sequencing test

Provider must supply confirming documentation of a positive RET-genomic alteration by genomic testing

Used as a single agent as first-line or subsequent-line therapy

Solid tumors with RET gene fusion - Covered indication

Retevmo may be used when ALL of the following are met:

Member (adult or pediatric ≥ 2 years of age) with recurrent, unresectable, or metastatic solid tumor

Tumor is positive for RET gene fusion as detected by an FDA-approved test

Provider must supply confirming documentation of a positive RET-genomic alteration by genomic testing

Disease has progressed following one or more prior systemic therapies

Used as monotherapy

Thyroid cancer - Covered indication

Retevmo may be used when ANY of the following covered scenarios apply (each scenario has its internal ALL requirements):

ANY of the following

Medullary Thyroid Cancer
- Member (adult or pediatric ≥ 2 years of age) with advanced/metastatic medullary thyroid cancer
- Tumor is RET-mutation or RET-fusion positive
  Provider must supply confirming documentation of a positive RET-genomic alteration by genomic testing
- Member requires systemic therapy
- Used as a single agent
Non-medullary thyroid cancers (Anaplastic/Follicular/Hurthle Cell/Papillary)

Continuation Therapy Criteria

Continuation requests exemption

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

Member has not experienced disease progression on the requested medication

See documentation requirement

Requested medication was used within the last year without a lapse of more than 30 days of having an active authorization

No additional medication(s) are being added to the continuation request

Documentation Required

Continuation exemption documentation

For continuation requests for a medication that would otherwise be not approvable, document all of the following: the member has not experienced disease progression on the requested medication; the requested medication was used within the last year without a lapse of more than 30 days of having an active authorization; and no additional medication(s) are being added to the continuation request.

Unproven / Exclusions (Not Covered Conditions)

Exclusion criteria (Not covered conditions / denials)

Do not authorize if ANY of the following exclusion criteria are met:

Lack of confirming documentation of a positive RET-genomic alteration (fusion or mutation) by genomic testing

Provider must supply confirming documentation

Disease progression while receiving Retevmo or another RET inhibitor (e.g., pralsetinib)

Concurrent use with other anti-cancer therapy including targeted therapy, immunotherapy and/or chemotherapy

Concurrent therapy is a basis for denial

Dosing exceeds single dose limits: 120 mg for weight < 50 kg or 160 mg for weight ≥ 50 kg in adult and adolescent patients ≥ 12 years based on body weight120 mg (weight < 50 kg) or 160 mg (weight ≥ 50 kg)

Denial for dosing exceedance

Dosing exceeds single dose limit of 160 mg in pediatric patients 2 to < 12 years based on body surface area160 mg

Denial for dosing exceedance

Pediatric patients 2 to < 12 years of age with body surface area < 0.33 m2< 0.33 m2 excludes

Treatment exceeds maximum monthly limits90 (40 mg) or 60 (80 mg) capsules/tablets per month; 60 (120 mg) or 60 (160 mg) tablets per month

Denial for quantity exceedance

Investigational use for an off-label indication lacking sufficient evidence or not generally accepted by the medical community (insufficient evidence defined by lack of adequate representation of patient/ cancer characteristics, regimens, or clinically meaningful outcomes per ASCO criteria)

Insufficient experimental design or reliance on inadequate evidence sources (case reports, abstracts without full articles) as sole basis for coverage

Provider Actions & Prior Authorization

Prior Authorization

Prior authorization requirement

Evolent processes all medication requests and prior authorization is required for Retevmo (selpercatinib). Billing uses HCPCS code J8999 for selpercatinib.

Documentation Required

Confirm RET genomic alteration

Supply confirming documentation of a positive RET-genomic alteration (fusion or mutation) by genomic testing to support authorization.

Denial Risk

Denial for concurrent anti-cancer therapy

Claims may be denied when Retevmo is used concurrently with other anti-cancer therapies. Concurrent use with targeted therapy, immunotherapy, or chemotherapy is an exclusion and may result in denial.

Denial Risk

Denial for dosing or quantity exceedance

Claims may be denied if dosing or quantity thresholds are exceeded. Single-dose limits and maximum monthly quantities specified in the policy must not be exceeded.

Affected code: J8999
Single dose limits: 120 mg (weight < 50 kg) or 160 mg (weight ≥ 50 kg) for adults/adolescents ≥ 12 years; 160 mg single-dose limit for pediatric patients 2 to <12 years based on body surface area
Maximum monthly limits: 90 (40 mg) or 60 (80 mg) capsules/tablets per month; 60 (120 mg) or 60 (160 mg) tablets per month

Documentation Required

Continuation exemption documentation

For continuation requests of a not-approvable medication, document that the member has not experienced disease progression on the requested medication; the medication was used within the last year without a lapse of more than 30 days of having an active authorization; and no additional medication(s) are being added to the continuation request.

Clinical Evidence & References

Evidence: Key trials and sources cited for selpercatinib include LIBRETTO‑001, LIBRETTO‑121, LIBRETTO‑431, the Retevmo prescribing information (Lilly 2024), and guideline/compendia sources such as NCCN, ASCO and CMS‑recognized compendia. Coverage decisions rely on FDA labeling, CMS‑approved compendia, NCCN/ASCO guidance, and peer‑reviewed literature that meets CMS standards (Medicare Benefit Policy Manual Chapter 15).

Background

Policy summary: This policy defines accepted indications for Retevmo (selpercatinib), including FDA‑approved and selected off‑label uses supported by compendia or acceptable peer‑reviewed literature. Continuation rules can allow renewal of a not‑approvable medication when strict conditions are met.

Continuation exemption: An exemption allowing continuation requests for a not‑approvable medication if no disease progression, the medication was used within the last year without a lapse >30 days of active authorization, and no additional medications are being added.

Dosing and quantity thresholds

Pediatric body surface area minimumPediatric patients 2 to < 12 years of age with body surface area < 0.33 m2 are excluded

Single dose limits (adolescents/adults)120 mg (weight < 50 kg) or 160 mg (weight >= 50 kg)

Single dose limit (pediatric 2 to <12 years)160 mg

Maximum monthly quantities90 (40 mg) or 60 (80 mg) capsules/tablets per month; 60 (120 mg) or 60 (160 mg) tablets per month

Revision History

November 2025conversion/replacement and indication updates

Converted to new Evolent guideline template and replaced prior guideline UM ONC_1405; indication section updated. (Context: is_material false)

November 2024exclusion criteria/tablet strengths and dosage updates

Added new tablet strengths to exclusion criteria and updated maximum dosage form quantities in exclusion criteria. (Context: is_material false)

Policy Summary

PayerNeighborhood Health Plan of Rhode Island

PolicyRetevmo

Policy CodePolicy N/A

Change TypeTemplate conversion; indication and dosing updates

Effective Date

Next Review Date

Key ActionProvider must supply confirming documentation of a positive RET-genomic alteration (fusion or mutation) by genomic testing to support authorization.

SourceLink

On This Page

OpenPayer

Retevmo

Coverage Summary

Initial Therapy Criteria (Covered Indications)

Continuation Therapy Criteria

Unproven / Exclusions (Not Covered Conditions)

Provider Actions & Prior Authorization

Applicable Codes

Clinical Evidence & References

Background

Revision History