Neighborhood Health RI Retevmo Coverage Update

Coverage Criteria for Retevmo (selpercatinib)

General coverage requirements

Covered when ALL of the following are met for the specified indication

General requirement: Use is supported by FDA labeling, CMS compendia, NCCN/ASCO guidelines, or acceptable peer-reviewed literature

Core evidence requirement

Biomarker confirmation: Presence of RET genomic alteration (fusion or mutation) confirmed by gene sequencing or an FDA-approved test as specified per indication

Required for coverage

NSCLC indication

Non-Small Cell Lung Cancer

NSCLC RET fusion: Member has advanced/recurrent/metastatic Non‑Small Cell Lung Cancer that is positive for a RET genomic alteration confirmed by a gene sequencing test

Retevmo to be used as a single agent in first or subsequent line of therapy

RET fusion-positive solid tumors

Solid tumors with RET gene fusion

Unresectable/metastatic RET fusion solid tumor: Adult or pediatric members ≥ 2 years with recurrent unresectable or metastatic solid tumor positive for RET gene fusion detected by an FDA‑approved test, AND disease progression following one or more prior systemic therapies

Monotherapy use (selpercatinib) per policy

Thyroid cancer indications

Thyroid cancer

Medullary thyroid cancer: Adult or pediatric members ≥ 2 years with advanced/metastatic medullary thyroid cancer that is RET‑mutation or RET‑fusion positive who require systemic therapy

Retevmo used as single agent

Non‑medullary thyroid cancer: Adult or pediatric members ≥ 2 years with RET‑fusion or RET‑mutation positive non‑medullary thyroid cancer (including anaplastic, follicular, Hurthle cell, papillary) who require systemic therapy and have disease refractory to radioactive iodine when RAI is appropriate and tumor is RAI‑avid

Retevmo used as single agent

Coverage will be denied when there is a lack of confirming documentation of a positive RET genomic alteration (fusion or mutation) by genomic testing. Providers must submit results from gene sequencing or an FDA‑approved test demonstrating the RET alteration to meet the policy’s biomarker confirmation requirement.

Coverage is excluded for members who have demonstrated disease progression while receiving Retevmo or another RET inhibitor (e.g., pralsetinib). Requests for continued therapy after progression on a RET inhibitor will be denied.

Concurrent administration of Retevmo with other anti‑cancer therapies is not covered. Specifically, concurrent use with targeted therapy, immunotherapy, and/or chemotherapy is an exclusion and will result in denial of coverage.

Coverage is excluded when dosing exceeds the policy’s single‑dose limits. The policy specifies a single dose limit of 120 mg for patients weighing <50 kg and 160 mg for patients weighing ≥50 kg in patients ≥12 years of age, and a 160 mg single‑dose limit for pediatric patients 2 to <12 years of age based on body surface area. Orders exceeding these single‑dose limits will be denied.

Retevmo is not covered for pediatric patients aged 2 to <12 years with a body surface area <0.33 m2. Requests for treatment in this population are excluded under the policy.

Investigational or off‑label use lacking sufficient evidence is excluded. The policy denies coverage for off‑label indications that are not supported by adequate evidence as defined by absence from CMS‑recognized compendia or acceptable peer‑reviewed literature. The policy outlines criteria for sufficient evidence, including appropriate representation of the patient and cancer in published evidence, relevance of the treatment regimen, and demonstration of clinically meaningful outcomes (e.g., ASCO‑recommended effect sizes). Case reports and abstracts without full peer‑reviewed articles generally do not provide sufficient support.

Use is considered not medically necessary for indications or populations that lack sufficient supporting evidence as defined in the exclusion criteria. If the indication is absent from CMS‑recognized compendia and unsupported by acceptable peer‑reviewed literature (per the policy’s evidence standards), the request will be deemed not medically necessary and denied.

Initial Therapy Criteria

Initial therapy criteria

Initial coverage conditions

Indication-specific: Member meets the specific indication criteria per policy (NSCLC, RET‑fusion solid tumor after prior systemic therapy, or thyroid cancer as specified) AND has confirmatory RET genomic testing

Monotherapy requirement

Age requirement: For solid tumors and thyroid cancer, pediatric coverage requires age ≥ 2 years where specified

As stated per indication

Continuation / Renewal Criteria

Continuation therapy

Continuation requests

Continuation criteria: Requested medication was used within the last year AND member has not experienced disease progression or intolerance AND no additional medications are added to the continuation request

Continuation requests exempt from new authorization criteria if met

Provider Actions and Requirements

Prior Authorization

Prior Authorization Required

Prior authorization is required. All medication requests are processed by Evolent/Utilization Management and are subject to review and approval by the Utilization Management Department and Committee.

All requests must be submitted to Evolent/UM for prior authorization

Documentation Required

Required Documentation

Documentation must be provided to support the indication for Retevmo (selpercatinib).

Acceptable sources: FDA label, CMS-recognized compendia, NCCN or ASCO clinical guidelines, or peer-reviewed literature that meets CMS Medicare Benefit Policy Manual Chapter 15 standards
Include results confirming positive RET genomic alteration (fusion or mutation) by an FDA-approved or validated genomic test
Clinical history showing prior therapies, dates of administration, and response/progression status (if applicable)

Step Therapy Requirements

Step	Indication/Population	Requirement	Coverage
1	Recurrent unresectable or metastatic solid tumors with RET gene fusion (adult or pediatric ≥2 years)	Member has disease progression following one or more prior systemic therapies; RET gene fusion confirmed by an FDA‑approved test or gene sequencing	Covered with criteria

Quantity and Dose Limits

Retevmo (selpercatinib) — Quantity & Dose Limits

Monthly capsule/tablet limits90 capsules (40 mg) OR 60 capsules (80 mg) per month; OR 60 tablets (120 mg) OR 60 tablets (160 mg) per month

Single-dose weight-based limits (ages ≥12 yrs)Single dose limit 120 mg for weight <50 kg or 160 mg for weight ≥50 kg in adult and adolescent patients (≥12 years)

Pediatric single-dose limit (ages 2 to <12 yrs)Single dose limit 160 mg in pediatric patients 2 to <12 years based on body surface area

BSA exclusion for young pediatricsPediatric patients 2 to <12 years with body surface area <0.33 m2 are excluded

Definitions

RET Genomic Alteration — Required Confirmation

DefinitionA RET genomic alteration is a RET fusion or RET mutation confirmed by genomic testing (e.g., gene sequencing or an FDA‑approved test)

NSCLC requirementAdvanced/recurrent/metastatic NSCLC must be positive for a RET genomic alteration confirmed by gene sequencing to qualify for Retevmo

Solid tumor requirementUnresectable or metastatic solid tumors (age ≥2 years) must have RET gene fusion detected by an FDA‑approved test

Thyroid cancer requirementMedullary or non‑medullary thyroid cancers (age ≥2 years) must be RET‑mutation or RET‑fusion positive to qualify

Background

Selpercatinib (Retevmo) is a selective, targeted RET inhibitor used to treat cancers with RET alterations. The policy covers Retevmo for RET fusion‑positive non‑small cell lung cancer, RET fusion‑positive solid tumors in patients aged ≥2 years after progression on prior systemic therapy, and RET‑mutant or RET‑fusion positive thyroid cancers in adults and pediatric patients aged ≥2 years when systemic therapy is required. Use must align with FDA labeling, CMS‑recognized compendia, or acceptable peer‑reviewed literature, and requires confirmatory RET genomic testing for eligibility.

Site of Care

Note

Requests processed and reviewed by UM/Evolent (site of care)

All requests are reviewed and processed by Evolent/UM; the policy does not specify site‑of‑care settings beyond UM review and approval.

OpenPayer

Retevmo (selpercatinib) — Coverage Criteria