CurrentCignaPolicy N/A

Oncology (Oral - Rearranged During Transfection-Targeting Agent) - Retevmo PA Policy

Prior authorization requirements for coverage of Retevmo (selpercatinib capsules and tablets) for FDA‑approved RET-altered cancers and select other RET fusion–positive indications for Cigna-administered health benefit plans.

Policy Summary

PayerCigna

PolicyOncology (Oral - Rearranged During Transfection-Targeting Agent) - Retevmo PA Policy

Policy CodePolicy N/A

Change TypeMaterial clinical revisionspediatric age expansionformulation added

Effective DateN/A

Next Review DateJun 14, 2023

Key ActionObtain prior authorization and submit documentation of diagnosis, FDA‑approved RET test results, age, disease status, and prior treatment history for coverage.

SourceLink

POLICY UPDATE CHANGES

Overview updated from accelerated approval language to full approval for advanced or metastatic RET fusion-positive thyroid cancer in adults and pediatric patients ≥ 2 years who are radioactive iodine-refractory and require systemic therapy.

A new formulation of Retevmo tablets was added; same criteria apply as capsules.

Pediatric age requirement for thyroid cancer and solid tumor indications changed from ≥ 12 years to ≥ 2 years.

Policy name changed to 'Oncology (Oral - Rearranged During Transfection-Targeting Agent) - Retevmo PA Policy'.

3FDA-approved indication groups

1 yrTypical approval duration

≥2 yrsMinimum pediatric age

NMIOther uses

NCCNGuideline support

Coverage Criteria for Retevmo (selpercatinib)

FDA-Approved Indications

Covered when ALL of the following are met for each FDA‑approved indication

NSCLC (Non-Small Cell Lung Cancer): Approve for 1 year if ALL: A) patient is ≥ 18 years of age; AND B) patient has recurrent, advanced, or metastatic disease; AND C) the tumor is RET fusion-positive (rearranged during transfection).

Thyroid Cancer: Approve for 1 year if ALL: A) patient is ≥ 2 years of age; AND B) patient has RET fusion-positive disease, RET mutation-positive disease, or a RET pathogenic variant; AND C) patient meets ONE of: i) anaplastic thyroid cancer; OR ii) disease requires systemic therapy AND ONE of: a) medullary thyroid cancer; OR b) radioactive iodine‑refractory disease.

Solid Tumors: Approve for 1 year if ALL: A) patient is ≥ 2 years of age; AND B) patient has recurrent, advanced, or metastatic disease; AND C) the tumor is RET fusion-positive (rearranged during transfection).

Policy Summary

PayerCigna

PolicyOncology (Oral - Rearranged During Transfection-Targeting Agent) - Retevmo PA Policy

Policy CodePolicy N/A

Change TypeMaterial clinical revisionspediatric age expansionformulation added

Effective DateN/A

Next Review DateJun 14, 2023

Key ActionObtain prior authorization and submit documentation of diagnosis, FDA‑approved RET test results, age, disease status, and prior treatment history for coverage.

SourceLink

On This Page

Trek Health ingests and normalizes Transparency in Coverage data and payer policy updates to give provider organizations a clear view of how commercial reimbursement behaves across markets, payers, and services. Our platform transforms raw payer disclosures into structured intelligence that supports contract evaluation, payer negotiations, and service line strategy. By combining market benchmarks with ongoing policy visibility, Trek helps teams identify variability, risk, and opportunity in commercial reimbursement. The result is faster insight, stronger negotiating positions, and more informed financial decisions.

Regimen	Indication / NCCN role
Retevmo (selpercatinib)
First-line treatment for RET-rearranged (RET rearrangement–positive) recurrent, advanced, or metastatic non–small cell lung cancer — listed by NCCN as a preferred option (category 1). If RET rearrangement is identified during first-line systemic therapy, interrupt current therapy and initiate Retevmo.

Authorization, Documentation, and Billing Guidance

Prior Authorization

Prior Authorization Required

Prior Authorization is recommended and required for prescription benefit coverage of Retevmo. Approvals are issued for 1 year when the specified indication criteria are met.

Retevmo (selpercatinib) requires prior authorization for coverage.
Approvals are issued for a duration of 1 year for covered indications.

Step Therapy

No explicit step therapy (fail‑first) requirements are listed for Retevmo. Coverage decisions are criterion‑based and determined by diagnosis, age, RET alteration status, and disease setting per the FDA‑approved and supported indications.

Step‑therapy: None specified — authorization is based on meeting the coverage criteria for the applicable indication.

Documentation Required

Required Documentation and Denial Risk

Providers must submit documentation to support that the requested use meets the applicable benefit plan terms and the policy criteria. Claims submitted without covered diagnosis/procedure codes or required supporting documentation will be denied.

Required documentation includes: clinical notes supporting diagnosis and disease stage, age, and treatment history as applicable; FDA‑approved test results confirming RET fusion or RET mutation/pathogenic variant as required for the indication; pathology reports and molecular testing reports showing RET status; documentation of prior treatments or systemic therapy necessity when applicable (e.g., radioactive iodine‑refractory status for thyroid cancer).
Billing note: Use the most appropriate diagnosis and procedure codes as of the date of service. Claims submitted for services not accompanied by covered diagnosis/procedure codes under this policy will be denied as not covered.

Biomarker and Testing Requirements

RET gene fusion, RET mutation, RET pathogenic variant — biomarker requirements

Required test for FDA indicationsDetection of RET gene fusion, RET mutation, or RET pathogenic variant must be by an FDA‑approved test.

RET fusion required for other supportive usesFor non‑FDA supportive indications (e.g., histiocytic neoplasms), authorization requires presence of a RET fusion (rearranged during transfection).

Age thresholdsFDA‑approved thyroid and solid tumor indications: patient ≥ 2 years; NSCLC indication: patient ≥ 18 years.

Disease status requirementNSCLC and solid tumor indications require locally advanced, recurrent, or metastatic disease; thyroid indications require advanced or metastatic disease and specific subcriteria.

Regulatory note for solid tumorsRET fusion–positive solid tumor indication was approved under accelerated approval and may require confirmatory trial verification for continued approval.

Key Definitions

RET fusion-positive (definition and uses)

DefinitionRET fusion-positive (rearranged during transfection; RET fusion) — tumor demonstrates RET gene fusion as detected by an FDA‑approved test.

Clinical context (NSCLC)NSCLC indication requires the tumor be RET fusion-positive for approval (patients ≥ 18 years with recurrent/advanced/metastatic disease).

Included tumor typesRET fusion–positive solid tumors include examples such as breast, cervical, cholangiocarcinoma, colorectal, esophageal, gastric, ovarian, pancreatic, salivary gland, soft tissue sarcoma, small bowel, and unknown primary.

RET mutation / pathogenic variant (definition and thyroid indication)

DefinitionRET mutation / pathogenic variant — presence of a RET mutation or RET pathogenic variant as detected by an FDA‑approved test, used for thyroid cancer indications.

Thyroid indication specificsThyroid cancer approval covers RET mutation‑positive or RET pathogenic variant disease in adults and pediatric patients ≥ 2 years who require systemic therapy; additional criteria (anaplastic histology or medullary/RAI‑refractory disease) apply.

Required testDetection must be by an FDA‑approved test as specified for the thyroid cancer indication.

OpenPayer

Oncology (Oral - Rearranged During Transfection-Targeting Agent) - Retevmo PA Policy

Coverage Criteria for Retevmo (selpercatinib)

Preferred Regimens and Guideline Positioning

Authorization, Documentation, and Billing Guidance

Codes and Billing

Line of Therapy Situations

Biomarker and Testing Requirements

Key Definitions

Background on Retevmo