CurrentCignaPolicy N/A

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

Prior authorization policy for Retevmo (selpercatinib capsules and tablets) under Cigna health benefit plans, defining coverage criteria for FDA-approved indications and select other uses with supportive evidence, approval durations, and non-covered conditions.

Policy Summary

PayerCigna

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

Policy CodePolicy N/A

Change TypeRevised / Clarified

Effective Date

Next Review Date

Key ActionPrior authorization is required and approvals are provided for 1 year for covered indications; document RET gene fusion, RET mutation, or RET pathogenic variant status, patient age, and disease status.

POLICY UPDATE CHANGES

Policy name was changed to 'Oncology (Oral - Rearranged During Transfection-Targeting Agent) - Retevmo PA Policy' on 04/20/2025.

Overview updated to reflect 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 (06/13/2024).

Thyroid and solid tumor pediatric age indications expanded to ≥ 2 years in prior revision history (dates: 06/14/2023 and earlier entries noted).

A new formulation of Retevmo tablets was added previously; criteria are the same as for capsules.

Most recent annual revision on 05/07/2025 noted 'No criteria changes.'

3FDA-approved indication groups (NSCLC, Thyroid, Solid tumors)

1Other supported indication group (Histiocytic neoplasm)

1 yearStandard approval duration

≥2Minimum pediatric age for thyroid and solid tumor indications

Coverage Summary & Stance

Coverage: This prior authorization policy covers Retevmo (selpercatinib) capsules and tablets under Cigna health benefit plans for FDA-approved indications and select other uses with supportive evidence. Coverage is provided with criteria (covered_with_criteria) and approvals are issued for 1 year when the patient meets the applicable policy criteria.

Key Policy Highlights

FDA-approved indication groups3 (Non-Small Cell Lung Cancer; Thyroid Cancer; Solid Tumors)

Other supported indication group1 (Histiocytic neoplasm: Langerhans cell histiocytosis, Erdheim‑Chester disease, Rosai‑Dorfman disease)

Standard approval duration1 year (prior authorizations are approved for 1 year)

Pediatric minimum age≥ 2 years (for thyroid and solid tumor indications)

Last review date2025-05-07

StatusCURRENT

FDA-Approved Indications (Initial Therapy Criteria)

FDA-Approved Indications

Approve for 1 year if the patient meets ALL of the following per indication:

Non-Small Cell Lung Cancer indication

NSCLC criteria
- Age: Patient is ≥ 18 years of age
- Disease status: Patient has recurrent, advanced, or metastatic disease
- Biomarker: The tumor is rearranged during transfection (RET) fusion-positive
  as detected by an FDA-approved test

Other Uses with Supportive Evidence

Approve for 1 year if the patient meets ALL of the following:

Histiocytic Neoplasm

Age: Patient is ≥ 18 years of age
Histiocytic subtypes
- Langerhans: Patient has Langerhans cell histiocytosis
- Erdheim-Chester: Patient has Erdheim-Chester disease

Conditions Not Covered / Exclusions

Conditions Not Covered

Not medically necessary when criteria are not met:

Not covered uses: Retevmo is considered not medically necessary for ANY other use(s) not specified in this policy

Criteria will be updated as new published data are available.

Provider Actions & Authorization Requirements

Prior Authorization

Prior authorization required

Prior authorization is recommended/required for prescription benefit coverage of Retevmo. When approved for a covered indication, authorization is provided for a 1-year duration.

Documentation Required

Documentation of molecular status required

Providers must document the patient’s RET molecular status as applicable to the indication: RET gene fusion, RET mutation, or RET pathogenic variant. In addition, document patient age and relevant disease status (for example, recurrent/advanced/metastatic disease or radioactive iodine–refractory status) to meet coverage criteria.

Applicable Codes

Drug (NDC / HCPCS) codesNDC|HCPCS

No codes listed

Clinical Evidence & Guideline References

Evidence sources include the prescribing information: Retevmo tablets and capsules, Eli Lilly; September 2024, and guideline references from the NCCN Drugs & Biologics Compendium and NCCN disease-specific guidelines (2024-2025 versions cited).

The policy notes that some indications (RET fusion solid tumors) were initially granted accelerated approval and later verified or updated as described in the policy background and overview.

Definitions

RET fusion: Rearranged during transfection (RET) gene fusion detected by an FDA-approved test.

RET pathogenic variant: RET mutation or pathogenic variant as described in prescribing information or molecular testing.

Revision History

05/07/2025annual_revisionLatest

Annual revision — No criteria changes.

04/20/2025policy_name_change

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

06/13/2024approval_update

Policy Summary

PayerCigna

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

Policy CodePolicy N/A

Change TypeRevised / Clarified

Effective Date

Next Review Date

On This Page

Thyroid Cancer indication

Thyroid age and biomarker
- Age: Patient is ≥ 2 years of age
- RET status: Patient has rearranged during transfection (RET) fusion-positive, RET mutation-positive disease, or RET pathogenic variant
  as described in prescribing information or molecular testing
- Thyroid disease-specific
  - Anaplastic: Patient has anaplastic thyroid cancer
  - Medullary or radioactive iodine-refractory: The disease requires treatment with systemic therapy and patient meets ONE of the following: (a) The patient has medullary thyroid cancer; OR (b) The disease is radioactive iodine-refractory

Solid Tumors indication

Solid tumor age: Patient is ≥ 2 years of age
Disease status: Patient has recurrent, advanced, or metastatic disease
Biomarker: The tumor is rearranged during transfection (RET) fusion-positive
Examples include breast, cervical, cholangiocarcinoma, colorectal, esophageal, gastric, ovarian, pancreatic, salivary gland, soft tissue sarcoma, small bowel adenocarcinoma, and unknown primary cancer

Rosai-Dorfman: Patient has Rosai-Dorfman disease

Biomarker: Patient has a rearranged during transfection (RET) fusion

Denial Risk

Denial if criteria not met

Claims will be denied as not covered when billed for conditions or diagnoses that are not included in this policy (i.e., uses other than the listed FDA‑approved indications or the specified supported uses).

06/14/2023pediatric_expansion

Prior revision noted expansion of pediatric age indications: thyroid and solid tumor age requirements changed to ≥ 2 years (material change noted in history and prior entries).

formulation_update

A new formulation of Retevmo tablets was added previously; the same criteria apply as those for capsules.

historical_note

Policy has undergone annual revisions and updates documented in the history section; review dates include 06/05/2024 and others.