WHA
 

Retevmo (selpercatinib)

Indications for Prior Authorization

Retevmo (selpercatinib)
  • For diagnosis of Non-Small Cell Lung Cancer (NSCLC)
    Indicated for the treatment of adult patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) with a rearranged during transfection (RET) gene fusion, as detected by an FDA-approved test.

  • For diagnosis of Medullary Thyroid Cancer (MTC)
    Indicated for the treatment of adults and pediatric patients 2 years of age and older with advanced or metastatic medullary thyroid cancer (MTC) with a RET mutation, as detected by an FDA-approved test, who require systemic therapy.

  • For diagnosis of Thyroid Cancer
    Indicated for the treatment of adults and pediatric patients 2 years of age and older with advanced or metastatic thyroid cancer with a RET gene fusion, as detected by an FDA-approved test, who require systemic therapy and who are radioactive iodine-refractory (if radioactive iodine is appropriate).

  • For diagnosis of Solid Tumors
    Indicated for the treatment of adults and pediatric patients 2 years of age or older with locally advanced or metastatic solid tumors with a RET gene fusion, as detected by an FDA-approved test, that have progressed on or following prior systemic treatment or who have no satisfactory alternative treatment options.

Criteria

Retevmo

Prior Authorization (Initial Authorization)

Length of Approval: 12 Month(s)
For diagnosis of Non-Small Cell Lung Cancer (NSCLC)

  • Diagnosis of non-small cell lung cancer (NSCLC)
    • AND
  • Disease is ONE of the following:
    • Locally Advanced
    • Metastatic
    AND
  • Presence of rearranged during transfection (RET) gene fusion-positive tumor(s) as detected by an FDA-approved test or a test performed at a facility approved by Clinical Laboratory Improvement Amendments (CLIA)
Retevmo

Prior Authorization (Initial Authorization)

Length of Approval: 12 Month(s)
For diagnosis of Medullary Thyroid Cancer (MTC)

  • Diagnosis of medullary thyroid cancer (MTC)
    • AND
  • Disease is ONE of the following:
    • Advanced
    • Metastatic
    AND
  • Patient is 2 years of age or older
    • AND
  • Presence of rearranged during transfection (RET) gene fusion-positive tumor(s) as detected by an FDA-approved test or a test performed at a facility approved by Clinical Laboratory Improvement Amendments (CLIA)
    • AND
  • Disease requires treatment with systemic therapy
Retevmo

Prior Authorization (Initial Authorization)

Length of Approval: 12 Month(s)
For diagnosis of Thyroid Cancer

  • Diagnosis of thyroid cancer
    • AND
  • Disease is ONE of the following:
    • Advanced
    • Metastatic
    AND
  • Patient is 2 years of age or older
    • AND
  • Presence of rearranged during transfection (RET) gene fusion-positive tumor(s) as detected by an FDA-approved test or a test performed at a facility approved by Clinical Laboratory Improvement Amendments (CLIA)
    • AND
  • Disease requires treatment with systemic therapy
    • AND
  • ONE of the following:
    • Patient is radioactive iodine-refractory
    • Radioactive iodine therapy is not appropriate
Retevmo

Prior Authorization (Initial Authorization)

Length of Approval: 12 Month(s)
For diagnosis of Solid Tumors

  • Diagnosis of solid tumors
    • AND
  • Disease is ONE of the following:
    • Locally Advanced
    • Metastatic
    AND
  • Patient is 2 years of age or older
    • AND
  • Presence of rearranged during transfection (RET) gene fusion-positive tumor(s) as detected by an FDA-approved test or a test performed at a facility approved by Clinical Laboratory Improvement Amendments (CLIA)
    • AND
  • ONE of the following:
    • Disease has progressed on or following prior systemic treatment (e.g., chemotherapy)
    • There are no satisfactory alternative treatment options
Retevmo

Prior Authorization (Reauthorization)

Length of Approval: 12 Month(s)
For diagnosis of All indications listed above

  • Patient does not show evidence of progressive disease while on therapy

  • Guideline ID
    GL-685201

  • Formulary
    ehb

  • Effective date
    Sep 1, 2026

  • P&T approval date
    Jul 15, 2020

P & T Revisions

2026-08-04, 2026-06-17, 2025-07-11, 2024-11-06, 2024-08-15, 2024-06-18, 2023-08-02, 2023-08-02, 2022-11-21, 2022-08-03, 2021-07-26, 2021-05-21, 2021-04-09, 2020-11-23, 2020-07-16, 2020-06-29

  1. Retevmo Prescribing Information. Lilly USA, LLC. Indianapolis, IN. July 2026.
  • 2026-08-04: Background updates to indications section as solid tumors indication updated to traditional (full) approval.
  • 2026-06-17: Annual Review 2026 - No criteria changes. Background updates.
  • 2025-07-11: Annual Review 2025. Updated program for standard mutation testing verbiage with no change to clinical intent.
  • 2024-11-06: Background updates to MTC Indication section to reflect upgrade to full approval status.
  • 2024-08-15: Added new tablet formulation to Guideline. Existing criteria applies.
  • 2024-06-18: update guideline
  • 2023-08-02: Annual review: No criteria changes. Updated indications.
  • 2023-08-02: Removed specialist requirement
  • 2022-11-21: Update Guideline
  • 2022-08-03: Annual review: No criteria changes.
  • 2021-07-26: annual review: updated references, no changes to criteria
  • 2021-05-21: Addition of EHB formulary to guideline, no changes to criteria
  • 2021-04-09: Updated GPIs
  • 2020-11-23: updated criteria to define "RET" within criterion. No changes to clinical criteria
  • 2020-07-16: New program
  • 2020-06-29: New program