Pharmacy Prior Authorization Criteria

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. This indication is approved under accelerated approval based on overall response rate and duration of response. Continued approval for this indication may be contingent upon verification and description of clinical benefit in confirmatory trial(s).

Criteria

Retevmo Tablets, Retevmo Capsules

Prior Authorization (Initial Authorization)

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

• Diagnosis of non-small cell lung cancer (NSCLC)
AND
• Disease is ONE of the following:
• Locally Advanced
• Metastatic
AND
• Disease has presence of rearranged during transfection (RET) gene fusion-positive tumor(s) as detected by a U.S. Food and Drug Administration (FDA) - approved test or a test performed at a facility approved by Clinical Laboratory Improvement Amendments (CLIA)

Retevmo Tablets, Retevmo Capsules

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
• Disease has presence of rearranged during transfection (RET) gene mutation tumor(s) as detected by a U.S. Food and Drug Administration (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 Tablets, Retevmo Capsules

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
• Disease has presence of rearranged during transfection (RET) gene fusion-positive tumor(s) as detected by a U.S. Food and Drug Administration (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 Tablets, Retevmo Capsules

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
• Disease has presence of rearranged during transfection (RET) gene fusion-positive tumor(s) as detected by a U.S. Food and Drug Administration (FDA) -approved test or a test performed at a facility approved by Clinical Laboratory Improvement Amendments (CLIA) [A, 1]
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 Tablets, Retevmo Capsules

Prior Authorization (Reauthorization)

Length of Approval: 12 Month(s)
For diagnosis of Non-Small Cell Lung Cancer, Medullary Thyroid Cancer (MTC), Thyroid Cancer, Solid Tumors

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

P & T Revisions

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

References

1. Retevmo Prescribing Information. Lilly USA. Indianapolis, IN. September 2024.

---

End Notes

1. An FDA-approved companion diagnostic test for the detection of RET gene fusions and RET gene mutations in plasma or in tumors other than NSCLC and thyroid cancer is not currently available.

---

Revision History

• 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

---