Pharmacy Prior Authorization Criteria

Gavreto (pralsetinib)

Indications for Prior Authorization

Gavreto (pralsetinib)

• For diagnosis of Non-Small Cell Lung Cancer (NSCLC)
  Indicated for the treatment of adult patients with metastatic RET fusion-positive non-small cell lung cancer (NSCLC) as detected by an FDA approved test.

• For diagnosis of RET Fusion-Positive Thyroid Cancer
  Indicated for the treatment of adult and pediatric patients 12 years of age and older with advanced or metastatic RET fusion-positive thyroid cancer who require systemic therapy and who are radioactive iodine-refractory (if radioactive iodine is appropriate)

  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

Gavreto

Prior Authorization (Initial Authorization)

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

• Diagnosis of non-small cell lung cancer (NSCLC)
AND
• Presence of metastatic rearranged during transfection (RET) gene fusion-positive tumor(s) as detected with an FDA-approved test or a test performed at a facility approved by Clinical Laboratory Improvement Amendments (CLIA)

Gavreto

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
• Presence of rearranged during transfection (RET) gene fusion-positive tumor(s)
AND
• Patient is 12 years of age or older
AND
• Disease requires treatment with systemic therapy
AND
• ONE of the following :
• Patient is radioactive iodine-refractory
• Radioactive iodine therapy is not appropriate

Gavreto

Prior Authorization (Reauthorization)

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

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

P & T Revisions

2024-11-15, 2023-12-13, 2023-09-13, 2023-06-29, 2022-11-02, 2022-01-31, 2021-12-01, 2021-10-08, 2021-04-06, 2020-10-27

References

1. Gavreto Prescribing Information. Blueprint Medicines Corporation. Cambridge, MA. March 2024.

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End Notes

1. Endocrinologist added in prescriber requirement to align with Retevmo. During Retevmo consult provider stated adding endocrinologist as an additional option.

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Revision History

• 2024-11-15: 2024 Annual Review - minor updates
• 2023-12-13: 2023 Annual Review - no changes
• 2023-09-13: Removal of MTC indication
• 2023-06-29: Removed specialist requirement
• 2022-11-02: 2022 Annual Review
• 2022-01-31: Removed step through Retevmo, removed all NF criteria.
• 2021-12-01: Program update to include NF criteria
• 2021-10-08: 2021 Annual Review
• 2021-04-06: Update to add step through Retevmo and GPI replication update.
• 2020-10-27: New Program

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