Pharmacy Prior Authorization Criteria

Pemazyre (pemigatinib) - PA, NF

Indications for Prior Authorization

Pemazyre (pemigatinib)

• For diagnosis of Cholangiocarcinoma
  Indicated for the treatment of adults with previously treated, unresectable locally advanced or metastatic cholangiocarcinoma with a fibroblast growth factor receptor 2 (FGFR2) fusion or other rearrangement as detected by an FDA-approved test.

  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 a confirmatory trial(s).

• For diagnosis of Myeloid/Lymphoid Neoplasms
  Indicated for the treatment of adults with relapsed or refractory myeloid/lymphoid neoplasms (MLNs) with fibroblast growth factor receptor 1 (FGFR1) rearrangement.

Criteria

Pemazyre

Prior Authorization (Initial Authorization)

Length of Approval: 12 Month(s)
For diagnosis of Cholangiocarcinoma

• Diagnosis of cholangiocarcinoma
AND
• Disease is one of the following:
• Unresectable locally advanced
• Metastatic
AND
• Disease is confirmed by the presence of a fibroblast growth factor receptor 2 (FGFR2) fusion or other rearrangement as detected by an FDA-approved test or a test performed at a facility approved by Clinical Laboratory Improvement Amendments (CLIA) [A]
AND
• Patient has received at least one prior line of therapy (e.g., chemotherapy)

Pemazyre

Prior Authorization (Initial Authorization)

Length of Approval: 12 Month(s)
For diagnosis of Myeloid/Lymphoid Neoplasms

• Diagnosis of Myeloid/Lymphoid Neoplasms (MLNs)
AND
• Disease is one of the following:
• Relapsed
OR
• Refractory
AND
• Disease is confirmed by the presence of fibroblast growth factor receptor 1 (FGFR1) rearrangement as detected by an FDA-approved test or a test performed at a facility approved by Clinical Laboratory Improvement Amendments (CLIA) [B]

Pemazyre

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

Pemazyre

Non Formulary

Length of Approval: 12 Month(s)
For diagnosis of Cholangiocarcinoma

• Submission of medical records (e.g., chart notes) confirming diagnosis of cholangiocarcinoma
AND
• Submission of medical records (e.g., chart notes) confirming disease is one of the following:
• Unresectable locally advanced
• Metastatic
AND
• Submission of medical records (e.g., chart notes) confirming disease is confirmed by the presence of a fibroblast growth factor receptor 2 (FGFR2) fusion or other rearrangement as detected by an FDA-approved test or a test performed at a facility approved by Clinical Laboratory Improvement Amendments (CLIA) [A]
AND
• Submission of medical records (e.g., chart notes) or paid claims confirming patient has received at least one prior line of therapy (e.g., chemotherapy)

Pemazyre

Non Formulary

Length of Approval: 12 Month(s)
For diagnosis of Myeloid/Lymphoid Neoplasms

• Submission of medical records (e.g., chart notes) confirming diagnosis of Myeloid/Lymphoid Neoplasms (MLNs)
AND
• Submission of medical records (e.g., chart notes) confirming disease is one of the following:
• Relapsed
OR
• Refractory
AND
• Submission of medical records (e.g., chart notes) confirming disease is confirmed by the presence of fibroblast growth factor receptor 1 (FGFR1) rearrangement as detected by an FDA-approved test or a test performed at a facility approved by Clinical Laboratory Improvement Amendments (CLIA) [B]

P & T Revisions

2025-04-30, 2024-05-01, 2023-06-14, 2023-05-03, 2022-10-04, 2022-05-06, 2021-08-20, 2021-08-02, 2021-06-15

References

1. Pemazyre Prescribing Information. Incyte Corporation. Wilmington, DE. June 2023.

---

End Notes

1. Per consultant feedback, rearrangement's are specific to FGFR2.
2. An FDA-approved test for detection of FGFR1 rearrangement in patients with relapsed or refractory myeloid/lymphoid neoplasm for selecting patients for treatment with Pemazyre is not available. However, MLNs with FGFR1 rearrangement can be confirmed with cytogenetic evaluation. [1]

---

Revision History

• 2025-04-30: 2025 Annual review- Enhancements to add standard verbiage for genetic testing and prior treatment criteria.
• 2024-05-01: 2024 Annual Review - updated references
• 2023-06-14: update guideline
• 2023-05-03: 2023 Annual Review
• 2022-10-04: Update to include new FDA indication
• 2022-05-06: 2022 Annual Review - addition of NF criteria section
• 2021-08-20: Updated criteria to include standard FDA/CLIA approved test verbiage to align with PI and Truseltiq.
• 2021-08-02: Annual review - updated references
• 2021-06-15: Annual review - updated references.

---