CurrentUnitedHealthcarePolicy 2025 P 1316-7

Pa Notification Pemazyre

Defines UnitedHealthcare prior authorization/notification criteria for pemigatinib (Pemazyre) including initial and reauthorization criteria for cholangiocarcinoma with FGFR2 fusion/rearrangement and myeloid/lymphoid neoplasms with FGFR1 rearrangement; pediatric (<19) prescriptions auto-process. Authorization durations and notes on state mandates and automated approvals are included.

Policy Summary

PayerUnitedHealthcare

PolicyPa Notification Pemazyre

Policy CodePolicy 2025 P 1316-7

Change TypeAnnual review (10/2025)prior material updates in 10/2024 and 10/2023

Effective DateDec 1, 2025

Next Review Date

Key ActionSubmit prior authorization/notification and documentation of the required FGFR2 or FGFR1 rearrangement; authorizations are issued for 12 months when criteria are met.

SourceLink

POLICY UPDATE CHANGES

10/2025 annual review: No updates to coverage criteria; updated references.

10/2024 annual review: Updated criteria for cholangiocarcinoma.

10/2023 annual review: Updated criteria for Myeloid/Lymphoid Neoplasms and references.

6/2021 addition: Coverage criteria for myeloid/lymphoid neoplasms according to NCCN.

6/2020 new program initiation for prior authorization/notification of Pemazyre.

2Covered Indications

12 moAuthorization Duration

<19Pediatric Auto-approval

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Coverage Summary

This policy covers Pemazyre (pemigatinib) for adults with previously treated, unresectable locally advanced or metastatic cholangiocarcinoma that has a FGFR2 fusion or other rearrangement and for relapsed/refractory myeloid/lymphoid/mixed lineage neoplasms with eosinophilia that have a FGFR1 rearrangement. Members under 19 years of age auto-process without coverage review. Authorizations are issued for 12 months when criteria are met. Note: the cholangiocarcinoma indication was granted under accelerated approval and continued approval may be contingent upon verification of clinical benefit in confirmatory trial(s).

Key Policy Quick Facts

Covered Indications2

Authorization Duration12 months

Pediatric Auto-approval<19 auto

Effective date2025-12-01

Last review2025-10

Policy number2025 P 1316-7

Initial Therapy Criteria

Initial Authorization — Cholangiocarcinoma

Pemazyre will be approved based on all of the following criteria:

ALL of the following

Diagnosis of cholangiocarcinoma
Disease is one of the following
- Unresectable locally advanced
- Resected gross residual (R2)
- Metastatic

Continuation / Reauthorization Criteria

Reauthorization — Cholangiocarcinoma

Pemazyre will be approved based on the following criterion:

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

Authorization will be issued for 12 months when criterion is met.

Reauthorization — Myeloid/Lymphoid/Mixed Lineage Neoplasms

Pemazyre will be approved based on the following criterion:

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

Authorization will be issued for 12 months when criterion is met.

Compendia / NCCN Recognition

NCCN Recommended Regimens

Recognition by NCCN supports coverage when criteria met:

Drug recognized for treatment of the cancer indication by The National Comprehensive Cancer Network Drugs and Biologics Compendium with a Category of Evidence and Consensus of 1, 2A, or 2B

Key evidence sources used in this policy include the FDA prescribing information (Pemazyre package insert) and the NCCN Drugs and Biologics Compendium; these references are cited in the policy bibliography.

Provider Actions & Authorization Requirements

Prior Authorization

Prior authorization/notification required

Pemazyre requires prior authorization/notification per UnitedHealthcare. Prescriptions for members under 19 years will automatically process without a coverage review. When criteria are met, authorization will be issued for 12 months.

Members <19 auto-process without coverage review
Authorization duration: 12 months when criteria met

Documentation Required

Molecular testing documentation required

Documentation of the relevant molecular alteration is required to meet coverage criteria: FGFR2 fusion or other rearrangement must be documented for cholangiocarcinoma; FGFR1 rearrangement must be documented for myeloid/lymphoid neoplasms.

Applicable Codes

ICD-10 (diagnosis codes referenced generically)ICD-10

No codes listed

NDC / HCPCS / CPT codesmixed

No codes listed

Specific NDC/HCPCS/CPT codes may be populated by the billing team; this policy references ICD-10 diagnosis codes generically. Automated approvals and reauthorizations may rely on diagnosis codes, previous claim/medication history, and claim logic as implemented by the program.

Clinical Evidence & References

Evidence: Pemazyre package insert, Incyte Corporation, June 2025; NCCN Drugs and Biologics Compendium, accessed September 3, 2025. The FDA prescribing information notes that the cholangiocarcinoma indication was approved under accelerated approval and that continued approval may depend on verification of clinical benefit in confirmatory trials.

Background

Background: Pemazyre (pemigatinib) is indicated for adults with previously treated, unresectable locally advanced or metastatic cholangiocarcinoma with an FGFR2 fusion or other rearrangement (approved under accelerated approval) and for adults with relapsed or refractory myeloid/lymphoid neoplasms with FGFR1 rearrangement. The NCCN also recommends Pemazyre for myeloid/lymphoid/mixed lineage neoplasms with eosinophilia and FGFR1 rearrangement. Continued approval for the cholangiocarcinoma indication may be contingent on confirmatory trials verifying clinical benefit.

Definitions: FGFR2 fusion or other rearrangement — a molecular alteration in fibroblast growth factor receptor 2 detected by an FDA-approved test; required for cholangiocarcinoma coverage. FGFR1 rearrangement — a molecular alteration in fibroblast growth factor receptor 1; required for myeloid/lymphoid neoplasm coverage. Documentation of these molecular test results is required to meet coverage criteria.

Revision History

10/2025annual_reviewLatest

Annual review performed; no updates to coverage criteria; updated references.

10/2024criteria_update

Annual review: Updated criteria for cholangiocarcinoma (material change).

10/2023criteria_update

Policy Summary

PayerUnitedHealthcare

PolicyPa Notification Pemazyre

Policy CodePolicy 2025 P 1316-7

Change TypeAnnual review (10/2025)prior material updates in 10/2024 and 10/2023

Effective DateDec 1, 2025

Next Review Date

Key ActionSubmit prior authorization/notification and documentation of the required FGFR2 or FGFR1 rearrangement; authorizations are issued for 12 months when criteria are met.

SourceLink

On This Page

Disease has presence of a fibroblast growth factor receptor 2 (FGFR2) fusion or other rearrangement

Patient has been previously treated

Authorization will be issued for 12 months when criteria are met.

Initial Authorization — Myeloid/Lymphoid/Mixed Lineage Neoplasms with Eosinophilia

Pemazyre will be approved based on both of the following criteria:

ALL of the following

Diagnosis of myeloid/lymphoid/mixed lineage neoplasms with eosinophilia
Presence of an FGFR1 rearrangement

Authorization will be issued for 12 months when criteria are met.

Patients less than 19 years of age

Pemazyre will be approved based on the following criterion:

Patient is less than 19 years of age

Authorization will be issued for 12 months. Prescriptions for members under age 19 will automatically process without a coverage review.

Documentation Required

Evidence of prior therapy for cholangiocarcinoma

For initial authorization in cholangiocarcinoma, documentation that the patient has been previously treated is required.

Denial Risk

Denial risk on progressive disease

Reauthorization may be denied if there is evidence of progressive disease while the patient is on Pemazyre therapy.

Billing Rule

State mandates and benefit plan may supersede

State mandates for off-label use, compendia requirements, federal regulatory requirements, and the member-specific benefit plan may impact or supersede policy language and coverage criteria where applicable.

Billing Rule

Automated approvals may apply

UnitedHealthcare may approve initial authorizations and reauthorizations based solely on prior claim or medication history, diagnosis codes (ICD-10), and/or claim logic. Use of automated approval and reapproval processes varies by program.

Annual review: Updated criteria for Myeloid/Lymphoid Neoplasms and references (material change).

6/2021addition

Addition: Coverage criteria for myeloid/lymphoid neoplasms according to NCCN (material change).

6/2020creation

Program created: New prior authorization/notification program initiation for Pemazyre.