CurrentColorado Rocky Mountain Health PlansPolicy N/A

Pemigatinib (Pemazyre) — Prior Authorization and Coverage Criteria

Prior authorization and coverage criteria for pemigatinib (Pemazyre) for treatment of FGFR2-fusion cholangiocarcinoma and FGFR1-rearranged myeloid/lymphoid neoplasms; affects providers submitting requests to the payer's pharmacy clinical programs.

Policy Summary

PayerColorado Rocky Mountain Health Plans

PolicyPemigatinib (Pemazyre) — Prior Authorization and Coverage Criteria

Policy CodePolicy

Change TypeAnnual review (10/2025)

Effective Date12/1/2025

Next Review Date

Key ActionSubmit prior authorization documenting diagnosis, relevant FGFR1/FGFR2 rearrangement, and prior treatment details to request a 12-month authorization.

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.

6/2022 addition of coverage criteria for myeloid/lymphoid neoplasms according to NCCN.

2 indicationscovered disease areas

12 monthsauthorization duration

FDA acceleratedcholangiocarcinoma pathway

2020-2025program review history

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Coverage and Authorization Criteria

Patients less than 19 years

Coverage for patients under 19

Pediatrics: Patient is less than 19 years of age

Authorization issued for 12 months

Coverage for Pemazyre (pemigatinib) is subject to the criteria contained in this policy. Members under 19 years of age are exempt from prior coverage review and the prescription will automatically process without a coverage review. State statutory mandates or member-specific benefit plan terms (including mandated coverage for off‑label uses or use of specific compendia) may supersede the criteria in this document.

Automated adjudication may be used for initial and reauthorizations. UnitedHealthcare may approve initial and re-authorization requests solely on prior claim/medication history, diagnosis codes (ICD‑10), and/or claims logic. Program-specific rules determine when automated approval applies. Supply limits may be in place.

Initial Authorization — Cholangiocarcinoma

Diagnosis of cholangiocarcinoma

Disease extent: Disease is unresectable locally advanced OR resected gross residual (R2) OR metastatic

Molecular marker: Presence of a fibroblast growth factor receptor 2 (FGFR2) fusion or other rearrangement

Prior treatment: Patient has been previously treated

Authorization will be issued for 12 months

Reauthorization — Cholangiocarcinoma

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

Authorization will be issued for 12 months

Initial Authorization — Myeloid/Lymphoid Neoplasms

Diagnosis of myeloid/lymphoid/mixed lineage neoplasms with eosinophilia

Molecular marker: Presence of an FGFR1 rearrangement

Authorization will be issued for 12 months

Reauthorization — Myeloid/Lymphoid Neoplasms

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

Authorization will be issued for 12 months

Initial Therapy Requirements

Initial therapy requirements

Initial authorization criteria summarized

Cholangiocarcinoma initial: Diagnosis of cholangiocarcinoma; disease unresectable locally advanced OR resected gross residual (R2) OR metastatic; presence of FGFR2 fusion or other rearrangement; patient has been previously treated

Authorization for 12 months

MLN initial: Diagnosis of myeloid/lymphoid/mixed lineage neoplasms with eosinophilia; presence of an FGFR1 rearrangement

Authorization for 12 months

Reauthorization / Continued Therapy

Reauthorization for continued therapy

Reauthorization rules

No progression: Patient does not show evidence of progressive disease while on Pemazyre therapy

Authorization renewed for 12 months

What Providers Must Do

Prior Authorization

Cholangiocarcinoma — initial authorization

Prior authorization required for initial treatment of cholangiocarcinoma with Pemazyre. Submit documentation confirming diagnosis and molecular testing.

Diagnosis: cholangiocarcinoma.
Disease status: unresectable locally advanced, resected gross residual (R2), or metastatic.
Molecular evidence: presence of an FGFR2 fusion or other rearrangement.
Prior systemic therapy: patient has been previously treated.
Authorization duration: up to 12 months.

Prior Authorization

Myeloid/lymphoid neoplasms — initial authorization

Prior authorization required for initial treatment of myeloid/lymphoid/mixed lineage neoplasms with eosinophilia. Provide diagnostic documentation and any relevant molecular/pathologic evidence.

Diagnosis: myeloid/lymphoid/mixed lineage neoplasms with eosinophilia.

Key Terms and Biomarkers

inv-14: FGFR2 fusion/rearrangement — biomarker definition and relevance

DefinitionFGFR2 fusion or other rearrangement — genomic alteration involving fibroblast growth factor receptor 2 (FGFR2) detected by an FDA‑approved test

Relevance to indicationRequired biomarker for Pemazyre use in previously treated, unresectable locally advanced or metastatic cholangiocarcinoma (accelerated approval)

Regulatory noteCholangiocarcinoma indication granted under FDA accelerated approval; continued approval may depend on confirmatory trials

Testing requirementPresence of FGFR2 fusion/rearrangement must be demonstrated by an FDA‑approved test (per product indication)

inv-15: FGFR1 rearrangement — biomarker definition for MLNs

Definition

Step Therapy Requirements

Step therapy requirement	Details
No step therapy requirement	This policy does not list any step therapy requirements for pemigatinib (Pemazyre).

Supply and Quantity Limits

inv-19: Pemazyre (pemigatinib) — quantity/supply limits may apply

Quantity/supply limitsSupply limits may be in place for Pemazyre (pemigatinib)

Automated approval noteUnitedHealthcare may approve initial and re‑authorization based on previous claim/medication history, diagnosis codes, and/or claim logic — which may interact with supply limits

Program variabilityUse of automated approval and re‑approval processes and any supply limits varies by program and/or therapeutic class

Drug Background and Indications

Pemazyre (pemigatinib) is a small‑molecule kinase inhibitor indicated in adults for certain FGFR‑driven malignancies. The policy addresses two covered disease areas: previously treated, unresectable locally advanced or metastatic cholangiocarcinoma with FGFR2 fusion/rearrangement, and relapsed or refractory myeloid/lymphoid neoplasms with FGFR1 rearrangement. Continued approval for the cholangiocarcinoma indication may depend on confirmatory data. Coverage and authorization durations follow the criteria below, and program rules (including automated approval pathways and any supply limits) apply as described.

Policy Revision History

2025-10annual reviewLatest

Annual review: No updates to coverage criteria; updated references.

2024-10annual review

Annual review: Updated criteria for cholangiocarcinoma.

2023-10annual review

Annual review: Updated criteria for Myeloid/Lymphoid Neoplasms and updated references.

Policy Summary

PayerColorado Rocky Mountain Health Plans

PolicyPemigatinib (Pemazyre) — Prior Authorization and Coverage Criteria

Policy CodePolicy

Change TypeAnnual review (10/2025)

Effective Date12/1/2025

Next Review Date

Key ActionSubmit prior authorization documenting diagnosis, relevant FGFR1/FGFR2 rearrangement, and prior treatment details to request a 12-month authorization.

SourceLink

On This Page

Provide supporting diagnostic records and molecular test results where applicable.

Authorization will follow review of documentation confirming indication.

Step Therapy

Step therapy

No explicit step therapy requirements are listed in this document. Providers should follow any plan-specific step therapy programs if communicated separately.

If state or plan mandates impose alternative step-therapy rules, those supersede this guidance.

Documentation Required

Automated approval and documentation

Automated approval and documentation: approvals or re-authorizations may be granted based on prior claim/medication history, ICD-10 diagnosis codes, and claim logic. Supply limits may apply.

Use of automated processes varies by program and therapeutic class.
Ensure claims and diagnosis coding accurately reflect the member’s condition to support automated processing.

Denial Risk

Denial triggers / applicability

Denial triggers and applicability: coverage requires meeting the specified diagnostic and molecular criteria; failure to provide required documentation or meet criteria may result in denial. State-specific mandates for coverage of off-label uses or alternative compendia may alter applicability.

Missing documentation of diagnosis, disease extent, prior treatment, or FGFR2 fusion/rearrangement for cholangiocarcinoma may trigger denial.
For members under 19 years, prescriptions may process automatically without coverage review per policy.
State mandates may require coverage beyond this document — those mandates supersede policy where applicable.

FGFR1 rearrangement — genomic rearrangement involving fibroblast growth factor receptor 1 (FGFR1)

Covered disease contextRequired biomarker for Pemazyre use in relapsed or refractory myeloid/lymphoid neoplasms (MLNs), including MLNs with eosinophilia per NCCN

Clinical guidanceNCCN recommends Pemazyre for myeloid/lymphoid/mixed lineage neoplasms with eosinophilia and FGFR1 rearrangement

2022-10annual review

Annual review: Updated criteria and background based on newly approved indication for myeloid/lymphoid neoplasms; added state mandate footnote.

2022-06annual review

Annual review: Revised grammar in criteria with no change to clinical intent; updated background with conditional approval language and updated references.

2021-06program addition

New prior authorization program established for Pemazyre (pemigatinib).

2020-06change control

Change control entry: initial program change control recorded.