CurrentCentenePolicy CP.PHAR.496

Clinical Policy: Pemigatinib (Pemazyre)

Defines Centene's medical necessity and prior authorization criteria for pemigatinib (Pemazyre) for adults with FGFR2‑rearranged cholangiocarcinoma or FGFR1‑rearranged myeloid/lymphoid neoplasms, and related administrative rules for other uses.

Policy Summary

PayerCentene

PolicyPemigatinib (Pemazyre) coverage criteria

Policy CodePolicy CP.PHAR.496

Change TypeNo material change

Effective Date09.01.20

Next Review Date

Key ActionSubmit prior authorization with documentation that all initial approval criteria are met, including diagnosis, molecular testing for FGFR2/FGFR1, specialist involvement, and dosing within limits.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

13.5 mgmax daily dose

≥18minimum age

12 moCommercial approval

6 moMedicaid/HIM initial

Jun 2023PI cited

Trek Health ingests and normalizes Transparency in Coverage data and payer policy updates to give provider organizations a clear view of how commercial reimbursement behaves across markets, payers, and services. Our platform transforms raw payer disclosures into structured intelligence that supports contract evaluation, payer negotiations, and service line strategy. By combining market benchmarks with ongoing policy visibility, Trek helps teams identify variability, risk, and opportunity in commercial reimbursement. The result is faster insight, stronger negotiating positions, and more informed financial decisions.

Initial Therapy — Cholangiocarcinoma

Covered when ALL of the following are met:

ALL of the following

Diagnosis of unresectable locally advanced or metastatic cholangiocarcinoma.
Prescribed by or in consultation with an oncologist.
Age ≥ 18 years.
Documentation of FGFR2 fusion or rearrangement.
Member has not previously received a selective FGFR inhibitor (e.g., Stivarga®, Truseltiq™).
Failure of at least one previous systemic cancer therapy (see Appendix B).
Prescribed as a single agent.
For Pemazyre requests, member must use pemagatibib, if available, unless contraindicated or clinically significant adverse effects are experienced.
- ANY of the following
  - Dose does not exceed 13.5 mg (1 tablet) per day for 14 days per 21-day cycle.
  - Dose is supported by practice guidelines or peer-reviewed literature for the relevant off-label use (prescriber must submit supporting evidence).
Prescribed regimen must be FDA-approved or recommended by NCCN.

Initial Therapy — Myeloid/Lymphoid Neoplasms

Covered when ALL of the following are met:

ALL of the following

Diagnosis of myeloid/lymphoid neoplasm (MLN).
Prescribed by or in consultation with an oncologist or hematologist.
Age ≥ 18 years.
Documentation of FGFR1 rearrangement.
For Pemazyre requests, member must use pemagatibib, if available, unless contraindicated or clinically significant adverse effects are experienced.

Provider Actions and Requirements

Prior Authorization

Prior Authorization Required

Prior authorization required — Prior authorization is required. Provider must submit documentation (such as office chart notes, laboratory results, pathology reports, molecular testing results, or other relevant clinical information) supporting that the member meets all applicable approval criteria (including diagnosis, documentation of FGFR2 fusion or FGFR1 rearrangement when indicated, oncologic history, prior systemic therapies, and prescribing specialist consultation).

Prior authorization required for Pemazyre (pemigatinib).
Documentation must include evidence of FGFR2 fusion/rearrangement for cholangiocarcinoma and FGFR1 rearrangement for myeloid/lymphoid neoplasms when applicable.
Prescriber specialty: oncology or hematology/oncology as specified in criteria.

Note

Approval Duration Requirement

Approval duration — For Commercial line(s) of business, approval duration is limited to 12 months or the duration of the request, whichever is less. Continue to submit clinical documentation to support ongoing medical necessity at renewal.

Revised approval duration for Commercial: 12 months or duration of request, whichever is less.

Documentation Required

Single-Agent and Dosing Cycle Requirement

Single-agent use and dosing cycle — For cholangiocarcinoma, pemigatinib must be prescribed as a single agent in accordance with NCCN recommendations. Dosing must adhere to the prescribing information: treatment is administered 14 days on treatment per 21-day cycle (example: dose not to exceed 13.5 mg [1 tablet] per day for 14 days of each 21-day cycle unless supported by guideline or peer-reviewed evidence and documented by the prescriber).

Single-agent use required for cholangiocarcinoma per NCCN.
Standard dose limit: ≤ 13.5 mg (1 tablet) per day for 14 days of a 21-day cycle unless alternative dosing is supported by practice guidelines or peer-reviewed literature and documentation is provided.
Refer to Pemazyre Prescribing Information (June 2023) to verify dosing, administration, and safety.
Prescriber must submit supporting evidence if using off-label dosing or schedule.

Denial Risk

Non‑Covered Indications and Indication Mismatch Denial Risk

Indication and coverage risks — Requests for indications that are not FDA‑approved and not addressed in this policy may be denied unless sufficient documentation is provided per applicable off‑label use policies. Use of pemigatinib inconsistent with the FDA‑labeled indication (for example, first‑line use in cholangiocarcinoma) may be denied; pemigatinib is indicated as second‑line therapy for cholangiocarcinoma, and first‑line use was removed from the policy. Providers should include strong supporting evidence when requesting off‑label use.

Non‑FDA approved indications not addressed in this policy require sufficient supporting documentation per off‑label policies (CP.CPA.09 for commercial, HIM.PA.154 for HIX, CP.PMN.53 for Medicaid).
Requests for first‑line use in cholangiocarcinoma may be denied because pemigatinib is indicated only as second‑line therapy.

Step	Requirement
1	Trial of pemagatibib is required if available unless contraindicated or clinically significant adverse effects are experienced.

Step	Requirement
1	Policy history: requirement added for single‑agent use in cholangiocarcinoma per NCCN before combination regimens (single‑agent use required).

Background

Pemigatinib (Pemazyre) is a selective fibroblast growth factor receptor (FGFR) tyrosine kinase inhibitor. It is FDA‑approved for treatment of adults with previously treated, unresectable locally advanced or metastatic cholangiocarcinoma with FGFR2 fusion or rearrangement, and for relapsed or refractory myeloid/lymphoid neoplasms (MLNs) with FGFR1 rearrangement. The cholangiocarcinoma indication received accelerated approval based on response rate and duration of response; clinical use and policy criteria reflect the labeled dosing schedule and NCCN guidance. Subsequent policy updates clarified that pemigatinib should be used as a single agent for cholangiocarcinoma per NCCN and that the standard dosing for cholangiocarcinoma is 13.5 mg PO once daily for 14 days followed by 7 days off in 21‑day cycles as specified in the prescribing information.

Definitions

fibroblast growth factor receptor (FGFR)

TermFibroblast growth factor receptor (FGFR)

DefinitionA family of receptor tyrosine kinases inhibited by pemigatinib (Pemazyre)

Clinical relevanceFGFR2 fusions/rearrangements identify cholangiocarcinoma patients eligible for pemigatinib; FGFR1 rearrangements relate to MLNs

myeloid/lymphoid neoplasm (MLN)

TermMyeloid/lymphoid neoplasm (MLN)

DefinitionHematologic neoplasms including disorders with FGFR1 rearrangement; may be relapsed or refractory and treated by specialists in hematology/oncology

Policy contextMLNs with FGFR1 rearrangement are an FDA‑labeled indication for pemigatinib; NCCN compendium lists related MLN subtypes as off‑label supportive uses

MLN — NCCN compendium supported off‑label indication

NCCN compendium listingMyeloid/lymphoid neoplasms with eosinophilia and tyrosine kinase fusion genes are listed as an NCCN compendium‑supported off‑label indication

Policy history3Q 2021 annual review added NCCN compendium supported off‑label use for MLNs with eosinophilia and tyrosine kinase fusion genes

ReferencesNCCN Myeloid/Lymphoid Neoplasms with Eosinophilia and Tyrosine Kinase Fusion Genes v2.2025 cited in references

OpenPayer

Clinical Policy: Pemigatinib (Pemazyre)

Coverage Criteria

Initial Therapy — Dosing and Constraints

Continuation Therapy

Provider Actions and Requirements

Dosing and Coding Information

Step Therapy Requirements

Quantity Limits

Background

Definitions