CurrentNeighborhood Health Plan of Rhode IslandPolicy N/A

Pemazyre (pemigatinib) — Coverage Criteria

Defines accepted indications, coverage criteria, coding, exclusions, and prior‑authorization expectations for pemigatinib (Pemazyre) for members of Neighborhood Health Plan of Rhode Island across commercial, exchange, and Medicaid lines of business.

Policy Summary

PayerNeighborhood Health Plan of Rhode Island

PolicyPemazyre (pemigatinib) — Coverage Criteria

Policy CodePolicy N/A

Change TypeIndication clarifications and dosing/quantity updates

Effective Date

Next Review Date

Key ActionObtain prior authorization and provide confirmatory FGFR2 (cholangiocarcinoma) or FGFR1 (MLNs) testing and supporting compendia or peer‑reviewed evidence.

SourceLink

POLICY UPDATE CHANGES

Converted to new Evolent guideline template and replaced prior UM ONC_1398 Pemazyre policy.

Updated indication section to clarify FGFR2 fusion/rearrangement for cholangiocarcinoma and FGFR1 rearrangement for MLNs.

Updated maximum dosage form quantities in exclusion criteria.

Clarified exclusion for investigational or off‑label uses lacking CMS‑recognized compendia or acceptable peer‑reviewed evidence.

2distinct covered indications

J8999HCPCS code

Commercial/Exchange/Medicaidlines of business

FGFR2+

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cholangiocarcinoma biomarker

Coverage Criteria

Cholangiocarcinoma (initial/covered)

Pemazyre is covered for cholangiocarcinoma when ALL of the following are met:

Cholangiocarcinoma coverage criteria: Member has unresectable or metastatic cholangiocarcinoma with disease progression on or after one prior therapy

Requires prior systemic therapy failure

Biomarker requirement: Tumor test positive for FGFR2 gene fusion or rearrangement confirmed by an approved test (e.g., FoundationOne CDX or other gene sequencing test)

Mandatory biomarker confirmation

Myeloid/Lymphoid Neoplasms (MLNs)

Pemazyre may be used for myeloid/lymphoid neoplasms when ALL of the following are met:

MLN coverage criteria: Member has relapsed after stem cell transplantation and/or after disease‑modifying therapies (e.g., chemotherapy)

Relapsed disease following prior therapies

Biomarker requirement for MLNs: Tumor is positive for FGFR1 rearrangement

Mandatory biomarker confirmation

Regimen	Indication	Key requirements / biomarker	Line of therapy	Coverage stance
Pemazyre (pemigatinib) monotherapy
Unresectable or metastatic cholangiocarcinoma with disease progression on or after one prior therapy
Tumor positive for FGFR2 gene fusion or rearrangement confirmed by an approved test (e.g., FoundationOne CDX or other gene sequencing test)
Second‑line or later (disease progression on or after one prior therapy)
Covered with criteria

Exclusions that will result in non‑coverage include disease progression while receiving Pemazyre (pemigatinib) or progression on a prior FGFR2 inhibitor (for example, futibatinib/Lytgobi). Coverage is also excluded when there is no confirmatory test documenting the required biomarker (FGFR2 fusion/rearrangement for cholangiocarcinoma or FGFR1 rearrangement for myeloid/lymphoid neoplasms).

Operational dosing and quantity limits are enforceable exclusions: any request that exceeds the single dose limit of 13.5 mg or the monthly tablet maximums will be excluded. The policy specifies a maximum of 14 tablets/month (for 4.5 mg, 9 mg, or 13.5 mg strengths) for cholangiocarcinoma and 28 tablets/month (for 4.5 mg, 9 mg, or 13.5 mg strengths) for MLNs.

Uses that lack sufficient evidentiary support are excluded. Specifically, investigational or off‑label indications that are not supported by CMS‑recognized compendia or acceptable peer‑reviewed literature are excluded. Case reports and meeting abstracts without a full peer‑reviewed publication are explicitly noted as inadequate evidence; the policy further outlines whether the patient population, regimen, outcomes, and study design in the literature adequately represent the requested use.

Pemazyre (pemigatinib) is considered not medically necessary for indications when the clinical evidence is insufficient—i.e., when the requested off‑label or investigational use is not supported by CMS‑recognized compendia or acceptable peer‑reviewed publications. Meeting abstracts and isolated case reports are generally insufficient to establish medical necessity.

Not medically necessary determinations may also be made when the available literature does not adequately represent the patient’s clinical characteristics, the administered therapeutic regimen, or clinically meaningful outcomes (as commonly defined by oncology standards such as ASCO guidance). In short, if the published evidence does not reasonably apply to the member’s disease context or fails to demonstrate clinically meaningful benefit, the use is not medically necessary.

Line of Therapy

second-line

Second‑line use: Disease progression on or after one prior therapy

Indicates second‑line or later therapy

salvage

Salvage use: Relapsed after stem cell transplantation and/or after disease‑modifying therapies

Salvage or relapsed/refractory setting

Biomarker Requirements

inv-17: FGFR2 — positive gene fusion or rearrangement by approved test (biomarker requirement for cholangiocarcinoma)

BiomarkerFGFR2 gene fusion or rearrangement positive in tumor by an approved test (e.g., FoundationOne CDx or other gene sequencing test)

IndicationRequired for Pemazyre coverage in unresectable or metastatic cholangiocarcinoma with progression after ≥1 prior therapy

Test requirementConfirmatory tumor testing must be available and documented

inv-18: FGFR1 — rearrangement present (biomarker requirement for myeloid/lymphoid neoplasms)

BiomarkerFGFR1 rearrangement present in the tumor

IndicationRequired for Pemazyre consideration in myeloid/lymphoid neoplasms (MLNs) after relapse post‑transplant or disease‑modifying therapy

Coding and Quantity Limits

Drug HCPCSHCPCS

J8999

pemigatinib

inv-06: Maximum tablets per month — Cholangiocarcinoma and MLNs max tablet quantities by strength/month

Cholangiocarcinoma — 4.5 mgMaximum 14 tablets per month

Cholangiocarcinoma — 9 mgMaximum 14 tablets per month

Cholangiocarcinoma — 13.5 mgMaximum 14 tablets per month

MLNs — 4.5 mgMaximum 28 tablets per month

MLNs — 9 mgMaximum 28 tablets per month

MLNs — 13.5 mgMaximum 28 tablets per month

Provider Actions and Documentation

Prior Authorization

Prior Authorization Required

Prior authorization is required. Evolent processes all medication requests from network ordering providers; medications not authorized by Evolent may be deemed not approvable and not reimbursable.

Evolent must receive and approve requests prior to dispensing.
Continuation requests may be exempt from re-review if continuation criteria are met (see continuation exemptions callout).

Note

Continuation Exemptions

Continuation requests are exempt from re‑review when all continuation criteria are satisfied. This allows ongoing therapy to proceed without a full new review if prior authorization conditions remain met.

Member has not experienced disease progression on the requested medication.
Requested medication was used within the last year without a lapse of more than 30 days of having an active authorization.
No additional medication(s) are being added to the continuation request.

Covered Regimens

Regimen	Indication	Key requirements / biomarker	Line of therapy	Coverage stance
Pemazyre (pemigatinib) monotherapy
Relapsed myeloid/lymphoid neoplasms (MLNs) after stem cell transplantation and/or after disease‑modifying therapies
Tumor positive for FGFR1 rearrangement
Salvage / relapsed setting following prior therapies
Covered with criteria

Background

Pemigatinib is a selective fibroblast growth factor receptor (FGFR) inhibitor with regulatory approval for use in patients with previously treated, locally advanced or metastatic cholangiocarcinoma harboring FGFR2 fusions or rearrangements. Evidence also supports activity in certain myeloid/lymphoid neoplasms with FGFR1 rearrangements, and policy coverage is biomarker‑driven to align treatment with these molecular alterations.

Policy Summary

PayerNeighborhood Health Plan of Rhode Island

PolicyPemazyre (pemigatinib) — Coverage Criteria

Policy CodePolicy N/A

Change TypeIndication clarifications and dosing/quantity updates

Effective Date

Next Review Date

Key ActionObtain prior authorization and provide confirmatory FGFR2 (cholangiocarcinoma) or FGFR1 (MLNs) testing and supporting compendia or peer‑reviewed evidence.

SourceLink

On This Page

Test requirementConfirmatory tumor testing must be available and documented

inv-13: Biomarker required for Pemazyre use in cholangiocarcinoma — FGFR2 fusion/rearrangement

Required biomarkerFGFR2 fusion or rearrangement confirmed by an approved test (e.g., FoundationOne CDx)

ContextMandatory for Pemazyre use in unresectable or metastatic cholangiocarcinoma

DocumentationConfirmatory test result must be supplied with the request

inv-14: Biomarker required for Pemazyre use in myeloid/lymphoid neoplasms — FGFR1 rearrangement

Required biomarkerFGFR1 rearrangement in the tumor

ContextMandatory for Pemazyre use in MLNs (relapsed after stem cell transplant and/or disease‑modifying therapies)

DocumentationConfirmatory test result must be supplied with the request

inv-07: Single dose limit — Single dose limit 13.5 mg

Single dose limitPemazyre (pemigatinib) single dose must not exceed 13.5 mg

RelevanceDosing above 13.5 mg is listed as an exclusion

DocumentationRequests must demonstrate single‑dose does not exceed this limit

Documentation Required

Required Documentation

Providers must support the use of Pemazyre (pemigatinib) with one of the accepted sources of clinical evidence. Documentation should be submitted with the authorization request to demonstrate that the indication and patient meet policy criteria.

Acceptable documentation: FDA-approved product labeling, CMS-recognized compendia, NCCN or ASCO clinical guidelines, or acceptable peer-reviewed literature that meets CMS Medicare Benefit Policy Manual Chapter 15 standards.
For cholangiocarcinoma: confirmatory tumor testing showing FGFR2 gene fusion or rearrangement (e.g., FoundationOne CDx or another validated gene sequencing test).
For myeloid/lymphoid neoplasms: confirmatory tumor testing showing FGFR1 rearrangement when applicable.
Include prior therapy history, dates of progression, and any prior exposure to FGFR inhibitors.

Denial Risk

Key Triggers for Denial

Key denial triggers — requests lacking required evidence or meeting exclusion criteria will be denied.

Disease progression while receiving Pemazyre (pemigatinib) or progression on a prior FGFR2 inhibitor (e.g., futibatinib).
No confirmatory test available to demonstrate the presence of the required FGFR2 (cholangiocarcinoma) or FGFR1 (MLNs) gene fusion/rearrangement.
Dosing that exceeds single dose limit of 13.5 mg or monthly maximum tablet limits (Cholangiocarcinoma: >14 tablets/month at any approved strength; MLNs: >28 tablets/month at any approved strength).
Investigational or off‑label use without sufficient supporting evidence from CMS-recognized compendia or acceptable peer‑reviewed literature (see policy for criteria defining sufficient evidence).