CurrentCignaPolicy N/A

Oncology - Balversa (erdafitinib) Prior Authorization Policy

Defines Cigna's prior authorization requirements and medical necessity criteria for coverage of Balversa (erdafitinib) for FDA-approved and select evidence-supported oncology indications for members of Cigna-administered health benefit plans.

Policy Summary

PayerCigna

PolicyOncology - Balversa (erdafitinib) Prior Authorization Policy

Policy CodePolicy N/A

Change TypeNo material change

Effective DateN/A

Next Review DateMar 26, 2025

Key ActionObtain prior authorization and document age, disease stage, relevant FGFR/FGFR3 genetic alterations, prior therapy history, and single-agent use to support coverage.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

1 yearstandard initial approval duration

FDA-approvedUrothelial carcinoma indication

2 tumor typesOther supported uses

Prior therapy requiredTherapy sequence

Coverage Criteria for Balversa (erdafitinib)

FDA-Approved Indication — Urothelial Carcinoma

Covered when ALL of the following are met for the FDA-approved urothelial carcinoma indication:

Urothelial carcinoma (FDA) criteria: A) Patient is ≥ 18 years of age; AND B) Patient has locally advanced or metastatic disease; AND C) Patient has susceptible fibroblast growth factor receptor (FGFR)3 genetic alterations; AND D) Patient has progressed during or following prior platinum-containing chemotherapy, other chemotherapy, or checkpoint inhibitor therapy; AND E) Medication is used as a single agent.

Approve for 1 year when all criteria met.

Other Use — Pancreatic Adenocarcinoma

Covered when ALL of the following are met for pancreatic adenocarcinoma (evidence-supported use):

Pancreatic adenocarcinoma criteria: A) Patient is ≥ 18 years of age; AND B) Patient has a fibroblast growth factor receptor (FGFR) genetic alteration; AND C) Patient has locally advanced, recurrent or metastatic disease; AND D) Medication is used for subsequent therapy; AND E) Medication is used as a single agent.

Policy Summary

PayerCigna

PolicyOncology - Balversa (erdafitinib) Prior Authorization Policy

Policy CodePolicy N/A

Change TypeNo material change

Effective DateN/A

Next Review DateMar 26, 2025

Key ActionObtain prior authorization and document age, disease stage, relevant FGFR/FGFR3 genetic alterations, prior therapy history, and single-agent use to support coverage.

SourceLink

On This Page

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Permitted Regimens

Regimen	Indication	Coverage status	Approval duration
Balversa (erdafitinib) — single-agent	Urothelial carcinoma with susceptible FGFR3 genetic alterations; adults ≥18 years; locally advanced or metastatic disease; progressed during or following prior platinum-containing chemotherapy, other chemotherapy, or checkpoint inhibitor therapy; used as a single agent.	Covered	Approve for 1 year when all criteria are met.
Balversa (erdafitinib) — single-agent	Pancreatic adenocarcinoma with FGFR genetic alteration; adults ≥18 years; locally advanced, recurrent, or metastatic disease; used for subsequent therapy; used as a single agent.	Covered	Approve for 1 year when all criteria are met.
Balversa (erdafitinib) — single-agent	Non-small cell lung cancer with FGFR alterations; adults ≥18 years; metastatic disease; used as a single agent.	Covered	Approve for 1 year when all criteria are met.

Biomarker and Diagnostic Requirements

inv-15: FGFR3 — susceptible FGFR3 genetic alterations identified by an FDA-approved companion diagnostic

BiomarkerSusceptible FGFR3 genetic alterations

Identification methodIdentified by an FDA‑approved companion diagnostic for Balversa

Required indicationRequired for FDA‑approved urothelial carcinoma indication

Age requirementPatient ≥ 18 years when used for urothelial carcinoma

inv-16: FGFR (unspecified subtype)

BiomarkerFGFR (fibroblast growth factor receptor) genetic alterations (unspecified subtype)

Supported tumor typesPancreatic adenocarcinoma and non‑small cell lung cancer (evidence‑supported uses)

Use contextRequired for evidence‑supported coverage as stated per tumor type criteria

Age requirementPatient ≥ 18 years for supportive uses

inv-11: susceptible FGFR3 genetic alterations — definition and companion diagnostic note

DefinitionSusceptible FGFR3 genetic alterations — FGFR3 molecular alterations that predict potential sensitivity to erdafitinib.

Diagnostic noteSelect patients for therapy based on an FDA‑approved companion diagnostic for Balversa.

Indication linkPresence of susceptible FGFR3 alterations is required for the FDA‑approved urothelial carcinoma indication.

Line of Therapy Requirements

Prior Authorization

Prior Authorization Required

Prior authorization is required for Balversa (erdafitinib) prior to initiation of therapy.

Authorization duration: Approve for 1 year when criteria are met.
Affected indication: Urothelial carcinoma with susceptible FGFR3 genetic alterations; other supported indications per policy (see criteria).

Documentation Required

Clinical documentation must be provided with the prior authorization request to support the request. At minimum submit the following: pathology or diagnostic report confirming urothelial carcinoma; results of an FDA-approved companion diagnostic demonstrating susceptible FGFR3 genetic alteration; prior treatment history including dates and agents (documentation of prior platinum-containing chemotherapy, other chemotherapy, or checkpoint inhibitor therapy); and treatment intent (single-agent use).

Pathology/diagnostic report confirming diagnosis.
Molecular testing report showing susceptible FGFR3 alteration (FDA-approved companion diagnostic recommended).
Detailed prior systemic therapy history with agents and dates (including platinum-based chemotherapy, other chemotherapies, and checkpoint inhibitors if applicable).
Planned regimen showing single-agent use of Balversa.
For non-urothelial or off-label supportive indications, documentation that medication is being used as subsequent therapy and meets listed criteria.

Step Therapy

Line of Therapy — Subsequent / Second-line

Therapy is reserved as subsequent-line treatment for urothelial carcinoma. Approvals are for patients with locally advanced or metastatic disease who have progressed on or after at least one line of prior systemic therapy including platinum-containing chemotherapy, other chemotherapy, or checkpoint inhibitor therapy. Balversa is not recommended for patients who are eligible for and have not received prior PD-1 or PD-L1 inhibitor therapy.

Requirement: Disease progression during or following prior systemic therapy (examples: cisplatin, carboplatin, gemcitabine, paclitaxel, doxorubicin, pembrolizumab, nivolumab, atezolizumab, durvalumab, avelumab).
Age requirement: Patient is ≥ 18 years of age.
Disease requirement: Locally advanced or metastatic disease.
Genetic requirement: Presence of susceptible FGFR3 genetic alterations.
Limit of use: Medication used as a single agent.

Provider Actions and Documentation Requirements

Prior Authorization

Prior authorization required; approvals issued for specified durations

Prior authorization is required for prescription benefit coverage of Balversa; when clinical criteria are met, approvals are provided for the durations specified in the policy (typically 1 year).

Approvals for covered indications (urothelial carcinoma, pancreatic adenocarcinoma, NSCLC) are noted as 1 year when criteria are met.

Documentation Required

Provide required clinical documentation (age, stage, biomarker, prior therapies, single‑agent use)

Submit documentation that demonstrates the patient is ≥18 years old, disease stage as specified for the indication (locally advanced, recurrent or metastatic or metastatic), presence of the required FGFR/FGFR3 genetic alteration (susceptible FGFR3 for urothelial carcinoma), prior therapy history for urothelial carcinoma (progression during or after platinum-containing chemo, other chemo, or checkpoint inhibitor), and that Balversa will be used as a single agent.

Age (≥18 years).
Disease stage: locally advanced, recurrent or metastatic (per indication).
Genetic test results showing FGFR or susceptible FGFR3 alteration (FDA‑approved companion diagnostic for urothelial carcinoma).
Prior therapy history (e.g., platinum-containing chemotherapy, other chemotherapy, checkpoint inhibitor) when applicable.
Plan to use medication as single-agent therapy.

Denial Risk

Non‑listed uses considered experimental/investigational (denial risk)

Use of Balversa for any indication not explicitly listed in the policy (FDA‑approved urothelial carcinoma with susceptible FGFR3 alterations, pancreatic adenocarcinoma, or NSCLC with FGFR alterations) is considered experimental, investigational or unproven and may be denied.

Coverage is limited to the specified indications; other uses are not covered and are subject to denial.

Revision History

2025-03-26policy reviewLatest

Policy reviewed; clinical criteria and review date recorded (next review scheduled 2025-03-26).

2025-02-28guideline update referenced

NCCN Bladder Cancer Guidelines (version 7.2024) referenced in clinical context for supportive guidance on urothelial carcinoma management.

2025-02-03guideline update referenced

NCCN Pancreatic Adenocarcinoma Guidelines (version 2.2025) referenced for supportive evidence on pancreatic adenocarcinoma use.

2025-01-14guideline update referenced

NCCN Non-Small Cell Lung Cancer Guidelines (version 3.2025) referenced for supportive evidence on NSCLC use.

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