ModifiedCentenePolicy CP PHAR.423

Erdafitinib (Balversa) coverage for FGFR-altered cancers

Defines medical necessity and prior authorization criteria for erdafitinib (Balversa) for adults with FGFR3-altered urothelial carcinoma and selected NCCN-recommended off-label cancer indications; applies to Centene-affiliated health plans and lines of business listed.

Policy Summary

PayerCentene

PolicyErdafitinib (Balversa) coverage for FGFR-altered cancers

Policy CodePolicy CP PHAR.423

Change TypeModified indications, added off-label NCCN uses, monotherapy and generic product preference

Effective Date09.01.19

Next Review Date

Key ActionSubmit prior authorization with documentation of diagnosis, FGFR3 alteration, oncologist involvement, age >18, prior platinum-containing chemotherapy and PD-1/PD-L1 inhibitor therapy, and dosing within limits.

SourceLink

POLICY UPDATE CHANGES

Updated FDA labeled indication for UC to remove accelerated approval language and include limitation of use; removed coverage of patients with FGFR2 genetic alterations to be consistent with revised FDA indication and NCCN recommendations; added requirement to use generic erdafitinib if available for initial and continued therapy.

Added NCCN-recommended off-label indications: pancreatic adenocarcinoma, cholangiocarcinoma, and NSCLC.

Added monotherapy requirement per NCCN and New Century Health.

Added requirement to use generic erdafitinib for initial and continued therapy if available.

Updated wording for prior chemotherapy (gemcitabine -> other chemotherapy) to align with NCCN Compendium and revised approval durations for commercial vs Medicaid/HIM.

9 mg/dayMaximum labeled erdafitinib dose

Adults >18 yrs

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Coverage Criteria

inv-01: Initial Therapy (UC)

Covered when ALL of the following are met

Initial UC criteria: 1) Diagnosis of recurrent, locally advanced, or metastatic urothelial carcinoma; 2) Prescribed by or in consultation with an oncologist; 3) Age > 18 years; 4) Presence of susceptible FGFR3 genetic alterations (see Appendix D); 5) Prescribed as single-agent therapy; 6) Prescribed as subsequent therapy following platinum-containing chemotherapy and PD-1 or PD-L1 inhibitor therapy (or other chemotherapy per Appendix B); 7) For Balversa requests, member must use erdafitinib (generic) if available unless contraindicated or clinically significant adverse effects are experienced; 8) Dose does not exceed both: (i) 9 mg per day and (ii) 3 tablets per day — OR dose supported by practice guidelines or peer-reviewed literature for the relevant off-label use (prescriber must submit supporting evidence);

Approval duration: 6 months

inv-02: Continuation Therapy

Covered when ALL of the following are met

Continued therapy: 1) Member is currently receiving medication via Centene benefit or documentation supports the member has been receiving Balversa for a covered indication for at least 30 days; 2) Member is responding positively to therapy; 3) Prescribed as single-agent therapy; 4) For Balversa requests, member must use erdafitinib (generic) if available unless contraindicated or clinically significant adverse effects are experienced; 5) If request is for a dose increase, new dose must not exceed both: (i) 9 mg per day and (ii) 3 tablets per day — OR the new dose is supported by practice guidelines or peer-reviewed literature (prescriber must submit supporting evidence);

Approval duration: 12 months

Non-FDA approved indications that are not specifically addressed in this policy are not authorized for coverage unless the provider supplies sufficient clinical documentation demonstrating efficacy and safety in accordance with the plan's off‑label use requirements. Follow the referenced off‑label use policies for required evidence: CP.CPA.09 (Commercial), HIM.PA.154 (Health Insurance Marketplace), or CP.PMN.53 (Medicaid).

Coverage for patients with FGFR2 genetic alterations has been removed to align the policy with the revised FDA labeled indication and current NCCN recommendations. Requests for erdafitinib for tumors characterized by FGFR2 alterations will not meet the policy's biomarker requirement for approval unless future guidance or labeling changes reinstate FGFR2 as an eligible alteration.

Per the FDA limitation of use and reflected in the policy updates, Balversa (erdafitinib) is not recommended for patients who are eligible for but have not received prior PD‑1 or PD‑L1 inhibitor therapy. This sequencing requirement should be documented in the prior authorization submission and is enforced consistent with the labeled limitation and the policy's therapy‑line criteria.

Regimen	Notes
Start 8 mg PO once daily (two 4 mg tablets); increase to 9 mg PO once daily (three 3 mg tablets) if serum phosphate < 9.0 mg/dL at 14–21 days and no ocular toxicity	Maximum dose 9 mg/day

Off‑label Indication	Coverage Basis
Pancreatic adenocarcinoma	Added as NCCN Compendium–recommended off‑label indication; must meet policy off‑label criteria
Cholangiocarcinoma	Added as NCCN Compendium–recommended off‑label indication; must meet policy off‑label criteria
Non‑small cell lung cancer (NSCLC)	Added as NCCN Compendium–recommended off‑label indication; must meet policy off‑label criteria

Coding and Monitoring

Serum phosphate check for dose escalation

Serum phosphate thresholdSerum phosphate < 9.0 mg/dL measured at 14–21 days after starting therapy

Timing for checkMeasure serum phosphate between days 14 and 21 after treatment initiation

Action if threshold metEligible for dose escalation from 8 mg QD to 9 mg QD if no ocular toxicity

Provider Actions and Requirements

Prior Authorization

Prior Authorization Required

Prior authorization is required for initial and continued use of erdafitinib (Balversa) under this policy. Initial requests must document the diagnosis and that the prescriber is an oncologist or consulted with one, the member is >18 years, presence of susceptible FGFR3 genetic alterations (when applicable), use as single-agent therapy, prior therapy history where required (e.g., prior platinum-containing chemotherapy and PD-1/PD-L1 inhibitor for urothelial carcinoma or other chemotherapy per Appendix B/NCCN), dosing within limits or supported by guidelines for off‑label use, and that erdafitinib is the preferred product when a generic is available unless contraindicated.

Initial approval: document diagnosis of recurrent, locally advanced, or metastatic urothelial carcinoma when applicable; FGFR status must be provided (see Appendix D).
Requests for off‑label NCCN-recommended uses must include evidence supporting dosing and indication.
Approval duration for initial therapy: 6 months (commercial durations revised per policy updates).
Prior authorization may also be required for prior chemotherapies and PD-1/PD-L1 agents referenced in criteria.

Prior Authorization

Prior Authorization and Product Preference

Line of Therapy

inv-19: second-line

Line requirements: Subsequent therapy following platinum-containing chemotherapy and PD-1/PD-L1 inhibitor therapy (for urothelial carcinoma); for off-label pancreatic adenocarcinoma and cholangiocarcinoma, prescribed as subsequent therapy per Appendix B; for cholangiocarcinoma, prior pemigatinib and futibatinib (Pemazyre and Lytgobi) failure unless contraindicated.

Biomarker and Genetic Testing Requirements

FGFR3 (and FGFR fusions)

Required biomarkerPresence of susceptible FGFR3 genetic alterations (mutations or FGFR3 gene fusions) is required for the FDA‑approved UC indication

Confirmation recommendationFor UC, confirm FGFR3 genetic alterations prior to initiation; FDA‑approved companion diagnostic information available via FDA website

Applicable usesRequired for initial and continued therapy for urothelial carcinoma and for specified NCCN off‑label indications where FGFR3 alterations are relevant

FGFR2

Coverage changeCoverage removed for patients with FGFR2 genetic alterations to align with revised FDA indication and NCCN recommendations

Policy impact

Definitions

Susceptible FGFR3 genetic alterations

Example point mutationsFGFR3 mutations studied and listed include R248C, S249C, G370C, Y373C

Example gene fusionsFGFR3 gene fusions studied include FGFR3-TACC3 and FGFR3-BAIAP2L1

Use in confirmationThese specific alterations were included in confirmatory clinical studies and support eligibility for the UC indication

Monotherapy requirement

Single‑agent requirementErdafitinib must be prescribed as monotherapy per NCCN and New Century Health guidance

Policy appearanceMonotherapy requirement added to initial and continued therapy criteria during 3Q 2023 and operationalized in policy updates

Dosing and Covered Regimens

Indication	Dosing / Titration
Urothelial carcinoma (locally advanced or metastatic)	Start 8 mg PO once daily (two 4 mg tablets); increase to 9 mg PO once daily (three 3 mg tablets) if serum phosphate < 9.0 mg/dL at 14–21 days and no ocular toxicity; maximum 9 mg/day

Off‑label Indication	Coverage Basis
Pancreatic adenocarcinoma	NCCN Compendium–recommended off‑label use; coverage requires meeting all policy off‑label criteria and supporting documentation
Cholangiocarcinoma	NCCN Compendium–recommended off‑label use; coverage requires meeting all policy off‑label criteria and supporting documentation
Non‑small cell lung cancer (NSCLC)	NCCN Compendium–recommended off‑label use; coverage requires meeting all policy off‑label criteria and supporting documentation

Background

Erdafitinib is an FGFR kinase inhibitor indicated for adult patients with locally advanced or metastatic urothelial carcinoma who harbor susceptible FGFR3 genetic alterations and whose disease has progressed on or after at least one line of prior systemic therapy. The labeled indication includes a limitation of use: Balversa is not recommended for patients who are eligible for but have not received prior PD‑1 or PD‑L1 inhibitor therapy.

Policy Summary

PayerCentene

PolicyErdafitinib (Balversa) coverage for FGFR-altered cancers

Policy CodePolicy CP PHAR.423

Change TypeModified indications, added off-label NCCN uses, monotherapy and generic product preference

Effective Date09.01.19

Next Review Date

SourceLink

On This Page

Denial Risk

Documentation and Denial Risk

Provider must submit supporting clinical documentation with the prior authorization request. Lack of adequate documentation that the member meets all approval criteria — including diagnosis, FGFR alteration status, prior therapies, oncologist involvement, and rationale for non‑preferred product use — may result in denial.

Acceptable documentation: office chart notes, pathology/genetic testing reports showing FGFR3 alteration, lab results, prior therapy records, and treatment rationale.
Requests for non‑FDA approved indications must include strong supporting evidence per off‑label use policies (CP.CPA.09, HIM.PA.154, CP PMN.53) or they may be denied.

Documentation Required

Supporting Clinical Documentation

Clinical documentation should specifically support the requested indication and therapy sequence. For urothelial carcinoma align with FDA labeled indication and NCCN Compendium guidance (including FGFR3 status and prior platinum/PD‑1/PD‑L1 therapy where required). For NCCN-recommended off‑label uses (pancreatic adenocarcinoma, cholangiocarcinoma, NSCLC), include evidence of susceptible FGFR alterations and prior therapy failure where applicable.

Document FGFR testing results (appendix D) for indication verification.
Provide prior treatment history (e.g., platinum-containing chemotherapy, PD‑1/PD‑L1 inhibitors) and dates.
If dosing exceeds FDA limits, include peer‑reviewed literature or practice guideline support for off‑label dosing.