Clinical Policy: Erdafitinib (Balversa) coverage
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Clinical coverage and prior authorization criteria for erdafitinib (Balversa) for treatment of urothelial carcinoma and select off-label NCCN-recommended uses, applicable to Peach State Health Plan lines of business including Commercial, HIM/ICHRA, and Medicaid.
Added off-label indications per NCCN Compendium for pancreatic adenocarcinoma, cholangiocarcinoma, and non-small cell lung cancer (NSCLC).
Revised initial approval durations from 6 months to 12 months.
Added requirement to use generic erdafitinib, if available, unless contraindicated or adverse effects.
Updated FDA labeled indication for UC to include limitation of use regarding prior PD-1/PD-L1 inhibitor therapy.
Updated FDA labeled indication for urothelial carcinoma (UC) to remove accelerated approval language and include limitation of use; removed coverage of patients with FGFR2 genetic alterations.
Added monotherapy requirement per NCCN and New Century Health.
Added initial and continued therapy criteria to use generic erdafitinib if available.
Updated previous-therapy language from 'gemcitabine chemotherapy' to 'other chemotherapy' to align with NCCN Compendium and revised Commercial approval durations to align with Medicaid and HIM.
Per NCCN Compendium, added off-label indications of pancreatic adenocarcinoma, cholangiocarcinoma, and non–small cell lung cancer (NSCLC).
Revised initial approval durations from 6 months to 12 months and added ICHRA line of business.
Coverage Criteria
Initial Therapy — Urothelial Carcinoma
Covered when ALL of the following are met:
Initial Therapy — NCCN Recommended Uses (off-label)
Covered when ALL of the following are met for each listed off-label indication:
Continuation Therapy
Covered when ALL of the following are met:
Non‑FDA approved indications that are not specifically addressed in this policy are not authorized unless the provider submits sufficient documentation demonstrating efficacy and safety consistent with Peach State Health Plan off‑label use policies.
Coverage for patients with FGFR2 genetic alterations has been removed; requests for erdafitinib for that patient population are no longer covered under this policy.
Per the FDA‑labeled limitation of use, Balversa (erdafitinib) is not recommended for treatment of patients who are eligible for and have not received prior PD‑1 or PD‑L1 inhibitor therapy. Prior receipt of PD‑1/PD‑L1 inhibitor therapy is required before using Balversa in eligible patients.
Initial Therapy Criteria by Indication
Initial Therapy Criteria — Initial therapy criteria by indication
Initial therapy criteria by indication:
Initial Therapy — Initial authorization requirements updated to align with NCCN Compendium and prefer generic erdafitinib when available
Initial authorization requirements updated to align with NCCN Compendium and prefer generic erdafitinib when available:
Continuation / Renewal Criteria
Continuation Therapy — Continuation therapy requirements for all indications in Section I
Continuation therapy requirements for all indications in Section I:
Continuation Therapy — Continuation/renewal approvals adjusted to use generic erdafitinib if available and to updated durations
Continuation/renewal approvals adjusted to prefer generic erdafitinib when available and to updated approval durations:
Provider Actions & Prior Authorization
Prior authorization required; approval based on meeting initial criteria
Prior authorization is required for erdafitinib (Balversa). Approval is granted only when the detailed initial approval criteria for the requested indication and dosing are met. Approval duration for initial requests is 12 months.
Prior authorization: required documentation and approval duration
Submit prior authorization with documentation of the indication, prior chemotherapy history (platinum-containing, PD‑1/PD‑L1 inhibitor, or other chemotherapy as applicable), and confirmation that erdafitinib will be used as monotherapy. Initial approvals are issued for 12 months.
Therapy sequencing: single‑agent and subsequent therapy requirement
Erdafitinib must be prescribed as a single‑agent (monotherapy) and used as subsequent therapy after the specified prior therapies outlined in the criteria (e.g., platinum‑containing chemotherapy, PD‑1/PD‑L1 inhibitor therapy, or other chemotherapy).
- Monotherapy requirement added per NCCN/New Century Health (policy history).
Prior therapy language aligned to NCCN ("other chemotherapy")
Policy language for prior therapy was updated to replace 'gemcitabine chemotherapy' with 'other chemotherapy' to align previous‑therapy requirements with the NCCN Compendium.
Required supporting documentation (office notes, labs, other clinical info)
Providers must submit supporting clinical documentation such as office chart notes, laboratory results, or other clinical information that demonstrates the member meets all approval criteria.
- Include documentation of prior systemic therapies and sequencing per indication.
FGFR3 genetic testing documentation required for UC
For urothelial carcinoma, confirm the presence of a susceptible FGFR3 genetic alteration prior to initiation and provide the genetic test results; when available, include results from an FDA‑approved companion diagnostic.
- Appendix D specifies FGFR3 mutations/fusions studied (e.g., R248C, S249C, G370C, Y373C; FGFR3‑TACC3, FGFR3‑BAIAP2L1).
- FDA companion diagnostic information referenced at FDA site per Appendix D.
Clinical documentation must align to NCCN Compendium and FDA labeling
Document the indication and prior therapies in the request consistent with NCCN Compendium and FDA‑labeled indications; policy updates require documentation aligned to NCCN‑based criteria and the revised approval durations.
- Indicate whether generic erdafitinib will be used if available, unless contraindicated or due to adverse effects.
Denial risk if documentation or indication justification is insufficient
A request may be denied if documentation does not support that the member meets all approval criteria or if a non‑listed/non‑covered indication is requested without appropriate off‑label justification per off‑label use policies.
- Non‑FDA approved indications not addressed in this policy require sufficient efficacy/safety documentation per off‑label use policies.
Coverage limitation: FGFR2 alterations not covered
Coverage for patients with FGFR2 genetic alterations has been removed; requests for patients with FGFR2 alterations may be denied under this policy.
Step Therapy / Sequencing
| Step | Requirement |
|---|---|
| 1 | Erdafitinib must be prescribed as subsequent (single‑agent) therapy after prior platinum‑containing chemotherapy, prior PD‑1 or PD‑L1 inhibitor therapy, or other chemotherapy; prescribed by or in consultation with an oncologist, age ≥ 18, presence of susceptible FGFR3 genetic alterations, use generic erdafitinib if available unless contraindicated, and dosing not to exceed 9 mg/day and 3 tablets/day (or dose supported by practice guidelines/peer‑reviewed literature). |
| Step | Policy Change / Alignment |
|---|---|
| 1 | Prior‑therapy language updated to align with the NCCN Compendium: previous wording 'gemcitabine chemotherapy' replaced with 'other chemotherapy' when describing required prior therapies; reflected in prior‑therapy requirement for erdafitinib as subsequent therapy. (See policy revision history.) |
Quantity Limits & Dosing Constraints
Coding & Lab Thresholds
Definitions
Background
Erdafitinib is a fibroblast growth factor receptor (FGFR) kinase inhibitor indicated for adults with locally advanced or metastatic urothelial carcinoma that harbors susceptible FGFR3 genetic alterations, for patients whose disease progressed on or after at least one prior systemic therapy. Selection of patients should be informed by an FDA‑approved companion diagnostic. The FDA‑labeled indication includes a limitation of use regarding prior PD‑1/PD‑L1 inhibitor therapy, and the policy has been updated to remove coverage for patients with FGFR2 alterations to align with the current labeling and internal review.
Site of Care
Oral agent: approval durations aligned across lines of business
Erdafitinib is an oral oncology agent; approval durations (initial and continued) are aligned across lines of business and are specified in the policy (initial approval = 12 months).
Revision History
Revised initial approval durations from 6 months to 12 months and added ICHRA line of business (3Q 2026 annual review).
Per NCCN Compendium, added off-label indications for pancreatic adenocarcinoma, cholangiocarcinoma, and non–small cell lung cancer (3Q 2025 annual review).
Updated prior-therapy language from 'gemcitabine chemotherapy' to 'other chemotherapy' and revised Commercial approval durations to align with Medicaid and HIM (3Q 2024 annual review).
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