ModifiedNeighborhood Health Plan of Rhode IslandPolicy N/A

Balversa (erdafitinib) for unresectable or metastatic urothelial carcinoma

Defines accepted indications, continuation criteria, exclusion criteria, coding, and applicable lines of business for coverage and utilization management of Balversa (erdafitinib) processed by Evolent for Neighborhood Health Plan of Rhode Island.

Policy Summary

PayerNeighborhood Health Plan of Rhode Island

PolicyBalversa (erdafitinib) for unresectable or metastatic urothelial carcinoma

Policy CodePolicy N/A

Change TypeRevised (template conversionexclusion/indication updates)

Effective Date

Next Review Date

Key ActionProvider must supply tumor tissue test results demonstrating documented FGFR3 genomic aberration using the FDA-approved companion diagnostic (therascreen) or another appropriate genomic test.

SourceLink

POLICY UPDATE CHANGES

Converted to new Evolent guideline template and updated exclusion criteria (February 2025).

Updated indication section to restrict use to members with FGFR3 genomic aberrations and updated exclusion criteria (February 2024).

1Indication covered (urothelial carcinoma with FGFR3 alteration)

3Prior therapy pathways

2Hard exclusions (no FGFR3 test; progression)

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Coverage Summary

Coverage stance: covered_with_criteria for Balversa (erdafitinib) when used as a single agent for members with unresectable or metastatic urothelial carcinoma and a documented FGFR3 genomic aberration. Applicable lines of business: CHIP, Commercial, Exchange/Marketplace, Medicaid, Medicare Advantage. Scope summary: Defines accepted indications, continuation criteria, exclusion criteria, coding, and applicable lines of business for coverage and utilization management of Balversa (erdafitinib) processed by Evolent for Neighborhood Health Plan of Rhode Island.

Quick facts and thresholds

Single dose limit9 mg

Maximum tablets per month84 (3 mg); 56 (4 mg); 28 (5 mg)

Indication coveredUnresectable or metastatic urothelial carcinoma with documented FGFR3 genomic aberration

Policy statusMODIFIED

Last review2025-02

Initial Therapy Criteria (Urothelial carcinoma)

Initial therapy - Urothelial carcinoma

Balversa (erdafitinib) is covered as a single agent when ALL of the following are met:

ALL of the following

Member has unresectable or metastatic urothelial carcinoma
Documented FGFR3 genomic aberration in tumor tissue using the FDA approved companion diagnostic (therascreen) or another appropriate genomic test
Prior therapy requirements
- Member has had disease progression on or intolerance to platinum-based chemotherapy AND disease progression on or intolerance to Immune Checkpoint Inhibitor therapy (e.g., avelumab, nivolumab, or pembrolizumab)

Continuation Therapy Criteria

Continuation therapy

Continuation requests are permitted when ALL of the following are met:

ALL of the following

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

Exclusion / Not Medically Acceptable

Exclusion / Not medically acceptable

Use is excluded/not approvable when ANY of the following apply:

ANY of the following

Disease progression while receiving Balversa (erdafitinib)
Lack of test results confirming a FGFR3 genomic alteration in the tumor tissue
Members who are eligible for and have not received prior Immune Checkpoint Inhibitor therapy
Concurrent use with other chemotherapy, targeted therapies, or definitive radiotherapy

Applicable Codes

Drug HCPCS/J-codeHCPCSCovered

J8999

erdafitinib

Provider Actions & Billing Rules

Prior Authorization

Prior authorization required

Evolent is responsible for processing all medication requests; medications not authorized by Evolent may be deemed not approvable and not reimbursable. Requests must be supported by FDA labeling, CMS-recognized compendia, NCCN/ASCO guidelines, or acceptable peer-reviewed literature.

Documentation Required

Document FGFR3 genomic aberration

Provider must supply tumor tissue test results demonstrating documented FGFR3 genomic aberration using FDA-approved companion diagnostic (therascreen) or another appropriate genomic test.

Denial Risk

Clinical Evidence & References

Evidence: Key trial/reference: Loriot Y et al., N Engl J Med. 2019 (Erdafitinib in Locally Advanced or Metastatic Urothelial Carcinoma); Loriot Y et al., N Engl J Med. 2023 (Erdafitinib or Chemotherapy in Advanced or Metastatic Urothelial Carcinoma); Balversa prescribing information, Janssen Products, LP, 2024.

Background

Background: This policy defines accepted indications for erdafitinib (Balversa), requiring a documented FGFR3 genomic aberration in tumor tissue and specific prior therapy history (progression on or intolerance to platinum-based chemotherapy and immune checkpoint inhibitor therapy, or if platinum-ineligible, progression on or intolerance to immune checkpoint inhibitor therapy). Continuation rules permit ongoing therapy when the member has no disease progression, the medication was used within the last year without a lapse of more than 30 days of active authorization, and no new medications are added. Scope summary: Defines accepted indications, continuation criteria, exclusion criteria, coding, and applicable lines of business for coverage and utilization management of Balversa (erdafitinib) processed by Evolent for Neighborhood Health Plan of Rhode Island; applicable lines of business include CHIP, Commercial, Exchange/Marketplace, Medicaid, and Medicare Advantage.

Revision History

2025-02conversionLatest

Converted to new Evolent guideline template; guideline replaces UM ONC_1374 Balversa (erdafitinib); exclusion criteria updated.

2024-02update

Updated indication section to restrict use to members with FGFR3 genomic aberrations; exclusion criteria updated; added new FDA reference.

Policy Summary

PayerNeighborhood Health Plan of Rhode Island

PolicyBalversa (erdafitinib) for unresectable or metastatic urothelial carcinoma

Policy CodePolicy N/A

Change TypeRevised (template conversionexclusion/indication updates)

Effective Date

Next Review Date

SourceLink

On This Page

If ineligible for platinum-containing therapy, member had disease progression on or intolerance to Immune Checkpoint Inhibitor therapy (e.g., atezolizumab, avelumab, nivolumab, or pembrolizumab)

Dosing exceeds single dose limit of Balversa (erdafitinib) 9 mg

Monthly tablet limits: Treatment exceeds the maximum limit of 84 (3 mg); 56 (4 mg), or 28 (5 mg) tablets/month84 (3 mg); 56 (4 mg); 28 (5 mg)

Investigational/off-label: Investigational use of Balversa (erdafitinib) with an off-label indication that is not supported by CMS-recognized compendia or acceptable peer-reviewed literature

Off-label indications not supported by CMS compendia or acceptable peer-reviewed literature; abstracts-only evidence is insufficient.

Abstracts only: Use supported only by abstracts without full article from approved peer-reviewed journals

Definitions: Continuation request exemption — Continuation requests for a not-approvable medication are exempt from this policy if all of the following are met: the member has not experienced disease progression on the requested medication; the requested medication was used within the last year without a lapse of more than 30 days of having an active authorization; and no additional medication(s) are being added to the continuation request. Investigational use — Off-label or investigational use is not approvable when evidence is insufficient or not generally accepted by the medical community; abstracts without a full peer-reviewed article are insufficient supporting evidence.

Denial if prior therapy requirements not met

Claims may be denied if member is eligible for but has not received prior immune checkpoint inhibitor therapy, or if required prior platinum-based chemotherapy/ICI progression or intolerance criteria are not met.

Billing Rule

Dose and monthly quantity limits

Do not exceed single dose limit of 9 mg and monthly tablet limits: 84 (3 mg), 56 (4 mg), or 28 (5 mg).

J8999