Pharmacy Prior Authorization Criteria

Balversa (erdafitinib)

Indications for Prior Authorization

Balversa (erdafitinib)

• For diagnosis of Urothelial Carcinoma
  Indicated for the treatment of adult patients with locally advanced or metastatic urothelial carcinoma (mUC) with susceptible FGFR3 genetic alterations whose disease has progressed on or after at least one line of prior systemic therapy.

  Select patients for therapy based on an FDA-approved companion diagnostic for BALVERSA.

  Limitations of Use: BALVERSA is not recommended for the treatment of patients who are eligible for and have not received prior PD-1 or PD-L1 inhibitor therapy.

Criteria

Balversa

Prior Authorization (Initial Authorization)

Length of Approval: 12 Month(s)

• Diagnosis of urothelial carcinoma
AND
• Disease is one of the following:
• Locally advanced
• Metastatic
AND
• Presence of susceptible fibroblast growth factor receptor (FGFR) 3 genetic alterations as detected by a U.S. Food and Drug Administration (FDA)-approved test (therascreen FGFR RGQ RT-PCR Kit) or a test performed at a facility approved by Clinical Laboratory Improvement Amendments (CLIA)
AND
• Disease has progressed on or after at least one line of prior systemic therapy (e.g., chemotherapy)
AND
• One of the following:
• Patient had been treated with prior PD-1 inhibitor therapy (e.g., Opdivo [nivolumab], Keytruda [pembrolizumab]) or PD-L1 inhibitor therapy (e.g., Bavencio [avelumab])
OR
• Patient is not a candidate for PD-1 or PD-L1 inhibitor therapy

Balversa

Prior Authorization (Reauthorization)

Length of Approval: 12 Month(s)

• Patient does not show evidence of progressive disease while on therapy

P & T Revisions

2024-03-22, 2023-06-15, 2023-05-22, 2022-05-20, 2021-08-02, 2021-06-02, 2020-05-11

References

1. Balversa Prescribing Information. Janssen Products, LP. Horsham, PA. January 2024.

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Revision History

• 2024-03-22: 2024 annual review: Updated criteria to align with expanded FDA-approved indication.
• 2023-06-15: Removal of specialist requirement
• 2023-05-22: Annual review - no criteria changes.
• 2022-05-20: Annual review: updated criteria to align with label. Updated references.
• 2021-08-02: Annual review: updated references, background, and added medication examples to criteria section
• 2021-06-02: Annual review: updated references, background, and added medication examples to criteria section
• 2020-05-11: Annual Review; cosmetic updates and updated references

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