BALVERSA, Erdafitinib Form

Erdafitinib (Balversa®) is a fibroblast growth factor receptor (FGFR) kinase inhibitor. FDA Approved Indication(s) Balversa is indicated for the treatment of adult patients with locally advanced or metastatic urothelial carcinoma (UC) 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(s) of use: Balversa is not recommended for the treatment of patients who are eligible for and have not received prior programmed cell death protein 1 (PD-1) or programmed death- ligand 1 (PD-L1) inhibitor therapy. Policy/Criteria Provider must submit documentation (such as office chart notes, lab results or other clinical information) supporting that member has met all approval criteria.
It is the policy of health plans affiliated with Centene Corporation® that Balversa is medically necessary when the following criteria are met:
I. Initial Approval Criteria
A. Urothelial Carcinoma (must meet all):

1. Diagnosis of recurrent, locally advanced, or metastatic UC;
   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 (e.g., cisplatin, carboplatin), PD-1 or PD-L1 inhibitor therapy (e.g., Keytruda®), or gemcitabine-containing chemotherapy (see Appendix B); *Prior authorization may be required for chemotherapy and Keytruda
2. For Balversa requests, member must use erdafitinib, if available, unless contraindicated or clinically significant adverse effects are experienced;

3. Request meets one of the following (a or b): a. Dose does not exceed both of the following (i and ii): i. 9 mg per day; Page 1 of 6

   CLINICAL POLICY Erdafitinib ii. 3 tablets per day; b. Dose is supported by practice guidelines or peer-reviewed literature for the relevant off-label use (prescriber must submit supporting evidence). *Prescribed regimen must be FDA-approved or recommended by NCCN
   Approval duration:
   Medicaid/HIM – 6 months
   Commercial – 12 months or duration of request, whichever is less
   B. Other diagnoses/indications (must meet 1 or 2):

4. If this drug has recently (within the last 6 months) undergone a label change (e.g., newly approved indication, age expansion, new dosing regimen) that is not yet reflected in this policy, refer to one of the following policies (a or b): a. For drugs on the formulary (commercial, health insurance marketplace) or PDL (Medicaid), the no coverage criteria policy for the relevant line of business: CP.CPA.190 for commercial, HIM.PA.33 for health insurance marketplace, and CP.PMN.255 for Medicaid; or b. For drugs NOT on the formulary (commercial, health insurance marketplace) or PDL (Medicaid), the non-formulary policy for the relevant line of business: CP.CPA.190 for commercial, HIM.PA.103 for health insurance marketplace, and CP.PMN.16 for Medicaid; or
5. If the requested use (e.g., diagnosis, age, dosing regimen) is NOT specifically listed under section III (Diagnoses/Indications for which coverage is NOT authorized) AND criterion 1 above does not apply, refer to the off-label use policy for the relevant line of business: CP.CPA.09 for commercial, HIM.PA.154 for health insurance marketplace, and CP.PMN.53 for Medicaid.
   II. Continued Therapy A. Urothelial Carcinoma (must meet all):
6. Currently receiving medication via Centene benefit, or documentation supports that member is currently receiving Balversa for a covered indication and has received this medication for at least 30 days;

7. Member is responding positively to therapy;

   3. Prescribed as single-agent therapy;
   4. For Balversa requests, member must use erdafitinib, if available, unless contraindicated or clinically significant adverse effects are experienced;
   5. If request is for a dose increase, request meets one of the following (a or b): a. New dose does not exceed both of the following (i and ii): i. 9 mg per day; ii. 3 tablets per day; b. New dose is supported by practice guidelines or peer-reviewed literature for the relevant off-label use (prescriber must submit supporting evidence). *Prescribed regimen must be FDA-approved or recommended by NCCN
      Approval duration:
      Medicaid/HIM – 12 months
      Commercial – 12 months or duration of request, whichever is less Page 2 of 6

   CLINICAL POLICY Erdafitinib B. Other diagnoses/indications (must meet 1 or 2):

8. If this drug has recently (within the last 6 months) undergone a label change (e.g., newly approved indication, age expansion, new dosing regimen) that is not yet reflected in this policy, refer to one of the following policies (a or b): a. For drugs on the formulary (commercial, health insurance marketplace) or PDL (Medicaid), the no coverage criteria policy for the relevant line of business: CP.CPA.190 for commercial, HIM.PA.33 for health insurance marketplace, and CP.PMN.255 for Medicaid; or b. For drugs NOT on the formulary (commercial, health insurance marketplace) or PDL (Medicaid), the non-formulary policy for the relevant line of business: CP.CPA.190 for commercial, HIM.PA.103 for health insurance marketplace, and CP.PMN.16 for Medicaid; or

9. If the requested use (e.g., diagnosis, age, dosing regimen) is NOT specifically listed under section III (Diagnoses/Indications for which coverage is NOT authorized) AND criterion 1 above does not apply, refer to the off-label use policy for the relevant line of business: CP.CPA.09 for commercial, HIM.PA.154 for health insurance marketplace, and CP.PMN.53 for Medicaid.
   III. Diagnoses/Indications for which coverage is NOT authorized:
   A. Non-FDA approved indications, which are not addressed in this policy, unless there is sufficient documentation of efficacy and safety according to the off label use policies – CP.CPA.09 for commercial, HIM.PA.154 for health insurance marketplace, and CP.PMN.53 for Medicaid or evidence of coverage documents.
   IV. Appendices/General Information Appendix A: Abbreviation/Acronym Key FDA: Food and Drug Administration FGFR: fibroblast growth factor receptor NCCN: National Comprehensive Cancer Network PD-1: programmed cell death protein 1 PD-L1: programmed death-ligand
   UC: urothelial carcinoma Appendix B: Therapeutic Alternatives
   This table provides a listing of preferred alternative therapy recommended in the approval criteria. The drugs listed here may not be a formulary agent for all relevant lines of business and may require prior authorization.
   Dosing Regimen Drug Name Dose Limit/ Maximum Dose Varies Varies Varies Varies Varies Varies carboplatin cisplatin
   gemcitabine PD-1 inhibitors Keytruda (pembrolizumab) UC (labeled use for locally advanced or metastatic disease): 200 mg IV once every 3 weeks until disease progression, unacceptable toxicity, or (in patients without disease progression) for up to 24 months 200 mg/3 weeks Page 3 of 6

   CLINICAL POLICY Erdafitinib Therapeutic alternatives are listed as Brand name® (generic) when the drug is available by brand name only and generic (Brand name®) when the drug is available by both brand and generic. Appendix C: Contraindications/Boxed Warnings None reported
   Appendix D: General Information
   • The presence of FGFR3 genetic alterations should be confirmed prior to initiation of treatment with Balversa. Patients with at least 1 of the following genetic alterations: FGFR3 gene mutations (R248C, S249C, G370C, Y373C) or FGFR3 gene fusions (FGFR3-TACC3, FGFR3-BAIAP2L1) were studied in the confirmatory clinical study for approval. Information on FDA-approved tests for the detection of FGFR3 genetic alterations in UC is available at: http://www.fda.gov/CompanionDiagnostics. • V. Dosage and Administration
   Indication UC Dosing Regimen 8 mg (two 4 mg tablets) PO QD with a dose increase to 9 mg (three 3 mg tablets) QD if serum phosphate level is < 9.0 mg/dL at 14-21 days and there are no ocular disorders or Grade 2 or greater adverse reactions Maximum Dose 9 mg/day VI. Product Availability
   Tablets: 3 mg, 4 mg, 5 mg VII.