BALVERSA (erdafitinib)

BALVERSA (erdafitinib)

SELF ADMINISTRATION-ORAL

Indications for Prior Authorization:

• Treatment of adult patients with locally advanced or metastatic urothelial carcinoma (mUC), that has

  • Susceptible FGFR3 or FGFR2 genetic alternations AND

  • Progressed during or following at least one line of prior platinum-containing chemotherapy including within 12 months of neoadjuvant or adjuvant platinum-containing chemotherapy

• This indication is approved under accelerated approval based on the tumor response rate.  Continued approval for this indication may be contingent upon verification and description of clinical benefit in confirmatory trials

Patients must meet the following criteria for the indications(s) above:

• Patient is 18 years or older, AND
• Prescribed by or in consultation with an oncologist, AND
• Chart note documentation is provided supporting diagnosis or locally advanced or metastatic urothelial carcinoma, AND
• Patient has susceptible fibroblast growth factor receptor 3 (FGFR3) or fibroblast growth factor receptor 2 (FGFR2) genetic alterations, AND
• Patient has progressed during or following prior platinum-containing chemotherapy (i.e., cisplatin, oxaliplatin), AND

Renewal:

• Phosphate levels 14 to 21 days after initialing treatment:
  • PO4 < 5.5mg/dL and no ocular disorder or Grade 2 or greater adverse reactions: increase dose to 9 mg once daily (monitor phosphate levels monthly for hyperphosphatemia)

The following conditions do not meet the criteria for use as established by WHA P&T committee:

• All non-FDA approved uses not listed in the approved indications

Dosing:

• Recommended starting dose is 8 mg (two 4 mg tablets) orally once daily, with a dose increase to 9 mg (three 3 mg tablets) once daily based on serum phosphate (PO4) levels and tolerability at 14 to 21 days.

Approval:

• Initial approval: 3 weeks
• Renewal: 6 months