Balversa

Drug - Balversa™ (erdafinitib) [Janssen Products LP]

September 2019

Therapeutic area - Oral Oncology

Initial approval criteria

Patient is ≥ 18 years old AND
Patient has diagnosis of locally advanced or metastatic urothelial carcinoma AND
Patient has a susceptible FGFR3 or FGFR2 genetic alterations as determined by an FDA-approved companion diagnostic AND
Patient has progressed during or following ≥ 1 prior line of platinum-containing chemotherapy, including within 12 months of neoadjuvant or adjuvant platinum-containing chemotherapy AND
Patient has received a baseline ophthalmological examination (e.g., assessment of visual acuity, slit lamp examination, fundoscopy, and optical coherence tomography) AND
Patient has had a baseline serum phosphate level measurement and it is within normal limits AND
Patient phosphate intake is restricted to < 800 mg per day AND
Patient will not be on concomitant therapy with strong CYP2C9 or CYP3A4 inhibitors (e.g., fluconazole, itraconazole) or with strong CYP2C9 or CYP3A4 inducers (e.g., rifampicin) or, if therapy is unavoidable, prescriber attestation that the patient will be monitored closely for adverse reactions and/or dose modifications AND
Erdafitinib will be used as a single agent
Initial approval is for 6 months

Patient continues to meet above criteria AND
Patient has positive disease response, defined as disease stabilization or decrease in size of tumor or tumor spread AND
Patient does not have unacceptable toxicity (e.g., central serous retinopathy/retinal pigment epithelial detachment (CSR/RPED), severe hyperphosphatemia) AND
Patient’s serum phosphate level is < 7 mg/dL AND
Patient continues to receive ophthalmological examinations (e.g., assessment of visual acuity, slit lamp examination, fundoscopy, and optical coherence tomography)
Renewal approval is for 6 months

MHCP Provider Call Center 651-431-2700 or 800-366-5411