Zejula

Drug - Zejula® (niraparib) [Tesaro]

January 2018

Therapeutic Area - Oral Oncology

Initial approval criteria

• Patient is at least 18 years old AND 
• Patient is diagnosed with recurrent epithelial ovarian, fallopian tube, or primary peritoneal cancer AND 
• Zejula will be used as monotherapy AND 
• Therapy to begin no later than 8 weeks after the most recent platinum-containing regimen AND 
• Must have had complete or partial response to platinum-based chemotherapy AND 
• Prescriber must attest that female patients of reproductive potential will receive reproductive health counseling during treatment with Zejula and for at least 6 months following the last dose
• Initial approval is for 6 months

Renewal approval criteria

• Patient continues to meet initial review criteria AND 
• Patient demonstrates no disease progression AND 
• Absence of unacceptable toxicity (e.g. thrombocytopenia, anemia, neutropenia, hypertension, nausea, vomiting, abdominal pain/distention, dyspnea, fatigue/asthenia)
• Renewal approval is for 12 months

Quantity limits

102 tablets per 34 days

Questions?

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