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DrugZejula® (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


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

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