CDA | Evidence Driven
CDA | Evidence Driven

Niraparib (Zejula) for first line Ovarian Cancer - Details

Details

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Generic Name:
Niraparib
Project Status:
Complete
Therapeutic Area:
First Line OC
Manufacturer:
GlaxoSmithKline Inc.
Brand Name:
Zejula
Project Line:
Reimbursement Review
Project Number:
PC0224-000
NOC Status at Filing:
Pre NOC
Performance Metric:
Achieved
Strength:
100 mg
Tumour Type:
Gynecology
Indications:
Ovarian Cancer
Funding Request:
Maintenance treatment of adult patients with advanced epithelial ovarian, fallopian tube, or primary peritoneal cancer who are in a complete or partial response to first-line platinum-based chemotherapy
Review Status:
Final Recommendation Posted
Pre Noc Submission:
Yes
Sponsor:
GlaxoSmithKline Inc.
Submission Date:
Submission Deemed Complete:
Stakeholder Input Deadline ‡:
Check-point meeting:
pERC Meeting:
Initial Recommendation Issued:
Feedback Deadline ‡:
Recommendation Type:
Reimburse with clinical criteria and/or conditions
pERC Meeting:
Final Recommendation:

Files

Niraparib (Zejula) first line OC – pERC Final Recommendation Final Recommendation April 29, 2021 View PDF
Niraparib (Zejula) first line OC – Final Economic Guidance Report Guidance Report April 29, 2021 View PDF
Niraparib (Zejula) first line OC – Final Clinical Guidance Report Guidance Report April 29, 2021 View PDF
Niraparib (Zejula) first line OC – pERC Initial Recommendation Initial Recommendation March 4, 2021 View PDF
Niraparib (Zejula) first line OC – PAG Feedback on Initial Recommendation Feedback April 29, 2021 View PDF
Niraparib (Zejula) first line OC – Manufacturer Feedback on Initial Recommendation Feedback April 29, 2021 View PDF
Niraparib (Zejula) first line OC – Patient Advocacy Group Feedback on Initial Recommendation Feedback April 29, 2021 View PDF
Niraparib (Zejula) first line OC – Clinician Feedback on Initial Recommendation Feedback April 29, 2021 View PDF
Niraparib (Zejula) first line OC – Patient Advocacy Group COI Declarations COI Declarations April 29, 2021 View PDF
Niraparib (Zejula) first line OC – Clinician COI Declarations COI Declarations April 29, 2021 View PDF

‡ Patient Advocacy Groups (or individual patients and caregivers when there is no patient group) and Clinicians who are registered with pCODR are eligible to provide Input and Feedback. Deadlines for Input and Feedback are by the end of the pCODR business day (5P.M. Eastern Time) of the date noted.

Last Updated : April 29, 2021