CADTH | Evidence Driven
CADTH | Evidence Driven

Gazyva for Follicular Lymphoma (previously untreated) – Details

Details

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Generic Name:
Obinutuzumab
Project Status:
Complete
Therapeutic Area:
Follicular Lymphoma (previously untreated)
Manufacturer:
Hoffmann-La Roche Limited
Brand Name:
Gazyva
Project Line:
Reimbursement Review
Project Number:
PC0126-000
NOC Status at Filing:
Pre NOC
Strength:
25 mg/mL
Tumour Type:
Lymphoma
Indications:
Follicular Lymphoma (previously untreated)
Funding Request:
For the treatment of patients with previously untreated stage II bulky (>7cm), III or IV follicular lymphoma (FL)
Pre Noc Submission:
Yes
Sponsor:
Hoffmann-La Roche Limited
Submission Date:
Submission Deemed Complete:
Prioritization Requested:
Requested and Not Granted
Stakeholder Input Deadline ‡:
Check-point meeting:
pERC Meeting:
Initial Recommendation Issued:
Feedback Deadline ‡:
Notification to Implement Issued:
Recommendation Type:
Do not reimburse
pERC Meeting:
Final Recommendation Issued:

Files

Provincial Funding Summary View PDF
Obinutuzumab (Gazyva) FL (previously untreated) - pERC Final Recommendation Final Recommendation November 1, 2018 View PDF
Obinutuzumab (Gazyva) FL (previously untreated) - Final Clinical Guidance Report Guidance Reports November 1, 2018 View PDF
Obinutuzumab (Gazyva) FL (previously untreated) - Final Economic Guidance Report Guidance Reports November 1, 2018 View PDF
Obinutuzumab (Gazyva) FL (previously untreated) - pERC Initial Recommendation Initial Recommendation August 30, 2018 View PDF
Obinutuzumab (Gazyva) FL (previously untreated) - PAG Feedback on pERC Initial Recommendation Feedback November 1, 2018 View PDF
Obinutuzumab (Gazyva) FL (previously untreated) - Submitter Feedback on pERC Initial Recommendation Feedback November 1, 2018 View PDF
Obinutuzumab (Gazyva) FL (previously untreated) - Clinician Feedback on pERC Initial Recommendation Feedback November 1, 2018 View PDF
Obinutuzumab (Gazyva) FL (previously untreated) - Patient COI Declarations COI Declarations November 1, 2018 View PDF
Obinutuzumab (Gazyva) FL (previously untreated) - Clinician COI Declarations COI Declarations November 1, 2018 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 : November 16, 2018