CDA | Evidence Driven
CDA | Evidence Driven

Venetoclax (Venclexta) in combo with Obinutuzumab for CLL - Details

Details

Files
Generic Name:
Venetoclax Obinutuzumab
Project Status:
Complete
Therapeutic Area:
Obinutuzumab for CLL
Manufacturer:
AbbVie Corporation
Brand Name:
Venclexta
Project Line:
Reimbursement Review
Project Number:
PC0212-000
NOC Status at Filing:
Pre NOC
Performance Metric:
Achieved
Strength:
10 mg, 50 mg and 100 mg
Tumour Type:
Leukemia
Indications:
Chronic Lymphocytic Leukemia (CLL)
Funding Request:
Venetoclax (VENCLEXTA) in combination with obinutuzumab for the treatment of adult patients with previously untreated chronic lymphocytic leukemia (CLL) who are fludarabine ineligible.
Pre Noc Submission:
Yes
Sponsor:
AbbVie Corporation
Submission Date:
Submission Deemed Complete:
Stakeholder Input Deadline ‡:
Check-point meeting:
pERC Meeting:
Initial Recommendation Issued:
Feedback Deadline ‡:
Notification to Implement Issued:
Recommendation Type:
Reimburse with clinical criteria and/or conditions
pERC Meeting:
Final Recommendation Issued:

Files

VENETOCLAX (VENCLEXTA) OBINUTUZUMAB CLL – pERC Final Recommendation Final Recommendation November 17, 2020 View PDF
VENETOCLAX (VENCLEXTA) OBINUTUZUMAB CLL – Final Economic Guidance Report Guidance Report November 17, 2020 View PDF
VENETOCLAX (VENCLEXTA) OBINUTUZUMAB CLL – Final Clinical Guidance Report Guidance Reports November 17, 2020 View PDF
Venetoclax (Venclexta) Obinutuzumab CLL – pERC Initial Recommendation Initial Recommendation October 29, 2020 View PDF
VENETOCLAX (VENCLEXTA) OBINUTUZUMAB CLL – PAG Feedback on Initial Recommendation Feedback November 17, 2020 View PDF
VENETOCLAX (VENCLEXTA) OBINUTUZUMAB CLL – Manufacturer Feedback on Initial Recommendation Feedback November 17, 2020 View PDF
VENETOCLAX (VENCLEXTA) OBINUTUZUMAB CLL – Patient Advocacy Group Feedback on Initial Recommendation Feedback November 17, 2020 View PDF
VENETOCLAX (VENCLEXTA) OBINUTUZUMAB CLL – Clinician Feedback on Initial Recommendation Feedback November 17, 2020 View PDF
VENETOCLAX (VENCLEXTA) OBINUTUZUMAB CLL – Patient Advocacy Group COI Declarations COI Declarations November 17, 2020 View PDF
VENETOCLAX (VENCLEXTA) OBINUTUZUMAB CLL – Clinician COI Declarations COI Declarations November 17, 2020 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 : December 2, 2020