CDA | Evidence Driven
CDA | Evidence Driven

Darzalex for Multiple Myeloma (second-line or beyond) – Details

Details

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Generic Name:
Daratumumab
Project Status:
Complete
Therapeutic Area:
Multiple Myeloma (second-line)
Manufacturer:
Janssen Inc.
Brand Name:
Darzalex
Project Line:
Reimbursement Review
Project Number:
PC0104-000
NOC Status at Filing:
Pre NOC
Performance Metric:
Achieved
Strength:
20mg/mL
Tumour Type:
Myeloma
Indications:
Multiple Myeloma (second-line or beyond)
Funding Request:
In combination with lenalidomide and dexamethasone, or bortezomib and dexamethasone, for the treatment of patients with multiple myeloma who have received at least one prior therapy
Pre Noc Submission:
Yes
Sponsor:
Janssen Inc.
Submission Date:
Submission Deemed Complete:
Prioritization Requested:
Not Requested
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

Provincial Funding Summary View PDF
Daratumumab (Darzalex) Multiple Myeloma (second-line or beyond) - pERC Final Recommendation Final Recommendation October 5, 2017 View PDF
Daratumumab (Darzalex) Multiple Myeloma (second line) - Final Clinical Guidance Report Guidance Reports October 5, 2017 View PDF
Daratumumab (Darzalex) Multiple Myeloma (second line) - Final Economic Guidance Report Guidance Reports October 5, 2017 View PDF
Daratumumab (Darzalex) Multiple Myeloma (second line) - pERC Initial Recommendation Initial Recommendation August 3, 2017 View PDF
Daratumumab (Darzalex) Multiple Myeloma (second-line or beyond) - PAG Feedback on Initial Recommendation Feedback October 5, 2017 View PDF
Daratumumab (Darzalex) Multiple Myeloma (second-line or beyond) - Manufacturer Feedback on Initial Recommendation Feedback October 5, 2017 View PDF
Daratumumab (Darzalex) Multiple Myeloma (second-line or beyond) - Patient Group Feedback on Initial Recommendation Feedback October 5, 2017 View PDF
Daratumumab (Darzalex) Multiple Myeloma (second-line or beyond) - Clinician Feedback on Initial Recommendation Feedback October 5, 2017 View PDF
Daratumumab (Darzalex) Multiple Myeloma (second-line or beyond) - Patient Group COI Declarations COI Declarations October 5, 2017 View PDF
Daratumumab (Darzalex) Multiple Myeloma (second-line or beyond) - Clinician COI Declarations COI Declarations October 5, 2017 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 : October 24, 2017