CDA | Evidence Driven
CDA | Evidence Driven

Darzalex in combo with Bortezomib, Melphalan and Prednisone for Multiple Myeloma (newly diagnosed) – Details

Details

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Generic Name:
Daratumumab
Project Status:
Complete
Therapeutic Area:
BMP for Multiple Myeloma (newly diagnosed)
Manufacturer:
Janssen Inc.
Brand Name:
Darzalex
Project Line:
Reimbursement Review
Project Number:
PC0148-000
NOC Status at Filing:
Post NOC
Performance Metric:
Achieved
Strength:
100 mg/5mL and 400 mg/20mL
Tumour Type:
Myeloma
Indications:
Multiple Myeloma (newly diagnosed)
Funding Request:
In combination with bortezomib, melphalan and prednisone, for the treatment of patients with newly diagnosed multiple myeloma who are not suitable for autologous stem cell transplant
Sponsor:
Janssen Inc.
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

Provincial Funding Summary View PDF
Daratumumab (Darzalex)+BMP for MM – pERC Final Recommendation Final Recommendation August 29, 2019 View PDF
Daratumumab (Darzalex)+BMP for MM – Final Economic Guidance Report Guidance Reports August 29, 2019 View PDF
Daratumumab (Darzalex)+BMP for MM – Final Clinical Guidance Report Guidance Reports August 29, 2019 View PDF
Daratumumab (Darzalex)+BMP for MM – pERC Initial Recommendation Initial Recommendation July 5, 2019 View PDF
Daratumumab (Darzalex)+BMP for MM – PAG Feedback on Initial Recommendation Feedback August 29, 2019 View PDF
Daratumumab (Darzalex)+BMP for MM – Manufacturer Feedback on Initial Recommendation Feedback August 29, 2019 View PDF
Daratumumab (Darzalex)+BMP for MM – Patient Advocacy Group Feedback on Initial Recommendation Feedback August 29, 2019 View PDF
Daratumumab (Darzalex)+BMP for MM – Clinician Feedback on Initial Recommendation Feedback August 29, 2019 View PDF
Daratumumab (Darzalex)+BMP for MM – Patient Advocacy Group COI Declarations COI Declarations August 29, 2019 View PDF
Daratumumab (Darzalex)+BMP for MM – Clinician COI Declarations COI Declarations August 29, 2019 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 : September 16, 2019