daratumumab

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Generic Name:
daratumumab
Project Status:
Complete
Therapeutic Area:
Light chain (AL) amyloidosis
Manufacturer:
Janssen Inc.
Brand Name:
Darzalex
Project Line:
Reimbursement Review
Project Number:
PC0257-000
Tumour Type:
Other
NOC Status at Filing:
Post NOC
Performance Metric:
Achieved
Biosimilar:
No
Manufacturer Requested Reimbursement Criteria1:
Darzalex SC in combination with bortezomib, cyclophosphamide, and dexamethasone, for the treatment of adult patients with newly diagnosed light chain (AL) amyloidosis
Submission Type:
Initial
Fee Schedule:
Schedule A
Indications:
Darzalex SC in combination with bortezomib, cyclophosphamide, and dexamethasone, for the treatment of adult patients with newly diagnosed light chain (AL) amyloidosis.
Recommendation Type:
Reimburse with clinical criteria and/or conditions
Final Recommendation:
  1. The requested reimbursement criteria are provided by the applicant and do not necessarily reflect the views of Canada's Drug Agency. Reimbursement criteria from Canada's Drug Agency will be documented in the final recommendation, if applicable.

Key Milestones2

Call for patient/clinician input open16-Jun-21
Call for patient/clinician input closed09-Aug-21
Clarification:

- Patient input submission received from Myeloma Canada

Submission received15-Jul-21
Submission accepted29-Jul-21
Review initiated30-Jul-21
Draft CADTH review report(s) provided to sponsor for comment20-Oct-21
Deadline for sponsors comments29-Oct-21
CADTH review report(s) and responses to comments provided to sponsor19-Nov-21
Expert committee meeting (initial)01-Dec-21
Draft recommendation issued to sponsor15-Dec-21
Draft recommendation posted for stakeholder feedback23-Dec-21
End of feedback period14-Jan-22
Final recommendation posted15-Feb-22
Deadline for sponsor to submit redaction requests on draft CADTH review report(s)11-Feb-22
CADTH review report(s) posted16-May-22