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

Biosimilar:

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:

January 28, 2022

The requested reimbursement criteria are provided by the applicant and do not necessarily reflect the views of CADTH. Reimbursement criteria from CADTH will be documented in the final recommendation, if applicable.

Key Milestones²
Call for patient/clinician input open	16-Jun-21
Call for patient/clinician input closed	09-Aug-21
Clarification: - Patient input submission received from Myeloma Canada
Submission received	15-Jul-21
Submission accepted	29-Jul-21
Review initiated	30-Jul-21
Draft CADTH review report(s) provided to sponsor for comment	20-Oct-21
Deadline for sponsors comments	29-Oct-21
CADTH review report(s) and responses to comments provided to sponsor	19-Nov-21
Expert committee meeting (initial)	01-Dec-21
Draft recommendation issued to sponsor	15-Dec-21
Draft recommendation posted for stakeholder feedback	23-Dec-21
End of feedback period	14-Jan-22
Final recommendation posted	15-Feb-22
Deadline for sponsor to submit redaction requests on draft CADTH review report(s)	11-Feb-22
CADTH review report(s) posted	16-May-22