polatuzumab vedotin

Details

Generic Name:
polatuzumab vedotin
Project Status:
Active
Therapeutic Area:
Large B-cell lymphoma
Manufacturer:
Hoffmann La-Roche
Call for patient/clinician input open:
Brand Name:
Polivy
Project Line:
Reimbursement Review
Project Number:
PC0313-000
Call for patient/clinician input closed:
Tumour Type:
Lymphoma
NOC Status at Filing:
Post NOC
Biosimilar:
No
Manufacturer Requested Reimbursement Criteria1:
Polatuzumab vedotin in combination with rituximab, cyclophosphamide, doxorubicin, and prednisone (R-CHP) for the treatment of adult patients with previously untreated large B-cell lymphoma (LBCL), including diffuse large B-cell lymphoma (DLBCL) not otherwise specified (NOS), high grade B-cell lymphoma, Epstein-Barr virus-positive (EBV+) DLBCL NOS, and T-cell/histiocyte rich LBCL.
Submission Type:
Initial
Fee Schedule:
Schedule A
Indications:
Polatuzumab vedotin in combination with rituximab, cyclophosphamide, doxorubicin, and prednisone (R-CHP) for the treatment of adult patients with previously untreated large B-cell lymphoma (LBCL), including diffuse large B-cell lymphoma (DLBCL) not otherwise specified (NOS), high grade B-cell lymphoma, Epstein-Barr virus-positive (EBV+) DLBCL NOS, and T-cell/histiocyte rich LBCL.
Date NOC Issued:
  1. 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 open31-Jan-23
Call for patient/clinician input closed27-Mar-23
Clarification:

- Patient input submission received from Lymphoma Canada

Submission received01-Mar-23
Submission accepted15-Mar-23
Review initiated16-Mar-23
Draft CADTH review report(s) provided to sponsor for comment02-Jun-23
Deadline for sponsors comments13-Jun-23
CADTH review report(s) and responses to comments provided to sponsor27-Jul-23
Expert committee meeting (initial)09-Aug-23
Draft recommendation issued to sponsor22-Aug-23
Draft recommendation posted for stakeholder feedback31-Aug-23
End of feedback period15-Sep-23
Clarification:

- Reconsideration: major revisions requested by sponsor