pertuzumab

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Generic Name:
pertuzumab
Project Status:
Complete
Therapeutic Area:
Early stage breast cancer
Manufacturer:
Hoffmann-La Roche Limited
Brand Name:
Perjeta
Project Line:
Reimbursement Review
Project Number:
PC0241-000
Tumour Type:
Breast
NOC Status at Filing:
Post NOC
Biosimilar:
No
Manufacturer Requested Reimbursement Criteria1:
Pertuzumab in combination with trastuzumab and chemotherapy for the neoadjuvant treatment of patients with HER2-positive, locally advanced, inflammatory, or early stage breast cancer (either >2 cm in diameter or node positive). Patients should receive neoadjuvant treatment with pertuzumab in combination with trastuzumab and chemotherapy for three to six cycles depending on the regimen chosen. Patients who start pertuzumab in combination with trastuzumab and chemotherapy in the neoadjuvant setting and do not have residual disease following surgery should continue to receive adjuvant trastuzumab to complete one year of HER2-directed therapy.
Submission Type:
Initial
Fee Schedule:
Schedule A
Indications:
Perjeta in combination with trastuzumab and chemotherapy for the neoadjuvant treatment of patients with HER2-positive, locally advanced, inflammatory, or early stage breast cancer (either 2 cm in diameter or node positive).
Recommendation Type:
Do not reimburse
Final Recommendation:
  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 Milestones

Call for patient/clinician input open16-Mar-21
Call for patient/clinician input closed07-May-21
Clarification:

- Patient input submission received from Canadian Breast Cancer Network and Rethink Breast Cancer

Submission received14-Apr-21
Submission accepted28-Apr-21
Review initiated29-Apr-21
Draft CADTH review report(s) provided to sponsor for comment21-Jul-21
Deadline for sponsors comments30-Jul-21
CADTH responses on draft review report(s) provided to sponsor26-Aug-21
Expert committee meeting (initial)08-Sep-21
Draft recommendation issued to sponsor21-Sep-21
Draft recommendation posted for stakeholder feedback01-Oct-21
End of feedback period18-Oct-21
Clarification:

- Reconsideration: major revisions requested by sponsor

Expert committee meeting12-Jan-22
Final recommendation issued to sponsor and drug plans25-Jan-22
Final recommendation posted10-Feb-22
Deadline for sponsor to submit redaction requests on draft CADTH review report(s)08-Feb-22
CADTH review report(s) posted27-Apr-22