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

Performance Metric:

Achieved

Biosimilar:

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:

January 25, 2022

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 Milestones
Call for patient/clinician input open	16-Mar-21
Call for patient/clinician input closed	07-May-21
Clarification: - Patient input submission received from Canadian Breast Cancer Network and Rethink Breast Cancer
Submission received	14-Apr-21
Submission accepted	28-Apr-21
Review initiated	29-Apr-21
Draft CADTH review report(s) provided to sponsor for comment	21-Jul-21
Deadline for sponsors comments	30-Jul-21
CADTH responses on draft review report(s) provided to sponsor	26-Aug-21
Expert committee meeting (initial)	08-Sep-21
Draft recommendation issued to sponsor	21-Sep-21
Draft recommendation posted for stakeholder feedback	01-Oct-21
End of feedback period	18-Oct-21
Clarification: - Reconsideration: major revisions requested by sponsor
Expert committee meeting	12-Jan-22
Final recommendation issued to sponsor and drug plans	25-Jan-22
Final recommendation posted	10-Feb-22
Deadline for sponsor to submit redaction requests on draft CADTH review report(s)	08-Feb-22
CADTH review report(s) posted	27-Apr-22