CADTH | Evidence Driven
CADTH | Evidence Driven

Trastuzumab emtansine for Metastatic Breast Cancer - Details

Details

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Generic Name:
Trastuzumab emtansine
Project Status:
Complete
Therapeutic Area:
Advanced or Metastatic Breast Cancer
Manufacturer:
Hoffman-La Roche Ltd.
Brand Name:
Kadcyla
Project Line:
Reimbursement Review
Project Number:
PC0024-000
Strength:
100mg and 160 mg vial
Tumour Type:
Breast
Indications:
Metastatic Breast Cancer
Funding Request:
The treatment of patients with HER2-positive, unresectable locally advanced or metastatic breast cancer who have received prior treatment with trastuzumab and a taxane
Review Status:
Complete
Pre Noc Submission:
Yes
Sponsor:
Hoffman-La Roche Ltd.
Submission Date:
Submission Deemed Complete:
Prioritization Requested:
Requested and Granted
Stakeholder Input Deadline ‡:
Check-point meeting:
pERC Meeting:
Initial Recommendation Issued:
Feedback Deadline ‡:
Notification to Implement Issued:
Clarification:
A delay in the receipt of marketing authorization (NOC) from Health Canada has impacted the review timeline.
Recommendation Type:
Reimburse with clinical criteria and/or conditions
Clarification:
A delay in the receipt of marketing authorization (NOC) from Health Canada has impacted the review timeline.
pERC Meeting:
Final Recommendation Issued:

Files

Provincial Funding Summary View PDF
Trastuzumab emtansine (Kadcyla) for MBC - Partially Unredacted pERC Final Recommendation Final Recommendation January 10, 2014 View PDF
Trastuzumab emtansine (Kadcyla) for MBC - Final Clinical Guidance Report Guidance Reports January 10, 2014 View PDF
Trastuzumab emtansine (Kadcyla) for MBC - Final Economic Guidance Report Guidance Reports January 10, 2014 View PDF
Trastuzumab emtansine (Kadcyla) for MBC - pERC Initial Recommendation Initial Recommendation October 31, 2013 View PDF
Trastuzumab emtansine (Kadcyla) for MBC - PAG Feedback on Initial Recommendation Feedback January 10, 2014 View PDF
Trastuzumab emtansine (Kadcyla) for MBC - Manufacturer (Hoffman-La Roche Ltd.) Feedback on Initial Recommendation Feedback January 10, 2014 View PDF
Trastuzumab emtansine (Kadcyla) for MBC - Patient Advocacy Group (CBCN) COI Declarations Feedback January 10, 2014 View PDF
Trastuzumab emtansine (Kadcyla) for MBC - Patient Advocacy Group (ReBC) COI Declarations Feedback January 10, 2014 View PDF

‡ Patient Advocacy Groups (or individual patients and caregivers when there is no patient group) and Clinicians who are registered with pCODR are eligible to provide Input and Feedback. Deadlines for Input and Feedback are by the end of the pCODR business day (5P.M. Eastern Time) of the date noted.

Last Updated : January 27, 2014