Last Updated : December 21, 2021
Details
FilesGeneric Name:
tucatinib
Project Status:
Complete
Therapeutic Area:
Advanced or Metastatic Breast Cancer
Manufacturer:
Seagen Canada Inc.
Call for patient/clinician input open:
Brand Name:
Tukysa
Project Line:
Reimbursement Review
Project Number:
PC0243-000
Call for patient/clinician input closed:
Tumour Type:
Breast
NOC Status at Filing:
Post NOC
Biosimilar:
No
Manufacturer Requested Reimbursement Criteria1:
In combination with trastuzumab and capecitabine for treatment of patients with locally advanced unresectable or metastatic HER2-positive breast cancer, including patients with brain metastases, who have received prior treatment with trastuzumab, pertuzumab, and trastuzumab emtansine, separately or in combination.
Submission Type:
Initial
Fee Schedule:
Schedule A
Indications:
Tucatinib is indicated in combination with trastuzumab and capecitabine for treatment of patients with locally advanced unresectable or metastatic HER2-positive breast cancer, including patients with brain metastases, who have received prior treatment with trastuzumab, pertuzumab, and trastuzumab emtansine, separately or in combination.
Date NOC Issued:
Recommendation Type:
Reimburse with clinical criteria and/or conditions
Final Recommendation:
- 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 | February 26, 2021 |
| Clarification:
- Patient input submission received from Canadian Breast Cancer Network and Rethink Breast Cancer |
|
| Call for patient/clinician input closed | April 23, 2021 |
| Submission received | March 26, 2021 |
| Submission accepted | April 12, 2021 |
| Review initiated | April 13, 2021 |
| Draft CADTH review report(s) provided to sponsor for comment | June 25, 2021 |
| Deadline for sponsors comments | July 07, 2021 |
| CADTH responses on draft review report(s) provided to sponsor | August 26, 2021 |
| Expert committee meeting (initial) | September 08, 2021 |
| Draft recommendation posted for stakeholder feedback | October 1, 2021 |
| End of feedback period | October 18, 2021 |
| Final recommendation issued to sponsor and drug plans | November 01, 2021 |
| Final recommendation posted | November 17, 2021 |
| Deadline for sponsor to submit redaction requests on draft CADTH review report(s) | November 15, 2021 |
| CADTH review report(s) posted | January 13, 2022 |
Files
Last Updated : December 21, 2021