Last Updated : November 18, 2024
Details
FilesGeneric Name:
alectinib
Project Status:
Active
Therapeutic Area:
ALK-positive NSCLC
Manufacturer:
Hoffmann-La Roche Limited
Call for patient/clinician input open:
Brand Name:
Alecensaro
Project Line:
Reimbursement Review
Project Number:
PC0350-000
Call for patient/clinician input closed:
Tumour Type:
Lung
NOC Status at Filing:
Pre NOC
Performance Metric:
Achieved
Biosimilar:
No
Manufacturer Requested Reimbursement Criteria1:
Alecensaro as adjuvant treatment following tumour resection in adult patients with Stage IB (4 cm) - IIIA (according to AJCC/UICC 7th edition) anaplastic lymphoma kinase (ALK)-positive non-small cell lung cancer.
Submission Type:
Initial
Companion Diagnostics:
Yes
Fee Schedule:
Schedule A
Indications:
Alecensaro as adjuvant treatment following tumor resection for patients with anaplastic lymphoma kinase (ALK)-positive non-small cell lung cancer (NSCLC).
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.
| Call for patient/clinician input open | 06-Mar-24 |
|---|---|
| Call for patient/clinician input closed | 30-Apr-24 |
| Clarification: - Patient input submission received from Lung Cancer Canada and the Lung Health Foundation / Ontario Lung Association | |
| Submission received | 18-Apr-24 |
| Submission accepted | 03-May-24 |
| Review initiated | 06-May-24 |
| Draft CADTH review report(s) provided to sponsor for comment | 24-Jul-24 |
| Deadline for sponsors comments | 02-Aug-24 |
| CADTH review report(s) and responses to comments provided to sponsor | 29-Aug-24 |
| Expert committee meeting (initial) | 11-Sep-24 |
| Draft recommendation issued to sponsor | 23-Sep-24 |
| Draft recommendation posted for stakeholder feedback | 03-Oct-24 |
| End of feedback period | 18-Oct-24 |
| Final recommendation issued to sponsor and drug plans | 30-Oct-24 |
| Final recommendation posted | 18-Nov-24 |
| Deadline for sponsor to submit redaction requests on draft CADTH review report(s) | 14-Nov-24 |
| CADTH review report(s) posted | - |
Files
Last Updated : November 18, 2024