Canada’s Drug Agency | Drugs, Health Technologies and Systems.
Canada’s Drug Agency | Drugs, Health Technologies and Systems.

alectinib

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Generic 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:
  1. 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 Milestones2
Call for patient/clinician input openMarch 06, 2024
Call for patient/clinician input closedApril 30, 2024
Clarification:

- Patient input submission received from Lung Cancer Canada and the Lung Health Foundation / Ontario Lung Association

Submission receivedApril 18, 2024
Submission acceptedMay 03, 2024
Review initiatedMay 06, 2024
Draft Canada's Drug Agency review report(s) provided to sponsor for commentJuly 24, 2024
Deadline for sponsors commentsAugust 02, 2024
Canada's Drug Agency review report(s) and responses to comments provided to sponsorAugust 29, 2024
Expert committee meeting (initial)September 11, 2024
Draft recommendation issued to sponsorSeptember 23, 2024
Draft recommendation posted for stakeholder feedbackOctober 03, 2024
End of feedback periodOctober 18, 2024
Final recommendation issued to sponsor and drug plansOctober 30, 2024
Final recommendation postedNovember 18, 2024
Deadline for sponsor to submit redaction requests on draft Canada's Drug Agency review report(s)November 14, 2024
Canada's Drug Agency review report(s) posted-

Files

Recommendation and Reason View PDF
Patient, Clinician and Industry Group Input View PDF
Last Updated : January 22, 2025