Last Updated : July 13, 2022
Details
FilesGeneric Name:
selpercatinib
Project Status:
Complete
Therapeutic Area:
RET fusion-positive non-small cell lung cancer
Manufacturer:
Eli Lilly Canada Inc.
Call for patient/clinician input open:
Brand Name:
Retevmo
Project Line:
Reimbursement Review
Project Number:
PC0261-000
Call for patient/clinician input closed:
Tumour Type:
Lung
NOC Status at Filing:
Post NOC
Performance Metric:
Achieved
Biosimilar:
No
Manufacturer Requested Reimbursement Criteria1:
As monotherapy for the first-line treatment of adult patients with metastatic RET fusion-positive non-small cell lung cancer (NSCLC).
As monotherapy for the treatment of adult patients with metastatic RET fusion-positive non-small cell lung cancer (NSCLC) and who have received prior systemic therapy.
Submission Type:
Initial
Fee Schedule:
Schedule A
Indications:
Indicated as monotherapy for the treatment of metastatic RET fusion-positive non-small cell lung cancer (NSCLC) in adult patients.
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 Milestones2 |
|
|---|---|
| Call for patient/clinician input open | 19-Jul-21 |
| Call for patient/clinician input closed | 13-Sep-21 |
| Clarification:
- Patient input submission received from the Canadian Lung Cancer Advocacy Group Breathe Hope, CanCertainty and Lung Cancer Canada |
|
| Submission received | 17-Aug-21 |
| Submission accepted | 25-Oct-21 |
| Clarification:
- Submission was not accepted for review on 31 Aug 21 |
|
| Review initiated | 26-Oct-21 |
| Draft CADTH review report(s) provided to sponsor for comment | 20-Jan-22 |
| Deadline for sponsors comments | 31-Jan-22 |
| CADTH review report(s) and responses to comments provided to sponsor | 25-Feb-22 |
| Expert committee meeting (initial) | 09-Mar-22 |
| Draft recommendation issued to sponsor | 22-Mar-22 |
| Draft recommendation posted for stakeholder feedback | 31-Mar-22 |
| End of feedback period | 14-Apr-22 |
| Final recommendation issued to sponsor and drug plans | 28-Apr-22 |
| Final recommendation posted | 16-May-22 |
| Deadline for sponsor to submit redaction requests on draft CADTH review report(s) | 12-May-22 |
| CADTH review report(s) posted | 13-Jul-22 |
Files
Last Updated : July 13, 2022