selpercatinib

Details

Files
Generic 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:
  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 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