Last Updated : January 6, 2023
Details
FilesGeneric Name:
pralsetinib
Project Status:
Complete
Therapeutic Area:
RET fusion-positive non-small cell lung cancer
Manufacturer:
Hoffmann-La Roche Ltd.
Brand Name:
Gavreto
Project Line:
Reimbursement Review
Project Number:
PC0283-000
Tumour Type:
Lung
NOC Status at Filing:
Post NOC
Performance Metric:
Achieved
Biosimilar:
No
Manufacturer Requested Reimbursement Criteria1:
For the treatment of adult patients with rearranged during transfection (RET) fusion-positive locally advanced unresectable or metastatic non-small cell lung cancer (NSCLC).
Submission Type:
Initial
Fee Schedule:
Schedule A
Tumour Type:
Lung
Indications:
Gavreto is indicated for the treatment of adult patients with rearranged during transfection (RET) fusion-positive locally advanced unresectable or metastatic 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.
Key Milestones2 | |
|---|---|
| Call for patient/clinician input open | February 08, 2022 |
| Call for patient/clinician input closed | April 01, 2022 |
| Clarification: - Patient input submission received from Lung Cancer Canada | |
| Submission received | March 09, 2022 |
| Submission accepted | March 23, 2022 |
| Review initiated | March 24, 2022 |
| Draft CADTH review report(s) provided to sponsor for comment | June 16, 2022 |
| Deadline for sponsors comments | June 27, 2022 |
| CADTH review report(s) and responses to comments provided to sponsor | July 28, 2022 |
| Expert committee meeting (initial) | August 10, 2022 |
| Draft recommendation issued to sponsor | August 24, 2022 |
| Draft recommendation posted for stakeholder feedback | September 01, 2022 |
| End of feedback period | September 16, 2022 |
| Final recommendation issued to sponsor and drug plans | September 29, 2022 |
| Final recommendation posted | October 18, 2022 |
| Deadline for sponsor to submit redaction requests on draft CADTH review report(s) | October 14, 2022 |
| CADTH review report(s) posted | January 06, 2023 |
Files
Last Updated : January 6, 2023