Last Updated : July 26, 2024
Details
FilesGeneric Name:
dostarlimab
Project Status:
Complete
Therapeutic Area:
Endometrial cancer
Manufacturer:
GlaxoSmithKline Inc.
Call for patient/clinician input open:
Brand Name:
Jemperli
Project Line:
Reimbursement Review
Project Number:
PC0325-000
Call for patient/clinician input closed:
Tumour Type:
Gynecology
NOC Status at Filing:
Pre NOC
Performance Metric:
Achieved
Biosimilar:
No
Manufacturer Requested Reimbursement Criteria1:
Jemperli (dostarlimab for injection) is indicated: in combination with platinum-containing chemotherapy for the treatment of adult patients with primary advanced or recurrent mismatch repair deficient (dMMR)/microsatellite instability-high (MSI-H) endometrial cancer.
Submission Type:
Initial
Companion Diagnostics:
Yes
Fee Schedule:
Schedule A
Indications:
Jemperli (dostarlimab for injection) is indicated in combination with carboplatin and paclitaxel for the treatment of adult patients with primary advanced or recurrent mismatch repair deficient (dMMR)/microsatellite instability-high (MSI-H) endometrial cancer who are candidates for systemic therapy.
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 | 05-Sep-23 |
|---|---|
| Call for patient/clinician input closed | 30-Oct-23 |
| Clarification: - No patient input submission received | |
| Submission received | 18-Oct-23 |
| Submission accepted | 01-Nov-23 |
| Review initiated | 02-Nov-23 |
| Draft CADTH review report(s) provided to sponsor for comment | 29-Jan-24 |
| Deadline for sponsors comments | 07-Feb-24 |
| CADTH review report(s) and responses to comments provided to sponsor | 01-Mar-24 |
| Expert committee meeting (initial) | 13-Mar-24 |
| Draft recommendation issued to sponsor | 27-Mar-24 |
| Draft recommendation posted for stakeholder feedback | 04-Apr-24 |
| End of feedback period | 18-Apr-24 |
| Final recommendation issued to sponsor and drug plans | 03-May-24 |
| Final recommendation posted | 22-May-24 |
| Deadline for sponsor to submit redaction requests on draft CADTH review report(s) | 17-May-24 |
| CADTH review report(s) posted | 24-Jul-24 |
Files
Last Updated : July 26, 2024