Last Updated : January 19, 2022
Details
FilesGeneric Name:
romosozumab
Project Status:
Complete
Therapeutic Area:
Osteoporosis, postmenopausal women
Manufacturer:
Amgen Canada Inc.
Brand Name:
Evenity
Project Line:
Reimbursement Review
Project Number:
SR0676-000
NOC Status at Filing:
Post NOC
Performance Metric:
N/A delay outside our control - Temporary suspension and/or submission of new information by sponsor
Biosimilar:
No
Manufacturer Requested Reimbursement Criteria1:
The treatment of osteoporosis in postmenopausal women with a history of osteoporotic fracture and who are at very high risk for future fracture.
Submission Type:
Initial
Fee Schedule:
Schedule A
Indications:
The treatment of osteoporosis in postmenopausal women at high risk for fracture, defined as a history of osteoporotic fracture, or multiple risk factors for fracture.
Date NOC Issued:
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 | 04-Jan-21 |
| Call for patient/clinician input closed | 26-Feb-21 |
| Clarification: - Patient input submission received from Osteoporosis Canada | |
| Submission received | 01-Feb-21 |
| Submission accepted | 16-Feb-21 |
| Review initiated | 25-Feb-21 |
| Clarification: - Submission temporarily suspended pending receipt of information - Additional information has been received and the temporary suspension of the review has been lifted | |
| Draft CADTH review report(s) provided to sponsor for comment | 29-Jul-21 |
| Deadline for sponsors comments | 10-Aug-21 |
| CADTH responses on draft review report(s) provided to sponsor | 10-Sep-21 |
| Expert committee meeting (initial) | 22-Sep-21 |
| Draft recommendation issued to sponsor | 05-Oct-21 |
| Draft recommendation posted for stakeholder feedback | 14-Oct-21 |
| End of feedback period | 28-Oct-21 |
| Final recommendation issued to sponsor and drug plans | 11-Nov-21 |
| Final recommendation posted | 29-Nov-21 |
| Deadline for sponsor to submit redaction requests on draft CADTH review report(s) | 25-Nov-21 |
| CADTH review report(s) posted | 19-Jan-22 |
Files
Last Updated : January 19, 2022