Generic Name: romosozumab
Brand Name: Evenity
Manufacturer: Amgen Canada Inc.
Therapeutic Area: Osteoporosis, postmenopausal women
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.
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
NOC Status at Filing: Post NOC
Project Status: Active
Companion Diagnostics: No
Fee Schedule: Schedule A
- The requested reimbursement criteria are provided by the applicant and do not necessarily reflect the views of CADTH. Reimbursement criteria from CADTH will be documented in the final recommendation, if applicable.
Key Milestones2 |
|
|---|---|
| Call for patient/clinician input open | January 04, 2021 |
| Call for patient/clinician input closed | February 26, 2021 |
| Clarification:
- Patient input submission received from Osteoporosis Canada |
|
| Submission received | February 01, 2021 |
| Submission accepted | February 16, 2021 |
| Review initiated | February 25, 2021 |
| Draft CADTH review report(s) provided to sponsor for comment | May 11, 2021 |
| Deadline for sponsors comments | May 20, 2021 |
| CADTH responses on draft review report(s) provided to sponsor | July 09, 2021 |
| Expert committee meeting (initial) | July 21, 2021 |
| Draft recommendation issued to sponsor | August 03, 2021 To August 05, 2021 |
| Draft recommendation posted for stakeholder feedback | - |