CADTH | Evidence Driven
CADTH | Evidence Driven

romosozumab

Details

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Generic 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
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:
  1. 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 open04-Jan-21
Call for patient/clinician input closed26-Feb-21
Clarification:

- Patient input submission received from Osteoporosis Canada

Submission received01-Feb-21
Submission accepted16-Feb-21
Review initiated25-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 comment29-Jul-21
Deadline for sponsors comments10-Aug-21
CADTH responses on draft review report(s) provided to sponsor10-Sep-21
Expert committee meeting (initial)22-Sep-21
Draft recommendation issued to sponsor05-Oct-21
Draft recommendation posted for stakeholder feedback14-Oct-21
End of feedback period28-Oct-21
Final recommendation issued to sponsor and drug plans11-Nov-21
Final recommendation posted29-Nov-21
Deadline for sponsor to submit redaction requests on draft CADTH review report(s)25-Nov-21
CADTH review report(s) posted19-Jan-22

Files

Recommendation and Reasons View PDF
Clinical and Pharmacoeconomic combined Report View PDF
Patient Group Input Submissions View PDF
Stakeholder feedback on Draft Recommendation View PDF
Last Updated : January 19, 2022