romosozumab


( Last Updated : November 29, 2021)
Generic Name:
romosozumab
Project Status:
Active
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

Details


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 Milestones

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