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romosozumab

Last Updated: March 11, 2021
Result type: Reports
Project Number: SR0676-000
Product Line: Reimbursement Review

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

  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 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 -