etonogestrel

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Generic Name:

etonogestrel

Project Status:

Complete

Therapeutic Area:

Prevention of pregnancy

Manufacturer:

Merck Canada Inc.

Call for patient/clinician input open:

May 6, 2020

Brand Name:

Nexplanon

Project Line:

Reimbursement Review

Project Number:

SR0648-000

Call for patient/clinician input closed:

June 25, 2020

NOC Status at Filing:

Post NOC

Performance Metric:

Achieved

Biosimilar:

Manufacturer Requested Reimbursement Criteria¹:

Indicated for the prevention of pregnancy for up to 3 years

Submission Type:

Initial

Fee Schedule:

Schedule A

Indications:

Indicated for the prevention of pregnancy for up to 3 years

Recommendation Type:

Reimburse with clinical criteria and/or conditions

Final Recommendation:

October 20, 2020

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 input open	May 06, 2020
Call for patient input closed	June 25, 2020
Clarification: - No patient input submission received
Submission received	June 03, 2020
Clarification: Submission was previously withdrawn and has been refiled by the sponsor
Submission accepted	June 17, 2020
Review initiated	June 18, 2020
Draft Canada's Drug Agency review report(s) provided to sponsor for comment	July 31, 2020
Deadline for sponsors comments	August 12, 2020
Canada's Drug Agency responses on draft review report(s) provided to sponsor	September 03, 2020
Expert committee meeting (initial)	September 16, 2020
Draft recommendation issued to sponsor	September 28, 2020
End of embargo period	October 13, 2020
Final recommendation issued to sponsor and drug plans	October 20, 2020
Final recommendation posted	October 22, 2020
Deadline for sponsor to submit redaction requests on draft Canada's Drug Agency review report(s)	November 03, 2020
Canada's Drug Agency review report(s) posted	December 07, 2020