darolutamide

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Generic Name:

darolutamide

Project Status:

Complete

Therapeutic Area:

Metastatic castration-sensitive prostate cancer

Manufacturer:

Bayer Inc.

Brand Name:

Nubeqa

Project Line:

Reimbursement Review

Project Number:

PC0294-000

Tumour Type:

Genitourinary

NOC Status at Filing:

Pre NOC

Biosimilar:

Manufacturer Requested Reimbursement Criteria¹:

In combination with docetaxel for the treatment of metastatic castration-sensitive prostate cancer (mCSPC) in patients who are chemotherapy-eligible.

Submission Type:

Initial

Fee Schedule:

Schedule A

Tumour Type:

Genitourinary

Indications:

For the treatment of patients with metastatic castration sensitive prostate cancer (mCSPC) in combination with docetaxel.

Recommendation Type:

Reimburse with clinical criteria and/or conditions

Final Recommendation:

January 5, 2023

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
Milestones title	Date
Call for patient/clinician input open	May 17, 2022
Call for patient/clinician input closed	July 11, 2022
Clarification: - Patient input submission received from Canadian Cancer Society and Canadian Cancer Survivor Network
Submission received	June 16, 2022
Submission accepted	June 30, 2022
Review initiated	July 04, 2022
Draft CADTH review report(s) provided to sponsor for comment	September 26, 2022
Deadline for sponsors comments	October 05, 2022
CADTH review report(s) and responses to comments provided to sponsor	October 28, 2022
Expert committee meeting (initial)	November 09, 2022
Draft recommendation issued to sponsor	November 23, 2022
Draft recommendation posted for stakeholder feedback	December 01, 2022
End of feedback period	December 15, 2022
Final recommendation issued to sponsor and drug plans	January 05, 2023
Final recommendation posted	January 23, 2023
Deadline for sponsor to submit redaction requests on draft CADTH review report(s)	January 19, 2023
CADTH review report(s) posted	March 28, 2023

Last Updated : March 28, 2023