CDA | Evidence Driven
CDA | Evidence Driven

Keytruda Metastatic Urothelial Carcinoma (first line) – Details

Details

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Generic Name:
Pembrolizumab
Project Status:
Complete
Therapeutic Area:
MUC First line
Manufacturer:
Merck Canada
Brand Name:
Keytruda
Project Line:
Reimbursement Review
Project Number:
PC0177-000
NOC Status at Filing:
Pre NOC
Strength:
25 mg/mL
Tumour Type:
Genitourinary
Indications:
Metastatic Urothelial Carcinoma (first line)
Funding Request:
For the treatment of patients with locally advanced or metastatic urothelial carcinoma, as monotherapy, in adults who are not eligible for cisplatin-containing chemotherapy and whose tumours express PD‑L1 [Combined Positive Score (CPS) ≥10] as determined by a validated test, or in patients who are not eligible for any platinum‑containing chemotherapy regardless of PD‑L1 status
Pre Noc Submission:
Yes
Sponsor:
Merck Canada
Submission Date:
Stakeholder Input Deadline ‡:
Check-point meeting (target date):
pERC Meeting:
Initial Recommendation Issued:
Feedback Deadline ‡:
Notification to Implement Issued:
Recommendation Type:
Do not reimburse
pERC Meeting:
Final Recommendation Issued:

Files

Provincial Funding Summary View PDF
Pembrolizumab (Keytruda) for MUC (First line) – pERC Final Recommendation Final Recommendation October 3, 2019 View PDF
Pembrolizumab (Keytruda) for MUC (First line) – Final Economic Guidance Report Guidance Reports October 3, 2019 View PDF
Pembrolizumab (Keytruda) for MUC (First line) – Final Clinical Guidance Report Guidance Reports October 3, 2019 View PDF
Pembrolizumab (Keytruda) for MUC (First line) – pERC Initial Recommendation Initial Recommendation August 1, 2019 View PDF
Pembrolizumab (Keytruda) for MUC (First line) – PAG Feedback on Initial Recommendation Feedback October 3, 2019 View PDF
Pembrolizumab (Keytruda) for MUC (First line) – Manufacturer Feedback on Initial Recommendation Feedback October 3, 2019 View PDF
Pembrolizumab (Keytruda) for MUC (First line) – Patient Advocacy Group Feedback on Initial Recommendation Feedback October 3, 2019 View PDF
Pembrolizumab (Keytruda) for MUC (First line) – Clinician Feedback on Initial Recommendation Feedback October 3, 2019 View PDF
Pembrolizumab (Keytruda) for MUC (First line) – Patient Advocacy Group COI Declarations COI Declarations October 3, 2019 View PDF
Pembrolizumab (Keytruda) for MUC (First line) – Clinician COI Declarations COI Declarations October 3, 2019 View PDF

‡ Patient Advocacy Groups (or individual patients and caregivers when there is no patient group) and Clinicians who are registered with pCODR are eligible to provide Input and Feedback. Deadlines for Input and Feedback are by the end of the pCODR business day (5P.M. Eastern Time) of the date noted.

Last Updated : October 21, 2019