pembrolizumab

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Generic Name:
pembrolizumab
Project Status:
Complete
Therapeutic Area:
Melanoma Adjuvant Treatment
Manufacturer:
Merck Canada Inc.
Brand Name:
Keytruda
Project Line:
Reimbursement Review
Project Number:
PC0286-000
Tumour Type:
Skin & Melanoma
NOC Status at Filing:
Pre NOC
Performance Metric:
Achieved
Biosimilar:
No
Manufacturer Requested Reimbursement Criteria1:
Pembrolizumab is indicated for the adjuvant treatment of adult and pediatric (12 years and older) patients with Stage IIB or IIC melanoma following complete resection.
Submission Type:
Initial
Fee Schedule:
Schedule A
Tumour Type:
Skin & Melanoma
Indications:
Pembrolizumab is indicated for the adjuvant treatment of adult and pediatric (12 years and older) patients with Stage IIB or IIC melanoma following complete resection.
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 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/clinician input openMarch 28, 2022
Call for patient/clinician input closedMay 20, 2022
Clarification:

- Patient input submission received from Melanoma Canada and Save Your Skin Foundation>

Submission receivedApril 26, 2022
Submission accepted
Review initiatedMay 11, 2022
Draft CADTH review report(s) provided to sponsor for commentJuly 26, 2022
Deadline for sponsors commentsAugust 05, 2022
CADTH review report(s) and responses to comments provided to sponsorSeptember 01, 2022
Expert committee meeting (initial)September 14, 2022
Draft recommendation issued to sponsorSeptember 28, 2022
Draft recommendation posted for stakeholder feedbackOctober 06, 2022
End of feedback periodOctober 21, 2022
Final recommendation issued to sponsor and drug plansNovember 04, 2022
Final recommendation postedNovember 22, 2022
Deadline for sponsor to submit redaction requests on draft CADTH review report(s)November 18, 2022
CADTH review report(s) postedFebruary 06, 2023