mavacamten

Details

Files
Generic Name:
mavacamten
Project Status:
Complete
Therapeutic Area:
Obstructive hypertrophic cardiomyopathy
Manufacturer:
Bristol Myers Squibb
Brand Name:
Camzyos
Project Line:
Reimbursement Review
Project Number:
SR0755-000
NOC Status at Filing:
Pre NOC
Performance Metric:
Achieved
Biosimilar:
No
Manufacturer Requested Reimbursement Criteria1:
For the treatment of symptomatic obstructive hypertrophic cardiomyopathy (oHCM) of New York Heart Association (NYHA) Class II-III in adult patients, aligned with the pivotal phase 3 EXPLORER-HCM patient population.
Submission Type:
Initial
Fee Schedule:
Schedule A
Indications:
Treatment of symptomatic obstructive hypertrophic cardiomyopathy (oHCM) of New York Heart Association (NYHA) Class II-III in adult patients.
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 openAugust 24, 2022
Call for patient/clinician input closedOctober 17, 2022
Clarification:

- Patient input submission received from the Canadian Heart Patient Alliance and the HeartLife Foundation

Submission receivedSeptember 22, 2022
Submission acceptedOctober 06, 2022
Review initiatedOctober 07, 2022
Draft CADTH review report(s) provided to sponsor for commentJanuary 05, 2023
Deadline for sponsors commentsJanuary 16, 2023
CADTH review report(s) and responses to comments provided to sponsorFebruary 09, 2023
Expert committee meeting (initial)February 22, 2023
Draft recommendation issued to sponsorMarch 08, 2023
Draft recommendation posted for stakeholder feedbackMarch 16, 2023
End of feedback periodMarch 31, 2023
Final recommendation issued to sponsor and drug plansApril 14, 2023
Final recommendation postedMay 03, 2023
Deadline for sponsor to submit redaction requests on draft CADTH review report(s)May 01, 2023
CADTH review report(s) postedJune 23, 2023