Last Updated : June 23, 2023
Details
FilesGeneric 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
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:
- 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.
| Call for patient/clinician input open | August 24, 2022 |
|---|---|
| Call for patient/clinician input closed | October 17, 2022 |
| Clarification: - Patient input submission received from the Canadian Heart Patient Alliance and the HeartLife Foundation | |
| Submission received | September 22, 2022 |
| Submission accepted | October 06, 2022 |
| Review initiated | October 07, 2022 |
| Draft CADTH review report(s) provided to sponsor for comment | January 05, 2023 |
| Deadline for sponsors comments | January 16, 2023 |
| CADTH review report(s) and responses to comments provided to sponsor | February 09, 2023 |
| Expert committee meeting (initial) | February 22, 2023 |
| Draft recommendation issued to sponsor | March 08, 2023 |
| Draft recommendation posted for stakeholder feedback | March 16, 2023 |
| End of feedback period | March 31, 2023 |
| Final recommendation issued to sponsor and drug plans | April 14, 2023 |
| Final recommendation posted | May 03, 2023 |
| Deadline for sponsor to submit redaction requests on draft CADTH review report(s) | May 01, 2023 |
| CADTH review report(s) posted | June 23, 2023 |
Files
Last Updated : June 23, 2023