CDA | Evidence Driven
CDA | Evidence Driven

palovarotene

Details

Files
Generic Name:
palovarotene
Project Status:
Complete
Therapeutic Area:
Fibrodysplasia Ossificans Progressiva
Manufacturer:
Ipsen Biopharmaceuticals Canada, Inc.
Brand Name:
Sohonos
Project Line:
Reimbursement Review
Project Number:
SR0761-000
NOC Status at Filing:
Post NOC
Performance Metric:
Achieved
Biosimilar:
No
Manufacturer Requested Reimbursement Criteria1:
Sohonos (palovarotene capsules) is indicated to reduce the formation of heterotopic ossification in adults and children aged 8 years and above for females and 10 years and above for males with Fibrodysplasia (myositis) Ossificans Progressiva.
Submission Type:
Initial
Fee Schedule:
Schedule E
Indications:
​Sohonos (palovarotene capsules) is indicated to reduce the formation of heterotopic ossification in adults and children aged 8 years and above for females and 10 years and above for males with Fibrodysplasia (myositis) Ossificans Progressiva.
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 openSeptember 22, 2022
Call for patient/clinician input closedNovember 11, 2022
Clarification:

- Patient input submission received from The Canadian FOP Network (CFOPN) & The Canadian Organization for Rare Disorders (CORD)

Submission receivedOctober 21, 2022
Submission acceptedNovember 04, 2022
Review initiatedNovember 07, 2022
Draft CADTH review report(s) provided to sponsor for commentFebruary 06, 2023
Deadline for sponsors commentsFebruary 15, 2023
CADTH review report(s) and responses to comments provided to sponsorMarch 09, 2023
Expert committee meeting (initial)March 22, 2023
Draft recommendation issued to sponsorApril 05, 2023
Draft recommendation posted for stakeholder feedbackApril 13, 2023
End of feedback periodApril 27, 2023
Final recommendation issued to sponsor and drug plansMay 11, 2023
Final recommendation postedMay 30, 2023
Deadline for sponsor to submit redaction requests on draft CADTH review report(s)May 26, 2023
CADTH review report(s) postedAugust 01, 2023

Files

Recommendation and Reasons View PDF
Clinical, Pharmacoeconomic, Ethics, and Stakeholder Input Combined Report View PDF
Stakeholder Feedback on Draft Recommendation View PDF
Last Updated : August 1, 2023