triheptanoin

Details

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Generic Name:
triheptanoin
Project Status:
Complete
Therapeutic Area:
Long-chain fatty acid oxidation disorders
Manufacturer:
Ultragenyx Canada Inc
Brand Name:
Dojolvi
Project Line:
Reimbursement Review
Project Number:
SR0684-000
NOC Status at Filing:
Post NOC
Performance Metric:
Achieved
Biosimilar:
No
Manufacturer Requested Reimbursement Criteria1:
Ultragenyx is requesting triheptanoin be reimbursed for the treatment of adult and pediatric patients with long-chain fatty acid oxidation disorders (LC-FAOD)
Submission Type:
Initial
Fee Schedule:
Schedule A
Indications:
Dojolvi (triheptanoin) is indicated as a source of calories and fatty acids for the treatment of adult and pediatric patients with long-chain fatty acid oxidation disorders (LC-FAOD). ​
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 Milestones

Call for patient/clinician input open26-Feb-21
Call for patient/clinician input closed23-Apr-21
Clarification:

- Patient input submission received from MitoAction

Submission received31-Mar-21
Submission accepted15-Apr-21
Review initiated16-Apr-21
Draft CADTH review report(s) provided to sponsor for comment30-Jun-21
Deadline for sponsors comments12-Jul-21
CADTH responses on draft review report(s) provided to sponsor06-Aug-21
Expert committee meeting (initial)18-Aug-21
Draft recommendation issued to sponsor31-Aug-21
Draft recommendation posted for stakeholder feedback09-Sep-21
End of feedback period23-Sep-21
Clarification:

- Reconsideration: major revisions requested by sponsor

Expert committee meeting24-Nov-21
Draft recommendation posted for stakeholder feedback16-Dec-21
End of feedback period07-Jan-22
Final recommendation issued to sponsor and drug plans21-Jan-22
Final recommendation posted08-Feb-22
Deadline for sponsor to submit redaction requests on draft CADTH review report(s)04-Feb-22
CADTH review report(s) posted08-Apr-22