triheptanoin

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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

Biosimilar:

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:

January 21, 2022

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.

Key Milestones
Call for patient/clinician input open	26-Feb-21
Call for patient/clinician input closed	23-Apr-21
Clarification: - Patient input submission received from MitoAction
Submission received	31-Mar-21
Submission accepted	15-Apr-21
Review initiated	16-Apr-21
Draft CADTH review report(s) provided to sponsor for comment	30-Jun-21
Deadline for sponsors comments	12-Jul-21
CADTH responses on draft review report(s) provided to sponsor	06-Aug-21
Expert committee meeting (initial)	18-Aug-21
Draft recommendation issued to sponsor	31-Aug-21
Draft recommendation posted for stakeholder feedback	09-Sep-21
End of feedback period	23-Sep-21
Clarification: - Reconsideration: major revisions requested by sponsor
Expert committee meeting	24-Nov-21
Draft recommendation posted for stakeholder feedback	16-Dec-21
End of feedback period	07-Jan-22
Final recommendation issued to sponsor and drug plans	21-Jan-22
Final recommendation posted	08-Feb-22
Deadline for sponsor to submit redaction requests on draft CADTH review report(s)	04-Feb-22
CADTH review report(s) posted	08-Apr-22