triheptanoin


( Last Updated : September 9, 2021)
Generic Name:
triheptanoin
Project Status:
Active
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

Details


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). ​
  1. 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.

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Key Milestones2

Call for patient/clinician input open February 26, 2021
Call for patient/clinician input closed April 23, 2021
Clarification:

- Patient input submission received from MitoAction

Submission received March 31, 2021
Submission accepted April 15, 2021
Review initiated April 16, 2021
Draft CADTH review report(s) provided to sponsor for comment June 30, 2021
Deadline for sponsors comments July 12, 2021
CADTH responses on draft review report(s) provided to sponsor August 06, 2021
Expert committee meeting (initial) August 18, 2021
Draft recommendation issued to sponsor August 31, 2021
Draft recommendation posted for stakeholder feedback September 9, 2021
End of feedback period September 23, 2021