sodium phenylbutyrate and ursodoxicoltaurine


( Last Updated : October 24, 2022)
Generic Name:
sodium phenylbutyrate and ursodoxicoltaurine
Project Status:
Complete
Therapeutic Area:
Amyotrophic lateral sclerosis (ALS)
Manufacturer:
Amylyx Canada
Brand Name:
Albrioza
Project Line:
Reimbursement Review
Project Number:
SR0711-000
NOC Status at Filing:
Pre NOC

Details

Manufacturer Requested Reimbursement Criteria1:
For the treatment of patients with amyotrophic lateral sclerosis (ALS).
Submission Type:
Initial
Fee Schedule:
Schedule A
Indications:
For the treatment of patients with amyotrophic lateral sclerosis (ALS).
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 CADTH. Reimbursement criteria from CADTH will be documented in the final recommendation, if applicable.

Key Milestones2

Call for patient/clinician input open27-Oct-21
Call for patient/clinician input closed16-Dec-21
Clarification:

- Patient input submission received from The ALS Society of Canada and ALS Action Canada

Submission received24-Nov-21
Submission accepted08-Dec-21
Review initiated09-Dec-21
Draft CADTH review report(s) provided to sponsor for comment07-Mar-22
Deadline for sponsors comments16-Mar-22
CADTH review report(s) and responses to comments provided to sponsor12-May-22
Expert committee meeting (initial)25-May-22
Draft recommendation issued to sponsor13-Jun-22
Draft recommendation posted for stakeholder feedback23-Jun-22
End of feedback period08-Jul-22
Final recommendation issued to sponsor and drug plans21-Jul-22
Final recommendation posted08-Aug-22
Deadline for sponsor to submit redaction requests on draft CADTH review report(s)05-Aug-22
CADTH review report(s) posted21-Oct-22

Files

Recommendation and Reasons

Clinical and Pharmacoeconomic combined Report

Stakeholder feedback on Draft Recommendation