sodium phenylbutyrate and ursodoxicoltaurine

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Generic Name:

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

Performance Metric:

N/A delay outside our control - Application delayed at sponsor’s request

Biosimilar:

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:

July 21, 2022

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 open	27-Oct-21
Call for patient/clinician input closed	16-Dec-21
Clarification: - Patient input submission received from The ALS Society of Canada and ALS Action Canada
Submission received	24-Nov-21
Submission accepted	08-Dec-21
Review initiated	09-Dec-21
Draft CADTH review report(s) provided to sponsor for comment	07-Mar-22
Deadline for sponsors comments	16-Mar-22
CADTH review report(s) and responses to comments provided to sponsor	12-May-22
Expert committee meeting (initial)	25-May-22
Draft recommendation issued to sponsor	13-Jun-22
Draft recommendation posted for stakeholder feedback	23-Jun-22
End of feedback period	08-Jul-22
Final recommendation issued to sponsor and drug plans	21-Jul-22
Final recommendation posted	08-Aug-22
Deadline for sponsor to submit redaction requests on draft CADTH review report(s)	05-Aug-22
CADTH review report(s) posted	21-Oct-22

Last Updated : October 24, 2022