Alpha1-proteinase inhibitor (Human)


( Last Updated : June 14, 2022)
Generic Name:
Alpha1-proteinase inhibitor (Human)
Project Status:
Complete
Therapeutic Area:
Severe Alpha1-proteinase inhibitor deficiency
Manufacturer:
CSL Behring Canada, Inc.
Brand Name:
Zemaira
Project Line:
Reimbursement Review
Project Number:
ST0702-000
NOC Status at Filing:
Post NOC

Details


Manufacturer Requested Reimbursement Criteria1:
For maintenance treatment in adults with severe A1-PI deficiency and clinical evidence of emphysema. Patients are to be under optimal pharmacologic and non-pharmacologic treatment and show evidence of progressive lung disease (e.g., lower forced expiratory volume per second (FEV1) predicted, lower diffusion capacity, impaired walking capacity or increased number of exacerbations) as evaluated by a healthcare professional experienced in the treatment of A1-PI deficiency. (As per Health Canada approved Product Monograph)
Submission Type:
Initial
Fee Schedule:
Schedule A
Indications:
Indicated for maintenance treatment in adults with severe alpha1-proteinase inhibitor (A1-PI) deficiency (e.g., genotypes PiZZ, PiZ(null), Pi(null,null), PiSZ) and clinical evidence of emphysema. Patients are to be under optimal pharmacologic and non-pharmacologic treatment and show evidence of progressive lung disease (e.g., lower forced expiratory volume per second (FEV1) predicted, lower diffusion capacity, impaired walking capacity or increased number of exacerbations) as evaluated by a healthcare professional experienced in the treatment of A1-PI deficiency.
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 open02-Sep-21
Call for patient/clinician input closed25-Oct-21
Clarification:

- Patient input submission received from Alpha-1 Canada

Submission received01-Oct-21
Submission accepted18-Oct-21
Review initiated19-Oct-21
Draft CADTH review report(s) provided to sponsor for comment07-Jan-22
Deadline for sponsors comments18-Jan-22
CADTH review report(s) and responses to comments provided to sponsor10-Feb-22
Expert committee meeting (initial)23-Feb-22
Draft recommendation issued to sponsor09-Mar-22
Draft recommendation posted for stakeholder feedback17-Mar-22
End of feedback period31-Mar-22
Final recommendation issued to sponsor and drug plans13-Apr-22
Final recommendation posted02-May-22
Deadline for sponsor to submit redaction requests on draft CADTH review report(s)28-Apr-22
CADTH review report(s) posted14-Jun-22