Last Updated : June 14, 2022
Details
FilesGeneric 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
Biosimilar:
No
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:
- 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 open | 02-Sep-21 |
| Call for patient/clinician input closed | 25-Oct-21 |
| Clarification: - Patient input submission received from Alpha-1 Canada | |
| Submission received | 01-Oct-21 |
| Submission accepted | 18-Oct-21 |
| Review initiated | 19-Oct-21 |
| Draft CADTH review report(s) provided to sponsor for comment | 07-Jan-22 |
| Deadline for sponsors comments | 18-Jan-22 |
| CADTH review report(s) and responses to comments provided to sponsor | 10-Feb-22 |
| Expert committee meeting (initial) | 23-Feb-22 |
| Draft recommendation issued to sponsor | 09-Mar-22 |
| Draft recommendation posted for stakeholder feedback | 17-Mar-22 |
| End of feedback period | 31-Mar-22 |
| Final recommendation issued to sponsor and drug plans | 13-Apr-22 |
| Final recommendation posted | 02-May-22 |
| Deadline for sponsor to submit redaction requests on draft CADTH review report(s) | 28-Apr-22 |
| CADTH review report(s) posted | 14-Jun-22 |
Files
Last Updated : June 14, 2022