Alpha1-proteinase inhibitor (Human)


( Last Updated : September 1, 2021)
Generic Name:
Alpha1-proteinase inhibitor (Human)
Project Status:
Pending
Therapeutic Area:
Severe Alpha1-proteinase inhibitor deficiency
Call for patient/clinician input open:
Brand Name:
Zemaira
Project Line:
Reimbursement Review
Project Number:
ST0702-000
Call for patient/clinician input closed:

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:
Pending
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.
Anticipated Date:
  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.