Human alpha1-proteinase inhibitor (Respreeza®)

Assessment Status Assessment process complete
Drug Human alpha1-proteinase inhibitor
Brand Respreeza®
Indication For maintenance treatment, to slow the progression of emphysema in adults with documented severe alpha1-proteinase inhibitor deficiency (e.g. genotypes PiZZ, PiZ(null), Pi(null, null), PiSZ). Patients are to be under optimal pharmacologic and nonpharmacological treatment and show evidence of progressive lung disease (e.g. lower forced expiratory volume per second (FEV1) predicted, impaired walking capacity or increased number of exacerbations) as evaluated by a healthcare professional experienced in the treatment of alpha1-proteinase inhibitor deficiency.
Assessment Process
Rapid review commissioned 20/01/2016
Rapid review completed 05/02/2016
Rapid review outcome Full Pharmacoeconomic Evaluation Recommended
Full pharmacoeconomic assessment commissioned by HSE 13/06/2016
NCPE assessment completed 09/12/2016
NCPE assessment outcome Reimbursement Not Recommended The manufacturer CSL Behring confirmed that the compassionate access programme is being extended until the end of January 2017 when the programme is due to end.

Technical Report

The cost-effectiveness of human alpha-1 proteinase inhibitor (Respreeza®) has not been demonstrated and therefore is not recommended for reimbursement.