| Assessment Status | Assessment process complete |
| HTA ID | - |
| 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. |
The cost-effectiveness of human alpha-1 proteinase inhibitor (Respreeza®) has not been demonstrated and therefore is not recommended for reimbursement.
