| Assessment Status | NCPE Assessment Process Complete |
| HTA ID | 20048 |
| Drug | Amikacin Sulfate |
| Brand | Arikayce® liposomal nebuliser dispersion |
| Indication | For the treatment of non-tuberculous mycobacterial (NTM) lung infections caused by Mycobacterium avium Complex (MAC) in adults with limited treatment options who do not have cystic fibrosis. |
| Assessment Process | |
| Rapid review commissioned | 28/10/2020 |
| Rapid review completed | 18/12/2020 |
| Rapid review outcome | A full HTA is recommended to assess the clinical effectiveness and cost effectiveness of amikacin sulfate (Arikayce® liposomal nebuliser dispersion (ALND) compared with the current standard of care, on the basis of the proposed price relative to currently available therapies. |
| Full pharmacoeconomic assessment commissioned by HSE | 04/01/2021 |
| Pre-submission consultation with Applicant | 06/12/2021 |
| Full submission received from Applicant | 01/04/2022 |
| Preliminary review sent to Applicant | 30/08/2022 |
| NCPE assessment re-commenced | 05/09/2022 |
| Factual accuracy sent to Applicant | 08/12/2022 |
| NCPE assessment re-commenced | 16/12/2022 |
| NCPE assessment completed | 20/12/2022 |
| NCPE assessment outcome | The NCPE recommends that inhaled liposomal amikacin, in addition to guideline-based therapy, for the treatment of adult patients with NTM lung infections caused by MAC and who have failed at least six months of guideline-based therapy, be considered for reimbursement if cost-effectiveness can be improved relative to existing treatments*. |
*This recommendation should be considered while also having regard to the criteria specified in the Health (Pricing and Supply of Medical Goods) Act 2013.
The HSE has approved reimbursement following confidential price negotiations. October 2023