| Assessment Status | 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.
