Amikacin Sulfate (Arikayce® liposomal nebuliser dispersion) is indicated 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.
|NCPE Assessment Process||Complete|
|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||04/01/2022|
|Full HTA Submission received from Applicant||01/04/2022|
|Preliminary review sent to Applicant||30/08/2022|
|NCPE assessment re-commenced||05/09/2022|
|Factual accuracy check 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.