Amikacin Sulfate (Arikayce® liposomal nebuliser dispersion). HTA ID: 20048

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*.

Technical Summary

Plain English Summary

*This recommendation should be considered while also having regard to the criteria specified in the Health (Pricing and Supply of Medical Goods) Act 2013.