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.

The HSE has approved reimbursement following confidential price negotiations. October 2023