Advice

following a full submission considered under the orphan medicine process:

amikacin liposomal nebuliser dispersion (Arikayce®) is not recommended for use within NHSScotland.

Indication under review: 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. Consideration should be given to official guidance on the appropriate use of antibacterial agents.

The addition of amikacin liposomal nebuliser dispersion to standard oral guideline-based therapy for MAC NTM lung infections significantly increased the proportion of patients achieving sputum culture conversion at 6 months and post-treatment at 3 months.

The submitting company’s justification of the treatment’s cost in relation to its health benefits was not sufficient and in addition the company did not present a sufficiently robust economic analysis to gain acceptance by SMC.

This advice takes account of views from a Patient and Clinician Engagement (PACE) meeting.

Medicine details

Medicine name:
amikacin (Arikayce)
SMC ID:
SMC2369
Indication:

Non-tuberculous mycobacterial (NTM) lung infections caused by Mycobacterium avium Complex (MAC) in adults with limited treatment options who do not have cystic fibrosis. Consideration should be given to official guidance on the appropriate use of antibacterial agents.

Pharmaceutical company
Insmed
BNF chapter
Respiratory system
Submission type
Full
Status
Not recommended
Date advice published
13 September 2021