Amikacine Medicine 03 June 2025 Extended indication Amikacin in combination with a background regimen for the treatment of newly diagnosed nontuberculous mycobacterial infection in adults and the elderly with pulmonary infection caused by Mycobacterium avium complex. Therapeutic value No estimate possible yet Total cost Registration phase Clinical trials Product Active substance Amikacine Domain Infectious diseases Reason of inclusion Indication extension IND Main indication Bacterial infections Extended indication Amikacin in combination with a background regimen for the treatment of newly diagnosed nontuberculous mycobacterial infection in adults and the elderly with pulmonary infection caused by Mycobacterium avium complex. Current proprietary name Already available biosimilars / generics Proprietary name Arikayce Manufacturer Insmed Portfolio holder Mechanism of action Antibiotic Route of administration Inhalation Therapeutical formulation Liquid for inhalation vapor Budgetting framework Extramural (GVS) Centre of expertise Radboud-UMC, afdeling Longziekten, Nijmegen. Additional remarks Suspensie voor pulmonale verneveling Registration Registration route Centralised (EMA) Type of trajectory Normal trajectory Particularity ATMP No Submission date September 2026 Expected Registration October 2027 Orphan drug Yes Registration phase Clinical trials Reimbursement Medicine sluice Additional remarks Tijdslijn op basis van IHSI-inschatting. Therapeutic value Current treatment options Rifampicine (of rifabutin) en ethambutol en macrolide antibioticum (claritromycine dan wel azitromycine). Therapeutic value No estimate possible yet This assessment does not indicate any potential inclusion in the package. Substantiation De fase 3 studie loopt nog met een backbone met twee geneesmiddelen in plaats van drie. Duration of treatment Frequency of administration 1 times a day Dosage per administration 250mg References NCT04677569 (ENCORE) Additional remarks Expected patient volume per year Patient volume < 300 Market share is generally not included unless otherwise stated. Maximum patient volume for sluice References Radboudumc Additional remarks In Nederland wordt het aantal patiënten met een moeilijk te bestrijden longinfectie door MAC geschat op ongeveer 300. Expected cost per patient per year Cost References medicijnkosten.nl Additional remarks Arikayce, dispersie voor vernevelvloeistof 59mg/ml, 1ml €411,48. Potential total cost per year Total cost Total cost for sluice Additional remarks Off label use Off label use Indications off label use References Additional remarks Indication extension Indication extensions Indication extensions References Additional remarks Other information Additional remarks