(B-108) Characteristics and Comorbidities of Amikacin Liposome Inhalation Suspension (ALIS) Initiators in U.S. Claims

Background: Arikayce® (amikacin liposome inhalation suspension; ALIS) is the first therapy approved by the U.S. Food and Drug Administration for the treatment of Mycobacterium avium complex lung disease as part of a combination antibacterial regimen in patients who do not achieve negative sputum cultures after a minimum of 6 consecutive months of a multidrug background regimen therapy (e.g., a macrolide-containing regimen).

Objectives: We sought to describe the patient characteristics and comorbidities of ALIS initiators in clinical practice using U.S. claims data.

Methods: The study population consisted of ALIS initiators in the Optum Research Database or Medicare Part D database from 01 October 2018 through 31 December 2023. Initiation was defined as a first dispensing of ALIS after a minimum of 6 months of continuous insurance coverage, with the 6-month pre-ALIS period serving as the baseline period. Demographics, claims with diagnoses of pulmonary nontuberculous mycobacteria (PNTM), and other frequently occurring diagnoses within the baseline period were described.

Results: ALIS initiators (n=644) had a mean (SD) age of 69.6 (11.7) years with 68.6% being female. In the baseline period, 96.3% had mycobacteria infection (ICD-10-CM code A31.0, A31.8, A31.9), and 89.9% had PNTM (A31.0). Other common baseline respiratory diagnoses were bronchiectasis (J47.*, 69.6%); abnormalities of breathing (R06.*, 50.6%); cough (R05.*, 49.5%); other chronic obstructive pulmonary disease (COPD; J44.*, 47.8%); and pneumonia, unspecified organism (J18.*, 35.7%).

Conclusions: This analysis describes ALIS initiators in a large U.S. insurance claims database. ALIS initiators were frequently comorbid for multiple respiratory diagnoses in addition to PNTM.