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Abstract

RATIONALE

Mycobacterium avium complex (MAC) lung disease (LD) is a rare infectious disease with substantial disease burden, high rates of hospitalizations, and where 20% to 40% of patients do not respond to prescribed treatments. In 2018, amikacin liposome inhalation suspension (ALIS) became the first therapy approved by FDA for refractory MAC-LD. In clinical trials, addition of ALIS to guideline-based therapy showed evidence of MAC infection elimination in sputum by month 6, which was maintained in most patients through the end of treatment (up to 12 months post conversion). The objective of this study was to assess changes in hospitalizations among patients initiating ALIS in the real-world setting.

METHODS

This retrospective cohort study used All-Payer Claims Database to identify patients receiving ALIS from 10/1/2018 to 4/30/2021. Patients aged >18 years, with ≥1 pharmacy claim for ALIS, with >12 months of continuous enrollment in health plans both before and after ALIS initiation were included. All-cause and respiratory disease-related hospitalizations (including inpatient stays and hospital emergency department visits leading to hospitalizations) were compared for the 12 months before and after ALIS initiation. Hospitalizations were reported for every 6-month interval of the study period; the 6-months before ALIS initiation was the reference period for statistical comparisons.

RESULTS

After eligibility criteria were applied, 331 patients receiving ALIS were identified (mean [± SD] age, 64.6±16.0 years; female, 77.9%). Among them, 65.9% and 27.8% had Medicare and commercial plans, respectively. Geographically, patients were from the South (45.9%), the Northeast (22.4%), the West (19.0%), and the North Central US (12.7%). Approximately 46% of patients had COPD and 57% had bronchiectasis. Hospitalizations were the highest in the 6 months before ALIS initiation. A significant reduction in the proportion of patients hospitalized and mean number of hospitalizations per person/6 months were observed after ALIS initiation (Figure). Compared with the 6 months before ALIS initiation, approximately 28% and 43% fewer patients had respiratory disease-related hospitalizations during months 0 to 6 and 7 to 12 after ALIS initiation follow-up, respectively. The average respiratory disease-related hospitalizations decreased by 43%- 44% for both months 0 to 6 and 7 to 12 after ALIS initiation follow-up. A similar trend was observed for all-cause hospitalizations.

CONCLUSIONS

This study provides the first real-world evidence on the benefits of adding ALIS to the treatment regimen for patients. Both all-cause and respiratory disease-related hospitalizations were significantly reduced in the 12 months following ALIS initiation.

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