BACKGROUND: Approximately 6–49% of patients with metastatic non-small cell lung cancer (mNSCLC) treated with first- and second-generation (1/2G) epidermal growth factor receptor-tyrosine kinase inhibitors (EGFR-TKIs) in trials experience severe adverse events (SAEs). The real-world economic burden of such SAEs has not been studied.

OBJECTIVES: To estimate incremental economic burden associated with SAEs in patients with mNSCLC treated with first-line (1L) EGFR-TKIs.

METHODS: The IQVIA^TM Real-World Data Adjudicated Claims – US database (Q2/2012–Q1/2017) was used to identify adults treated with 1/2G 1L EGFR-TKIs (first dispensing defined index) for mNSCLC with ≥1 lung cancer diagnosis code, no lung surgery claims, and no administration of other mNSCLC treatments within 3 months pre-index. SAEs were selected from EGFR-TKI prescribing information (cardiac and cerebrovascular [CV] events, interstitial lung disease [ILD], diarrhea, renal failure, skin and ocular disorders, hepatotoxicity, microangiopathic hemolytic anemia [MAHA], gastrointestinal perforation) and identified based on hospitalization claims. Adjusted healthcare resource utilization (HRU) rate ratios (RR) and cost differences (CD) comparing patients with and without SAEs were estimated using multivariate Poisson and linear regression, respectively.

RESULTS: Among 1,646 patients, 86.9% were treated with erlotinib, 12.1% with afatinib, 1.0% with gefitinib. Overall, patients with SAEs had higher rates of hospitalizations (RR=6.15; p<0.05) and outpatient visits (RR=1.21; p<0.05) versus without SAEs. Select SAEs with the greatest burden of hospitalization were MAHA (RR=4.21; p<0.05) and cardiac and CV events (RR=4.03; p<0.05). MAHA (RR=1.34; p<0.05) and ILD (RR=1.20; p<0.05) were associated with the greatest outpatient visit burden. High incremental HRU contributed to higher costs among patients with versus without SAEs, overall (CD=$4,700; p<0.05) and in the analysis of select SAEs (e.g., MAHA CD=$10,143; p<0.05).

CONCLUSIONS: SAEs are associated with high HRU, contributing to higher costs in patients with mNSCLC treated with 1/2G EGFR-TKIs in 1L. EGFR-TKI treatments with better safety profiles may help alleviate this burden.