AIM: To examine migraine-related healthcare utilisation among bank employees in China, and to estimate the economic burden of migraines.
METHODS: A cross-sectional survey was conducted in Guizhou province, China between May and October 2022. The HARDSHIP questionnaire was used to identify migraine-positive individuals and enquire about their healthcare utilisation and productivity losses. A probabilistic decision-analytic model with a micro-costing approach was used to estimate the economic burden from the perspectives of the healthcare system, employers, and society. All costs were expressed in 2022 United States dollars. One-way and probabilistic sensitivity analyses were performed.
RESULTS: Nearly half of individuals with migraines reported not seeking medical care. Only 21.8% reported seeking outpatient consultations, 52.5% reported taking medicines, and 27.1% reported using complementary therapies. Chronic migraine patients had significantly higher healthcare utilisation than episodic migraine patients. Among individuals with a monthly migraine frequency of 15 days or more, 63.6% took inappropriate treatments by excessively using acute medications. Migraines in the banking sector in Guizhou cost the healthcare system a median of $7,578.0 thousand (25th to 75th percentile $4,509.2-$16,434.9 thousand) per year, employers $89,750.3 thousand (25th to 75th percentile $53,211.6-$151,162.2 thousand), and society $108,850.3 thousand (25th to 75th percentile $67,370.1-$181,048.6 thousand). The median societal cost per patient-year is $3,078.1. Migraine prevalence and productivity losses were identified as key cost drivers.
CONCLUSIONS: The study points to the need to raise awareness of migraines across all stakeholders and to improve the organisation of the migraine care system. A substantial economic burden of migraines on the healthcare system, employers, and society at large was highlighted. These cost estimates offer evidence-based benchmarks for assessing economic savings from improved migraine management, and can also draw the attention of Chinese policymakers to prioritise migraine policies within the banking and other office-based occupations.
METHODS: EMPOWER-Lung 1 was a multicentre, open-label, randomised, phase 3 trial. We enrolled patients (aged ≥18 years) with histologically confirmed squamous or non-squamous advanced non-small-cell lung cancer with PD-L1 tumour expression of 50% or more. We randomly assigned (1:1) patients to intravenous cemiplimab 350 mg every 3 weeks for up to 108 weeks, or until disease progression, or investigator's choice of chemotherapy. Central randomisation scheme generated by an interactive web response system governed the randomisation process that was stratified by histology and geographical region. Primary endpoints were overall survival and progression free survival, as assessed by a blinded independent central review (BICR) per Response Evaluation Criteria in Solid Tumours version 1.1. Patients with disease progression on cemiplimab could continue cemiplimab with the addition of up to four cycles of chemotherapy. We assessed response in these patients by BICR against a new baseline, defined as the last scan before chemotherapy initiation. The primary endpoints were assessed in all randomly assigned participants (ie, intention-to-treat population) and in those with a PD-L1 expression of at least 50%. We assessed adverse events in all patients who received at least one dose of their assigned treatment. This trial is registered with ClinicalTrials.gov, NCT03088540.
FINDINGS: Between May 29, 2017, and March 4, 2020, we recruited 712 patients (607 [85%] were male and 105 [15%] were female). We randomly assigned 357 (50%) to cemiplimab and 355 (50%) to chemotherapy. 284 (50%) patients assigned to cemiplimab and 281 (50%) assigned to chemotherapy had verified PD-L1 expression of at least 50%. At 35 months' follow-up, among those with a verified PD-L1 expression of at least 50% median overall survival in the cemiplimab group was 26·1 months (95% CI 22·1-31·8; 149 [52%] of 284 died) versus 13·3 months (10·5-16·2; 188 [67%] of 281 died) in the chemotherapy group (hazard ratio [HR] 0·57, 95% CI 0·46-0·71; p<0·0001), median progression-free survival was 8·1 months (95% CI 6·2-8·8; 214 events occurred) in the cemiplimab group versus 5·3 months (4·3-6·1; 236 events occurred) in the chemotherapy group (HR 0·51, 95% CI 0·42-0·62; p<0·0001). Continued cemiplimab plus chemotherapy as second-line therapy (n=64) resulted in a median progression-free survival of 6·6 months (6·1-9·3) and overall survival of 15·1 months (11·3-18·7). The most common grade 3-4 treatment-emergent adverse events were anaemia (15 [4%] of 356 patients in the cemiplimab group vs 60 [17%] of 343 in the control group), neutropenia (three [1%] vs 35 [10%]), and pneumonia (18 [5%] vs 13 [4%]). Treatment-related deaths occurred in ten (3%) of 356 patients treated with cemiplimab (due to autoimmune myocarditis, cardiac failure, cardio-respiratory arrest, cardiopulmonary failure, septic shock, tumour hyperprogression, nephritis, respiratory failure, [n=1 each] and general disorders or unknown [n=2]) and in seven (2%) of 343 patients treated with chemotherapy (due to pneumonia and pulmonary embolism [n=2 each], and cardiac arrest, lung abscess, and myocardial infarction [n=1 each]). The safety profile of cemiplimab at 35 months, and of continued cemiplimab plus chemotherapy, was generally consistent with that previously observed for these treatments, with no new safety signals INTERPRETATION: At 35 months' follow-up, the survival benefit of cemiplimab for patients with advanced non-small-cell lung cancer was at least as pronounced as at 1 year, affirming its use as first-line monotherapy for this population. Adding chemotherapy to cemiplimab at progression might provide a new second-line treatment for patients with advanced non-small-cell lung cancer.
FUNDING: Regeneron Pharmaceuticals and Sanofi.