Real-world costs of obesity-related complications over eight years: a US retrospective cohort study in 28,500 individuals.

BACKGROUND: Obesity-related complications (ORCs) are associated with high costs for healthcare systems. We assessed the relationship between comorbidity burden, represented by both number and type of 14 specific ORCs, and total healthcare costs over time in people with obesity in the USA. METHODS: Adults (≥ 18 years old) identified from linked electronic medical records and administrative claims databases, with a body mass index measurement of 30-< 70 kg/m2 between 1 January 2007 and 31 March 2012 (earliest measurement: index date), and with continuous enrolment for ≥ 1 year pre index (baseline year) and ≥ 8 years post index, were included. Individuals were grouped by type and number of ORCs during the pre-index baseline year. The primary outcome was annual total adjusted direct per-person healthcare costs. RESULTS: Of 28,583 included individuals, 12,686 had no ORCs, 7242 had one ORC, 4180 had two ORCs and 4475 had three or more ORCs in the baseline year. Annual adjusted direct healthcare costs increased with the number of ORCs and over the 8-year follow-up. Outpatient costs were the greatest contributor to baseline annual direct costs, irrespective of the number of ORCs. For specific ORCs, costs generally increased gradually over the follow-up; the largest percentage increases from year 1 to year 8 were observed for chronic kidney disease (+ 78.8%) and type 2 diabetes (+ 47.8%). CONCLUSIONS: In a US real-world setting, the number of ORCs appears to be a cost driver in people with obesity, from the time of initial obesity classification and for at least the following 8 years.

Clinical outcomes associated with pathogenic genomic instability mutations in prostate cancer: a retrospective analysis of US pharmacy and medical claims data.

Background: Prostate cancer (PC) is a clinically heterogenous disease, and genetic mutations may be useful for patient risk stratification. This retrospective cohort study compared clinical outcomes, pharmacy use, and outpatient resource use in PC patients with and without pathogenic genomic instability mutations, including DNA repair deficiency (DRD) mutations and those in TP53, PTEN, and RB1. Methods: Patients ≥18 years newly-diagnosed with PC between June 2011-March 2016 were identified in medical and prescription claims databases linked to a genomic dataset. All-cause and PC-specific pharmacy use and outpatient resource use (office visits, laboratory tests, radiology examinations, and radiation therapies) over 1, 2, and 3 years and time to evidence of disease progression after PC diagnosis, based on secondary cancer diagnosis codes and treatments received, were evaluated in mutation carriers with ≥1 of 24 gene mutations and in a sub-set of DRD gene mutation carriers, with each compared to non-mutation carriers. Results: Mutation carriers (n = 274) and non-mutation carriers (n = 74) had similar demographic and clinical features. Non-mutation carriers had lower risks of developing metastasis and castration-resistant PC than mutation carriers (hazard ratio [HR] = 0.7, 95% CI = 0.5-0.9; HR = 0.5, 95% CI = 0.3-0.9, respectively) and DRD mutation carriers (HR = 0.5, 95% CI = 0.3-0.7; HR = 0.4, 95% CI = 0.2-0.7, respectively). Compared to non-mutation carriers, mutation carriers had more all-cause pharmacy claims over 2 years of follow-up (74.4 vs 59.1, p = 0.04) and more PC-specific pharmacy claims over 2 years (11.1 vs 6.5, p = 0.01) and 3 years (17.9 vs 9.8, p = 0.01) of follow-up. No differences were observed in outpatient resource use during the follow-up period by mutation status. Conclusion: PC patients carrying ≥1 pathogenic DNA instability mutation, and DRD mutation carriers specifically, had higher clinical burden than non-mutation carriers. Targeted therapies for these patients are needed to reduce clinical burden and associated healthcare resource utilization.

The impact of copay assistance on patient out-of-pocket costs and treatment rates with ALK inhibitors.

INTRODUCTION: The patient cost burden of oral anticancer medicines has been associated with prescription abandonment, delayed treatment initiation, and poorer health outcomes in the US. Since 2011, several small molecule tyrosine kinase inhibitors have been approved for the treatment of non-small cell lung cancer (NSCLC) patients with rearrangement of the anaplastic lymphoma kinase (ALK) gene. The objective of this study was to measure the impact of copay assistance on patient cost sharing and treatment patterns in patients prescribed oral ALK inhibitors (ALKi's). METHODS: Patterns of claims approval/rejection and payment/reversal, out-of-pocket (OOP) costs, and treatment persistence were reported for patients identified in the IQVIA Formulary Impact Analyzer database from January 2013 to August 2017 linked to a medical claims database. The primary study cohorts were patients with copay assistance, including manufacturer's copay cards, other discount cards, or free-trial vouchers, on the index ALKi claim, and patients without copay assistance at any time during the follow-up period. RESULTS: In total, 3,143 patients were included in analyses related to claim patterns, and 1,685 patients were included in analyses related to treatment persistence. Copay assistance decreased the OOP cost for the first approved ALKi by $1,930, on average. Patients with copay assistance picked up ALKi prescriptions from the pharmacy sooner than patients without copay assistance (2.6 days vs 25.7 days). In adjusted analyses, patients with copay assistance had 88.2% lower risk of abandoning their first approved prescription and 24.3% lower risk of discontinuing treatment with the first observed ALKi (all p < 0.001). CONCLUSION: Copay assistance reduced the patient cost burden for ALKi's and was associated with patients picking up their ALKi prescriptions, beginning ALKi treatment sooner, and remaining on treatment.