Treatment Patterns in Patients with Locally Advanced or Metastatic Non-Small-Cell Lung Cancer Treated with Epidermal Growth Factor Receptor-Tyrosine Kinase Inhibitors: Analysis of US Insurance Claims Databases.

BACKGROUND: Most patients with epidermal growth factor receptor mutation-positive (EGFRm) non-small-cell lung cancer (NSCLC) acquire resistance to first-line (1L) first- or second-generation (1G/2G) EGFR-TKIs; therefore, it is important to optimize 1L treatment to improve patient outcomes. OBJECTIVE: To retrospectively examine treatment patterns in locally advanced/metastatic NSCLC using MarketScan® Commercial and Medicare Supplemental Databases (all US census regions). PATIENTS AND METHODS: Adults with a lung cancer diagnosis code between 1 January 2015-31 March 2018 were analyzed from diagnosis (index) through a variable-length follow-up. Patients had ≥ 1 pharmacy claim for 1G/2G EGFR-TKIs on or within 60 days post-index. Data were stratified by presence or absence of central nervous system (CNS) metastases (30 days pre-index through study end). RESULTS: 578 patients were included (median age 63 years, 64% female). Median follow-up was 13.5 months. The most frequently prescribed 1L EGFR-TKI was erlotinib (414/578, 72%). Median time to 1L treatment discontinuation was 8.2 (95% confidence interval (CI) 6.9, 9.0) months in patients diagnosed with CNS metastases at any time, and 7.7 (95% CI 6.9, 8.9) months in patients without CNS metastases. 270/578 patients (47%) discontinued 1L EGFR-TKIs; 209/270 (77%) initiated second-line (2L) therapy, most frequently osimertinib (96/209, 46%). CONCLUSIONS: In an analysis of US claims data, nearly half of patients discontinued 1L EGFR-TKIs, and 46% who initiated 2L received osimertinib. As nearly a quarter of patients who discontinued 1L EGFR-TKIs did not receive 2L treatment, this study highlights the need for optimal 1L treatment in EGFRm locally advanced/metastatic NSCLC.

The direct and indirect costs of adult atopic dermatitis.

BACKGROUND: Atopic dermatitis is considered a childhood illness, and the direct and indirect health care burden of atopic dermatitis in adults is not fully understood. OBJECTIVE: To measure the direct and indirect costs of atopic dermatitis among adults in 2018. METHODS: This retrospective cohort study compared commercial and Medicare-insured adults with atopic dermatitis in 2018 with directly matched (1:3) adults without atopic dermatitis. Atopic dermatitis prevalence was reported. Health care utilization, direct health care costs, and work loss data were compared between cohorts. This analysis was repeated for adults with atopic dermatitis in 2016 and 2017. RESULTS: 31,164 adults with atopic dermatitis in 2018 were identified and directly matched (1:3) to controls. Adults with atopic dermatitis had greater utilization of outpatient services, outpatient pharmacy services, and short-term disability benefits than controls. Unadjusted annual health care costs in 2018 were $4,979 higher for adults with atopic dermatitis ($14,603) than for the matched controls ($9,624), driven by outpatient services and pharmacy. Findings were supported by analyses of adults from 2016 and 2017 and multivariable analyses. One limitation of this study was that patients with mild cases of atopic dermatitis may not seek medical treatment and may be underrepresented in the study cohort. CONCLUSIONS: The direct health care and indirect (short-term disability) health care costs of atopic dermatitis present a significant health care burden among the adult population. DISCLOSURES: This study was funded by Eli Lilly and Company. Employees of Eli Lilly were involved in the planning, execution, and interpretation of the study. Pierce is employed by Eli Lilly and Company. Boytsov and Goldblum were employed by Eli Lilly and Company Health at the time this research was conducted. Manjelievskaia and Brouillette are employed by IBM Watson Health, which received funding from Eli Lilly and Company to conduct this study. Bonafede and Onyekwere were employed at IBM Watson Health at the time this research was conducted.

Dose escalation and associated costs in biologic treatment of psoriasis based on real-world data.

OBJECTIVES: This study documents real-world patterns and additional costs of above-label (≥10% above the recommended maintenance dose) use of biologics in patients with plaque psoriasis. MATERIALS AND METHODS: This was a descriptive, retrospective cohort analysis using the IBM MarketScan Commercial and Medicare Supplemental Databases. Adult patients diagnosed with plaque psoriasis initiating treatment with etanercept, adalimumab, ixekizumab, or secukinumab between 1 January 2015 and 30 November 2019 (index) were eligible. Only biologics approved prior to 2017 were included to ensure data for all agents was available throughout the study period. Patients had no other indications for biologics of interest. Outcomes were measured in the 12-month follow-up period after start of maintenance dosing. RESULTS: Of 6453 patients included, 708 (11.0%) received etanercept, 4654 (72.1%) received adalimumab, 228 (3.5%) received ixekizumab, and 863 (13.4%) received secukinumab. Above-label dosing was recorded in 326 (46.0%) patients receiving etanercept, 513 (11.0%) receiving adalimumab, 40 (17.5%) receiving ixekizumab, and 79 (9.2%) receiving secukinumab. Mean time to above-label use for all treatments was 50.7-99.5 days; the median was 21-37 days. Mean duration of above-label use for all treatments was 130-196 days; the median was 35-175 days. Mean total additional annual psoriasis-related medical/pharmacy costs associated with above-label use were $312/$16,475 for etanercept, $278/$9,773 for adalimumab, $124/$5,202 for ixekizumab, and $277/$9,288 for secukinumab. Above-label use was generally not associated with safety concerns; however, gastrointestinal and combined "other" nonrespiratory infections were significantly more frequent in patients receiving adalimumab above-label. CONCLUSIONS: Above-label use of biologics for psoriasis treatment was most frequent for patients receiving etanercept, followed by ixekizumab, adalimumab, and secukinumab. Above-label vs on-label use resulted in additional costs but few significant safety concerns.

Treatment discontinuation of long-acting injectables or oral atypical antipsychotics among Medicaid recipients with schizophrenia.

Aims: Among patients with schizophrenia, poor adherence and persistence with oral atypical antipsychotics (OAA) often results in relapse and hospitalization. Second-generation antipsychotic long-acting injectables (SGA LAI) have demonstrated higher adherence than first-generation antipsychotic LAI and OAA therapies. This study aimed to determine whether SGA LAIs are associated with better persistency compared to OAA among Medicaid recipients with schizophrenia. Materials and methods: From the MarketScan Medicaid Database (January 1, 2010-June 30, 2016), patients aged ≥18 years with schizophrenia and ≥2 pharmacy claims more than 90 days apart for the same SGA LAI or OAA were selected. New users of the specific antipsychotic agent were classified, based on their index agent, as: OAA, paliperidone palmitate LAI (PPLAI), aripiprazole LAI (ALAI), and risperidone LAI (RLAI). Discontinuation during 1 year of follow-up was defined as a ≥ 60-day gap in the index OAA or SGA LAI medication past the exhaustion of the previous claim's supply. Inverse probability of treatment weights (IPTW) balanced the cohort characteristics, and weight outliers (<0.1 or >0.9) were excluded. IPTW-weighted Cox proportional hazards regression estimated hazard ratios for discontinuation. Results: Cohorts included 7,029 OAA, 4,302 PPLAI, 586 ALAI, and 1,456 RLAI patients. Mean age was 38.0-41.0 years and 44.0-46.6% were female. Persistence was significantly longer in the SGA LAI cohorts than in the OAA cohort. Adjusted hazard ratios (95% confidence intervals) for discontinuation were 0.60 (0.56-0.64) for PPLAI, 0.69 (0.60-0.79) for ALAI, and 0.70 (0.64-0.77) for RLAI vs OAA. Limitations: Results may not be generalizable to patients covered by commercial or Medicare insurance, and limitations inherent to any claims-based retrospective analysis apply. Conclusions: SGA LAI may be a valuable option for treating schizophrenia given the improvement in persistence.

Treatment patterns and costs among biologic-naive patients initiating apremilast or biologics for psoriatic arthritis.

Aim: We evaluated treatment patterns and healthcare costs of initiating psoriatic arthritis (PsA) treatment with oral apremilast versus biologics. Methods: Claims data identified biologic-naive adults with PsA who initiated either apremilast or a biologic from 2013 to 2016. Results: Medication adherence was similar at 12 months (76.9 vs 73.4%; p = 0.175) between apremilast (n = 381) and matched biologic (n = 761) patients. Apremilast users had $12,715 lower total costs per-patient-per-month (p < 0.001), largely due to outpatient pharmacy and medical costs. Conclusion: Commercially insured patients with PsA initiating apremilast had adherence similar to those initiating biologics but lower total healthcare costs.

Relationship Between Treatment Initiation and Healthcare Costs in Alzheimer's Disease.

The relationship between Alzheimer's disease (AD) treatment patterns and healthcare costs is unknown. Administrative claims data from the MarketScan Commercial and Medicare databases covering 2010 through 2016 were used to identify the comorbidities, treatment patterns, and healthcare costs in the three years prior to and one year post medical diagnosis of AD in 21,448 patients with no treatment and 57,970 patients with treatment. Pre-index mean annual costs ranged from $14,228 to $26,876, and post-index mean annual costs ranged from $21,052 to $45,685 depending on age and treatment timing. After adjusting for baseline characteristics, patients 50-100 years old who initiated treatment with an FDA approved drug prior to or concurrent with diagnosis had healthcare costs 9%-19% lower in the year following diagnosis than those who did not receive treatment. Early or concurrent treatment is associated with lower overall healthcare costs in the year following AD diagnosis.

Real-world US healthcare costs of psoriasis for biologic-naive patients initiating apremilast or biologics.

AIM: Biologics and apremilast have advanced psoriasis management by adding treatment options. This study evaluated persistence, adherence and healthcare costs among biologic-naive patients receiving apremilast or biologics. METHODS: Administrative claims data for adults starting apremilast or biologics from 1 January 2013 to 30 June 2016 were matched based on demographics. RESULTS: Apremilast (n = 703) and biologics (n = 1378) had similar baseline characteristics. 12-month persistence and adherence rates were similar. Adjusted total healthcare costs were lower with apremilast versus biologics (p < 0.001) due to lower total outpatient pharmacy costs (p < 0.001). CONCLUSION: Real-world apremilast users had similar adherence and lower total healthcare costs versus biologic users. Apremilast's cost advantage was evident regardless of whether the patients were persistent or nonpersistent, or switched or did not switch treatments.

Healthcare costs among adults with type 2 diabetes initiating saxagliptin or linagliptin: a US-based claims analysis.

OBJECTIVE: To compare healthcare costs of adults with type 2 diabetes (T2D) after initiation of saxagliptin or linagliptin, two antidiabetic medications in the dipeptidyl peptidase-4 inhibitor medication class. METHODS: Patients with T2D who were at least 18 years old and initiated saxagliptin or linagliptin (index date) between 1 June 2011 and 30 June 2014 were identified in the MarketScan Commercial and Medicare Supplemental Databases. All-cause healthcare costs and diabetes-related costs (T2D diagnosis on a medical claim and/or an antidiabetic medication claim) were measured in the 1 year follow-up period. Saxagliptin and linagliptin initiators were matched using propensity score methods. Cost ratios (CRs) and predicted costs were estimated from generalized linear models and recycled predictions. RESULTS: There were 34,560 saxagliptin initiators and 18,175 linagliptin initiators identified (mean ages 57 and 59; 55% and 56% male, respectively). Before matching, saxagliptin initiators had significantly lower all-cause total healthcare costs than linagliptin initiators (mean = $15,335 [SD $28,923] vs. mean = $20,069 [SD $48,541], p < .001) and significantly lower diabetes-related total healthcare costs (mean = $6109 [SD $13,851] vs. mean = $7393 [SD $26,041], p < .001). In matched analyses (n = 16,069 per cohort), saxagliptin initiators had lower all-cause follow-up costs than linagliptin initiators (CR = 0.953, 95% CI = 0.932-0.974, p < .001; predicted costs = $17,211 vs. $18,068). There was no significant difference in diabetes-related total costs after matching; however, diabetes-related medical costs were significantly lower for saxagliptin initiators (CR = 0.959, 95% CI = 0.927-0.993, p = 0.017; predicted costs = $3989 vs. $4159). CONCLUSIONS: Adult patients with T2D initiating treatment with saxagliptin had lower total all-cause healthcare costs and diabetes-related medical costs over 1 year compared with patients initiating treatment with linagliptin.

Healthcare Costs Among Adults with Type 2 Diabetes Initiating DPP-4 Inhibitors.

INTRODUCTION: Oral antidiabetes medications, including dipeptidyl peptidase-4 inhibitors (DPP-4is) saxagliptin and sitagliptin, are used for the treatment of type 2 diabetes (T2D). The study objective was to compare all-cause and diabetes-related costs following initiation of saxagliptin or sitagliptin. METHODS: Patients aged ≥ 18 years initiating saxagliptin or sitagliptin between January 1, 2009 and January 31, 2012 in the Truven Health MarketScan Commercial and Medicare Supplemental databases were identified. Patients were required to have continuous enrollment for ≥ 365 days before and ≥ 365 days after the index date (date of the first saxagliptin or sitagliptin claim). Additionally, patients were required to have a claim with a T2D diagnosis (ICD-9-CM 250.×0, 250.×2) and no claims for a DPP-4i medication before the index date. All-cause and diabetes-related medical costs and total costs (including pharmacy costs) were captured over the 1-year follow-up period. Generalized linear models with log link and gamma distribution were fit to compare costs between the two cohorts using cost ratios, controlling for patient baseline characteristics. Recycled prediction methods were used to generate adjusted predicted costs and confidence intervals. RESULTS: The final sample comprised 3354 saxagliptin initiators and 26,895 sitagliptin initiators. The average age of saxagliptin and sitagliptin initiators was 57 years and just over 50% were males. After adjusting for baseline characteristics, saxagliptin patients had significantly lower average all-cause medical costs (cost ratio = 0.901, P < 0.001; predicted mean costs: $8687 vs. $9646) compared with sitagliptin patients over the 1-year follow-up. Findings were consistent for diabetes-related medical costs (cost ratio = 0.890, P < 0.001; predicted mean costs: $2180 vs. $2450). Total costs were also lower for saxagliptin initiators (cost ratio = 0.950, P = 0.002; predicted mean costs: $13,911 vs. $14,651) over the 1-year follow-up period. CONCLUSION: Initiation of treatment with saxagliptin was associated with lower medical costs over 1 year compared with initiation of sitagliptin among adults with T2D. FUNDING: AstraZeneca.

Persistence, adherence, and all-cause healthcare costs in atazanavir- and darunavir-treated patients with human immunodeficiency virus in a real-world setting.

OBJECTIVES: Atazanavir (ATV) and darunavir (DRV) are protease inhibitors approved for HIV treatment in combination with ritonavir (/r). The objectives of this study were to compare persistence (time to treatment discontinuation/modification), adherence, and healthcare costs among patients with human immunodeficiency virus (HIV) initiating ATV/r or DRV/r. METHODS: This retrospective cohort study used commercial and Medicaid administrative insurance claims data. Patients initiating ATV/r or DRV/r from 2006-2013 with continuous enrollment for ≥6 months before and ≥3 months after initiation were included. Patients were followed from initiation until discontinuation/modification (≥30 day gap in ATV or DRV or initiation of a new antiretroviral medication), during which time adherence (proportion of days covered [PDC], with PDC ≥80% or 95% considered adherent) and per-patient per-month (PPPM) total healthcare costs were measured. DRV/r patients were propensity score matched to ATV/r patients at a 1:1 ratio to achieve balance on potentially confounding demographic and clinical factors. Commercial and Medicaid samples were analyzed separately, as were antiretroviral (ART)-naïve and experienced patients. RESULTS: The final samples comprised 2988 commercially-insured and 1158 Medicaid-insured patients. There were no significant differences in hazards of discontinuation/modification between the ATV/r or DRV/r cohorts. With respect to odds of being adherent, the only marginally significant result was comparing odds of achieving PDC ≥80% among ART-naïve Medicaid patients, which favored ATV/r. All other adherence comparisons were not significant. Although ATV/r cohorts tended to have lower PPPM costs, the majority of these differences were not statistically significant. CONCLUSIONS: Patients with HIV treated with either ATV/r or DRV/r had similar time to treatment discontinuation/modification, adherence, and monthly healthcare costs. Results were similar across the pre-specified sub-groups. These findings are useful not only as an insight into clinical practice, but also as a resource for healthcare providers and payers evaluating treatment options for HIV+ individuals.

No difference in persistence to treatment with atazanavir or darunavir in HIV patients in a real-world setting.

INTRODUCTION: There is a lack of data comparing the protease inhibitors (PIs) atazanavir (ATV) and darunavir (DRV) in a real-world setting. This study compared persistence (time to switch/discontinuation) to therapy between ATV-treated and DRV-treated patients with human immunodeficiency virus (HIV). MATERIALS AND METHODS: Retrospective, observational cohort study using US insurance claims for commercially and Medicaid-insured patients. Patients were aged ≥18 years and initiated an ATV- or DRV-based regimen boosted with ritonavir between 7/1/2006 and 3/31/2013, with ≥6 months of continuous enrolment prior to and ≥3 months of continuous enrolment following initiation; patients were required to have ≥1 inpatient or outpatient medical claim with an ICD-9-CM diagnosis code for HIV during that time period of enrolment. Patients with no claims for antiretroviral therapy (ART) any time prior to initiation were considered to be ART-naïve. Time to switch/discontinuation was defined as the number of days from initiation of the regimen until earliest of: (1) a ≥30-day continuous gap in therapy in ATV or DRV; (2) a prescription claim for an ART agent that was not part of the initial regimen (with the exception of changes in concomitant nucleoside reverse transcriptase inhibitors or the addition of integrase inhibitors); (3) censoring at a ≥30-day continuous gap in therapy in ritonavir; (4) censoring at disenrolment from insurance benefits or (5) censoring at the study end date (9/30/2013 in the commercial data and 12/31/2013 in the Medicaid data). Time to switch/discontinuation was compared using incidence rates and multivariable Cox proportional hazards models adjusted for calendar time, patient demographics and clinical characteristics. RESULTS: Table 1 displays the study results and cohort sample sizes. Mean ages across the cohorts were 41-42 years. The proportions of patients who were ART-naïve were 58-59% among the ATV/r cohorts and 53-55% among the DRV/r cohorts. There were no significant differences in the adjusted hazards of switch/discontinuation between the cohorts. CONCLUSIONS: The incidence of switch/discontinuation was higher among Medicaid patients (who may be socioeconomically disadvantaged) than Commercial patients. There were no significant differences in persistence (time to switch/discontinuation) with the initiated PI among HIV patients who initiated an ATV-based regimen versus a DRV-based regimen.