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Supplemental Digital Content is available in the text., Goals: This US-based, retrospective claims study aimed to investigate disease burden and treatment patterns in patients with eosinophilic esophagitis (EoE), and to compare health care resource use (HCRU) in patients with EoE and matched controls without EoE. Materials and Methods: Patients with a diagnosis of EoE and ≥12 months of prediagnosis data were identified from the Truven Health MarketScan Research databases (January 2008 to September 2016) and followed up from the diagnosis date until termination of eligibility for a health plan. Patient clinical characteristics and HCRU were recorded in the 12 months before diagnosis; HCRU and treatment patterns were recorded during follow-up. HCRU in patients with EoE and matched controls was compared during the 12-month postdiagnosis period. Results: Among the 23,003 patients with EoE (mean age: 34.3 y; 64.8% male), gastroesophageal reflux disease was the most common prediagnosis condition (34.6%). After diagnosis, the most common off-label, first-line treatments were proton pump inhibitor monotherapy (52.8%) and topical corticosteroid monotherapy (21.5%). Overall, 3336 patients (14.5%) received at least 3 lines of off-label pharmacotherapy. Outpatient visits (recorded in 99.9% of patients on and postdiagnosis) were most frequently to gastroenterologists/pediatric gastroenterologists (49.5% prediagnosis, 72.6% on and postdiagnosis). Inpatient admissions and outpatient and emergency room visits were more likely in patients with EoE than in matched controls (P

Background: Patients with short-bowel syndrome and intestinal failure (SBS-IF) require parenteral support (PS) and may need long-term home-care support. This survey assessed the impact of care provision on adult caregivers of adult patients receiving PS for SBS-IF. Methods: An online, cross-sectional survey of caregivers of adults with a self-reported physician diagnosis of SBS-IF was conducted in France, Germany, Italy, the UK, and USA. Impact on caregivers was evaluated using the 18-item Caregiver Strain Index (CSI), the Work Productivity and Activity Impairment Questionnaire: Specific Health Problem (WPAI:SHP), and self-reporting impact questionnaires. Results: Caregivers (N = 121; aged 51 ± 13.7 years; 59% women) provided assistance for a mean of 9.9 ± 12.53 years; 77% were providing care 7 days per week. Patients (51 ± 16.4 years; 56% women) of caregivers were typically family members: spouse/partner (61%), adult son/daughter (19%), or parent (10%). Caregivers reported experiencing some strain (CSI score 4 ± 3.4). Among 71 of 73 employed caregivers, the WPAI:SHP assessment showed that caregivers missed 7% ± 12.7% of work hours in the preceding week and were present but not productive at work 37% ± 23.1% of the time; 28% of caregivers reported a reduced number of working hours because of caregiving. Many caregivers reported limitations in recreational activities (53%), and ≥30% had difficulty spending time with family and friends. Caregivers (87%) also reported worrying about the patient's health. Conclusions: Caregivers of adult patients with SBS-IF experience negative daily personal impacts and loss of productivity arising from their caregiving responsibilities.

BACKGROUND & AIMS We evaluated treatment withdrawal, long-term outcomes, and safety of budesonide oral suspension (BOS) 2.0 mg twice daily in patients with eosinophilic esophagitis who completed a 12-week induction study. METHODS Induction full responders (≤6 eosinophils per high-power field [eos/hpf] and ≥30% reduction in the Dysphagia Symptom Questionnaire score) to BOS 2.0 mg twice daily (ORBIT1/SHP621-301/NCT02605837) were randomized to continue BOS (BOS-BOS) or withdraw to placebo (BOS-PBO) for 36 weeks (ORBIT2/SHP621-302/NCT02736409). Induction partial responders and nonresponders, and patients who received induction placebo, received BOS for 36 weeks. The primary end point was the proportion of BOS-BOS and BOS-PBO patients who relapsed (≥15 eos/hpf and ≥4 days of dysphagia [Dysphagia Symptom Questionnaire] over 2 weeks) by week 36. The key secondary end point was the proportion of induction partial responders and nonresponders who fully responded after 52 weeks of total BOS therapy. Other secondary end points included the proportion of induction full responders with histologic responses (≤1, ≤6

Eosinophilic esophagitis (EoE) is a chronic, immune-mediated esophageal disease for which there is currently no approved treatment in the USA and only one approved therapy in Europe. EoE can significantly affect the lives of patients and caregivers; however, little has been published about patients’ experiences from symptom onset to diagnosis and treatment. This was a cross-sectional, qualitative research study. During one-on-one semi-structured interviews, patients with EoE in the USA and their caregivers provided information about their experiences of EoE before and during diagnosis, and their current experiences. Qualitative data were analyzed using a content analysis approach. The study included children aged 6–11 years with EoE (n = 4) and their caregivers (n = 4); adolescents aged 12–17 years with EoE (n = 7) and their caregivers (n = 7); and adults aged ≥ 18 years with EoE (n = 20). The diagnosis of EoE was often arduous and took many years. Patients and caregivers were frequently frustrated with the complexities of diagnosing EoE, which often involved multiple healthcare providers and procedures. Patients reported physical and psychosocial burdens associated with EoE before diagnosis, including interference with social activities, school, and work. Patients also reported feeling frustrated or anxious. These burdens frequently remained after diagnosis. Caregivers also reported anxiety and, in some cases, interference with their ability to work. This study of EoE describes the difficult journey faced by patients and their caregivers from symptom onset to diagnosis and beyond.

The AIDS Clinical Trial Group (ACTG) 5257 clinical trial showed that raltegravir (RAL) was superior to atazanavir/ritonavir (ATV/r) and darunavir/ritonavir (DRV/r), when used in combination with emtricitabine/tenofovir DF (FTC/TDF), in a 96-week composite endpoint combining virologic efficacy and tolerability for treatment-naive adults with HIV-1 infection. This study aimed to estimate the efficiency associated with these three regimens in Spain.An economic model was developed to estimate costs for antiretroviral drugs, adverse event management, and HIV care for individuals initiating first-line therapy. Antiretroviral drug costs were based on hospital costs with mandatory discounts applied. Adverse event management costs and HIV care costs were obtained from published sources and inflated to 2015 euros. Head-to-head efficacy and safety data (discontinuation rates, mean CD4 cell-count changes, adverse event incidence) up to 96 weeks for each regimen were obtained from the clinical trial. The efficiency of each regimen, as measured by the cost per successfully treated patient (i.e. on first-line therapy for 96 weeks), was estimated and examined in sensitivity analyses. All cost outcomes were discounted at 3.0% annually.Total costs per successfully treated patient were €22,377 for RAL, €26,629 for ATV/r, and €23,928 for DRV/r. These results were found to be robust in sensitivity analyses.RAL has the lowest cost per successfully treated patient when compared with DRV/r and ATV/r, each used in combination with FTC/TDF, for treatment-naive adults with HIV-1 infection in Spain. This economic evidence complements the clinical benefits of RAL reported in the ACTG 5257 clinical trial.

Randomized clinical trials have demonstrated that the efficacy of a fixed-dose single-tablet combination containing sumatriptan and naproxen sodium (S/NS) was greater than either of its individual components. Simplifying drug regimens (e.g., via a fixed-dose combination) has been shown to improve “real-world” outcomes by reducing pill burden and treatment regimen complexity, improving adherence, and reducing healthcare resource use and associated costs; however, no studies assessing such outcomes have been conducted to date for the acute treatment of migraine. To assess migraine-related healthcare resource use and associated costs for subjects prescribed S/NS vs. subjects prescribed single-entity oral triptans (SOTs) within a managed care population in the USA. In this retrospective analysis of administrative claims data from July 1, 2008 to December 31, 2009 (IMS LifeLink), subjects meeting the following criteria were selected: one or more pharmacy claim(s) for either S/NS or SOT (index date), aged 18–64 years; at least one migraine diagnosis, and continuous enrollment in the 6 months prior to and post the index date. The study population was subsequently stratified for two analyses: triptan-naive (triptan naive in the 6-month period prior to the index date) and triptan-switch (triptan user in the 6-month period prior to the index date and switching to another triptan). Subjects prescribed S/NS were propensity-score matched with subjects prescribed SOT (triptan-naive analysis: 1:3; triptan-switch analysis: 1:1) to assess differences in healthcare resource use and associated costs (2009 US$) between the S/NS and SOT groups. Results from the triptan-naive and triptan-switch analyses suggest that subjects prescribed S/NS are likely to have similar healthcare resource use patterns as those either newly initiated on an SOT or switching SOTs, as measured by migraine medication use, migraine-related healthcare resource use, and all-cause healthcare resource use. One exception was the observed increased use of opioids in the SOT group compared with the S/NS group (change in mean number of tablets pre-index vs. post-index, S/NS vs. SOT; triptan-naive analysis: 8.6 vs.18.3, p = 0.045; triptan-switch analysis: −8.2 vs. 17.7; p = 0.120). Total costs from the triptan-naive analysis indicated that the S/NS group had lower migraine-related (US$744 vs. US$820; p = 0.067) and all-cause healthcare costs (US$4,391 vs. US$4,870; p = 0.040) when compared with the SOT group, driven by savings in medical costs (migraine-related: US$252 vs. US$380; p = 0.001; all-cause: US$3,023 vs. US$3,599; p = 0.014). However, no significant differences were observed for total costs from the triptan-switch analysis (migraine-related healthcare costs, S/NS vs. SOT: US$1,159 vs. US$1,117; p = 0.929; all-cause healthcare costs: US$5,128 vs. US$4,788; p = 0.381). Study results suggest similar healthcare resource use patterns and associated costs when comparing S/NS and SOT across a triptan-naive and triptan-experienced population. While the current study focuses on direct medical costs, future studies should extend beyond such a perspective to explore functional status, productivity, and health-related quality of life and satisfaction, attributes not captured in administrative claims data, but nonetheless important treatment goals.

Two previous retrospective database analyses compared early combination therapy with an α-blocker (AB) and 5-α reductase inhibitor (5-ARI) to delayed combination therapy and found that patients receiving the delayed combination therapy were more likely to have clinical progression, acute urinary retention (AUR), and surgery. Although these studies indicate the clinical benefits of early treatment, both studies failed to take into account important baseline clinical measures, such as prostate-specific antigen (PSA) values.This study was designed to compare clinical and cost differences in men with benign prostatic hyperplasia (BPH) who initiated early versus delayed combination therapy with a 5-ARI + an AB, factoring in baseline PSA values.This retrospective claims data analysis assessed data from14 million US men with linked medical data, pharmacy data, laboratory results, and enrollment information from January 1, 2000, to December 31, 2009. Men aged 50 or older and treated for BPH with a 5-ARI + an AB were identified. Patients were required to be eligible for services at least 6 months before and 12 months after the index medication date. Patients were assigned to 1 of 2 treatment groups based on therapy (early or delayed) and 3 cohorts based on availability of PSA laboratory values (patients with a PSA value, patients with a PSA value1.5 and10, and all patients). Using a logistic model, the likelihood of clinical progression (defined as the occurrence of AUR or prostate surgery) during the 12 months after the date of first prescription fill was compared between BPH patients receiving early versus delayed combination therapy. BPH-related medical costs (excluding pharmacy costs) were assessed using generalized linear models.Among the 13,551 patients identified for study inclusion, the highest risks for clinical progression, AUR, and prostate-related surgery were consistently demonstrated in patients with a PSA1.5 and10. Across all 3 cohorts, the delayed combination-treatment group was more likely to have clinical progression, AUR, and prostate-related surgeries versus the early combination-treatment group. The incremental difference in BPH-related costs between the delayed and early combination-treatment groups was $190 per patient overall; the greatest incremental difference ($397) was observed in patients with PSA1.5 and10.The results suggest that early initiation of combination therapy with 5-ARI + an AB, compared with delayed initiation, can reduce the risks for clinical progression, AUR, and prostate-related surgeries, as well as BPH-related medical costs, in patients with BPH.

As of 2013, an estimated 1,242,000 people were living with HIV-1 infection in the United States (US) [1]. While improvements in the treatment of HIV-1 infection during the last decade have increased life expectancy and quality of life for individuals with HIV, the cost of care has risen. The first HIV regimen chosen for a treatment-naive individual has implications for treatment and care in the long-term. When considering the available treatments, it is important to select the most effective, safe, and economical regimen that meets the patient's individual needs. The AIDS Clinical Trial Group (ACTG) 5257 head-to-head clinical trial investigated common integrase and protease inhibitors for treatment-naive individuals not receiving efavirenz or other nonnucleoside reverse transcriptase inhibitors. The objective of this large study (N = 1,809) was to compare the efficacy and tolerability of raltegravir (RAL) 400 mg twice daily, atazanavir + ritonavir (ATV/r) 300 mg/100 mg once daily, and darunavir + ritonavir (DRV/r) 800 mg/100 mg once daily, each in combination with emtricitabine/tenofovir disoproxil fumarate (FTC/TDF) 200 mg/300 mg once daily, among treatment-naive adults in the US [2, 3]. The results of the ACTG 5257 trial indicated that, at 96 weeks of follow-up, the RAL regimen was superior to the ATV/r and DRV/r regimens in a composite endpoint combining virologic efficacy and tolerability [2, 3]. However, ACTG 5257 did not investigate the economic implications of these first-line HIV treatment regimens. Cost information is an essential complement to efficacy and safety data for prescribers and payers making decisions about HIV treatment in the US. The objective of this study was to estimate the total HIV treatment costs associated with the three antiretroviral (ARV) regimens examined in ACTG 5257—RAL, ATV/r, or DRV/r—when used in combination with FTC/TDF for treatment-naive adults with HIV-1 infection in the US.

OBJECTIVE: To illustrate how simple difference and relative difference methods can be used to interpret health-related quality-of-life (HRQL) benefits from a treatment, using the proportion of patients achieving a meaningful improvement in HRQl. DESIGN: The data used in this analysis were from two identical randomized clinical trials which compared, chronic obstructive pulmonary disease (COPD}- related quality-of-life benefits of salmeterol, ipratropium, and placebo. MAIN OUTCOME MEASURES: Simple and relative difference equations were applied to the proportion of patients who experienced a meaningful improvement in COPD-related quality of life. RESULTS: Simple difference showed that for 100 patients receiving placebo, an additional 14 (95% C15, 23) would have a meaningful HRQL improvement if given salmeterol, while an additional a (95% CI-1, 17) would have a meaningful improvement if given ipratropium. Using relative difference, for every 100 subjects who fail to respond to placebo, 21 (95% Cia, 31) would...

Although there is an abundance of evidence regarding clinical efficacy and safety of benign prostatic hyperplasia (BPH) treatment, real-world evidence is lacking for pharmacotherapy utilization and trends. It is unclear how evidence demonstrating the efficacy of combination 5-alpha reductase inhibitors and alpha blockers for improving symptoms and reducing risk of disease progression translates into real-world practice for the treatment of BPH. A retrospective study of a database was conducted to describe pharmacotherapy utilization/trends in the treatment of BPH among patients in the managed care setting. After inclusion and exclusion criteria were applied, the final sample size was 107,038. The proportion of patients with BPH receiving 5-alpha reductase inhibitors therapy increased (21.1% in 2003 to 30.5% in 2007), as did the proportion receiving combination therapy (10.7% and 16.1%, respectively). We observed an almost 50% increase in 5-alpha reductase inhibitors use over 5 years and a 60% increase in the use of combination 5-alpha reductase inhibitors/alpha blockers therapy.

The primary objective of this study was to evaluate the length of 5-alpha reductase inhibitor (5ARI) therapy on the likelihood of acute urinary retention (AUR) and prostate surgery in patients diagnosed with benign prostatic hyperplasia (BPH). Additionally, this study attempted to quantify the relationship between length of 5ARI therapy and monthly BPH-related medical costs.This study used MarketScan® claims data from January 1, 2003, to December 31, 2008. Male Medicare patients ≥ 65 years and Medicaid patients ≥ 50 years who received a diagnosis of BPH and at least one claim for a 5ARI during the study period were included. Cox proportional hazards models were used to evaluate the effect of length of therapy on AUR and surgery, whereas generalized linear models were used to assess the effect on costs.In 28,903 patients, every additional 30 days of 5ARI therapy reduced the likelihood of AUR and prostate surgery by 14 and 11%, respectively, while each 30-day increment of 5ARI therapy reduced BPH-related costs by 15%.For patients remaining on 5ARI therapy, significant clinical and economic benefits may be realized, including reductions in AUR and prostate surgery rates and reduced medical costs for these clinical events.