Predictors of glycemic control and diabetes-related costs among type 2 diabetes patients initiating therapy with liraglutide in the United States.

OBJECTIVE: Liraglutide has been shown to significantly improve glycemic control and reduce body weight while minimizing the risk of hypoglycemia in adult patients with type 2 diabetes (T2D). This study aimed to identify characteristics that predict clinical and economic outcomes associated with liraglutide therapy in clinical practice in the US. METHODS: Using the Truven Health MarketScan Laboratory Database, glycemic control (A1C <7%) and diabetes-related costs were evaluated in T2D patients initiating liraglutide between January 1, 2010 and June 30, 2012. Patients were required to have ≥1 post-index claim for liraglutide and A1C values at baseline and 6 months follow-up. All valid values of baseline A1C were included. Patients previously treated with GLP-1 receptor agonist(s) or insulin, or with evidence of type 1 diabetes, pregnancy, or gestational diabetes during the study period were excluded. Multivariable regression models were used to identify predictors of glycemic control and diabetes-related costs. RESULTS: Of 417 patients newly treated with liraglutide, 54.0% achieved glycemic control (A1C <7%) during follow-up. Factors associated with increased odds of glycemic control during follow-up were: being female, POS/EPO health plan type, baseline A1C, early liraglutide initiation (0-1 prior oral anti diabetics [OADs] vs ≥2), adherence to liraglutide (defined as the proportion of days covered [PDC]), and diabetic retinopathy. Being female, earlier liraglutide initiation (0-1 prior OADs), and higher patient share of liraglutide costs were associated with significantly lower diabetes-related costs during follow-up. Factors associated with significantly higher post-index diabetes-related costs were: higher baseline A1C, baseline use of sulfonylureas, and diabetic retinopathy. CONCLUSIONS: Within this commercially-insured population of T2D patients treated with liraglutide, gender, baseline A1C, early liraglutide initiation (0-1 prior OADs), diabetic retinopathy, better adherence, and patient share of liraglutide costs were associated with increased odds of achieving glycemic control and the odds of having higher or lower diabetes-related costs.

Incidence of genitourinary conditions in women with a diagnosis of vulvar/vaginal atrophy.

OBJECTIVES: Vulvar/vaginal atrophy (VVA) is one genitourinary condition associated with a decline in estrogen. This may be bothersome for women following menopause. Although the clinical features of VVA and other conditions after menopause have been documented, few studies have quantified the magnitude of association between VVA and other genitourinary conditions. METHODS: A VVA cohort was identified from two United States administrative claims databases. A matched cohort of an equal number of controls was randomly selected from a pool of women 40-79 years of age without VVA. Baseline characteristics and medical history were tabulated for the VVA cohort and matched controls. Six genitourinary conditions ('urinary tract infections', 'other/unspecified genitourinary symptoms', 'other inflammatory diseases of female pelvic organs', 'menopausal disorders', 'female genital pain and other symptoms', and 'other/unspecified female genital disorders') were hypothesized a priori to be associated with VVA. Adjusted incidence rate ratios measured the strength of association of VVA with each condition. RESULTS: A total of 9080 women aged 40-79 years with newly diagnosed VVA during 2000-2010 were identified. The mean age of VVA patients and matched controls was 60.2 years. At baseline, a significantly (p < 0.001) higher proportion of women in the VVA cohort had a diagnosis of angina, osteoporosis, migraines, insomnia, or anxiety, or received estrogen supplementation or selective estrogen receptor modulators. VVA patients had a significantly (p < 0.001) higher incidence of each of the genitourinary conditions compared to controls. The condition most strongly associated with VVA with a relative risk of 6.2 was 'other inflammatory diseases of female pelvic organs'. CONCLUSIONS: Women with VVA have a greater risk of genitourinary conditions compared to those without. The overall prevalence of VVA and other genitourinary conditions may be underreported as claims data only captures information for patients under medical care and many women do not seek consultation for VVA symptoms.

Cost-effectiveness of efavirenz vs rilpivirine in HIV patients initiating first-line combination antiretroviral therapy.

OBJECTIVE: In US treatment guidelines, efavirenz (EFV) is the preferred non-nucleoside reverse transcriptase inhibitor (NNRTI) for first-line HIV treatment. In the ECHO and THRIVE trials comparing EFV with another NNRTI, rilpivirine (RPV), both medications had similar virologic suppression rates at 96-weeks; however, RPV had higher rates of virologic failure and drug resistance and lower rates of discontinuation due to adverse events. This study compared the cost-effectiveness of EFV to RPV in first-line HIV treatment in the US. METHODS: A Markov model with 14 health states was constructed to estimate 10-year costs and clinical outcomes from a US payer perspective for antiretroviral naïve HIV patients initiating EFV or RPV. First-line efficacy data came from 96-week results of the ECHO and THRIVE trials, which compared EFV and RPV, both in combination with two nucleos(t)ide reverse transcriptase inhibitors. Other clinical inputs, mortality rates, and costs (2011 US$) came from published sources. Subsequent therapy lines (second, third, non-suppressive) were based on US treatment guidelines and common to both treatment arms. Robustness of study results was assessed in sensitivity analyses varying model inputs by ±25%. Potential limitations of the model center on the ability of any model to capture the clinical complexity of HIV treatment. RESULTS: In the base case, 10-year costs were lower for EFV compared to RPV ($214,031 vs $222,090). Life expectancy (8.44 years) and years without AIDS (8.40 years) were equal; years in virologic suppression were similar (EFV = 7.87 years, RPV = 7.86 years). EFV had modest cost savings compared to RPV in terms of incremental cost-effectiveness per life-year gained, life-year gained in viral suppression, and life-year gained without AIDS. In sensitivity analyses, EFV remained cost-saving compared to RPV in over 90% of scenarios, demonstrating the robustness of study results. CONCLUSIONS: EFV was predicted to be modestly cost-saving compared with RPV over 10 years in US patients initiating first-line HIV treatment. Sensitivity analyses suggest that results may hold across multiple settings.

Retrospective administrative database study of the time period of venous thromboembolism risk during and following hospitalization for major orthopedic or abdominal surgery in real-world US patients.

PURPOSE: To assess the incidence and time course of symptomatic venous thromboembolism (VTE) events in patients during and following hospitalization for major orthopedic or abdominal surgery. METHODS: Data were extracted from the Thomson Reuters MarketScan(®) Inpatient Drug Link File for surgical patients admitted between January 2005 and December 2008. The analysis included 8989 abdominal surgery patients and 4220 orthopedic surgery patients. The cumulative risks of VTE and VTE hazard were assessed over a 180-day evaluation period after the hospital admission date, using Kaplan-Meier analysis and LOESS regression, respectively. RESULTS: In total, 305 (2.3%) patients experienced a symptomatic VTE event. These were most frequent during days 1-9 (78 events) and 10-19 (72 events). In all, 64% of events occurred after discharge. Venous thromboembolism hazard peaked at approximately 1.3 per 1000 person-days (day 8) following orthopedic surgery and at approximately 0.52 per 1000 person-days (day 11) following abdominal surgery. In-hospital pharmacologic prophylaxis was received by 88.3% and 30.2% of orthopedic and abdominal surgery patients, respectively, whereas pharmacologic prophylaxis following hospitalization was received by 41.3% and 3.0% of patients, respectively. CONCLUSIONS: The time course of VTE in major surgery patients suggests that VTE risk is highest during the first 19 days after admission and that considerable VTE risk extends into the period after discharge.

The Novartis health index: a method for valuing the economic impact of risk reduction in a workforce.

OBJECTIVES: To develop a calculator that measures the potential cost impact of changes in health risks and presents results graphically. METHODS: Demographic and health risk data for Novartis employees were input into a calculator that estimated employer medical care, short-term disability, absenteeism, and presenteeism costs associated with risk prevalence, based on a previous cross-sectional analysis of the association between risks and costs. Estimated costs were presented as a relative score, the Novartis Health Index, which is a measure of the overall costs associated with the risk profile of a population of interest. RESULTS: The population of Novartis employees had an index score of 81.5 (out of 100), indicating a relatively healthy risk profile, and baseline annual costs of $9619 per employee. Risk reduction of 1% and 10% for tobacco, alcohol use, and emotional health risks had the potential to generate annual savings of $91,500 and $915,000, respectively. CONCLUSIONS: The Novartis Health Index framework allows employers to track performance relative to health risk management using a single, accessible, user-friendly measure.

Incremental 1-year medical resource utilization and costs for patients with herpes zoster from a set of US health plans.

BACKGROUND: Nearly 1 million new episodes of herpes zoster (HZ) occur annually in the US, yet little is known about the medical resource utilization (RU) and costs associated with HZ and its complications. OBJECTIVES: To describe the medical RU and cost burden of HZ in the first 90 days and the first year after diagnosis from the health insurer perspective and to stratify this burden for patients diagnosed with post-herpetic neuralgia (PHN) and those who are immunocompromised. In addition, this study explores costs from the societal perspective as a result of work loss in the first year after diagnosis. METHODS: The medical RU and cost data were obtained from the MarketScan Research Database for the years 1998-2003. This database contains inpatient, outpatient and prescription drug data for approximately 14 million individuals of all ages, covered under a variety of fee-for-service and capitated provider reimbursement arrangements, including those with Medicare and private insurance. The work loss estimates were based on the MarketScan Health and Productivity Management Database. Claims for services incurred between 1 January 1998 and 31 December 2003 were screened to identify a cohort of HZ patients based on the presence of at least one International Classification of Diseases, 9th Revision (ICD-9) diagnosis code 053.xx. Each patient was assigned an index date based on the earliest observed occurrence of an HZ diagnosis. A cohort of PHN patients was identified as a subset of the HZ cohort with ICD-9 codes 053.12, 053.13, 053.19 or 729.2x in the period of 90 days to 12 months after the index date. Multivariable regression was used to compare HZ cases with matched controls after adjusting for demographic characteristics, insurance status, co-morbidities and medical expenditure in the 6 months prior to diagnosis for each of the endpoints. Separate regression models were developed, in which age and immune status were stratified. All costs were adjusted to March 2008 values using the medical care component of the Consumer Price Index. The average per patient cost of all HZ cases was $US605 in the first 90 days after diagnosis and $US1052 at 1 year. For the subset with PHN, the average per patient cost of HZ at 1 year was $US3815. For the subset with an immunocompromising condition, the average HZ cost at 1 year was $US1745. The majority of the costs were the result of outpatient visits and prescription drugs. The subset of HZ cases that had both absence hour and short-term disability (STD) records available had 26.5 absence hours and 2.9 STD days. Healthcare utilization, medical care costs and work loss all increased with age for all HZ cases. Based on the results from the present study, the direct medical cost burden of HZ in the US is high, exceeding $US1000 per HZ patient. This direct medical cost may be nearly twice as high in immunocompromised patients and four times as high in the subset of HZ cases with PHN. The direct medical cost burden of HZ may exceed $US1 billion annually in the US. The majority of medical RU and cost burden is incurred by the elderly. Although many people with HZ may no longer be in the workforce, HZ does contribute to lost work time.

Clinical and economic outcomes in patients at risk of venous thromboembolism receiving appropriate enoxaparin or unfractionated heparin prophylaxis.

Clinical and economic outcomes were compared following appropriate prophylaxis with enoxaparin or unfractionated heparin (UFH) in a large, real-world population of US hospitalised medical and surgical patients at risk of venous thromboembolism (VTE). Discharges from the Thomson Reuters MarketScan Hospital Drug Database (January 2004-March 2007) of patients aged > or =40 years, at risk of VTE according to the 7(th) American College of Chest Physicians (ACCP) guidelines, who spent > or =6 days in hospital and received appropriate ACCP-recommended enoxaparin or UFH prophylaxis were included. Patients with contraindications to anticoagulation were excluded. Hospital-acquired VTE, adverse events, and hospital costs for enoxaparin versus UFH were compared using univariate and multivariate analyses. Of the 5,136 discharges included, 4,014 (78%) received enoxaparin and 1,122 (22%) received UFH. Compared with UFH, enoxaparin was associated with significantly lower risk of hospital-acquired VTE (adjusted odds ratio [OR] 0.51, 95% confidence interval [CI] 0.30-0.86, p = 0.012), pulmonary embolism (adjusted OR 0.33, 95% CI 0.14-0.79, p = 0.013) or adverse events (adjusted OR 0.73, 95% CI 0.54-0.98, p = 0.034). Total hospital costs per discharge were lower for enoxaparin (US $16,865 +/- 10,979) than UFH (US $19,252 +/- 14,970), with a mean difference of US $2,388 in favour of enoxaparin (p < 0.001) (adjusted difference US $439, 95% CI US $ -39 to 909, p = 0.072). In patients at risk of VTE, appropriate enoxaparin prophylaxis was associated with a reduction in hospital-acquired VTE, adverse events, and costs compared with appropriate UFH prophylaxis. Increased appropriate use of enoxaparin in patients at risk of VTE may help to reduce the clinical and economic burden of this condition.

Using a personal health care cost calculator to estimate future expenditures based on individual health risks.

OBJECTIVE: To describe the development and application of an innovative Health Improvement Cost Calculator tool designed to help individuals recognize the link between their current health risks, future medical costs, and productivity. METHODS: We describe how the Calculator was developed using data from studies that tie health care costs and productivity to population health risks, and how changes in risks are projected to reduce future spending for individual workers. RESULTS: Two simulations of the model illustrate how individuals may realize future economic costs or benefits depending on whether they maintain or change their health-risk profile. CONCLUSIONS: The Calculator has the potential to be a powerful motivational tool for individuals, especially those heading toward retirement, who are looking to understand the relationships between their health risks, future medical spending, and impacts on productivity.

Dose trends for second-generation antipsychotic treatment of schizophrenia and bipolar disorder.

BACKGROUND: Antipsychotic dosing used in clinical practice can differ from dosing originally recommended in product labeling. This has been reported for olanzapine and quetiapine, where higher doses are commonly used. This may be the case for ziprasidone as well. METHOD: To characterize changes over time in dosing for the initial and subsequent prescriptions of first-line second-generation antipsychotics used during treatment episodes for outpatients with schizophrenia and bipolar disorder, the 2001-2005 Thomson MarketScan Medicaid Database (Medicaid) and the 2001-2006 MarketScan Commercial Claims and Encounters Database (Commercial) were analyzed. Dose trends were evaluated using autoregressive time-series models. RESULTS: Data were available for 49180 treatment episodes of schizophrenia (4683 Commercial and 44497 Medicaid) and 83289 treatment episodes of bipolar disorder (57961 Commercial and 25328 Medicaid). The initial prescription mean daily and overall mean daily doses of ziprasidone in schizophrenia episodes significantly increased across the Medicaid and Commercial populations, with similar trends observed for bipolar episodes. The first (May 2001) and last (December 2005) observed 3-month mean daily doses for ziprasidone were 112 mg/d and 138 mg/d for patients with schizophrenia and 93 mg/d and 113 mg/d for those with bipolar disorder in the Medicaid cohort, with similar findings for the Commercial cohort. Consistently significant trends in dose changes were not observed for the other medications, although quetiapine and olanzapine doses generally increased while aripiprazole and risperidone doses generally decreased. CONCLUSIONS: There remains a need for controlled randomized clinical trials that test fixed doses of antipsychotics to ascertain the dose-response relationship within the dose range used in contemporary clinical practice.

Healthcare utilization and costs of patients with rosacea in an insured population.

BACKGROUND: Rosacea is a chronic, relapsing dermatologic condition that affects an estimated 14 million people in the U.S. However, there is little data in the literature on the healthcare utilization and costs of patients with rosacea in insured populations. METHODS: This retrospective, observational, cohort study used the MarketScan databases to identify a rosacea cohort of patients with medical and prescription drug claims between 2002 and 2005. Inclusion criteria were (1) age 30 years and older, (2) at least one medical claim with a primary or secondary diagnosis of rosacea (ICD-9-CM 695.3), (3) at least one pharmacy claim for a rosacea topical or systemic prescription drug, (4) a 6-month clean period prior to index drug and 12 months continuous enrollment after the index drug. Propensity score matching was used to match the rosacea cohort to a control group of patients without rosacea. Disease severity during the 6-month preperiod was assessed by the Charlson Comorbidity Index (CCI), the Chronic Disease Score (CDS), and the Elixhauser Index (EI). Healthcare utilization rates and costs were determined by the type of care for the 12-month postperiod. Costs were calculated for the 12-month post-period and adjusted to reflect 2005 costs. Healthcare utilization rates and costs were reported for inpatient hospital admissions, physician office visits, emergency room visits, other outpatient services, and outpatient pharmacy prescriptions. Both total healthcare and rosacea-related rates and costs were reported. RESULTS: There were no rosacea-related inpatient admissions and very few emergency department visits. More rosacea patients had a specialist visit than a primary care physician visit. The average number of rosacea-related prescriptions, for all patients, was 3.4 (SD 2.7) per year. Total annual healthcare expenditures for the rosacea patient cohort were $735 more than for the matched controls ($6,458 vs. $5,723). Of the total healthcare costs, annual rosacea-related expenditures were $276; approximately 70% of rosacea-related expenditures were due to prescription drugs. Topical drugs were the index drugs for 77% of rosacea patients with branded metronidazole, which is the most common topical drug. Of the 23% of rosacea patients with an oral index drug, generic antibiotic dosage forms of tetracyclines were the most common oral index drug therapy. CONCLUSIONS: This is the first extensive study of rosacea and its impact on healthcare utilization and costs in an insured population. Although rosacea is a common illness that does not have much financial impact on its sufferers, rosacea patients incurred slightly higher direct total healthcare costs than matched controls.