Building an Integrated Data Infrastructure to Examine the Spectrum of Suicide Risk Factors in Philadelphia Medicaid.

While there are many data-driven approaches to identifying individuals at risk of suicide, they tend to focus on clinical risk factors, such as previous psychiatric hospitalizations, and rarely include risk factors that occur in nonclinical settings, such as jails or emergency shelters. A better understanding of system-level encounters by individuals at risk of suicide could help inform suicide prevention efforts. In Philadelphia, we built a community-level data infrastructure that encompassed suicide death records, behavioral health claims, incarceration episodes, emergency housing episodes, and involuntary commitment petitions to examine a broader spectrum of suicide risk factors. Here, we describe the development of the data infrastructure, present key trends in suicide deaths in Philadelphia, and, for the Medicaid-eligible population, determine whether suicide decedents were more likely to interact with the behavioral health, carceral, and housing service systems compared to Medicaid-eligible Philadelphians who did not die by suicide. Between 2003 and 2018, there was an increase in the number of annual suicide deaths among Medicaid-eligible individuals, in part due to changes in Medicaid eligibility. There were disproportionately more suicide deaths among Black and Hispanic individuals who were Medicaid-eligible, who were younger on average, compared to suicide decedents who were never Medicaid-eligible. However, when we accounted for the racial and ethnic composition of the Medicaid population at large, we found that White individuals were four times as likely to die by suicide, while Asian, Black, Hispanic, and individuals of other races were less likely to die by suicide. Overall, 58% of individuals who were Medicaid-eligible and died by suicide had at least one Medicaid-funded behavioral health claim, 10% had at least one emergency housing episode, 25% had at least one incarceration episode, and 22% had at least one involuntary commitment. By developing a data infrastructure that can incorporate a broader spectrum of risk factors for suicide, we demonstrate how communities can harness administrative data to inform suicide prevention efforts. Our findings point to the need for suicide prevention in nonclinical settings such as jails and emergency shelters, and demonstrate important trends in suicide deaths in the Medicaid population.

Influence of Female Genital Mutilation/Cutting on Health Morbidity, Health Service Utilization and Satisfaction with Care among Somali Women and Teenage Girls in the United States.

INTRODUCTION: There is scant evidence on the health morbidities experienced by Somali women and girls affected by female genital mutilation/cutting (FGM/C) and their resultant health-seeking behavior in the USA as compared to those who have not undergone the procedure. To fill this gap, we conducted a comprehensive examination of health morbidity among women and teenage girls with and without FGM/C in a Somali migrant community. METHODS: Using a comprehensive community-based participatory research approach, a cross-sectional survey was administered to 879 Somali women and teenage girls in Phoenix and Tucson, Arizona. We employed Chi-square and analysis of variance to disentangle health and healthcare use among those with and without FGM/C. RESULTS: The majority of respondents had undergone FGM/C (79%). Respondents with FGM/C experienced significantly more health concerns compared to uncut women and girls, with those possessing Type III FGM/C experiencing significantly more obstetric, gynecologic, sexual, and mental health morbidity than those with Type I or Type II. Rates of service use, while varied, were low overall, particularly for mental health services, even with health insurance. The majority of respondents who sought care indicated that their concerns were resolved, and they were satisfied with the healthcare received. CONCLUSIONS: Community-engaged strategies that build upon satisfaction with care of women who seek care to enhance trust, nurture community embeddedness and facilitate peer navigation, while equipping health and social service providers with the competency and tools to provide respectful, trauma-informed care, will be critical to advance health equity for FGM/C-affected communities.

The Economic Benefit of Remission for Patients with Rheumatoid Arthritis.

INTRODUCTION: In patients with rheumatoid arthritis (RA), attaining remission or low disease activity (LDA), as recommended by the treat-to-target approach, has shown to yield improvement in symptoms and quality of life. However, limited evidence from real-world settings is available to support the premise that better disease control is associated with lower healthcare costs. This study fills in evidence gaps regarding the cost of care by RA disease activity (DA) states and by therapy. METHODS: This retrospective cohort study linked medical and prescription claims from Optum Clinformatics Data Mart to electronic health record data from Illumination Health over 1/1/2010-3/31/2020. Mean annual costs for payers and patients were examined, stratifying on DA state and baseline use of conventional synthetic disease-modifying antirheumatic drugs (csDMARDs), biologics, and targeted synthetic (ts)DMARDs. Subgroup analysis examining within-person change in costs pre- and post-initiation of new therapy was also performed. Descriptive statistics, means, and boot-strapped confidence intervals were analyzed by DA state and by RA therapy. Furthermore, multivariate negative binomial regression analysis adjusting for key baseline characteristics was conducted. RESULTS: Of 2339 eligible patients, 19% were in remission, 40% in LDA, 29% in moderate DA (MDA), and 12% in high DA (HDA) at baseline. Mean annual costs during follow-up were substantially less for patients in remission ($40,072) versus those in MDA ($56,536) and HDA ($59,217). For patients in remission, csDMARD use was associated with the lowest mean annual cost ($25,575), tsDMARD was highest ($75,512), and tumor necrosis factor inhibitor (TNFi) ($69,846) and non-TNFi ($57,507) were intermediate. Among new TNFi (n = 137) and non-TNFi initiators (n = 107), 31% and 26% attained LDA/remission, respectively, and the time to achieve remission/LDA was numerically shorter in TNFi vs. non-TNFi initiators. For those on biologics, mean annual within-person medical and inpatient costs were lower after achieving LDA/remission, although pharmacy costs were higher. CONCLUSIONS: Cost of care increased with increasing DA state, with patients in remission having the lowest costs. Optimizing DA has the potential for substantial savings in healthcare costs, although may be partially offset by the high cost of targeted RA therapies.

The rate, cost and outcomes of parathyroidectomy in the united states dialysis population from 2016-2018.

BACKGROUND: In end-stage kidney disease, patients may undergo parathyroidectomy if secondary hyperparathyroidism cannot be managed medically. This study was designed to estimate the parathyroidectomy rate in the United States (US) and to quantify changes in costs and other outcomes after parathyroidectomy. METHODS: This was a retrospective observational cohort study using US Renal Data System data for 2015-2018. Parathyroidectomy rates were estimated for adult hemodialysis and peritoneal dialysis patients alive at the beginning of 2016, 2017, and 2018 who were followed for a year or until parathyroidectomy, death, or transplant. Incremental differences in economic and clinical outcomes were compared before and after parathyroidectomy in adult hemodialysis and peritoneal dialysis patients who received a parathyroidectomy in 2016 and 2017. RESULTS: The rate of parathyroidectomy per 1,000 person-years decreased from 6.5 (95% CI 6.2-6.8) in 2016 to 5.3 (95% CI 5.0-5.6) in 2018. The incremental increase in 12-month cost after versus before parathyroidectomy was $25,314 (95% CI $23,777-$27,078). By the second month after parathyroidectomy, 58% of patients had a corrected calcium level < 8.5 mg/dL. In the year after parathyroidectomy (versus before), hospitalizations increased by 1.4 per person-year (95% CI 1.3-1.5), hospital days increased by 12.1 per person-year (95% CI 11.2-13.0), dialysis visits decreased by 5.2 per person-year (95% CI 4.4-5.9), and office visits declined by 1.3 per person-year (95% CI 1.0-1.5). The incremental rate per 1,000 person years for hematoma/bleed was 224.4 (95% CI 152.5-303.1), for vocal cord paralysis was 124.6 (95% CI 59.1-232.1), and for seroma was 27.4 (95% CI 0.4-59.0). CONCLUSIONS: Parathyroidectomy was a relatively uncommon event in the hemodialysis and peritoneal dialysis populations. The incremental cost of parathyroidectomy was mostly attributable to the cost of the parathyroidectomy hospitalization. Hypocalcemia occurred in over half of patients, and calcium and phosphate levels were reduced. Clinicians, payers, and patients should understand the potential clinical and economic outcomes when considering parathyroidectomy.

The value of new drugs for advanced prostate cancer.

BACKGROUND: The US Food and Drug Administration has recently approved a number of new cancer drugs. The clinical trials that serve as the basis for new cancer drug approvals may not reflect how the drugs will perform in routine practice and do not measure the impact of the drugs on spending. The authors sought to evaluate the real-world effectiveness and value of drugs recently approved for advanced prostate cancer. METHODS: Using Surveillance, Epidemiology, and End Results-Medicare data, the authors identified fee-for-service Medicare beneficiaries aged 65 years or older who began treatment with a drug approved for metastatic castration-resistant prostate cancer in 2007-2009, when only 1 drug was approved for metastatic castration-resistant prostate cancer, and in 2014-2016, when 5 additional drugs were approved. They calculated life expectancy and lifetime medical costs (ie, Medicare reimbursements) for each group. RESULTS: Between 2007-2009 and 2014-2016, life expectancy increased by 12.6 months. Lifetime medical costs increased by $87,000. The incremental cost per life-year gained was $83,000. CONCLUSION: The release of 5 new drugs coincided with increases in survival rates and spending. This study's estimates indicate that the new drugs collectively were cost-effective.

Long-term direct and indirect economic burden associated with osteoporotic fracture in US postmenopausal women.

The study examined long-term direct and indirect economic burden of osteoporotic fractures among postmenopausal women. Healthcare costs among fracture patients were substantial in first year after fracture and remained higher than fracture-free controls for 5 years which highlight needs for early detection of high-risk patients and continued management for osteoporosis. INTRODUCTION: This study compared direct and indirect healthcare costs between postmenopausal women and demographically matched controls in the 5 years after incident non-traumatic fracture, and by fracture type in commercially insured and Medicare populations. METHODS: Two hundred twenty-six thousand one hundred ninety women (91,925 aged 50-64 years; 134,265 aged ≥ 65 years) with incident non-traumatic fracture (hip, vertebral, and non-hip non-vertebral (NHNV)) from 2008 to 2017 were identified. Patients with fracture were directly matched (1:1) to non-fracture controls based on demographic characteristics. Direct healthcare costs were assessed using general linear models, adjusting for baseline costs, comorbidities, osteoporosis diagnosis, and treatment. Indirect costs associated with work loss due to absenteeism and short-term disability (STD) were assessed among commercially insured patients. Costs were standardized to 2019 US dollars. RESULTS: Osteoporosis diagnosis and treatment rates prior to fracture were low. Patients with fracture incurred higher direct costs across 5-year post-index compared with non-fracture controls, regardless of fracture type or insurance. For commercially insured hip fracture patients, the mean adjusted incremental direct healthcare costs in years 1, 3, and 5 were $59,327, $6885, and $3241, respectively. Incremental costs were lower, but trends were similar for vertebral and NHNV fracture types and Medicare-insured patients. Commercially insured patients with fracture had higher unadjusted indirect costs due to absenteeism and STD in year 1 and higher adjusted indirect costs due to STD at year 1 (incremental cost $5848, $2748, and $2596 for hip, vertebral, and NHNV fracture). CONCLUSIONS: A considerable and sustained economic burden after a non-traumatic fracture underscores the need for early patient identification and continued management.

Clinical and economic burden of intravenous paclitaxel or nab-paclitaxel for metastatic breast cancer.

BACKGROUND: Intravenous (IV) taxane therapy for metastatic breast cancer (mBC) has been associated with toxicities and demanding dosing schedules, which can limit treatment effectiveness. OBJECTIVES: To assess treatment patterns, toxicities, and costs in women with mBC initiating IV paclitaxel or IV nab-paclitaxel. METHODS: Adult women diagnosed with BC from January 1, 2014, to September 30, 2018, were identified in the MarketScan Commercial and MarketScan Medicare Supplemental databases. Women had a metastatic disease diagnosis and newly initiated treatment with IV paclitaxel/nab-paclitaxel (first administration date was considered the index date), and continuous enrollment for at least 12 months prior to and at least 3 months following the index date. Treatment discontinuation, dose reductions, toxicities, and health care utilization and costs per patient per month (PPPM) were assessed over the full follow-up and the index line of IV paclitaxel/nab-paclitaxel therapy (Index LOT). RESULTS: The sample included 8890 women aged 54.6 (±10.9) years, followed for 18.9 (±13.5) months. Most (82.0%) initiated IV paclitaxel/nab-paclitaxel monotherapy; 83.1% had early discontinuation (<18 weeks of treatment) of the Index LOT. Among the 6943 women eligible for the dose-change analysis, 42.4% evidenced an IV paclitaxel/nab-paclitaxel dose reduction ≥10% during the Index LOT. The most common toxicities during the Index LOT were gastrointestinal upset (30.5%), myelotoxicity (27.0%), infection (26.2%), general symptoms (25.9%), and chemotherapy-induced peripheral neuropathy (22.7%). Over follow-up, 39.7% of women had an inpatient admission and 43.0% had an emergency department visit. The mean of all-cause total costs was $11,991 PPPM, while BC-related total costs were $5320 PPPM. CONCLUSIONS: Many mBC patients initiating IV paclitaxel/nab-paclitaxel experienced dose reductions, toxicities, and/or early discontinuation of the Index LOT, which may limit treatment effectiveness. More tolerable treatments with reduced dosing complexity could improve mBC treatment and help contain costs.

Chemotherapy-induced peripheral neuropathy in metastatic breast cancer patients initiating intravenous paclitaxel/nab-paclitaxel.

BACKGROUND: Intravenous (IV) taxanes for metastatic breast cancer (mBC) are associated with toxicities, such as chemotherapy-induced peripheral neuropathy (CIPN), which can detrimentally impact outcomes. OBJECTIVE: To assess the impact of CIPN on clinical and economic outcomes in women with mBC, initiating IV paclitaxel/ nab-paclitaxel. METHODS: Adult women in the MarketScan Commercial and Medicare Supplemental Database with a mBC diagnosis, initiating IV paclitaxel or IV nab-paclitaxel (index date = first administration) from November 1, 2013, to September 30, 2018, who had no prior neuropathy diagnoses, and continuous enrollment 12 months prior to and ≥ 3 months following index were selected. Propensity score-matched CIPN and non-CIPN cohorts were defined, based on postindex CIPN diagnosis. Clinical characteristics and all-cause and breast cancer (BC)-related health care utilization and costs per patient per month (PPPM) were compared between matched CIPN and non-CIPN cohorts during follow-up. RESULTS: Among the 5870 women with mBC initiating IV paclitaxel/nab-paclitaxel, 42.7% developed CIPN. The matched cohorts each included 1950 women. Patients with CIPN were more likely to have a dose reduction (46.1% vs 38.2%, P < .001) or develop depression, diabetes, insomnia, liver dysfunction, or arthritis compared with the non-CIPN cohort, P < .05. Patients with CIPN were more likely to have an inpatient admission (39.2% vs 34.9%, P < .01) or emergency department visit (46.7% vs 35.6%, P < .001), as well as all-cause and BC-related costs that were $1102 and $725 PPPM higher, respectively, than women without CIPN (P < .01). CONCLUSIONS: CIPN was common in women, following IV paclitaxel/nab-paclitaxel treatment and was associated with dose reductions, the development of comorbidities, and elevated health care costs. Therapies for mBC that offer increased tolerability are needed to help improve patient outcomes and control costs.

Cost of home vs clinic administration of paclitaxel in metastatic breast cancer.

OBJECTIVES: To estimate the costs associated with home administration of oral paclitaxel and encequidar (novel P-glycoprotein pump inhibitor allowing oral paclitaxel bioavailability) compared with clinic/office administration of intravenous (IV) paclitaxel (175 mg/m2) and protein-bound paclitaxel in US patients with metastatic breast cancer. STUDY DESIGN: Economic analysis. METHODS: A cost calculator was constructed from a payer's perspective including all costs related to administration of the chemotherapies, including drug administration, premedications and concomitant medications, oncologist office visits, laboratory testing, and administration-related adverse events. Total administration cost per patient per month (PPPM) and 6-month costs per patient were estimated for oral paclitaxel and encequidar, 175 mg/m2 IV paclitaxel, and protein-bound paclitaxel. Three scenarios for oral paclitaxel and encequidar, a weekly IV paclitaxel scenario (80-100 mg/m2), and univariate sensitivity analyses were conducted. RESULTS: Home administration of oral paclitaxel and encequidar was associated with a total administration cost of $523 PPPM, 64.4% lower than once-every-3-weeks IV paclitaxel (175 mg/m2; $1469 PPPM) and 63.8% lower than protein-bound paclitaxel (260 mg/m2; $1445 PPPM). Difference in costs was driven largely by higher administration and premedication costs associated with IV therapies. Scenario analyses showed that increased clinical experience with home administration of oral paclitaxel and encequidar was associated with reduction in cost of care associated with its administration over time. For the weekly IV (80-100 mg/m2) paclitaxel scenario, the total administration cost was $2510 PPPM (4.8 times higher than for oral paclitaxel and encequidar). Univariate sensitivity analysis demonstrated that the model findings were robust. CONCLUSIONS: Home administration of oral paclitaxel and encequidar was associated with lower administration costs compared with once-every-3-weeks IV paclitaxel (175 mg/m2) and protein-bound paclitaxel, resulting in potential cost savings for payers.

Effect of clinically significant thresholds of eosinophil elevation on health care resource use in asthma.

BACKGROUND: Blood eosinophil counts correlate with exacerbations, but there is a lack of consensus on a clinically relevant definition of eosinophil count elevation. OBJECTIVE: To analyze health care resource use among patients with elevated blood eosinophil counts defined at 150 cells/µL or greater and 300 cells/µL or greater. METHODS: Data on patients who received a diagnosis of asthma between 2007 and 2016 were extracted from EMRClaims + database. Patients were defined as having elevated eosinophil counts if any test result during 3 months before follow-up found blood eosinophil count of 150 cells/µL or more or 300 cells/µL or more. Hospitalizations, emergency department visits, outpatient visits, and associated costs were compared. With logistic regression, likelihood of hospitalization was assessed in the presence of eosinophil elevation. RESULTS: Among 3687 patients who met the study criteria, 1152 received a test within 3 months before the follow-up period, of whom 644 (56%) had elevated eosinophil counts of 150 cells/µL or greater and 322 (29%) had eosinophil counts of 300 cells/µL or greater. Overall, the mean (SD) number of hospitalizations for patients with elevated eosinophil counts vs the comparator was significantly greater (0.29 [0.92] vs 0.17 [0.57], P < .001 at ≥150 cells/µL and 0.30 [0.95] vs 0.18 [0.61] at ≥300 cells/µL, P = .001). The total mean cost was significantly greater for patients with elevated eosinophil counts (at ≥150 cells/µL: $10,262 vs $7149, P < .001 and at ≥300 cells/µL: $9966 vs $7468, P = .003). CONCLUSION: Patients with asthma incurred greater health care resource use when their blood eosinophil counts were elevated at 150 cells/µL or greater and 300 cells/µL or greater as measured within 3 months of follow-up.

Crime Victimization, Health, and Female Genital Mutilation or Cutting Among Somali Women and Adolescent Girls in the United States, 2017.

Objectives. To examine if exposure to victimization (e.g., homicide, violence, sexual assault, arson, kidnapping) is related to health problems, health care access and barriers, and health needs-beyond the effects of female genital mutilation or cutting (FGM/C)-among Somali women and adolescent girls.Methods. We collected original survey data in 2017 from 879 female Somalis in Arizona.Results. Compared with nonvictims, victims experienced significantly more health problems, were significantly less likely to have a designated place to receive health care, and identified significantly more health care needs and barriers to health care. Victims were 4 times more likely to experience depression or trauma and more than twice as likely to experience sexual intercourse problems, pregnancy problems, and gynecological problems. Among Somalis with FGM/C, victims had a 15% higher predicted probability of pregnancy-related health problems and a 19% higher predicted probability of gynecological health problems compared with nonvictimized Somalis with FGM/C.Conclusions. Somalis exposed to victimization have more health problems, needs, and health care barriers.Public Health Implications. Although more than 98% of Somali women and adolescent girls have undergone FGM/C, crime victimization affects health more than FGM/C alone.

A Systematic Review of Direct Cardiovascular Event Costs: An International Perspective.

INTRODUCTION: There is a lack of comprehensive cost information for cardiovascular events since 2013. OBJECTIVE: A systematic review on the contemporary cost of cardiovascular events was therefore undertaken. METHODS: Methods complied with those recommended by the Cochrane Collaboration and the Centre for Reviews and Dissemination. Studies were unrestricted by language, were from 2013 to 23 December 2017, and included cost-of-illness data in adults with the following cardiovascular conditions: myocardial infarction (MI), stroke, transient ischaemic attack (TIA), heart failure (HF), unstable angina (UA), coronary artery bypass graft (CABG), percutaneous coronary intervention (PCI), or peripheral artery disease (PAD). Seven electronic databases were searched, namely Embase (Ovid), MEDLINE (Ovid), MEDLINE In-Process Citations and Daily Update (Ovid), NHS Economic Evaluation Database (NHS EED), Health Technology Assessment (HTA) database, Cochrane Central Register of Controlled Trials (CENTRAL), and PubMed. The included studies reported data from a variety of years (sometimes prior to 2013), so costs were inflated and converted to $US, year 2018 values, for standardization. RESULTS: After de-duplication, 29,945 titles and abstracts and then 403 full papers were screened; 82 studies (88 papers) were extracted. Year 1 average cost ranges were as follows: MI ($11,970 in Sweden to $61,864 in the USA), stroke ($10,162 in Spain to $46,162 in the USA), TIA ($6049 in Sweden to $25,306 in the USA), HF ($4456 in China to $49,427 in the USA), UA ($11,237 in Sweden to $31,860 in the USA), PCI ($17,923 in Italy to $45,533 in the USA), CABG ($17,972 in the UK to $76,279 in the USA). One Swedish study reported PAD costs in a format convertible to $US, 2018 values, with a mean annual cost of $15,565. CONCLUSIONS: There was considerable unexplained variation in contemporary costs for all major cardiovascular events. One emerging theme was that average costs in the USA were considerably higher than anywhere else.

Real-world outcomes in patients with chronic obstructive pulmonary disease initiating long-acting mono bronchodilator therapy.

BACKGROUND: Randomized clinical trials have shown long-acting mono bronchodilator therapy to be efficacious in improving lung function and dyspnea, while reducing exacerbations; however, less is known regarding the effectiveness in routine clinical practice. This study examined treatment patterns, rescue medication use, healthcare resource utilization and costs, and exacerbations in patients with chronic obstructive pulmonary disease (COPD) who initiated long-acting mono bronchodilator therapy in real-world settings. METHODS: This retrospective study used US claims data from adult patients with COPD initiating long-acting mono bronchodilator therapy between 1 January 2008 and 31 January 2015. Patients were required to have continuous health plan enrollment 12 months prior to (baseline period) and 12 months following therapy initiation (follow-up period). Outcomes, including treatment patterns, rescue medication use, exacerbations, and healthcare utilization and costs, were measured until the earliest of treatment augmentation or discontinuation, death, health plan disenrollment, or the end of the study period. Results were analyzed descriptively for all measures. Baseline and follow-up measures of all-cause and COPD-related healthcare costs and exacerbations [per patient per month (PPPM)] were compared using paired t tests. RESULTS: Among 27,394 patients with a mean follow up of 6.3 months, 18.2% augmented, 74.2% discontinued, and 7.6% continued long-acting mono bronchodilator therapy. Rescue medication use was prevalent during the follow-up period, with an average of 1.0 short-acting ß agonist (SABA) fills/month and 0.8 short-acting muscarinic antagonist (SAMA) fills/month, among patients with at least one fill for the medication of interest. PPPM mean number of exacerbations was more than triple (0.17 versus 0.05, p < 0.001) and PPPM exacerbation-related costs were more than double over the follow-up period compared with baseline ($1070 versus $485). COPD-related costs accounted for 50% of all-cause costs during the follow-up period and were significantly higher compared with baseline ($1206 versus $592, p < 0.001). CONCLUSIONS: Patients initiating long-acting mono bronchodilator therapy had high rates of medication discontinuation or augmentation. Patients used more rescue medications and experienced significantly more COPD exacerbations with higher healthcare costs compared with baseline. Further research is warranted to determine whether more aggressive initial therapy would result in symptom improvement.

Impact of Nonadherence to Inhaled Corticosteroid/LABA Therapy on COPD Exacerbation Rates and Healthcare Costs in a Commercially Insured US Population.

BACKGROUND: Evidence of poor patient adherence to medications for chronic obstructive pulmonary disease (COPD) is well-documented, but its impact on disease exacerbation rates and associated healthcare costs remains unclear. OBJECTIVE: To assess the association between adherence levels to different inhaled corticosteroid/long-acting ß2-adrenergic agonist (LABA) and COPD exacerbation rates and costs in a commercially insured population. METHODS: In this observational cohort study, patients with COPD (aged ≥40 years) who were treatment-naïve to inhaled corticosteroid/LABA and were initiating budesonide plus formoterol or fluticasone plus salmeterol between March 1, 2009, and January 31, 2014, were identified in a national representative claims database and were followed for up to 12 months. The date of the first prescription fill for either drug was defined as the index date. Patients were divided into 4 cohorts based on adherence to the index therapy, which was measured by proportion of days covered (PDC); the cohorts were classified as adherent (PDC ≥0.8), mildly nonadherent (0.5 ≤ PDC <0.8), moderately nonadherent (0.3 ≤ PDC <0.5), and highly nonadherent (PDC <0.3). Each nonadherent group was matched in a 1:1 ratio to the adherent group independently, based on prognostically important variables, using propensity score analyses. Exacerbation rates and healthcare costs were analyzed for 1 year after treatment initiation. RESULTS: During the study period, 13,657 eligible patients with COPD initiated inhaled corticosteroid/LABA; of these, only 1898 (13.9%) patients were adherent during follow-up. Group matching resulted in 1572 patients per group for comparison 1 (adherent vs mildly nonadherent), 1604 patients for comparison 2 (adherent vs moderately nonadherent), and 1755 patients for comparison 3 (adherent vs highly nonadherent). The moderately and highly nonadherent cohorts had higher exacerbation rates than the adherent patients (comparison 2: rate ratio [RR], 1.11; 95% confidence interval [CI], 1.01-1.21; P = .03; comparison 3: RR, 1.11; 95% CI, 1.01-1.21; P = .02). Adherent patients incurred significantly lower healthcare costs than all the nonadherent groups (comparison 1, $22,671 vs $25,545; P <.01; comparison 2, $22,508 vs $24,303; P <.01; comparison 3, $22,460 vs $25,148; P <.01). CONCLUSIONS: Patients adhered to their inhaled corticosteroid/LABA treatments had lower COPD exacerbation rates and lower healthcare costs compared with the moderately and highly nonadherent patients. Better adherence to maintenance therapies may help to reduce the clinical and economic burdens of COPD.

Lipid-lowering treatment modifications among patients with hyperlipidemia and a prior cardiovascular event: a US retrospective cohort study.

BACKGROUND: Numerous studies demonstrate that, even with use of statins, many patients are unable to meet their LDL-C goals. This study examined modifications to statin and/or ezetimibe therapy among patients with hyperlipidemia and prior history of cardiovascular (CV) events in a US commercially insured population. METHODS: Adults (age ≥18 years) initiating statins and/or ezetimibe between 1 January 2007 and 31 December 2008 were identified from HealthCore Integrated Research Database. The index date was the initiation date of statins and/or ezetimibe. All patients had ≥1 medical claims related to myocardial infarction, unstable angina, ischemic stroke, transient ischemic attack, coronary artery bypass graft, or percutaneous coronary intervention within 12 months prior to the index date. Treatment modifications to statins and/or ezetimibe initiated on the index date (index therapy) included permanent discontinuation of any lipid lowering therapy (LLT), rechallenge, switching, subtraction, augmentation, and dose changes. RESULTS: Among 17,902 patients, around 90% initiated with statin monotherapy, followed by statin and ezetimibe combination (3.0%: 18-64 years; 3.8%: ≥65 years). Ten percent or less initiated on high intensity statins. Most common treatment modifications were rechallenging index therapy (25.2%: 18-64 years, 27.0%: ≥65 years), switching (27.5%: 18-64 years, 24.6%: ≥65 years), and permanent discontinuation of any LLT (18.6%: 18-64 years, 21.0%: ≥65 years). Only 10% of patients in both groups underwent dose escalation. CONCLUSIONS: Real-world evidence indicates that few high-risk patients initiate therapy with high-intensity statins. More than 50% of patients underwent a rechallenge or switching. Despite high CVD risk profile, approximately 20% of patients permanently discontinued any LLT. Key limitations: Pharmacy claims do not provide information on whether patients who had a pharmacy fill actually took the medication as prescribed. It is unknown whether rechallenge was a simple delay in filling a prescription or an actual rechallenge of their index therapy. Reasons for treatment discontinuations or modifications were unavailable in claims data.

Clinical and economic burden associated with cardiovascular events among patients with hyperlipidemia: a retrospective cohort study.

BACKGROUND: Annual direct costs for cardiovascular (CV) diseases in the United States are approximately $195.6 billion, with many high-risk patients remaining at risk for major cardiovascular events (CVE). This study evaluated the direct clinical and economic burden associated with new CVE up to 3 years post-event among patients with hyperlipidemia. METHODS: Hyperlipidemic patients with a primary inpatient claim for new CVE (myocardial infarction, unstable angina, ischemic stroke, transient ischemic attack, coronary artery bypass graft, percutaneous coronary intervention and heart failure) were identified using IMS LifeLink PharMetrics Plus data from January 1, 2006 through June 30, 2012. Patients were stratified by CV risk into history of CVE, modified coronary heart disease risk equivalent, moderate- and low-risk cohorts. Of the eligible patients, propensity score matched 243,640 patients with or without new CVE were included to compare healthcare resource utilization and direct costs ranging from the acute (1-month) phase through 3 years post-CVE date (follow-up period). RESULTS: Myocardial infarction was the most common CVE in all the risk cohorts. During the acute phase, among patients with new CVE, the average incremental inpatient length of stay and incremental costs ranged from 4.4-6.2 days and $25,666-$30,321, respectively. Acute-phase incremental costs accounted for 61-75% of first-year costs, but incremental costs also remained high during years 2 and 3 post-CVE. CONCLUSIONS: Among hyperlipidemic patients with new CVE, healthcare utilization and costs incurred were significantly higher than for those without CVE during the acute phase, and remained higher up to 3 years post-event, across all risk cohorts.

A US Claims-Based Analysis of Real-World Lipid-Lowering Treatment Patterns in Patients With High Cardiovascular Disease Risk or a Previous Coronary Event.

The objective was to examine real-world treatment patterns of lipid-lowering therapies and their possible associated intolerance and/or ineffectiveness in patients with high cardiovascular disease (CVD) risk initiating statins and/or ezetimibe. Patients aged ≥18 years who initiated statins and/or ezetimibe from January 01, 2007, to June 30, 2011, were retrospectively identified from the IMS LifeLink PharMetrics Plus commercial claims database. Patients were further classified into 2 cohorts: (1) history of cardiovascular event (CVE) and (2) history of coronary heart disease risk equivalent (CHD RE). Patients had continuous health plan enrollment ≥1 year pre- and post-index date (statin and/or ezetimibe initiation date). Primary outcomes were index statin intensity, treatment modifications, possible associated statin/nonstatin intolerance and/or ineffectiveness issues (based on treatment modification), and time-to-treatment modifications. Analyses for each cohort were stratified by age group (<65 and ≥65 years). A total of 41,934 (history of CVE) and 170,344 patients (history of CHD RE) were included. On the index date, 8.8% to 25.1% of patients were initiated on high-intensity statin. Among patients aged <65, 79.2% and 48.8% of those with history of CVE and 78.6% and 47.3% of those with a history of CHD RE had ≥1 and 2 treatment modifications, respectively. Among all patients, 24.6% to 25.6% had possible statin intolerance and/or ineffectiveness issues after accounting for second treatment modification (if any). In conclusion, in patients with high CVD risk, index statin treatment modifications that imply possible statin intolerance and/or ineffectiveness were frequent; low use of high-intensity statins indicates unmet need in the management of hyperlipidemia and possible remaining unaccounted CVD residual risk.

Burden of First and Recurrent Cardiovascular Events Among Patients With Hyperlipidemia.

BACKGROUND: Acute cardiovascular (CV) events have been evaluated in patients with specific comorbidities but have not focused on patients with hyperlipidemia or on the their long-term costs. OBJECTIVES: To evaluate incidence of CV events, costs, and resource utilization among patients with hyperlipidemia and baseline risk of CV disease (CVD). METHODS: Patients (age 18 to 64 years) diagnosed with hyperlipidemia or using lipid-modifying medications were identified from administrative claims. Patients were categorized into 3 cohorts based on pre-index clinical characteristics-secondary prevention (SP; history of CV event, n = 15 613); high risk (HR; CVD, n = 47 600); and primary prevention (PP; no CV event history or CVD, n = 60 637)-and followed up to 2 years after the CV event. RESULTS: During follow-up, ≥1 new CV event occurred in 43.0% of the SP cohort, 33.9% of HR, and 20.9% of PP; and ≥3 new events occurred in 19.8% of the SP cohort, 12.9% of HR, and 5.5% of PP. Incremental total costs were $19 320 for SP, $20 003 for HR, and $17 650 for PP. Compared with patients with only 1 CV event, the mean 2-year cost was 30% higher in patients with 2 CV events and 48% higher in patients with 3 CV events. Only 50% of HR patients (with or without CV events) received statins. CONCLUSIONS: Patients with recurrent CV events had higher total health care costs during 24-month follow-up for each type of CV event. Total health care costs among patients with a CV event were higher for the initial as well as subsequent events. Statins and lipid-modifying medications were significantly underutilized in all cohorts, despite the presence of CVD.

Treatment patterns following discontinuation of adalimumab, etanercept, and infliximab in a US managed care sample.

OBJECTIVES: Because clinical guidelines do not offer clear recommendations for treatment options after discontinuing a tumor necrosis factor (TNF) blocker, this study evaluated treatment patterns within 360 days after discontinuation of TNF-blocker treatment. METHODS: The IMS LifeLink Health Plan Claims database was used to identify patients diagnosed with rheumatoid arthritis, psoriasis, psoriatic arthritis, or ankylosing spondylitis who received etanercept, adalimumab, or infliximab between January 1, 2005 and March 31, 2009. Discontinuation from index (first) TNF blocker was defined as switching to a different TNF blocker or a >45-day gap in therapy. Patients were categorized into mutually exclusive groups in descending order: (a) restart of index TNF blocker; (b) switch to another TNF blocker; (c) switch to a different biologic; (d) switch to nonbiologic therapy; or (e) no new treatment. RESULTS: Among 27,704 patients who initiated TNF-blocker therapy, 14,707 (53%) patients discontinued treatment over 1-3 years of follow-up. Within 360 days of discontinuing index TNF blocker, 53.4% of patients restarted index therapy: etanercept 59.9%, adalimumab 46.5%, and infliximab 43.1% (P < 0.001 for etanercept vs. adalimumab and infliximab). The majority of therapy restarts occurred within the first 3 months after discontinuation. Other patients switched to another TNF blocker: etanercept 17.1%, adalimumab 19.1% (P = 0.010 vs. etanercept), and infliximab 15.0% (P = 0.009 vs. etanercept). Switches from index TNF blocker to non-TNF-blocker biologic therapy were low: etanercept 1.9%, adalimumab 4.1%, and infliximab 10.7% (P < 0.001 for etanercept vs. adalimumab and infliximab). Switches from index TNF blocker to nonbiologic treatments were 5.4% for etanercept, 6.5% for adalimumab, and 6.9% for infliximab. CONCLUSIONS: Restarting of index TNF-blocker therapy occurs frequently after discontinuation, suggesting that long gaps in TNF-blocker therapy may be common. A significantly higher proportion of etanercept patients restarted their index TNF blocker within 3 months of discontinuation, compared with adalimumab and infliximab patients.