Enhancing Statin Adherence Using a Motivational Interviewing Intervention and Past Adherence Trajectories in Patients with Suboptimal Adherence.

BACKGROUND: Statins have been shown to be effective in reducing the occurrence of cardiovascular (CV) events and are widely prescribed for the risk reduction of CV diseases and recurrent CV events. However, poor adherence prevents some patients from receiving the maximum benefit of the therapy. Motivational interviewing (MoI) is a patient-centered collaborative approach that can be used to improve medication adherence. Group-based trajectory modeling depicts patterns of adherence over time and may help tailor the MoI intervention to further enhance adherence. OBJECTIVE: To assess the effect of a phone-based MoI intervention tailored by patients' past adherence trajectory in improving adherence to statins among patients in a Medicare Advantage prescription drug plan (MAPD). METHODS: Patients continuously enrolled in an MAPD from 2013 to 2017 with a statin prescription between January and June 2015 to allow 2 years of pre-index period and 1 year of follow-up were included in the study. Adherence to statins was measured monthly during the 1-year follow-up as proportion of days covered (PDC) and incorporated into a group-based trajectory model to provide 4 distinct patterns of adherence: adherent, rapid decline, gradual decline, and gaps in adherence. Patients in the 3 nonadherent groups were randomized to either control or intervention. The intervention was an initial counseling call and up to 2 monthly follow-up calls by pharmacy students trained in MoI, providing education consistent with a previously identified pattern of use. Refill data at 6 months post-intervention were evaluated to examine the intervention's effect on PDC, as continuous and dichotomized as PDC ≥ 0.8, as well as discontinuation. Multivariable regression adjusted for baseline demographics, clinical characteristics, and past adherence trajectory. RESULTS: There were 152 patients included in the analysis who received MoI phone calls and 304 randomly selected controls. Mean PDC for the intervention group (0.67 ± 0.3) was significantly higher than the control (0.55 ± 0.4; P < 0.001). The intervention group was also less likely to discontinue (OR = 0.38; 95% CI = 0.19-0.76) and more likely to be adherent in the linear regression model (ß = 12.4; P < 0.001) as well as in the logistic regression model (OR = 1.87; 95% CI = 1.18-2.95). Previous adherence trajectories were significantly associated with adherence in the follow-up. CONCLUSIONS: Patients who received the MoI intervention were more likely to be adherent and less likely to discontinue the statin in the 6 months follow-up compared with controls. Future research can identify other approaches to tailor interventions and expand the intervention to other languages. This intervention may also prove valuable to improve adherence to other medications for chronic and asymptomatic diseases. DISCLOSURES: This study was funded by Regeneron Pharmaceuticals, which provided critical input during study design, implementation, and manuscript preparation. Abughosh reports grants from Sanofi, BMS/Pfizer, and Valeant Pharmaceuticals, unrelated to this study. Vadhariya reports a past internship at Regeneron Pharmaceuticals, unrelated to this study. Esse, Serna, and Gallardo are employees of CareAllies, a Cigna subsidiary. Boklage is an employee of Regeneron Pharmaceuticals. Choi was an employee of Sanofi during this study. Johnson, Essien, Fleming, and Holstad have nothing to disclose. A poster based on this study was presented at AMCP Nexus 2018; October 22-25, 2018; Orlando, FL.

Budget impact analysis of sarilumab for the treatment of rheumatoid arthritis in patients with an inadequate response to conventional synthetic DMARD or TNF inhibitor therapies.

OBJECTIVE: To estimate the 5-year budget impact (BI) on a US health plan of introducing sarilumab - a human immunoglobulin G1 anti-IL-6 receptor α monoclonal antibody - as combination treatment with conventional synthetic disease-modifying antirheumatic drugs (csDMARDs) or monotherapy in patients with moderate-to-severe rheumatoid arthritis (RA). METHODS: BI analysis was conducted from a commercial payer perspective. Treatment-eligible populations included adult patients with moderate-to-severe RA and inadequate response (IR) to csDMARDs or tumor necrosis factor (TNF)-α inhibitors-IR. All licensed biologic treatments recommended by the American College of Rheumatology guidelines were included. RESULTS: For a hypothetical plan of one million members, 409 csDMARD-IR and 345 TNF-IR patients were annually eligible for combination therapy and 226 csDMARD and TNF-IR patients for monotherapy with sarilumab. Based on 2018 US direct treatment costs, the introduction of sarilumab was estimated to save $526,424, $322,637 and $264,306 over 5 years for csDMARD-IR combination therapy patients, TNF-IR combination therapy patients, and csDMARD-IR/TNF-IR monotherapy patients, respectively. As sarilumab absorbed a greater market share over the horizon, annual savings increased from years 1 to 5, $28,610 (-0.14%) to $194,646 (-0.83%) in csDMARD-IR, $16,986 (-0.11%) to $120,893 (-0.67%) in TNF-IR, and $14,256 (-0.13%) to $98,040 (-0.79%) in monotherapy. One-way sensitivity analyses revealed that the model was most sensitive to variations in sarilumab adherence. CONCLUSION: Total cost savings of introducing sarilumab to a health-care plan accrued from years 1 to 5, attributable to the lower treatment cost, stable dosing paradigm, and price parity for the two available doses (150 and 200 mg every 2 weeks) compared with alternative biologic DMARDs that have substantial variability in dose titration/schedules.

Trends in Statin Use 2009-2015 in a Large Integrated Health System: Pre- and Post-2013 ACC/AHA Guideline on Treatment of Blood Cholesterol.

PURPOSE: Implementation of the 2013 ACC/AHA cholesterol treatment guideline is likely to vary by statin benefit group. The aim of this study was to document trends in statin use before and after introduction of the ACC/AHA guideline. METHODS: We conducted a retrospective study with annual cohorts from 2009 to 2015 among members of Kaiser Permanente Southern California aged ≥ 21 years. Members were categorized into four mutually exclusive statin benefit groups: atherosclerotic cardiovascular disease (ASCVD), LDL-C ≥ 190 mg/dL in the last year, diabetes (aged 40-75 years), and 10-year ASCVD risk ≥ 7.5% (aged 40-75 years). RESULTS: The cohorts ranged from 1,993,755 members in 2009 to 2,440,429 in 2015. Approximately 5% of patients had ASCVD, 1% had LDL-C ≥ 190 mg/dL, 6% had diabetes, and 10% had a 10-year ASCVD risk ≥ 7.5% each year. Trends in statin use were stable for adults with ASCVD (2009 78%; 2015 80%), recent LDL-C ≥ 190 mg/dL (2009 45%; 2015 44%), and diabetes (2009 74%; 2015 73%), but increased for patients with 10-year ASCVD risk ≥ 7.5% (2009 36%; 2015 47%). High-intensity statin use also increased 142% and 54% among patients with LDL-C ≥ 190 mg/dL and those with ASCVD ≤ 75 years of age, respectively. Moderate-to-high intensity statin utilization increased over 50% among those with a 10-year ASCVD risk ≥ 7.5%. CONCLUSIONS: Statin use increased substantially among patients with 10-year ASCVD risk ≥ 7.5% and use of appropriate statin dosage increased in each of the four statin benefit groups between 2009 and 2015; however, there is room for improvement.

Budget Impact Analysis of PCSK9 Inhibitors for the Management of Adult Patients with Heterozygous Familial Hypercholesterolemia or Clinical Atherosclerotic Cardiovascular Disease.

OBJECTIVE: The aim of this study was to assess the budget impact of introducing the proprotein convertase subtilisin/kexin type 9 inhibitors (PCSK9i) alirocumab and evolocumab to market for the treatment of adults with heterozygous familial hypercholesterolemia or clinical atherosclerotic cardiovascular (CV) disease requiring additional lowering of low-density lipoprotein cholesterol (LDL-C). METHODS: A 3-year model estimated the costs of lipid-modifying therapy (LMT) and CV events to a hypothetical US health plan of 1 million members, comparing two scenarios-with and without the availability of PCSK9i as add-on therapy to statins. Proportions of patients with uncontrolled LDL-C despite receiving statins, and at risk of CV events, were estimated from real-world data. Total undiscounted annual LMT costs (2017 prices, including PCSK9i costs of $14,563.50), dispensing and healthcare costs, including the costs of CV events, were estimated for all prevalent patients in the target population, based on baseline risk factors. Maximum PCSK9i utilization of 1-5% over 3 years according to risk group (following the same pattern as current ezetimibe use), and 5-10% as a secondary scenario, were assumed. RESULTS: Total healthcare budget impacts per target patient (and per member) per month for years 1, 2 and 3 were $3.62($0.10), $7.22($0.20) and $10.79($0.30), respectively, assuming 1-5% maximum PCSK9i utilization, and $15.81($0.44), $31.52($0.88) and $47.12($1.31), respectively, assuming 5-10% utilization. Results were sensitive to changes in model timeframe, years to maximum PCSK9i utilization and PCSK9i costs. CONCLUSIONS: The budget impact of PCSK9i as add-on therapy to statins for patients with hypercholesterolemia is relatively low compared with published estimates for other specialty biologics. Drug cost rebates and discounts are likely to further reduce budget impact.

Identification of Patients with Statin Intolerance in a Managed Care Plan: A Comparison of 2 Claims-Based Algorithms.

BACKGROUND: While statins are safe and efficacious, some patients may experience statin intolerance or treatment-limiting adverse events. Identifying patients with statin intolerance may allow optimal management of cardiovascular event risk through other strategies. Recently, an administrative claims data (ACD) algorithm was developed to identify patients with statin intolerance and validated against electronic medical records. However, how this algorithm compared with perceptions of statin intolerance by integrated delivery networks remains largely unknown. OBJECTIVE: To determine the concurrent validity of an algorithm developed by a regional integrated delivery network multidisciplinary panel (MP) and a published ACD algorithm in identifying patients with statin intolerance. METHODS: The MP consisted of 3 physicians and 2 pharmacists with expertise in cardiology, internal medicine, and formulary management. The MP algorithm used pharmacy and medical claims to identify patients with statin intolerance, classifying them as having statin intolerance if they met any of the following criteria: (a) medical claim for rhabdomyolysis, (b) medical claim for muscle weakness, (c) an outpatient medical claim for creatinine kinase assay, (d) fills for ≥ 2 different statins excluding dose increases, (e) decrease in statin dose, or (f) discontinuation of a statin with a subsequent fill for a nonstatin lipid-lowering therapy. The validated ACD algorithm identified statin intolerance as absolute intolerance with rhabdomyolysis; absolute intolerance without rhabdomyolysis (i.e., other adverse events); or as dose titration intolerance. Adult patients (aged ≥ 18 years) from the integrated delivery network with at least 1 prescription fill for a statin between January 1, 2011, and December 31, 2012 (first fill defined the index date) were identified. Patients with ≥ 1 year pre- and ≥ 2 years post-index continuous enrollment and no statin prescription fills in the pre-index period were included. The MP and ACD algorithms were applied to the population, and concordance was examined using individual (i.e., sensitivity, specificity, positive predictive value [PPV], and negative predictive value [NPV]) and overall performance measures (i.e., accuracy, Cohen's kappa coefficient, balanced accuracy, F-1 score, and phi coefficient). RESULTS: After applying the inclusion criteria, 7,490 patients were evaluated for statin intolerance. The mean (SD) age of the population was 51.1 (8.5) years, and 55.7% were male. The MP and ACD algorithms classified 11.3% and 5.4% of patients as having statin intolerance, respectively. The concordance of the MP algorithm was mixed, with negative classification of statin intolerance measures having high concordance (specificity 0.91, NPV 0.97) and positive classification of statin intolerance measures having poor concordance (sensitivity 0.45, PPV 0.21). Overall performance measures showed mixed agreement between the algorithms. CONCLUSIONS: Both algorithms used a mix of pharmacy and medical claims and may be useful for organizations interested in identifying patients with statin intolerance. By identifying patients with statin intolerance, organizations may consider a variety of options, including using nonstatin lipid-lowering therapies, to manage cardiovascular event risk in these patients. DISCLOSURES: This study was funded by Regeneron Pharmaceuticals and Sanofi US. Boklage is employed by, and owns stock in, Regeneron, and Charland is employed by Sanofi. Bellows has received fees from Avenir for advisory board membership and grants from Myriad Genetics, Biogen, Janssen, and National Institutes of Health. Brixner reports advisory board and consultancy fees and grants from Sanofi. Mitchell reports consultancy fees from Sanofi. Study concept and design were contributed by Bellows, Boklage, Charland, and Brixner. Bellows, Sainski-Nguyen, and Olsen took the lead in data collection, along with Mitchell. Data interpretation was performed by Mitchell, along with the other authors. The manuscript was written by Bellows, Sainski-Nguyen, and Olsen and revised by all the authors.

An economic analysis of tolvaptan compared with fluid restriction among hospitalized patients with hyponatremia.

OBJECTIVE: The vasopressin-receptor antagonist tolvaptan is used for the treatment of hyponatremia (HN) in hospitalized patients with congestive heart failure (CHF) or syndrome of inappropriate antidiuretic hormone secretion (SIADH). The objective of this economic modeling study was to assess the potential cost and health outcomes associated with tolvaptan in comparison with fluid restriction (FR). METHODS: A decision-analytic model was developed to estimate potential cost and health outcomes associated with tolvaptan compared with FR among hospitalized CHF and SIADH patients with severe HN (serum sodium [SS] levels < 125 mEq/L). The model, which was populated with data from the published literature, assumes that response to treatment influences hospital length of stay, probability of an intensive care unit (ICU) admission, and probability of a 30-day all-cause hospital readmission. One-way and probabilistic sensitivity analyses (PSAs) assessed the influence of parameter uncertainty on model results. RESULTS: Model results suggest that, among hospitalized CHF patients with severe HN, the use of tolvaptan compared with FR may lead to reductions of 7.2% and 4.6% in ICU admissions and 30-day readmissions, respectively. Compared with FR, tolvaptan may result in total cost-savings of $156 per hospitalized CHF patient. Among hospitalized SIADH patients with severe HN, the model suggested reductions of 14.6% and 5.1% in ICU admissions and 30-day readmissions, respectively. Compared with FR, tolvaptan may result in total cost-savings of $135 per hospitalized SIADH patient. PSAs found that the probabilities of net cost-savings from the use of tolvaptan compared with FR were 64% and 59% among patients with severe HN with CHF and SIADH, respectively. CONCLUSIONS: Decision-analytic modeling based on published data for hospitalized CHF and SIADH patients with severe HN, indicates that tolvaptan compared with FR has the potential to improve health outcomes and produce cost-savings that more than offset the cost of tolvaptan.

Cost-effectiveness analysis of universal noninvasive testing for post-treatment confirmation of Helicobacter pylori eradication and the impact of patient adherence.

BACKGROUND: The treatment failure rate for Helicobacter pylori eradication therapy is ~20% due to poor patient compliance and increased antibiotic resistance. This analysis assessed the cost-effectiveness of universal post-treatment testing to confirm eradication of H. pylori infection in adults. METHODS: Decision-analytic models evaluated the cost-effectiveness of universal post-treatment testing (urea breath test [UBT] or monoclonal fecal antigen test [mFAT]) vs no testing (Model 1), and UBT vs mFAT after adjusting for patient adherence to testing (Model 2) in adults who previously received first-line antimicrobial therapy. Patients testing positive received second-line quadruple therapy; no further action was taken for those testing negative or with no testing (Model 1) or for those nonadherent to testing (Model 2). In addition to testing costs, excess lifetime costs and reduced quality-adjusted life-years (QALYs) due to continuing H. pylori infection were considered in the model. RESULTS: Expected total costs per patient were higher for post-treatment testing (UBT: US$325.76; mFAT: US$242.12) vs no testing (US$182.41) in Model 1 and for UBT (US$336.75) vs mFAT (US$326.24) in Model 2. Expected QALYs gained per patient were 0.71 and 0.72 for UBT and mFAT, respectively, vs no testing (Model 1), and the same was 0.37 for UBT vs mFAT (Model 2). The estimated incremental costs per QALY gained for post-treatment testing vs no testing were US$82.90-US$202.45 and, after adjusting for adherence, US$28.13 for UBT vs mFAT. CONCLUSION: Universal post-treatment testing was found to be cost-effective for confirming eradication of H. pylori infection following first-line therapy. Better adherence to UBT relative to mFAT was the key to its cost-effectiveness.

Impact of patient adherence on the cost-effectiveness of noninvasive tests for the initial diagnosis of Helicobacter pylori infection in the United States.

OBJECTIVE: Previous US-based economic models of noninvasive tests for diagnosis of Helicobacter pylori infection did not consider patient adherence or downstream costs of continuing infection. This analysis evaluated the long-term cost-effectiveness of the urea breath test (UBT), fecal antigen test (FAT), and serology for diagnosis of H. pylori infection after incorporating information regarding test adherence. MATERIALS AND METHODS: A decision-analytic model incorporating adherence information evaluated the cost-effectiveness of the UBT, FAT, and serology for diagnosis of H. pylori infection. Positive test results led to first-line triple therapy; no further action was taken for nonadherence or negative results. Excess lifetime costs and reduced quality-adjusted life-years (QALYs) were estimated for patients with continuing H. pylori infection. RESULTS: In the base-case scenario with estimated adherence rates of 86%, 48%, and 86% for the UBT, monoclonal FAT, and serology, respectively, corresponding expected total costs were US$424.99, $466.41, and $404.98/patient. Test costs were higher for the UBT, but were fully or partially offset by higher excess lifetime costs for the monoclonal FAT and serology. The QALYs gained/patient with the UBT vs monoclonal FAT and serology were 0.86 and 0.27, respectively. The UBT was dominant vs the monoclonal FAT, leading to lower costs and higher QALYs; the UBT was cost-effective vs serology (incremental cost/QALY gained $74). CONCLUSION: Based on a comprehensive modeled analysis that included consideration of patient test adherence and long-term consequences resulting from continuing H. pylori infection, the UBT provided the greatest economic value among noninvasive tests for diagnosis of H. pylori infection, because of high patient adherence and excellent test performance.

Systemic therapy for colorectal cancer: patterns of chemotherapy and biologic therapy use in nationally representative US claims database.

BACKGROUND: Treatment strategies for colorectal cancer (CRC) are highly variable. The aim of this study is to examine the patterns of chemotherapy and biologic therapy use for CRC patients in a national medical claims database. METHODS: A retrospective and observational analysis was performed using the i3 Innovus claims database to identify healthcare services consumed by patients aged 18 years and older, diagnosed with CRC between 1 January 2005 and 30 June 2009 in commercial health plans. RESULTS: Of 9,876 subjects diagnosed with CRC, fluorouracil (23.5 %) and capecitabine (10.0 %) were the dominant first-line monotherapies, followed by bevacizumab (3.2 %) and oxaliplatin (2.9 %). The most common combination regimen at first line and first and second line was FOLFOX (fluorouracil, leucovorin, and oxaliplatin; more than 25 %). The combinations FOLFIRI (fluorouracil, leucovorin, and irinotecan) plus bevacizumab (14.2 %) and FOLFOX plus bevacizumab (13.9 %) were significantly more frequent in third and successive lines of CRC therapy than other regimens (χ(2) = 191.2; P < 0.01). Additionally, the average annualized cost of CRC treatment for all patients was $US66,452, and the adjusted analysis demonstrated that patients receiving FOLFOX-A (FOLFOX + avastin) or FOLFIRI-A (FOLFIRI + avastin) had higher costs for CRC treatment. CONCLUSIONS: With the exception of a sizeable portion of patients on monotherapy, the treatment patterns for CRC were largely consistent with National Comprehensive Cancer Network (NCCN) guidelines.

Medical costs associated with use of systemic therapy in adults with colorectal cancer.

BACKGROUND: New cytotoxic agents and regimens, as well as immunotherapeutics, have recently been introduced for treatment of colorectal cancer (CRC).  OBJECTIVE: To identify the patient-related and clinical and treatment-related factors associated with higher total health care expenditures in newly diagnosed patients with CRC who are receiving systemic therapy (biologic or chemotherapy) from a commercially insured population.  METHODS: A longitudinal, retrospective analysis was employed to estimate costs and determinants of CRC treatment in a U.S. claims database for health care services used by commercial patients aged 18 to 64 years, who were diagnosed with CRC between January 1, 2005, and June 30, 2009. Generalized linear regression modeling was used to estimate the influence of demographic, clinical, and treatment factors on medical expenditures.  RESULTS: Among the 5,160 patients newly diagnosed with CRC, 99.6% of patients had chemotherapy; 32.6% had biologics; and 85.6% had other pharmaceuticals (excluding the chemotherapy and biologics of interest). The average annualized per patient cost of CRC treatment was $97,400 and consisted of chemotherapy ($17,500), biologics ($30,400), other pharmaceuticals ($2,300), inpatient treatment ($26,300), and outpatient treatment ($42,900). From first line only, first and second lines only, and third+ lines, the cost per patient was $70,500, $100,100, and $152,900, respectively. After adjusting for health care inflation, the average treatment cost of CRC patients increased by 73% from 2005 to 2009. Adjusted analyses showed that the higher medical cost for CRC patients was associated with use of new regimens, metastasis, comorbidities, surgery, radiation, insurance plan, age, sex, and region.   CONCLUSION: The health care cost of CRC treatment is increasing significantly over time, which is most likely caused by the use of new regimens, higher chances of surgery and radiation, and occurrence of various comorbidities and metastatic diseases due to increasing survival time.

Economic burden of non-cystic fibrosis bronchiectasis in the first year after diagnosis from a US health plan perspective.

BACKGROUND: Recent estimates suggest the prevalence of non-cystic fibrosis bronchiectasis (NCFB) may be increasing in the US. The objective of this study was to determine the current economic burden of NCFB compared with non-NCFB controls in the first year after diagnosis within a commercially enrolled US population. METHODS: A retrospective matched cross-sectional case control (1:3) study design was used. Data were derived from MarketScan(®) Commercial Claims and Encounters Database, which captures all patient-level demographic data and all medical and pharmacy claims during the period 1 January 2005 to 31 December 2009. NCFB patients were identified using ICD-9 codes 494.0 and 494.1. Individuals with medical claims for cystic fibrosis or chronic obstructive pulmonary disease were excluded. Incremental burden of NCFB was estimated for overall and respiratory-related expenditures using multivariate regression models which adjusted for baseline characteristics and healthcare resource utilization. All demographic characteristics and economic outcomes were ascertained in 12 months before (baseline period) and 12 months after (follow-up) index event, which was defined as the first bronchiectasis-related medical event. Non-parametric bootstrap technique was used to calculate the 95 % confidence limits for the adjusted estimate. All costs are inflation-adjusted to a baseline year of 2009 using the consumer price index. All statistical tests were conducted using SAS 9.2 and STATA 12.0. RESULTS: The study sample used for healthcare burden analyses had 9,146 cases and 27,438 matched controls. The majority of the sample was between the ages of 45-64 years old and 64 % were female. A greater proportion of cases than controls had an increase from baseline to follow-up in both total (49 vs 40 %) and respiratory-related costs (57 vs 25 %). The average increase in overall and respiratory-related costs compared with controls after adjusting for differences in baseline characteristics was US$2,319 (95 % CI 1,872-2,765) and US$1,607 (95 % CI 1,406-1,809), respectively. The primary driver for this increment was increase in outpatient visits of approximately 2 overall and 1.6 respiratory-related visits per patient per year, which translated to US$1,730 (95 % CI 1,332-2,127) and US$1,253 (95 % CI 1,097-1,408), respectively. CONCLUSION: This study found that the cost of managing NCFB in the first year within a commercially enrolled population may be burdensome. Compared with previously published estimates in the literature, the burden of NCFB may be also increasing.

Economic burden of Pseudomonas aeruginosa infection in patients with cystic fibrosis.

OBJECTIVE: Chronic infection with Pseudomonas aeruginosa (PA) is the primary cause of pulmonary deterioration in cystic fibrosis (CF). This study describes healthcare costs and resource utilization among CF patients following PA infection in the US. METHODS: This retrospective study utilized data from MarketScan claims database. CF patients with an initial PA infection were identified, and their healthcare utilization, medical and pharmacy costs were extracted for 12 months, pre- and post-PA infection. Descriptive and pair-wise non-parametric statistical analyses compared healthcare utilization and costs before and after infection. RESULTS: Three hundred and fifty-eight CF patients met study criteria (mean age 20.1 years; 48% female). Mean annual per-patient costs following initial PA infection increased by an estimated $18,516 (outpatient: $3113; inpatient: $10,123; pharmacy: $4943). Overall healthcare costs were significantly higher (p < 0.0001) following PA infection, as were overall inpatient visits, outpatient visits, and unique prescriptions (p < 0.0001). CONCLUSIONS: PA infection in cystic fibrosis creates a significant economic burden and the cost is not uniformly distributed across the healthcare components. LIMITATIONS: Key limitations of this study include the absence of clinical parameters to characterize PA infections and data on indirect costs such as loss of productivity or caretaker-related burden.

Use of drospirenone/ethinyl estradiol (DRSP/EE) among women with acne reduces acne treatment-related resources.

BACKGROUND AND OBJECTIVE: Acne is a common dermatologic condition that extends into middle age, particularly among women, and is associated with substantial healthcare resource utilization. Drospirenone (DRSP), a synthetic progestin, has anti-androgenic activity, and women using DRSP 3.0 mg/ethinyl estradiol (EE) 0.02 mg as a 24/4 regimen (DRSP/EE-24/4) for contraception also may use it for treatment of moderate acne. The study used a US national healthcare database to assess acne-related healthcare resource utilization among women aged 18-45 years before (pre-index) and after (post-index) initiation of DRSP/EE-24/4. METHODS: Resource utilization and costs were evaluated by age group (18-25, 26-35, or 36-45 years) and by type of acne medication (systemic antibiotic, topical, or anti-androgen). RESULTS: Data for 1340 women were evaluated. Overall, drug costs, medical costs, and total costs were decreased by 38%, 37%, and 37%, respectively (p<0.0001 for all) between the pre-index and post-index periods; significant differences were evident across age groups and acne medication categories. Total costs were significantly decreased for patients (41%) and healthcare plans (36%; p<0.0001 for both) overall and across age groups and drug classes. Acne-related claims and number of days using acne medication were reduced (by 37% each; p<0.0001 for both). STUDY LIMITATIONS: The study was retrospective in design and had a limited follow-up period. Database limitations restricted assessment of medication compliance and adherence. CONCLUSION: DRSP/EE-24/4 use was associated with substantial reductions in acne-related healthcare resource utilization, and reductions occurred regardless of age or type of acne medication. DRSP/EE-24/4 therefore represents a cost-effective option for the treatment of acne among women using DRSP/EE-24/4 for oral contraception.

Total costs and atrial fibrillation ablation success or failure in Medicare-aged patients in the United States.

INTRODUCTION: This retrospective cohort study compared the direct medical costs of successful versus unsuccessful catheter ablation in Medicare-aged patients with atrial fibrillation (AF), using medical claims data. METHODS: AF patients with > or = 12 months of continuous medical/pharmacy coverage pre- and postablation were identified from the MarketScan Medicare database (January 2003 to December 2006). For study inclusion, patients were required to have > or = 2 AF inpatient/outpatient visits within 6 months and to have received antiarrhythmic drug therapy within 12 months prior to the index ablation. Ablation success was defined as the absence of antiarrhythmic drug therapy 6-12 months postablation. RESULTS: Of 135 patients identified (67% men, mean age 73 years), ablation was successful in 69 (51.1%); most patients (96%) underwent a single procedure. Patients with successful ablation discontinued antiarrhythmic drug treatment after (mean) 54 days. Use of rate-control and anticoagulant drugs decreased after successful ablation, from 87% to 67% and from 86% to 64% of patients, respectively. Among failed ablation patients, 74% versus 70% received rate-control drugs, and 88% versus 82% received anticoagulants pre- versus postablation. Mean +/- SD per-patient procedural costs were $13,655+/-$12,761 for successful compared with $17,294+/-$26,502 (P=0.21) for failed ablation, while AF-related medical costs over 12 months postablation were $2394+/-$642 and $2703+/-$1706, respectively (P<0.001). Overall costs tended to be lower for successful ($16,049+/-$12,536) than for failed ($19,997+/-$13,958) AF ablation (P=0.07). These findings are subject to the limitations imposed by a retrospective database analysis and a small sample size. CONCLUSION: Outside the clinical-trial setting, catheter ablation for second-line treatment of AF proved unsuccessful in half of Medicare-aged patients. Direct medical costs did not differ significantly between patients with failed and successful ablations. The high rate and costs of AF ablation failure in the Medicare-aged population reinforce the need for better understanding of prognostic factors for ablation outcome.