Real-World Outcomes and Costs Following 6 Months of Treatment with the Long-Acting Injectable (LAI) Aripiprazole Lauroxil for the Treatment of Schizophrenia.

BACKGROUND: Continuous antipsychotic therapy is recommended as part of long-term maintenance treatment of schizophrenia, and gaps in antipsychotic treatment have been associated with increased risks of relapse and rehospitalization. Because the use of long-acting injectable (LAI) antipsychotics may reduce the likelihood of undetected medication gaps, initiating an LAI medication may affect resource utilization and costs. The LAI aripiprazole lauroxil (AL) was approved in the United States (US) in 2015 for the treatment of schizophrenia in adults. OBJECTIVE: The objective of this retrospective observational cohort study was to examine treatment patterns, resource utilization, and costs following initiation of AL for the treatment of schizophrenia in adults. METHODS: A retrospective analysis of Medicaid claims data identified a cohort of patients (N = 485) starting AL shortly after Food and Drug Administration approval in October 2015. Treatment patterns, resource utilization, and costs were compared 6 months before and after treatment initiation. Subgroup analyses were conducted based on the type of antipsychotic (LAI, oral, or none) received before initiation of AL. RESULTS: Over 6 months of follow-up, patients received an average of 4.6 injections out of a maximum of six (77%). After initiating AL, all-cause inpatient admissions decreased by 22.4%; other significant reductions were observed in mental health-related admissions and emergency room (ER) visits. All-cause inpatient costs decreased by an average of US$2836 per patient (p < 0.05) in the 6-month post-AL period, whereas outpatient pharmacy costs increased by US$4121 (p < 0.05), resulting in no significant difference in overall costs between the pre- and post-AL periods. The subgroup of patients who had been prescribed an oral antipsychotic before starting AL had significant reductions in proportion of patients with inpatient and ER visits and costs, but also reported a significant increase in pharmacy costs. CONCLUSIONS: AL was associated with a significant reduction in inpatient costs and an increase in outpatient pharmacy costs, resulting in no changes in total healthcare costs over 6 months. The adherence rate and reductions in inpatient use may indicate the potential for greater clinical stability among patients initiated on AL compared with their previous treatment.

Impact of pharmacy channel on adherence to oral oncolytics.

BACKGROUND: Oral chemotherapy is increasingly prescribed to treat cancer. Despite its benefits, concerns have been raised regarding adherence to therapy. The study objective was to compare and measure adherence, persistence, and abandonment in patients filling prescriptions in traditional retail (TR) versus specialty pharmacy (SP) channels. METHODS: Using a retrospective cohort design, we selected newly treated patients aged ≥18 years with a prescription for erlotinib, capecitabine, or imatinib during 2007-2011 from a Medco population of both United States commercial and Medicare health plans. Patients were classified according to pharmacy channel providing the medication. Abandonment was defined as a reversal following initial approval of the index prescription claim with no additional paid claims for agent within 90 days of reversal. Patients were considered adherent if the proportion of days covered between the date of the first and last oral prescription was ≥80%. RESULTS: In our retrospective cohort, 11,972 filled their prescriptions within the SP channel, and 30,394 filled their prescriptions within the TR channels, respectively. The SP channel had the highest proportion of adherent patients compared with TR (71.6% vs. 56.4%, P < .001). Abandonment of the initial prescription was low with overall rates of only 1.7%. In multivariate models controlling for demographic characteristics, index oncolytic, days of supply, and copay, SP channel (relative to TR) was significantly associated with lower rates of abandonment and increased adherence. CONCLUSIONS: Pharmacy channel may be influential on abandonment and adherence. Lower rates of abandonment and higher rates of adherence were observed among SP patients versus TR.

Changes in Patterns of Utilization and Cost of Health Care Services Associated With Initiation of Asenapine for the Treatment of Schizophrenia in Adults.

PURPOSE: To examine changes in patterns of utilization and cost of health care services associated with initiation of asenapine for the treatment of schizophrenia in adults. DESIGN: Retrospective cohort study using 2 large US health care claims databases. METHODOLOGY: All adults who initiated therapy with asenapine between Aug. 1, 2009, and Dec. 31, 2012, were identified; the date of the earliest claim for asenapine during this period was deemed the index date. Patients without ≥1 claims with a schizophrenia diagnosis within 12 months prior to the index date were excluded. We compared patterns of utilization and cost of health care services between 6-month periods immediately before and after index date ("preindex"and "postindex" respectively). RESULTS: 366 patients were identified who initiated asenapine and who met all other selection criteria; mean (SD) age was 40.5 (16.3) years and 57.1% were women. Relative to preindex, patients were less likely during postindex to be hospitalized (41.8% vs 26.2%, P<.001) or to visit the emergency room (24.9% vs 18.9%, P=.03). Mean (SD) total health care costs decreased by $4776 in the postindex period ($16,811 [$26,176] vs $12,035 [$17,037] during preindex), primarily due to a decrease in inpatient costs ($10,616 [$24,977] vs $5286 [$15,846]); mean pharmacy costs increased by $828 ($3656 [$3309] vs $4482 [$3,073]) (all P<.001). CONCLUSION: Use of asenapine for the treatment of schizophrenia was associated with reduced levels of health care utilization and cost during the 6-month period immediately following therapy initiation, primarily due to reduced levels of inpatient care.

Impact of initiation of asenapine on patterns of utilization and cost of healthcare resources associated with the treatment of bipolar I disorder.

OBJECTIVE: To assess the impact of initiation of asenapine on "real-world" levels of utilization and cost of healthcare services for the treatment of bipolar I disorder (BPD) in the US. METHODS: Using two large US healthcare claims databases that collectively included commercially insured patients aged < 65 years and Medicare enrollees, this study identified all adults (≥ 18 years) with evidence of BPD who began therapy with asenapine between 2009-2012. The date of the earliest claim for asenapine during this period was deemed the 'index date', and patients without continuous enrollment for the 6-month periods before and after this date were excluded ('pre-index' and 'post-index', respectively). Healthcare claims with a BPD diagnosis, plus psychiatric medications and the costs thereof (2012 dollars) were deemed 'BPD-related'. Differences in BPD-related utilization and cost of healthcare services were compared between the pre- and post-index periods. RESULTS: A total of 1403 patients met all selection criteria; the mean age was 42.8 years and 70.6% were women. Relative to pre-index, significant decreases were noted in post-index use of BPD-related healthcare services, most notably admissions (from 24.0% to 12.3% during the post-index period) and emergency department visits (from 4.6% to 2.6%) (both p < 0.05). While pharmacy costs increased, mean total post-index BPD-related healthcare costs were $979 lower than pre-index ($5002 vs $5981; p < 0.05), primarily due to the decrease in BPD-related admissions. CONCLUSIONS: Relative to the 6-month period beforehand, levels of utilization of BPD-related healthcare services and costs decreased during the 6-month period immediately following initiation of asenapine therapy.

Outcomes associated with comorbid atrial fibrillation and heart failure in Medicare beneficiaries with acute coronary syndrome.

BACKGROUND: Atrial fibrillation (AF) and heart failure (HF) are both common comorbid conditions of elderly patients with acute coronary syndrome (ACS), but published data on their associated clinical and economic outcomes are limited. METHODS: Our study included patients from the Medicare Current Beneficiary Survey with an incident hospitalization for ACS between 03/01/2002 and 12/31/2006. Applying population weights, we identified 795 incident ACS patients, representing more than 2.5 million Medicare beneficiaries. Of this population, 13.1% had comorbid AF, and 22.9% had HF, which were identified from Medicare claims during the 6 months prior to the first ACS event (index date) Subsequent cardiovascular (CV) hospitalizations and mortality were compared using Kaplan-Meier curves. Cox proportional hazards regressions were used to estimate the relative risk of AF and HF on CV events and mortality. Healthcare costs were summarized for the calendar year in which the incident ACS event occurred. RESULTS: HF was associated with a 41% higher risk of mortality (HR = 1.41; 95% confidence interval [CI] 1.05-1.89). Both AF (HR = 1.46; 95% CI 1.14-1.87) and HF (HR = 1.61; 95% CI 1.26-2.06) were associated with higher risks of subsequent CV events. During the year of the incident ACS event, ACS patients with comorbid AF or HF had approximately $18,000 higher total healthcare costs than those without these comorbidities. CONCLUSION: Using a nationally representative sample of Medicare beneficiaries, we observed a significantly higher clinical and economic burden of patients hospitalized for ACS with comorbid AF and HF compared with those without these conditions.

Moving branded statins to lowest copay tier improves patient adherence.

BACKGROUND: Statins are efficacious in reducing the risk of major cardiovascular events for both primary and secondary prevention, yet long-term adherence is poor. Their effectiveness could be compromised in actual practice when patients are not adherent to the treatments. Higher copayments have been shown to be associated with lower adherence to statins. OBJECTIVE: To assess the effect on patient adherence of moving branded atorvastatin and rosuvastatin from the second to the first tier by a Medicare Part D plan sponsor. METHODS: Pharmacy claims and eligibility records between July 1, 2009, and July 31, 2011, of Medicare Part D members not receiving the low-income subsidy were analyzed. New atorvastatin and rosuvastatin users in January 2010 (2010 cohort) were compared with those in January 2011 (2011 cohort) after this formulary tier change (tier-reduction group). Adherence was defined by the proportion of days covered (PDC) over 6 months. The impact of tier reduction on adherence was evaluated via logistic regression for binary outcome (PDC≥0.8) and generalized linear regression for continuous PDC by comparing the 2011 cohort with the 2010 cohort, adjusting for demographic and clinical characteristics. Other statin users (97% on generic statins) were also analyzed, serving as a nontier-reduction comparator group. RESULTS: We identified 12,437 members in the tier-reduction group. Between the 2010 and 2011 cohorts, mean PDC increased from 0.77 to 0.83, and the proportion of members with high adherence increased from 62.0% to 72.9% (both P < 0.001). After regression adjustment, members in the 2011 cohort were more likely to be adherent (OR=1.68; 95% CI=1.55-1.82) and had a 5.9% increase in PDC (P < 0.05). There was no significant increase in adherence observed in the comparator nontier-reduction group. CONCLUSION: Findings from this study suggest that financial incentives may improve medication adherence. Future studies should evaluate whether such formulary strategies improve long-term adherence and patient outcomes.

Estimated medical cost reductions associated with apixaban in real-world patients with non-valvular atrial fibrillation.

OBJECTIVE: The Apixaban for Reduction in Stroke and Other Thromboembolic Events in Atrial Fibrillation (ARISTOTLE) trial demonstrated that apixaban was effective in reducing the risk of stroke and major bleeding in non-valvular atrial fibrillation (NVAF) patients. Medical cost avoidance studies for oral anticoagulants have used warfarin event rates from clinical trials, which may not reflect the real-world (RW) setting. This study aimed to estimate the difference in medical costs associated with apixaban instead of warfarin in RW NVAF patients. METHODS: This study selected patients with NVAF diagnosis during 2007-2010 from a Medco population of US commercial and Medicare health plans. Stroke and major bleeding excluding intracranial hemorrhage (MBEIH) were identified using diagnosis codes. Pharmacy claims were used to define warfarin exposure periods. Rates of stroke and MBEIH were calculated during warfarin exposure. To estimate the absolute risk reduction (ARR) between warfarin and apixaban in RW, the relative risk reductions (RRR) from ARISTOTLE were multiplied by the event rates observed in RW during warfarin exposure. Medical cost reductions associated with apixaban were calculated by applying the ARR to the 1-year incremental cost for each event. Stroke and MBEIH costs were obtained from the literature and adjusted to 2011 levels. RESULTS: During a patient year, the use of apixaban instead of warfarin resulted in medical cost reductions of $493 for stroke and $752 for MBEIH and $1245 for the combined outcome of both events. The medical costs avoided were greater as baseline stroke risk increased. CONCLUSION: If RRRs demonstrated in ARISTOTLE persist in RW, the use of apixaban will be associated with lower medical costs vs warfarin. Main limitations of this study were: identification of clinical events using administrative codes rather than confirmatory clinical data, inability to evaluate the level of international normalized ratio (INR) control, and not including INR monitoring and drug costs.

Clinical and economic outcomes among hospitalized patients with acute coronary syndrome: an analysis of a national representative Medicare population.

OBJECTIVE: To evaluate the clinical and economic burden of acute coronary syndrome (ACS), a common cardiovascular illness, in the Medicare population. METHODS: Data from the Medicare Current Beneficiary Survey were analyzed. Patients with incident hospitalization for ACS without similar events during the 6 months prior were included. Outcomes evaluated included inpatient mortality, 30-day mortality and readmission, subsequent hospitalization events, and total direct health care costs. Sample population weights were applied, accounting for multistage sampling design to obtain nationally representative estimates for the US Medicare population. RESULTS: Between March 1, 2002 and December 31, 2006, we identified 795 incident ACS patients (mean age 76 years; 49% male) representing 2,542,211 Medicare beneficiaries. The inpatient mortality rate was 9.71% and the 30-day mortality ranged from 10.96% to 13.93%. The 30-day readmission rate for surviving patients was 18.56% for all causes and 17.90% for cardiovascular disease (CVD)-related diagnoses. The incidence of death since admission was 309 cases per 1000 person-years. Among patients discharged alive, the incidence was 197 for death, 847 for CVD-related admission, and 906 for all-cause admission. During the year when the ACS event occurred, mean annual total direct health care costs per person were US$50,458, with more than half attributable to inpatient hospitalization ($27,609). CONCLUSION: In this national representative Medicare population, we found a substantial clinical and economic burden for ACS. These findings suggest a continuing unmet medical need for more effective management of patients with ACS. The continuous burden underscores the importance of development of new interventions and/or strategies to improve long-term outcomes.

Antiepileptic drug treatment patterns and economic burden of commercially-insured patients with refractory epilepsy with partial onset seizures in the United States.

OBJECTIVE: To assess the economic burden in direct healthcare utilization and costs for refractory epileptic patients with partial onset seizures (POS) and assess the antiepileptic drug (AED) treatment patterns among these patients. METHODS: This retrospective database study analyzed administrative claims of commercially-insured patients with POS from 2004-2008. Healthcare costs and utilization were compared between refractory (defined as ≥3 AEDs) and non-refractory patients by calendar year and AED treatment patterns were described for refractory patients. RESULTS: Of the 79,149 patients identified (mean age 33 years; 54.8% female), 8714 (11%) were classified as refractory. In 2008, average annual healthcare costs for refractory patients were significantly higher than non-refractory patients ($33,613 vs $19,085), also by settings for inpatient ($11,780 vs $6076), outpatient ($13,431 vs $8637), and pharmacy costs ($8402 vs $4372) (all p < 0.001). Among refractory patients, close to one-third of total costs were for POS-related services. Similar trends were observed when assessing POS-related utilization and costs. The differences were consistent across all calendar years examined. Among refractory patients, 80.5% were on monotherapy at the beginning of the follow-up period. Levetiracetam is the common AED in mono/combination therapy as well as add-on/switch-to. LIMITATIONS: The onset of seizure cannot be identified, and the indication of each AED could not be confirmed from the pharmacy claims. Only direct medical costs were assessed. CONCLUSIONS: Pattern of use was very dynamic, suggesting seizures are not well-controlled. Improving seizure control and reducing economic burden of refractory epilepsy remain important unmet medical needs in this population.

Factors associated with adherence to phosphodiesterase type 5 inhibitors for the treatment of pulmonary arterial hypertension.

OBJECTIVES: To assess factors associated with adherence to phosphodiesterase type 5 inhibitors (PDE5Is) in the management of pulmonary arterial hypertension (PAH). METHODS: This study analyzed pharmacy benefit claims of naïve Adcirca and Revatio users between January 1, 2008 and December 31, 2010. Patients were considered adherent if their proportion of days covered (PDC) was ≥ 80% over a 6-month period. Logistic regressions were estimated to assess the factors associated with adherence. Analyses were stratified by use of a specialty pharmacy or retail pharmacy. A sensitivity analysis was performed by excluding individuals with 90-day supply. RESULTS: Of the total of 2143 patients included, 46.8% were adherent. Adherence was higher among 930 specialty pharmacy users (65.6%) than 1213 retail pharmacy users (32.3%, p < 0.001). Adherence was higher among Adcirca users (60.7%; approved dose 40 mg once-daily) than Revatio users (44.3%, p < 0.001; approved dose 20 mg thrice-daily). Among retail pharmacy users, adherence was higher in patients using Adcirca (OR = 2.59; 95% CI = 1.60-4.22) and patients with an index prescription given by pulmonologists (OR = 1.70; 95% CI = 1.15-2.50), while lower in patients with higher copayment ($51-$250: OR = 0.61, 95% CI = 0.42-0.90; $251+: OR = 0.57, 95% CI = 0.39-0.83). Among specialty pharmacy users, only high copayment ($251+: OR = 0.56, 95% CI = 0.35-0.90) was found to be a significant factor for non-adherence. After excluding individuals with 90-day supply, adherence rate was 29.6% in retail pharmacy and 57.9% in specialty pharmacy (p < 0.001), and regression results were similar. LIMITATIONS: Diagnosis of PAH was not confirmed without access to medical claims. Pharmacy refill records might not reflect actual consumption. Adherence evaluated for 6 months might not be generalizable to longer periods. CONCLUSION: Adherence to PDE5Is for PAH is sub-optimal. The findings suggest that adherence to PDE5Is in patients with PAH is associated with the use of specialty pharmacy, simpler dosing frequency, a lower financial barrier, and a prescription given by pulmonologists.

Caregiver assistance among Medicare beneficiaries with atrial fibrillation and factors associated with anticoagulant treatment.

BACKGROUND: Atrial fibrillation (AF) is the most common sustained cardiac arrhythmia and disproportionately affects the elderly. OBJECTIVE: This study describes patient characteristics and caregiver assistance among Medicare beneficiaries with AF and examines factors associated with receiving anticoagulant treatment. METHODS: Patients with AF and age/gender-matched controls were identified from Medicare Current Beneficiary Survey data from 2001 to 2006. A logistic regression model was used to assess factors associated with receiving anticoagulants in a subgroup of patients with AF whose treatment pattern was established for 2 consecutive years. Sample weights were applied to obtain nationally representative estimates. RESULTS: A total of 2990 patients with AF and 5980 control patients were included in the burden of disease analysis, and 1481 patients with AF were included in the anticoagulant predictor analysis. Patients with AF had a higher level of comorbidity (Charlson Comorbidity Index: 3.3 vs 1.5; P < 0.05), worse self-perceived health status (P < 0.001), and greater level of disability (P < 0.001) than their matched counterparts. A greater proportion of patients with AF required caregiver assistance (62.8% vs 51.5%; P < 0.001). Logistic regression found that higher Charlson Comorbidity Index scores, difficulty in obtaining necessary health care, older age, being widowed, a history of psychiatric disorders, and being underweight decreased the likelihood of receiving anticoagulant therapy. CONCLUSIONS: In a Medicare population, a greater need for caregiver assistance was observed in patients with AF. Subgroups characterized by frailty or inability for self-care were identified as being less likely to receive anticoagulant therapy. The need for caregiver assistance among patients with AF, as well as the patient subgroups identified as less likely to receive anticoagulant therapy, should be considered when making treatment decisions.

Medical resource use and costs related to central precocious puberty: a retrospective cohort study.

OBJECTIVE: To evaluate the economic burden of central precocious puberty (CPP) by examining direct health care resource utilization and costs. METHODS: Administrative claims from the Medstat MarketScan Commercial Claims database were analyzed, and 2 cohorts of children ≤ 12 years of age were identified. The CPP cohort included patients newly diagnosed with precocious sexual development and puberty (International Classification of Diseases, Ninth Revision, Clinical Modification code 259.1x) between January 1, 2004, and June 30, 2006 (date of the initial diagnosis of CPP was designated as the "index date") who used gonadotropin-releasing hormone agonists during the 12 months after diagnosis. Each patient with CPP was matched with 4 control patients without CPP on the basis of age, sex, geographic region, and type of health insurance plan. Resource utilization and costs during the 12 months before and the 12 months after the index date were examined. RESULTS: A total of 172 patients with CPP and 688 control patients were identified after matching. Approximately 62% of patients were 7 to 9 years of age, and 87% were female. The patients with CPP had higher annual health care costs than did the control patients during the 12-month pre-index ($10,968 versus $783; P<.001) and the 12-month post-index ($21,071 versus $849; P<.001) periods, primarily attributable to outpatient and pharmacy costs. For the patients with CPP, annual health care costs increased by $10,103 after diagnosis. On average, annual CPP-related costs were $10,605. Monthly total health care costs for the patients with CPP increased sharply during the first month after diagnosis and remained high throughout the post-index period. CONCLUSION: In this study, health care resource use and costs among patients with CPP were substantial before and after the initial diagnosis of CPP.

Clinical and economic outcomes associated with National Kidney Foundation guideline-concordant oral antidiabetic drug treatment among type 2 diabetes patients with chronic kidney disease.

OBJECTIVE: To assess outcomes associated with oral anti-diabetic drug (OAD) treatment concordant with guidelines from the National Kidney Foundation (NKF) among type 2 diabetes mellitus (T2DM) patients with chronic kidney disease (CKD). METHODS: Electronic health record data between 1/1/2005 and 10/31/2010 provided by an integrated health system were analyzed. T2DM patients were selected based on diagnosis from the health record. Patients with stages 3-5 CKD based on diagnosis or lab results were further identified with the date of first indicated CKD set as index date. Patients who had a medication order of OADs within three months of the index date were included. Patients were considered non-guideline-concordant if prescribed OADs that were recommended to be avoided or if they required dosage adjustment, but were unadjusted. Glycemic control, hospital admissions, and costs of encounters were assessed over a 12-month post-index period, and hypoglycemic events were evaluated until loss of follow-up. Regression analyses were performed, adjusting for patient demographic and clinical characteristics. RESULTS: Among 6058 patients (mean age: 70; 42% male), 45% were not [corrected] guideline-concordant. After adjusting for patient characteristics, guideline-concordant patients had a lower risk for hypoglycemic events (HR: 0.72; 95% CI: 0.62-0.83), were less likely to have a hospital admission (OR: 0.87; 95% CI: 0.77-0.98), and more likely to have glycemic control (OR: 1.64, 95% CI: 1.46-1.84). Non-guideline-concordant patients had annual encounter costs of 1.10 times those of guideline-concordant patients (marginal cost = $731; P = 0.04). LIMITATIONS: Unobservable confounders may still exist and bias the results; therefore, findings should be interpreted as associations instead of causations. Findings were based on a single integrated health system and may not be generalizable to larger populations. CONCLUSION: The findings of this exploratory study suggest that guideline-concordant treatment may yield better clinical and economic outcomes. Future research with a better controlled design is warranted to confirm these preliminary findings.

Medication adherence and healthcare costs among fibromyalgia patients treated with duloxetine.

OBJECTIVE: The study aims to examine predictors associated with duloxetine adherence and its association with healthcare costs among fibromyalgia patients. METHODS: Administrative claims from both commercially and Medicare supplemental-insured fibromyalgia patents aged 18+ who initiated duloxetine in 2006 were analyzed. Initiation was defined as a 90-day clean period without duloxetine. The dispense date of the first duloxetine prescription was denoted as the index date. Two cohorts were constructed based on duloxetine adherence over the 12-month postindex period (high adherence as medication possession ratio ≥0.8). Predictors of high adherence were examined via logistic regression. Generalized linear regressions were performed to estimate the association between duloxetine adherence and healthcare costs. RESULTS: A total of 4,869 commercially and 566 Medicare supplemental-insured fibromyalgia patients were identified. Two-thirds of patients had low adherence. Higher duloxetine average daily dose (ADD) was associated with increased adherence (reference group=30mg; Commercial: Odds ratio [OR]=3.03, 2.40, and 3.73 for 31 to 59mg, 60mg, and >60mg, respectively, all P<0.05; Medicare supplemental: OR=3.11, 2.33, and 4.76 for 31 to 59mg, 60mg, and >60mg, respectively, all P<0.05). Commercially insured patients with high adherence had significantly lower total healthcare costs than low-adherence patients (-$1,164, P<0.05), primarily because of lower inpatient (-$2,222, P<0.05) and outpatient (-$1,075, P<0.05) costs. Medicare supplemental-insured patients with high adherence had similar overall and inpatient costs, but significantly lower outpatient costs (-$2,025, P<0.05). CONCLUSION: Fibromyalgia patients with higher duloxetine ADD were more likely to adhere to the therapy. High duloxetine adherence was associated with lower (Commercial) or similar (Medicare supplemental) healthcare costs.

Opioid utilization and health-care costs among patients with diabetic peripheral neuropathic pain treated with duloxetine vs. other therapies.

OBJECTIVE: This retrospective cohort study assessed subsequent opioid utilization and health-care costs among patients with diabetic peripheral neuropathic pain (DPNP) who initiated duloxetine vs. other standard of care (SOC) treatments. METHODS: Medical and pharmacy claims were analyzed for commercially-insured individuals aged 18-64. Two study cohorts were constructed from DPNP patients who initiated duloxetine or SOC medications (tricyclic antidepressants, venlafaxine, gabapentin, pregabalin) between March 1, 2005 and December 31, 2005. Initiation was defined as a prior 90-day period without access of the medication. The dispense date of the first initiation was denoted as the index date. Patients with opioids dispensed in the prior 90 days were excluded. Opioid utilization including total days, number of prescriptions filled, and morphine equivalent dosage was assessed for overall, long-acting, and short-acting opioids. Health-care costs and opioid use in the 12-month post-index period were examined via multivariate regression analyses. RESULTS: Four hundred and ninety-nine DPNP patients (272 duloxetine, 227 SOC) were identified. SOC patients had higher prevalence of comorbidities and pre-index health-care costs than duloxetine patients. Controlling for cross-cohort differences, duloxetine patients were significantly less likely to use any opioids than SOC patients. Also, duloxetine patients had 20 fewer adjusted opioid supply days (largely due to the use of short-acting opioids, P < 0.05) and significantly lower adjusted total costs ($8,088, P < 0.05) and diabetes-related costs ($3,092, P < 0.05) in the 12-month post-index period, with most of the cost differences from lower outpatient costs. CONCLUSIONS: DPNP patients who initiated duloxetine therapy were less likely to have subsequent opioid use and had lower health-care costs than SOC patients.

The relationship between average daily dose, medication adherence, and health-care costs among diabetic peripheral neuropathic pain patients initiated on duloxetine therapy.

OBJECTIVE: To examine the relationship between average daily dose (ADD) of duloxetine, adherence to therapy, and health-care costs among patients with diabetic peripheral neuropathic pain (DPNP). METHODS: A retrospective analysis of commercially insured DPNP patients was conducted among those aged 18 to 64 years who initiated duloxetine therapy between Ocotober 1, 2004 and December 31, 2006. The dispense date of the first duloxetine prescription was defined as the index date. All duloxetine prescriptions over the 12-month post-index period were used to assess ADD and adherence. Four study cohorts were constructed based on ADD: 30 mg, 31 to 59 mg, 60 mg; and >60 mg. High adherence was defined as having a medication possession ratio for duloxetine of ≥0.8. Health-care costs over 12-month post-index period were estimated. Multiple regression models were used to examine the association between ADD, adherence, and health-care costs. RESULTS: The study sample included 1,351 DPNP patients (mean age: 55 years; male: 41%). Twelve percent of patients had a duloxetine ADD of 30 mg, 17% of 31 to 59 mg, 56% of 60 mg, and 15% of >60 mg. Patients with ADD of 30 mg (>60 mg) were significantly less (more) likely to adhere to duloxetine therapy compared with those in the 60 mg cohort. Controlling for cross-cohort demographic and clinical differences, patients with ADD of 30 mg, 31 to 59 mg, or >60 mg had significantly higher total health-care costs than those with ADD of 60 mg (adjusted differences: $6,090, $6,320, $6,466 for 30 mg, 31 to 59 mg, >60 mg, respectively, all P < 0.05). CONCLUSION: The findings suggest that having an ADD of 60 mg for duloxetine among commercially insured DPNP patients is associated with improved medication adherence and lower health-care costs.

A retrospective study on the impact of comorbid depression or anxiety on healthcare resource use and costs among diabetic neuropathy patients.

BACKGROUND: Diabetic neuropathy (DN) is a common complication of diabetes that has significant economic burden, especially for patients with comorbid depression or anxiety. This study examines and quantifies factors associated with healthcare costs among patients diagnosed with diabetic neuropathy (DN) with or without a comorbid diagnosis of depression or anxiety (DA) using retrospective administrative claims data. No study has examined the differences in economic outcomes depending on the presence of comorbid DA disorders. METHODS: Over-age-18 individuals with 1+ diagnosis of DN in 2005 were selected. The first observed DN claim was considered the "index date." All individuals had a 12-month pre-index and follow-up period. For both under-age-65 commercially insured and over-age-65 individuals with employer-sponsored Medicare supplemental insurance, we constructed 2 subgroups for individuals with DA (DN-DA) or without (DN-only). Patients' clinical characteristics over pre-index period were compared. Multivariate regressions were performed to assess whether DN-DA patients had higher utilization of healthcare resources and costs than DN-only patients, controlling for demographic and clinical characteristics. RESULTS: We identified 16,831 DN-only and 1,699 DN-DA patients in the Medicare supplemental cohort, as well as 17,205 and 3,105 in the commercially insured. DN-DA patients had higher prevalence of diabetes-related comorbidities for cardiovascular disease, cerebrovascular/peripheral vascular disease, nephropathy, obesity, and hypoglycemic events than DN-only patients (all p < 0.05). Controlling for differences in demographic and clinical characteristics, DN-DA patients had $9,235 (p < 0.05) higher total healthcare costs than patients with DN-only among those with Medicare supplemental coverage ($26,718 vs. $17,483), and $10,389 (p < 0.05) more total costs among commercially insured ($29,775 vs. $19,386). Factors associated with increased costs included insurance type, geographical region, diabetes-related comorbidities, and insulin therapy. CONCLUSION: These findings indicate that the healthcare costs were significantly higher for DN patients with depression or anxiety relative to those without such comorbid disorders.

Impact of comorbid depression or anxiety on patterns of treatment and economic outcomes among patients with diabetic peripheral neuropathic pain.

OBJECTIVE: The objective of this retrospective analysis was to assess the correlation of comorbid depression and/or anxiety to patterns of treatment, healthcare utilization, and associated costs among diabetic peripheral neuropathic pain (DPNP) patients, employing a large US administrative claims database. RESEARCH DESIGN AND METHODS: Patients under age 65 with commercial insurance and patients aged 65 and older with employer-sponsored Medicare supplemental insurance were selected for the study if they had at least one diagnosis of DPNP in 2005. The first observed DPNP claim was considered the 'index date.' All individuals had a 12-month pre-index and 12-month follow-up period. For both populations, two subgroups were constructed for individuals with depression and/or anxiety (DPNP-DA cohort) or without these disorders (DPNP-only cohort). Patients' demographic characteristics, clinical characteristics, and medication use were compared over the pre-index period. Healthcare expenditures and resource utilization were measured for the post-index period. Two-part models were used to examine the impact of comorbid depression and/or anxiety on healthcare utilization and costs, controlling for demographic and clinical characteristics. RESULTS: The study identified 11,854 DPNP-only and 1512 DPNP-DA patients in the Medicare supplemental cohort, and 11,685 and 2728 in the commercially insured cohort. Compared to DPNP-only patients over the follow-up period, a significantly higher percentage of DPNP-DA patients were dispensed pain and DPNP-related medication. All components of healthcare utilization, except home healthcare visits and physician office visits, were more likely to be provided to DPNP-DA patients versus the DPNP-only cohort (all p < 0.01). Controlling for differences in demographic and clinical characteristics, DPNP-DA patients had significantly higher total costs than those of DPNP-only patients for Medicare ($9134, p < 0.01) and commercially insured patients ($11,085, p < 0.01). LIMITATIONS: Due to the use of a retrospective administrative claims database, limitations of this study include the potential for selection bias between study cohorts, mis-identification of DPNP and/or depression, and inability to assess indirect costs as well as use and cost of over-the-counter medications. CONCLUSIONS: These findings indicate that the healthcare costs were significantly higher for DPNP patients comorbid with depression and/or anxiety relative to those without such disorders.

The economic burden of chronic obstructive pulmonary disease (COPD) in a U.S. Medicare population.

RATIONALE: Although the economic burden of COPD has gained attention in recent years, data on the costs of COPD among U.S. Medicare beneficiaries are lacking. METHODS: This study used administrative claims and eligibility records from a large U.S. multi-state Medicare managed care database. Study patients were 65+ years of age with paid claims during 2004. The COPD cohort comprised patients with 1+ inpatient/ER claims or 2+ outpatient claims (>30 days apart) for COPD (ICD-9-CM codes 491.xx, 492.x, 496). The comparison cohort included patients without COPD matched 3:1 to the COPD cohort on age, sex, enrollment months, and Medicare plan. Excess costs of COPD were estimated as the difference in overall health plan payments between the two cohorts during 2004. Attributable costs were calculated using medical claims with listed diagnoses of COPD or other respiratory-related conditions and pharmacy claims for respiratory medications. RESULTS: A total of 8370 patients were included in the COPD cohort and were matched to 25,110 comparison cohort patients. For both groups, mean (SD) age was 78 (8) years, 54% were female, and duration of eligibility was 11 (2) months. COPD patients were more likely to utilize healthcare services and had excess total healthcare costs about $20,500 higher (P<0.0001) than the comparison cohort. Comorbidities were high in the COPD cohort, accounting for 46% of the observed excess cost. The attributable cost of COPD averaged about $6,300; other respiratory-related costs averaged about $4,400. CONCLUSION: In this U.S. Medicare managed care population, COPD posed a substantial burden in terms of both respiratory-related and total healthcare costs. A comparison of these cost-of-illness estimates to those for elderly COPD patients in other countries would be of great interest, given the increasing age of populations in most Western countries.

Cost analysis of amlodipine versus enalapril in patients with coronary artery disease and normal blood pressure: findings from the CAMELOT economic substudy.

OBJECTIVES: To analyse 2-year hospitalization and cost data collected during a prospective, double-blind, randomized, controlled trial comparing amlodipine, enalapril and placebo in normotensive patients with coronary artery disease (CAD). METHODS: All patients who were enrolled in the CAMELOT study were included in this economic substudy. Patients with CAD and normal blood pressure were randomized to amlodipine, enalapril or placebo, and followed up for 24 months (between 1999 and 2004). Data on hospitalizations and medication use were obtained from the clinical trial. Costs were assigned from secondary sources. Total costs ($US, year 2004 values) were estimated as the sum of costs associated with cardiovascular hospitalizations, study medications and concomitant cardiovascular medications. Costs and resource use were analysed by treatment arm overall and for selected patient subgroups. Cost differences were evaluated using nonparametric bootstrap techniques. RESULTS: Of 1991 patients enrolled, 663 were treated with amlodipine, 673 were treated with enalapril and 655 were treated with placebo. Significantly fewer patients were hospitalized for cardiovascular reasons in the amlodipine group (16.4%) than in the placebo group (22.7%; p < 0.01), but not compared with the enalapril group (20.1%; p = 0.09). The amlodipine group also had numerically fewer days in hospital per patient (1.1) than the enalapril (1.3) and placebo (1.5) groups. Mean 2-year per-patient costs in the amlodipine group were estimated to be $US 609 and $US 717 lower than for the placebo and enalapril groups, respectively. CONCLUSIONS: These results suggest that use of amlodipine may reduce costs of care among CAD patients with normal blood pressure.