Health care costs in patients with painful diabetic peripheral neuropathy prescribed pregabalin or duloxetine.

BACKGROUND: Pregabalin and duloxetine are two FDA-approved medications for the treatment of pain associated with diabetic peripheral neuropathy (pDPN). The objective of this study was to compare changes in all-cause and pDPN-related health care costs in patients with pDPN initiated on pregabalin or duloxetine. METHODS: Patients at least 18 years of age initiating pregabalin or duloxetine between March 1, 2006 and December 31, 2008 were identified from a large U.S. managed care plan database. The date of the first pregabalin or duloxetine prescription was defined as the index date. Patients with claims-based evidence of pDPN and who had continuous enrollment for 6-month pre- and post-index periods were selected for study inclusion. Duloxetine patients with depression or generalized anxiety disorder (GAD) were excluded. All-cause and pDPN-related total health care costs (over 6 month pre-index and post-index periods) were analyzed with difference-in-differences (DiD) models. RESULTS: A total of 2,136 patients (1,785 pregabalin and 351 duloxetine) were identified. No significant differences in gender, age, or pre-index Quan-Charlson comorbidity score were observed between the two cohorts. No significant differences (pregabalin vs. duloxetine) in pre-index to post-index change in mean all-cause health care costs ($1,411 vs. $1,560, P = 0.93) or mean pDPN-related health care costs ($704 vs. -$240, P = 0.22) were found. The DiD models showed no significant difference in all-cause (mean) costs attributable to pregabalin vs. duloxetine therapy between pre-index and post-index periods (mean cost ratio = 0.97, 95% CI: 0.75 to 1.26), but showed that patients receiving pregabalin had a significantly higher increase in pDPN-related costs compared with patients receiving duloxetine (mean cost ratio = 2.35, 95% CI: 1.01 to 5.46). However, the difference (pre- to post-index) in pDPN-related costs attributable to pregabalin vs. duloxetine therapy was nonsignificant (mean cost ratio = 2.30, 95% CI: 0.93 to 5.68) in a sensitivity analysis in which patients with depression and GAD were excluded from both cohorts. CONCLUSION: No differences were noted in all-cause costs attributable to pregabalin or duloxetine. Although patients receiving pregabalin had a significantly greater pre- to post-index increase in pDPN-related health care costs compared with patients receiving duloxetine, this may have been due to an imbalance in patient exclusion criteria between cohorts.

Health care costs in patients with fibromyalgia on pregabalin vs. duloxetine.

BACKGROUND: The economic burden associated with fibromyalgia in the U.S. is substantial. The objective of this study was to compare changes in health care costs in fibromyalgia patients initiated on pregabalin and duloxetine in real-world settings. METHODS: Patients (≥ 18 years old) initiating pregabalin or duloxetine between June 1, 2007 and December 31, 2008 were identified using a U.S. managed care database. Patients were selected if they had ≥ 2 medical claims for fibromyalgia (ICD-9-CM, 729.1) at least 90 days apart or ≥ 1 claim for fibromyalgia followed within 30 days by a pharmacy claim for pregabalin. The date of the first pregabalin or duloxetine prescription was defined as the index date, and continuous enrollment for 6-month pre- and postindex periods was required. RESULTS: A total of 1,616 pregabalin and 207 duloxetine patients were identified. Treatment differences between pregabalin and duloxetine in the pre-/postindex change in mean [SD] all-cause total health care costs ($1,307 [16,747] vs. -$158 [17,337]; P = 0.24) or fibromyalgia-related total health care costs ($584 [3,834] vs. $759 [2,133]; P = 0.32) were not significant. Multivariate analysis using difference-in-differences models showed no significant difference in all-cause costs (mean cost ratio = 1.05, 95% CI: 0.84 to 1.31) or fibromyalgia-related costs (0.85, 95% CI: 0.61 to 1.18) between treatments during the postindex period. CONCLUSION: No significant differences were found between pregabalin and duloxetine in the pre- to postindex change in mean all-cause or fibromyalgia-related total health care costs.

Mapping the Gaps: Gender Differences in Preventive Cardiovascular Care among Managed Care Members in Four Metropolitan Areas.

BACKGROUND: Prior research documents gender gaps in cardiovascular risk management, with women receiving poorer quality routine care on average, even in managed care systems. Although population health management tools and quality improvement efforts have led to better overall care quality and narrowing of racial/ethnic gaps for a variety of measures, we sought to quantify persistent gender gaps in cardiovascular risk management and to assess the performance of routinely used commercial population health management tools in helping systems narrow gender gaps. METHODS: Using 2013 through 2014 claims and enrollment data from more than 1 million members of a large national health insurance plan, we assessed performance on seven evidence-based quality measures for the management of coronary artery disease and diabetes mellitus, a cardiac risk factor, across and within four metropolitan areas. We used logistic regression to adjust for region, demographics, and risk factors commonly tracked in population health management tools. FINDINGS: Low-density lipoprotein (LDL) cholesterol control (LDL < 100 mg/dL) rates were 5 and 15 percentage points lower for women than men with diabetes mellitus (p < .0001), and coronary artery disease (p < .0001), respectively. Adjusted analyses showed women were more likely to have gaps in LDL control, with an odds ratio of 1.31 (95% confidence interval, 1.27-1.38) in diabetes mellitus and 1.88 (95% confidence interval, 1.65-2.10) in coronary artery disease. CONCLUSIONS: Given our findings that gender gaps persist across both clinical and geographic variation, we identified additional steps health plans can take to reduce disparities. For measures where gaps have been consistently identified, we recommend that gender-stratified quality reporting and analysis be used to complement widely used algorithms to identify individuals with unmet needs for referral to population health and wellness behavior support programs.

Use of Anti-Tumor Necrosis Factor Therapy: A Retrospective Study of Monotherapy and Adherence to Combination Therapy with Non-Biologic Disease-Modifying Anti-Rheumatic Drugs.

INTRODUCTION: This study examined the use of anti-tumor necrosis factor (anti-TNF) monotherapy, adherence with non-biologic disease-modifying anti-rheumatic drugs (nbDMARDs) in patients receiving a combination of anti-TNF therapies and nbDMARDs, and the impact of nbDMARD adherence on anti-TNF persistence among patients with rheumatoid arthritis (RA). METHODS: Patients with RA (aged ≥18 years) from a US commercial health plan with claims for anti-TNFs (2006-2010) were defined as either biologic-naive or -exposed anti-TNF initiators based on previous nbDMARD use. Adherence to nbDMARDs and anti-TNF persistence were estimated. Cox regression estimated the association between nbDMARD adherence and anti-TNF persistence. RESULTS: Among 9764 patients identified (mean age 50.2 years; 78% female), 55% of biologic-naive patients and 49% of previously exposed patients initiated any combination therapy during follow-up. Among biologic-naive combination therapy patients, 53% adhered to nbDMARD therapy <80% of the time while receiving anti-TNF therapies; 33% had <60% adherence. Compared with the most adherent patients, patients adherent to nbDMARDs 20% to 79% of the time were 30% to 20% more likely to discontinue their anti-TNF therapy in the period >90 days after starting the anti-TNF therapy. This relationship was not observed for patients with nbDMARD adherence of <20% (who were less likely to discontinue their anti-TNF therapy during the first 90 days of treatment). CONCLUSION: Almost one-third of patients with RA receiving anti-TNF therapy received it as pure monotherapy. About one-third of combination therapy recipients had <60% adherence to nbDMARDs. Higher nbDMARD adherence may be associated with better anti-TNF persistence after an initial treatment period.

Impact of metastatic colorectal cancer stage and number of treatment courses on patient health care costs and utilization.

BACKGROUND: Advances in colorectal cancer (CRC) treatment and improved survival rates have led to higher costs associated with treating CRC. OBJECTIVE: To examine health care costs and utilization by initial CRC stage at diagnosis and the number of lines of treatment received by patients with metastatic CRC. METHODS: Adult patients with a diagnosis of CRC made from January 1, 2005 to May 31, 2010 were identified from the Oncology Management registry. Patients with stage IV CRC at initial diagnosis or who had advanced to stage IV CRC at the time of the study were included. Registry data included initial CRC stage and the date of diagnosis. Linked health care claims from a large US health insurance database affiliated with Optum were used to identify health care costs and patient characteristics. Multivariate regression analysis was used to estimate total 4-year health care costs stratified by stage and adjusted for patient characteristics. Follow-up ended at patient death, disenrollment from the health care plan, or study end (November 30, 2010). RESULTS: A total of 598 patients, followed for an average of 653 days after first evidence of metastasis, were included. At initial diagnosis, 91 patients had stages 0 to III CRC, 310 patients had stage IV CRC, and 197 patients had an unknown stage of CRC. The mean unadjusted total cost per patient (medical + pharmaceutical costs) was $252 200; outpatient hospital visits (excluding radiation and surgery) contributed most to the total cost, at a mean cost of $71 334. Hospitalization costs, with or without surgery (mean, $56 862), accounted for 33% of the $176 135 unadjusted mean cost for medical services (ambulatory visits [office and outpatient], emergency department visits, laboratory/radiology services, and inpatient admission). Chemotherapy and biologics were also costly (mean, $31 112 and $38 276, respectively). A general linear model analysis of estimated 4-year total costs showed that both CRC stage at diagnosis and the number of lines of treatment after metastasis had a statistically significant association with cost (P < 0.001). CONCLUSION: Variables that had a statistically significant association with cost (P < 0.05) were sex, age group, and follow-up Charlson Comorbidity Index score after metastases. After adjusting for the number of lines of treatment received, total 4-year costs were highest among patients who presented with stage IV CRC and lowest among patients who presented with stage III CRC and developed metastatic disease.

Psychotropic medication use and polypharmacy in children with autism spectrum disorders.

OBJECTIVE: The objectives of this study were to examine rates and predictors of psychotropic use and multiclass polypharmacy among commercially insured children with autism spectrum disorders (ASD). METHODS: This retrospective observational study used administrative medical and pharmacy claims data linked with health plan enrollment and sociodemographic information from 2001 to 2009. Children with ASD were identified by using a validated ASD case algorithm. Psychotropic polypharmacy was defined as concurrent medication fills across ≥ 2 classes for at least 30 days. Multinomial logistic regression was used to model 5 categories of psychotropic use and multiclass polypharmacy. RESULTS: Among 33,565 children with ASD, 64% had a filled prescription for at least 1 psychotropic medication, 35% had evidence of psychotropic polypharmacy (≥ 2 classes), and 15% used medications from ≥ 3 classes concurrently. Among children with polypharmacy, the median length of polypharmacy was 346 days. Older children, those who had a psychiatrist visit, and those with evidence of co-occurring conditions (seizures, attention-deficit disorders, anxiety, bipolar disorder, or depression) had higher odds of psychotropic use and/or polypharmacy. CONCLUSIONS: Despite minimal evidence of the effectiveness or appropriateness of multidrug treatment of ASD, psychotropic medications are commonly used, singly and in combination, for ASD and its co-occurring conditions. Our results indicate the need to develop standards of care around the prescription of psychotropic medications to children with ASD.

A comparison of mortality and costs associated with FOLFOX versus FOLFIRI in stage IV colorectal cancer.

OBJECTIVE: To examine cost and mortality among stage IV colorectal cancer (CRC) patients treated with 5-fluorouracil (5FU)/leucovorin/oxaliplatin (FOLFOX) or 5FU/leucovorin/irinotecan (FOLFIRI). METHODS: Adult CRC patients newly treated with FOLFOX or FOLFIRI were identified from a large database using medical and pharmacy claims for services delivered January 1, 2002 through December 31, 2005. Cancer stage for a subset of patients was abstracted from medical records. Outcomes were annualized costs calculated for 4 years of observation, and deaths as recorded by the National Death Index. Cost was analyzed using generalized linear modeling; mortality was modeled using Cox proportional hazards analysis. RESULTS: Unadjusted annualized median and mean costs were $134,401 and $152,213, respectively, for the FOLFOX cohort (n = 41) and $103,150 and $107,994 for the FOLFIRI cohort (n = 86). Death occurred among five (12%) FOLFOX and 42 (53%) FOLFIRI patients. Adjusted analysis revealed no significant difference in cost between cohorts, even after adjusting for reduced irinotecan costs due to generic availability. Incremental costs associated with one additional life saved per year were only $1,236 higher for patients treated with FOLFOX compared with FOLFIRI. Cox analysis revealed a significant survival advantage for FOLFOX over FOLFIRI (HR = 5.2; 95% CI: 1.7-15.8). CONCLUSIONS: A significant survival benefit was seen for CRC patients receiving FOLFOX versus FOLFIRI; multivariate analysis revealed no significant cost differences. However, the small sample size may have resulted in lack of adequate power to detect a difference between cohorts. There may be factors influencing mortality that were not included in the multivariate modeling.

Drug utilization patterns and cardiovascular outcomes in elderly patients newly initiated on atorvastatin or simvastatin.

BACKGROUND: Hydroxymethylglutaryl coenzyme-A reductase inhibitors simvastatin and atorvastatin are effective at lowering LDL-C levels and reducing the risk of cardiovascular (CV) events. OBJECTIVE: The objective of this study was to examine differences in drug utilization and CV event risk among elderly patients newly initiated on simvastatin versus atorvastatin. METHODS: This was a retrospective analysis using pharmacy and medical claims from a US health plan database. Enrollees aged ≥65 years, newly initiated on simvastatin or atorvastatin (index drugs) from July 1, 2006 to November 30, 2008 were identified for study inclusion. Patients were excluded if they had any prescriptions for clopidogrel, nitrates, or other dyslipidemia medication, or any CV events before index drug initiation. Adherence was calculated by proportion of days covered with index medication. CV events (myocardial infarction, ischemic heart disease, cerebrovascular disease, peripheral vascular disease, aortic aneurysm, revascularization, or heart failure) were identified from medical claims. RESULTS: There were 11,470 atorvastatin initiators and 20,132 simvastatin initiators identified. Mean age of these patients was 72 years; 40% were male; nearly half had hypertension; and more than a quarter had diabetes. The majority of statin therapy (77%) was prescribed by primary care physicians. Forty-nine percent of atorvastatin patients were initiated on a 10 mg-dose and 61% of simvastatin patients on 5-, 10-, or 20-mg doses. A larger percentage of patients in the simvastatin cohort were adherent to index therapy than patients in the atorvastatin cohort (43% vs 36%, respectively). Multivariate regression adjusting for patient characteristics revealed no significant difference in CV events between patients receiving atorvastatin versus simvastatin. CONCLUSIONS: In this study of elderly statin patients without recent evidence of CV events, the majority of patients started on low-dose therapy and did not achieve sufficient adherence. After controlling for patient and clinical characteristics, no statistically significant difference in risk of CV event was observed based on initiation with atorvastatin versus simvastatin.

Healthcare costs and nonadherence among chronic opioid users.

OBJECTIVES: To assess the health economic burden of chronic opioid users and to determine whether opioid regimen nonadherence contributes to increased healthcare costs. STUDY DESIGN: Retrospective claims-based analysis of patients with long-term prescription opioid use (>120 days of supply over 6 months). METHODS: Twelve-month healthcare utilization and costs were compared for chronic opioid users (n = 49,425) and, among chronic opioid users with urine drug-monitoring results (n = 2100), between adherent patients versus patients with evidence of nonadherence to their opioid regimen. Likely nonadherence was based on urine test results indicating absence of the prescribed drug, higher or lower than expected drug levels based on a proprietary algorithm, or presence of unprescribed or illegal drugs. The influence of nonadherence on total healthcare costs was assessed using multivariate models. RESULTS: Prevalence of chronic opioid use was 1.3%. Chronic opioid users had significantly greater healthcare utilization and costs than matched nonusers ($23,049 vs $4975; P <.001). Adherent patients (n = 442) had lower total healthcare costs than likely nonadherent patients (n = 1658; $23,160 vs $26,433; P = .036). After adjustment for demographics, likely nonadherence was significantly associated with elevated total healthcare costs (cost ratio [CR] 1.136; 95% confidence interval [CI] 1.00, 1.29; P = .048). When adjusting for other types of nonadherence, the presence of higher than expected levels of the prescribed opioid was associated with significantly elevated costs (CR 1.121; 95% CI 1.01, 1.25; P = .039). CONCLUSION: Chronic opioid users represent a substantial cost burden relative to similar patients without evidence of chronic pain. Among likely nonadherent chronic opioid users, those with evidence of opioid overuse had significantly elevated healthcare costs.