Duloxetine use in employees with low back pain: treatment patterns and direct and indirect costs.

OBJECTIVE: The study aims to examine real-world effects of duloxetine treatment for low back pain (LBP). METHODS: The study identified employees with ≥1 LBP diagnosis and ≥1 duloxetine prescription within a year after LBP diagnosis from a privately insured claims database (2004-2007). Duloxetine-treated employees were propensity score matched to employees initiating another pharmacological/noninvasive treatment in the same month from LBP diagnosis. Treatment patterns and costs were compared over the 6 months following treatment initiation. RESULTS: Relative to controls, duloxetine-treated employees (N = 753) had significantly lower rates of other pharmacological/noninvasive therapies and a similar LBP surgery rate (1.7% vs 2.8%, P = 0.1573). Duloxetine-treated employees, despite higher pharmacy costs, had similar direct (health care) costs ($4,935 vs $5,649, P = 0.2662), and significantly lower indirect (workloss) costs ($1,723 vs $2,198, P = 0.0036). CONCLUSIONS: Duloxetine treatment in LBP employees was associated with reduced rates of many nonsurgical therapies and lower indirect costs. The findings are limited by the observational study design and unmeasured potential confounders.

Implications of early treatment among Medicaid patients with Alzheimer's disease.

OBJECTIVE: The objective of this study was to examine the effect of treatment timing on risk of institutionalization of Medicaid patients with Alzheimer's disease (AD) and to estimate the economic implications of earlier diagnosis and treatment initiation. METHODS: New Jersey Medicaid claims data (1997-2009) were used retrospectively to study the effect of treatment on time to institutionalization. Observed Medicaid payments were used to calculate savings from delayed institutionalization, adjusting for cost offsets resulting from concurrent changes in use of other medical services. RESULTS: Initiation of existing therapies at earliest symptomatic onset is predicted to delay institutionalization by 91 days, reducing Medicaid costs by $19,108/institutionalized patient. Incorporating an 18.5% cost offset from increased use of other medical services as well as drug costs associated with earlier treatment results in net savings of $12,687/patient. Projected annual Medicaid savings exceed $1 billion. CONCLUSION: Earlier treatment leads to a small delay in institutionalization among AD patients, resulting in significant costs savings to Medicaid.

Pre-diagnosis excess acute care costs in Alzheimer's patients among a US Medicaid population.

BACKGROUND AND OBJECTIVES: Prior research has documented that Alzheimer's disease (AD) is associated with increased costs from comorbid conditions. However, little is known about medical resource utilization and costs among AD patients prior to the onset of cognitive symptoms. This study estimates excess acute care costs among Medicaid AD patients in the year prior to diagnosis. STUDY DESIGN: Administrative claims data for New Jersey Medicaid patients over the period 1997-2010 were retrospectively analyzed. The study focused on non-institutionalized AD patients and examined their medical costs compared with matched controls with no dementia over the 12 months prior to their preliminary diagnosis. Costs reflect amounts reimbursed by Medicaid to medical service providers, reported in 2010 US dollars. RESULTS: The study sample included 11,536 AD patients who were matched to controls. Average age was 76 years, and 76.2 % were female. Compared with matched controls, total medical costs over the 12-month pre-index period were US$ 5,549 higher among AD patients (US$ 14,977 vs. US$ 9,428, p < 0.001), of which US$ 3,321 (p < 0.001) was due to outpatient services. Home care and medical daycare services accounted for US $1,442 (p < 0.001) of the difference. Emergency department visits and inpatient care accounted for only a small fraction of the excess costs. CONCLUSIONS: Compared with controls, Medicaid AD patients incurred higher acute care costs in the 12 months prior to their preliminary diagnosis, suggesting room for beneficial interventions and better disease management should earlier diagnosis become possible. These findings may be especially relevant in light of new criteria facilitating earlier diagnosis of AD.

Matching-adjusted indirect comparison of adalimumab vs etanercept and infliximab for the treatment of psoriatic arthritis.

OBJECTIVES: No head-to-head trial has compared the efficacy of adalimumab vs etanercept and infliximab for psoriatic arthritis (PsA). This study implements a matching-adjusted indirect comparison technique to address that gap. METHODS: Patient-level data from a placebo-controlled trial of adalimumab (ADEPT) were re-weighted to match average baseline characteristics from pivotal published trials of etanercept and infliximab. ADEPT patients were re-weighted by odds of enrollment in comparator trials, estimated using logistic regression. Matched-on characteristics included PsA duration, age, gender, severity, active psoriasis, and concomitant treatment. After matching, placebo-adjusted treatment arms were compared at weeks 12 (or 14) and 24. Outcomes included ACR20/50/70, PsARC, HAQ, and modified TSS. PASI50/75/90 were compared for patients with active psoriasis. Cost per responder (CPR) was assessed in the US and Germany using matching-adjusted end-points and drug list prices. Statistical significance was assessed using weighted t-tests. RESULTS: After matching, adalimumab-treated patients had greater placebo-adjusted rates of ACR70 and PASI50/75/90 at week 24 compared with etanercept (all p < 0.05). Adalimumab patients had a higher placebo-adjusted rate of ACR70 than infliximab at week 14 (p = 0.034). Adalimumab treatment had lower CPR for ACR70 and PASI50/75/90 compared with etanercept at week 24, in both the US and Germany (all p < 0.02). Adalimumab had lower CPR than infliximab for all outcomes at week 24 (all p < 0.05). CONCLUSION: Adalimumab is associated with higher ACR70 and PASI50/75/90 response rates than etanercept at week 24 and a higher ACR70 response rate than infliximab at week 14. Adalimumab has significant advantages over etanercept and infliximab in CPR across multiple end-points. KEY LIMITATIONS: The matching-adjusted indirect comparison method cannot account for unobserved differences in patient characteristics across trials, and only a head-to-head randomized clinical trial can fully avoid the limitations of indirect comparisons. CPR findings are limited to the US and German markets, and may not be generalizable to other markets with different relative pricing.

Duloxetine use in chronic low back pain: treatment patterns and costs.

BACKGROUND: Little is known about the real-world treatment patterns and costs of patients with chronic low back pain (CLBP) who are treated with duloxetine compared with those receiving other non-surgical treatments. OBJECTIVE: Our objective was to compare the real-world treatment patterns and costs between patients with CLBP who initiated duloxetine and matched controls who initiated another non-surgical treatment. METHODS: The study sample was selected from a US privately insured claims database (2004-8). Selected patients were aged 18-64 years, and had a low back pain (LBP) diagnosis (per Healthcare Effectiveness Data and Information Set [HEDIS] specifications) with a subsequent CLBP-qualifying diagnosis recorded ≥90 days after the initial LBP diagnosis. Duloxetine-treated patients had ≥1 duloxetine prescription within 6 months after CLBP diagnosis, no prior duloxetine claim, and continuous eligibility ≥12 months before first LBP diagnosis and ≥6 months after index duloxetine prescription (study period). Because duloxetine patients had higher rates of co-morbidities, 553 duloxetine-treated patients were matched to 553 control patients who initiated another non-surgical LBP treatment based on propensity score and time from first LBP diagnosis to treatment initiation. A subset (n = 103 each) of matched employees with disability data was also analysed to assess work loss. Main outcomes measures included study period treatment rates and direct (medical and drug) costs from a third-party payer perspective and employee indirect (work-loss) costs. McNemar tests were used to compare LBP treatment rates. Bias-corrected bootstrapping t-tests were used to compare costs. RESULTS: After matching, the two groups had balanced baseline characteristics including demographics, LBP diagnostic categories, co-morbidity profiles, resource use, treatment patterns and mean direct costs. During the 6-month study period, matched duloxetine-treated patients had significantly lower rates of other pharmacological therapy (e.g. 56.2% vs 64.9% narcotic opioids, p = 0.0024; 34.9% vs 49.5% NSAIDs, p < 0.0001) and non-invasive therapy (28.8% vs 38.5% chiropractic therapy, p = 0.0007; 25.5% vs 35.4% physical therapy, p = 0.0004; 17.5% vs 28.4% exercise therapy, p < 0.0001) than controls. Duloxetine-treated patients versus controls had similar back surgery rates (2.2% vs 3.8%; p = 0.1127) and similar direct costs ($US7658 vs $US7439; p = 0.8119). Among CLBP employees, duloxetine-treated employees versus controls had lower rates of other non-surgical therapy, similar back surgery rates (0.0% vs 3.9%; p = 0.1250), lower total direct and indirect costs ($US5227 vs $US7299; p = 0.0418), and similar indirect costs ($US1806 vs $US2664; p = 0.0528). CONCLUSIONS: Duloxetine treatment in CLBP patients/employees versus other non-surgical treatment was associated with reduced rates of non-surgical therapies and similar back surgery rates, without increased costs.

Cost of post-traumatic stress disorder vs major depressive disorder among patients covered by medicaid or private insurance.

OBJECTIVE: To compare healthcare costs and resource utilization among patients with post-traumatic stress disorder (PTSD) vs control subjects with major depressive disorder (MDD) in populations covered by Medicaid or private insurance. STUDY DESIGN: Retrospective analysis of Medicaid and private insurance administrative claims data. METHODS: Patients with at least 2 PTSD diagnoses during or after 1999, and at least 1 PTSD diagnosis during or after 2003, were identified from deidentified Medicaid claims from Florida, Missouri, and New Jersey (1999-2007) and from a privately insured claims database (1999-2008). Patients had continuous eligibility 6 months before (baseline) and 12 months after (study period) the index date and were aged 18 to 64 years. Potential control subjects having MDD without PTSD diagnosis were identified using similar selection criteria. Control subjects with MDD were matched to patients with PTSD on age, sex, state or region, employment status (private insurance only), index year, and race/ethnicity (Medicaid only). Study period per-patient utilization and costs, calculated as reimbursements to providers for medical services and prescription drugs, were compared using univariate and multivariate analyses. RESULTS: Patients with PTSD had higher rates of other mental health disorders (eg, anxiety and bipolar disorder) and higher mental health-related resource use and costs than control subjects with MDD in both Medicaid and privately insured populations. The mean study period total direct healthcare costs were higher for patients with PTSD than for control subjects with MDD ($18,753 vs $17,990 for Medicaid and $10,960 vs $10,024 for private insurance, P <.05 for both). The difference in total direct costs was driven by higher mental health-related resource use for patients with PTSD. CONCLUSION: Patients having PTSD had 4.2% to 9.3% higher mean annual per-patient healthcare costs compared with matched control subjects having MDD among patients covered by Medicaid or private insurance.

Real-world practice patterns, health-care utilization, and costs in patients with low back pain: the long road to guideline-concordant care.

BACKGROUND CONTEXT: Treatment guidelines suggest that most acute low back pain (LBP) episodes substantially improve within a few weeks and that immediate use of imaging and aggressive therapies should be avoided. PURPOSE: Assess the actual practice patterns of imaging, noninvasive therapy, medication use, and surgery in patients with LBP, and compare their costs to those of matched controls without LBP. STUDY DESIGN: A retrospective analysis of claims data from 40 self-insured employers in the United States. PATIENT SAMPLE: The study sample included 211,551 patients, aged 18 to 64 years, with one LBP diagnosis or more (per Healthcare Effectiveness Data and Information Set specification) during 2004 to 2006, identified from a claims database. Patients had continuous eligibility for 12 months or more after their index LBP diagnosis (study period), for 6 months or more before their index diagnosis (baseline period), and no other LBP diagnosis during the baseline period. Patients with LBP were matched to a random cohort of patients without LBP by age, gender, employment status, and index year. OUTCOMES MEASURES: Physiological measures (eg, imaging and diagnostic tests), functional measures (eg, pharmacologic and nonpharmacologic treatment for LBP, health-care resource use), and direct (medical and prescription drug) and indirect (disability and medically related absenteeism) costs were assessed within the year after the LBP diagnosis. METHODS: Univariate analyses described treatment patterns and compared baseline characteristics and study period costs. RESULTS: Patients with LBP had significantly higher rates of baseline comorbidities and resource use compared with controls. Of patients with LBP, 41.6% had imaging mean (median) [standard deviation] 34.3 (0) [78.6] days after the LBP diagnosis. Most patients with LBP (69.4%) used medications starting 51.9 (8) [86.2] days after the diagnosis. Opioids were commonly prescribed early (41.6% of patients; after 82.8 (25) [105.9] days). Of patients with LBP, 2.05% had surgery during the study period. Patients with LBP were likely to have chiropractic treatment first, followed by pharmacotherapy with muscle relaxants and nonsteroidal anti-inflammatory drugs. Except for less surgery, these findings also held for patients with only nonspecific LBP. Patients with LBP had higher mean direct costs compared with controls ($7,211 vs. $2,382, respectively; p<.0001), with surgery patients having mean direct costs of $33,931. CONCLUSIONS: Contrary to clinical guidelines, many patients with LBP start incurring significant resource use and associated expenses soon after the index diagnosis. Achieving guideline-concordant care will require substantial changes in LBP practice patterns.

Comparative effectiveness without head-to-head trials: a method for matching-adjusted indirect comparisons applied to psoriasis treatment with adalimumab or etanercept.

The absence of head-to-head trials is a common challenge in comparative effectiveness research and health technology assessment. Indirect cross-trial treatment comparisons are possible, but can be biased by cross-trial differences in patient characteristics. Using only published aggregate data, adjustment for such biases may be impossible. Although individual patient data (IPD) would permit adjustment, they are rarely available for all trials. However, many researchers have the opportunity to access IPD for trials of one treatment, a new drug for example, but only aggregate data for trials of comparator treatments. We propose a method that leverages all available data in this setting by adjusting average patient characteristics in trials with IPD to match those reported for trials without IPD. Treatment outcomes, including continuous, categorical and censored time-to-event outcomes, can then be compared across balanced trial populations. The proposed method is illustrated by a comparison of adalimumab and etanercept for the treatment of psoriasis. IPD from trials of adalimumab versus placebo (n = 1025) were re-weighted to match the average baseline characteristics reported for a trial of etanercept versus placebo (n = 330). Re-weighting was based on the estimated propensity of enrolment in the adalimumab versus etanercept trials. Before matching, patients in the adalimumab trials had lower mean age, greater prevalence of psoriatic arthritis, less prior use of systemic treatment or phototherapy, and a smaller mean percentage of body surface area affected than patients in the etanercept trial. After matching, these and all other available baseline characteristics were well balanced across trials. Symptom improvements of ≥75% and ≥90% (as measured by the Psoriasis Area and Severity Index [PASI] score at week 12) were experienced by an additional 17.2% and 14.8% of adalimumab-treated patients compared with the matched etanercept-treated patients (respectively, both p < 0.001). Mean percentage PASI score improvements from baseline were also greater for adalimumab than for etanercept at weeks 4, 8 and 12 (all p < 0.05). Matching adjustment ensured that this indirect comparison was not biased by differences in mean baseline characteristics across trials, supporting the conclusion that adalimumab was associated with significantly greater symptom reduction than etanercept for the treatment of moderate to severe psoriasis.

Comparing healthcare costs of Medicaid patients with postherpetic neuralgia (PHN) treated with lidocaine patch 5% versus gabapentin or pregabalin.

OBJECTIVE: To compare healthcare resource utilization and costs of postherpetic neuralgia (PHN) patients initiating lidocaine patch 5% (lidocaine patch) or oral gabapentin/pregabalin. METHODS: Patients with PHN diagnosis, or herpes zoster diagnosis and ≥30 days PHN-recommended treatment were selected from de-identified Medicaid claims data from Florida, Iowa, Missouri, and New Jersey, 1999-2007. Patients initiated monotherapy with lidocaine patch or gabapentin/pregabalin after PHN diagnosis, had continuous eligibility 6 months before (baseline) and 6 months after (study period) medication index date, and were ≥18 years old. Lidocaine patch patients were matched to gabapentin/pregabalin patients based on their propensity to initiate treatment. Study period resource utilization and costs from a Medicaid perspective were compared between treatment groups using univariate analysis. RESULTS: Matched patients were on average 61.3 years old, approximately 73% were women, and 55% had other painful conditions during the baseline period. 6-month per patient PHN-related prescription drug costs were similar for matched lidocaine patch (n=312) and gabapentin/pregabalin (n=312) patients ($854 vs. 820, p=0.75), while PHN-related medical costs appeared lower in the lidocaine patch group ($145 vs. 353, p=0.12). Furthermore, there were no statistically significant differences between treatment groups during the observation period in overall resource utilization, total prescription drug costs, and total medical costs per patient. CONCLUSIONS: In spite of higher list prices, PHN patients treated with lidocaine patch cost no more than patients treated with gabapentin or pregabalin in terms of overall healthcare costs over the 6-month study period. The study suggests that PHN-related medical costs may be lower among lidocaine patch patients. LIMITATIONS: Findings are based on a Medicaid sample and may not be generalizable to all PHN patients.

Descriptive analysis of Medicaid patients with postherpetic neuralgia treated with lidocaine patch 5%.

OBJECTIVES: To compare demographic and comorbidity profiles and healthcare costs of Medicaid patients with postherpetic neuralgia (PHN) treated with lidocaine patch 5% (lidocaine patch) versus patients not treated with the lidocaine patch. Repeat comparison for the subset of patients treated in long-term care (LTC) settings. METHODS: Patients, age≥18 years, with PHN diagnosis, or PHN-likely patients with herpes zoster diagnosis and ≥30 days of PHN-recommended treatment, were identified in Medicaid claims from Florida, Iowa, Missouri, and New Jersey (1999-2007). Patients had continuous eligibility 6 months before (baseline) and 12 months after (study period) the PHN index date. Patients with ≥1 claim for a lidocaine patch during the study period (n=872) were compared to patients without a lidocaine patch claim (comparison group). Baseline characteristics, study period treatment and healthcare costs (reimbursements by Medicaid for medical services and prescription drugs) were compared between groups using univariate analyses. RESULTS: PHN patients in the lidocaine patch group were older (64.5 vs. 62.2 years; p=0.002) and had higher rates of pain-related comorbidities (e.g., back/neck pain, osteoarthritis) than comparison patients. Average PHN-related drug costs per patient were higher ($1994 vs. 1137; p<0.0001) among lidocaine patch patients, with lidocaine patch accounting for $505 of the difference. PHN-related medical costs appeared lower in the lidocaine patch group, although not statistically significant ($983 vs. 1294; p=0.1348). No significant differences were found in total healthcare costs ($20,175 vs. 19,124; p=0.3720) across groups, despite higher total prescription drug costs among lidocaine patch patients. A similar pattern was observed among LTC patients. CONCLUSIONS: Despite higher rates of comorbidities and prescription drug costs, lidocaine patch patients had similar study period healthcare costs as comparison patients. The cost of the lidocaine patch represented a small fraction of overall costs incurred over the study period. LIMITATIONS: Findings are based on a Medicaid sample and may not be generalizable to all PHN patients.

Assessing the relationship between compliance with antidepressant therapy and employer costs among employees in the United States.

OBJECTIVE: To assess effects of antidepressant treatment compliance on health care and workplace costs. METHODS: By using workplace survey data linked to two employers' health care claims, employees with depression/antidepressant claims were categorized into noncompliant/compliant groups. Annualized costs were compared between compliance groups, for the employees with antidepressant use and a subset diagnosed with depression. RESULTS: Among antidepressant users (N = 1224), medical costs were not statistically different for compliant versus noncompliant patients; drug costs were higher for compliant patients, primarily because of antidepressants' costs. Similar associations were observed among depressed patients (N = 488). Absenteeism costs were lower for compliant patients with antidepressant use ($3857 vs $4,907, P = 0.041) and among depressed patients ($3976 vs $5899, P = 0.047). Presenteeism costs were higher for depressed compliant patients ($19,170 vs $15,829, P = 0.011). CONCLUSIONS: Increased compliance with antidepressants is significantly associated with reduced absenteeism costs.