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.

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.

Comparison of health care use and costs in newly diagnosed and established patients with fibromyalgia.

UNLABELLED: In 2004, the American Pain Society (APS) issued evidence-based fibromyalgia treatment recommendations. The objective of this claims database analysis is to describe prescription and medical use in patients with newly diagnosed and established fibromyalgia. Privately insured patients with 2+ myalgia/myositis claims (1999 to 2005) were categorized as newly diagnosed or established; this dichotomy involves comparisons between prediagnosis (S1) and postdiagnosis (S2) stages in the newly diagnosed and between newly diagnosed (S2) and established patients (S3). Use of APS guideline medications increased across stages: selective serotonin reuptake inhibitors (SSRIs) (S1, S2, S3: 20.6%, 22.9%, 25.3%), serotonin norepinephrine reuptake inhibitors (SNRIs) (4.5%, 6.4%, 8.9%), pregabalin/gabapentin (5.4%, 7.4%, 8.8%), benzodiazepines (19.0%, 21.1%, 24.2%), non-benzodiazepine sedatives (9.1%, 11.5%, 13.7%) (all P < .0001), and opioids (39.5%, 43.3%, 43.9%; S1 vs S2, P < .0001; S2 vs S3, P = .2835). Use of multiple therapeutic classes also increased across stages: 3+ classes (7.1%, 9.6%, 11.8%) (all P < .0001). Office visits to providers increased, on average, after diagnosis: primary care (70.9%, 78.3%, 76.3%; all P < .0001), chiropractors (28.8%, 51.1%, 53.3%; all P < .0001), rheumatologists (4.2%, 9.9%, 10.5%; S1 vs S2, P < .0001; S2 vs S3, P = .0595), mental health (6.4%, 7.3%, 8.3%; S1 vs S2, P < .0001, S2 vs S3, P = .0003). Average health care costs rose after diagnosis in the newly diagnosed group (S1: $6555 vs S2: $8654, P < .0001). PERSPECTIVE: This paper investigates prescription drug and medical care use with respect to stages of fibromyalgia diagnosis. Established fibromyalgia patients use more medical resources and have higher rates of concomitant medication use than newly diagnosed fibromyalgia patients. Findings can help educate providers regarding optimal drug treatment patterns in this population.

Health care costs of adults treated for attention-deficit/hyperactivity disorder who received alternative drug therapies.

BACKGROUND: Many therapies exist for treating adult attention-deficit/hyperactivity disorder (ADHD), also referred to as attention-deficit disorder (ADD), but there is no research regarding cost differences associated with initiating alternative ADD/ADHD drug therapies in adults. OBJECTIVE: To compare from the perspective of a large self-insured employer the risk-adjusted direct health care costs associated with 3 alternative drug therapies for ADD in newly treated patients: extended-release methylphenidate (osmotic release oral system-MPH), mixed amphetamine salts extended release (MAS-XR), or atomoxetine. METHODS: We analyzed data from a US claims database of 5 million beneficiaries from 31 large self-insured employers (1999-2004). Analysis was restricted to adults aged 18 to 64 years with at least 1 diagnosis of ADD/ADHD (International Classification of Diseases, Ninth Revision, Clinical Modification [ICD-9-CM] codes 314.0x--attention deficit disorder; 314.00--attention deficit disorder without hyperactivity; or 314.01--attention-deficit disorder with hyperactivity) and at least 1 pharmacy claim for OROS-MPH, MAS-XR, or atomoxetine identified using National Drug Codes. In preliminary analysis, we calculated the duration of index ADHD drug therapy as time from index therapy initiation to a minimum 60-day gap. Because the median duration of index ADHD drug therapy was found to be approximately 90 days, the primary measures were total direct medical plus drug costs and medical-only costs computed over 6 months following therapy initiation. Adults were required to have continuous eligibility 6 months before and 6 months after their latest drug therapy initiation and no ADHD therapy during the previous 6 months. Cost was measured as the payment amount made by the health plan to the provider rather than billed charges, and it excluded patient copayments and deductibles. Medical costs included costs incurred for all-cause inpatient and outpatient/other services. Costs were adjusted for inflation to 2004 U.S. dollars using the consumer price index for medical care. T tests were used for descriptive cost comparisons. Generalized linear models (GLMs) were used to compare costs of adults receiving alternative therapies, adjusting for demographic characteristics, substance abuse, depression, and the Charlson Comorbidity Index. RESULTS: Of the 4,569 patients who received 1 of these 3 drug therapies for ADHD, 31.8% received OROS-MPH for a median duration of 99 days of therapy, 34.0% received MAS-XR for a median 128 days, and 34.2% received atomoxetine for a median 86 days. In the 6-month follow-up period, the mean (standard deviation) total medical and drug costs were $2,008 ($3,231) for OROS-MPH, $2,169 ($4,828) for MAS-XR, and $2,540 ($4,269) for atomoxetine-treated adults. The GLM for patient characteristics suggested that 6-month, risk-adjusted mean medical costs, excluding drug costs, for adults treated with OROS-MPH were $142 less (10.4%, $1,220 vs. $1,362) compared with MAS-XR (P =0.022) and $132 less (9.8%, $1,220 vs. $1,352) compared with atomoxetine (P =0.033); risk-adjusted mean medical costs were not significantly different between MAS-XR and atomoxetine. The GLM comparison of risk-adjusted total direct costs, including drug cost, was on average $156 less (8.0%, $1,782 vs. $1,938) for OROS-MPH compared with MAS-XR (P = 0.017) and $226 less (11.3%, $1,782 vs. $2,008) compared with atomoxetine (P <0.001); the risk-adjusted total direct costs were not significantly different between MAS-XR and atomoxetine. Two high-cost outliers (greater than 99.96th percentile, 1 each for OROS-MPH and atomoxetine) accounted for $47 (30%) of the $156 cost difference between OROS-MPH and MAS-XR and $11 (5%) of the $226 cost difference between OROS-MPH and atomoxetine, and the medical diagnoses for the highest-cost claims for these 2 outlier patients were unrelated to ADHD. CONCLUSIONS: After adjusting for patient characteristics including substance abuse, depression, and the Charlson Comorbidity Index, adults treated with OROS-MPH had, on average, slightly lower medical and total medical and drug costs than those treated with MAS-XR or atomoxetine over the 6-month period after drug therapy initiation. Approximately 30% of the cost difference compared with MAS-XR was attributable to 1 high-cost outlier with medical diagnoses for the highest-cost claim that were unrelated to ADHD.