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.

A case of intradural osteosarcoma of the spine.

BACKGROUND CONTEXT: Intradural-extramedullary spinal tumors and extradural osteosarcomas are both rare entities. Only one case of primary intradural-extramedullary osteosarcoma of the spine has been previously reported. This is the second reported case. PURPOSE: To describe a case of primary intradural-extramedullary osteosarcoma of the spine associated with rapid clinical deterioration. STUDY DESIGN: Case report of a 70-year-old woman who presented with a constellation of neurologic symptoms. METHODS: Review of patient files, radiographic studies, surgical images, histopathology, and relevant literature. RESULTS: The patient underwent tumor debulking but exhibited rapid, postsurgical, functional deterioration and died within 6 weeks. This case and the only previous case of its kind both occurred in individuals with a remote history of iophendylate (Myodil) myelogram. CONCLUSIONS: Primary intradural-extramedullary extraosseous osteosarcoma of the spine is an exceedingly rare entity with no established management approach. Iophendylate myelography may be implicated in the etiology of this tumor type.

A model to identify patients at risk for prescription opioid abuse, dependence, and misuse.

OBJECTIVE: The objective of this study was to use administrative claims data to identify and analyze patient characteristics and behavior associated with diagnosed opioid abuse. DESIGN: Patients, aged 12-64 years, with at least one prescription opioid claim during 2007-2009 (n = 821,916) were selected from a de-identified administrative claims database of privately insured members (n = 8,316,665). Patients were divided into two mutually exclusive groups: those diagnosed with opioid abuse during 1999-2009 (n = 6,380) and those without a diagnosis for opioid abuse (n = 815,536). A logistic regression model was developed to estimate the association between an opioid abuse diagnosis and patient characteristics, including patient demographics, prescription drug use and filling behavior, comorbidities, medical resource use, and family member characteristics. Sensitivity analyses were conducted on the model's predictive power. RESULTS: In addition to demographic factors associated with abuse (e.g., male gender), the following were identified as "key characteristics" (i.e., odds ratio [OR] > 2): prior opioid prescriptions (OR = 2.23 for 1-5 prior Rxs; OR = 6.85 for 6+ prior Rxs); at least one prior prescription of buprenorphine (OR = 51.75) or methadone (OR = 2.97); at least one diagnosis of non-opioid drug abuse (OR = 9.89), mental illness (OR = 2.45), or hepatitis (OR = 2.36); and having a family member diagnosed with opioid abuse (OR = 3.01). CONCLUSIONS: Using medical as well as drug claims data, it is feasible to develop models that could assist payers in identifying patients who exhibit characteristics associated with increased risk for opioid abuse. These models incorporate medical information beyond that available to prescription drug monitoring programs that are reliant on drug claims data and can be an important tool to identify potentially inappropriate opioid use.

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 role of tricyclic antidepressants in the treatment of fibromyalgia.

OBJECTIVE: To examine the real-world role of tricyclic antidepressants (TCAs) in fibromyalgia (FM) treatment. METHODS: Using privately insured U.S. administrative claims data, this study examined TCA use for newly diagnosed FM patients. Patients ages 18 to 64 years with ≥ 2 FM diagnoses (ICD-9-CM: 729.1) during Q1:2007 to Q1:2009, no previous FM diagnosis, and continuous eligibility for insurance during the year before and after the first FM diagnosis ("study period") were identified as newly diagnosed (N = 10,129). Treatment with TCAs was examined over the first treatment episode (allowing up to a 45-day gap between refills). A sensitivity analysis was performed excluding patients with depression/anxiety diagnoses during the study period. RESULTS: During the study period, 8.9% of patients with FM used TCAs at anytime, 5.0% used TCAs during the year before FM diagnosis, and 7.2% used TCAs during the year after. The mean (median) duration of the first treatment episode was 150 (58) days. During this episode, 84.0% used other medications concomitantly, with 60.3% using analgesics and 39.6% using other antidepressants. Additionally, 60.8% augmented TCA use with other drugs, 61.8% switched to another drug at the end of their TCA episode, and 22.8% discontinued TCAs without switching. Similar patterns were observed for the subset of patients with no depression or anxiety (N = 7,655). DISCUSSION: Research covering 1999 to 2005 using the same methods found that 15.9% of patients with FM used TCAs during the year before FM diagnosis and 20.7% used TCAs during the year after. These findings suggest that TCA use among the patients with FM is uncommon and may be declining in real-world practice.

Direct and indirect costs of patients treated with extended-release oxymorphone HCl or controlled-release oxycodone HCl.

OBJECTIVE: Compare direct and indirect costs of oxymorphone extended-release ('oxymorphone') and oxycodone controlled-release ('oxycodone') users. METHODS: Patients, aged 18+, with ≥1 claim for oxymorphone/oxycodone, Q2:2006-Q4:2009, were selected from a de-identified private payer claims database and observed from the first such claim ('index date') until the earliest of: use of comparator drug; end of continuous eligibility; 12 months ('study period'). Patients with claims for any formulation of the comparator drug during the first 30 days of the study period were excluded. Direct (medical and drug) costs paid by private insurers were reported for patients aged 18-64 (n = 8354) and 65+(n = 3515), as well as sub-sets without cancer (n = 7090 and n = 2444, respectively). Indirect costs (medically-related absenteeism and disability) were reported for all employees, aged 18-64 (n = 1313), and employees without cancer (n = 1146). Multivariate models were used to estimate risk-adjusted costs controlling for patient characteristics. RESULTS: Oxymorphone users, aged 18-64, had lower drug costs ($693 vs $763, p = 0.0035) and similar medical costs ($1875 vs $1976, p = 0.3570) per patient-month compared with oxycodone users (mean follow-up 236 and 280 days, respectively). Indirect costs were not different ($662 vs $670, p = 0.9370). Oxymorphone users, aged 65+, had similar Medicare supplemental drug costs ($533 vs $588, p = 0.0840) and lower medical costs ($459 vs $747, p < 0.0001). Results were comparable for subsets without cancer. LIMITATIONS: Patients with concomitant use of oxymorphone and oxycodone were excluded. CONCLUSIONS: Oxymorphone users incur lower risk-adjusted costs in several cost categories, compared with oxycodone users, and no higher costs in any of the examined categories.

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.

Societal costs of prescription opioid abuse, dependence, and misuse in the United States.

OBJECTIVES: The objective of this study was to estimate the societal costs of prescription opioid abuse, dependence, and misuse in the United States. METHODS: Costs were grouped into three categories: health care, workplace, and criminal justice. Costs were estimated by 1) quantity method, which multiplies the number of opioid abuse patients by cost per opioid abuse patient; and 2) apportionment method, which begins with overall costs of drug abuse per component and apportions the share associated with prescription opioid abuse based on relative prevalence of prescription opioid to overall drug abuse. Excess health care costs per patient were based on claims data analysis of privately insured and Medicaid beneficiaries. Other data/information were derived from publicly available survey and other secondary sources. RESULTS: Total US societal costs of prescription opioid abuse were estimated at $55.7 billion in 2007 (USD in 2009). Workplace costs accounted for $25.6 billion (46%), health care costs accounted for $25.0 billion (45%), and criminal justice costs accounted for $5.1 billion (9%). Workplace costs were driven by lost earnings from premature death ($11.2 billion) and reduced compensation/lost employment ($7.9 billion). Health care costs consisted primarily of excess medical and prescription costs ($23.7 billion). Criminal justice costs were largely comprised of correctional facility ($2.3 billion) and police costs ($1.5 billion). CONCLUSIONS: The costs of prescription opioid abuse represent a substantial and growing economic burden for the society. The increasing prevalence of abuse suggests an even greater societal burden in the future.

Direct and indirect costs of non-vertebral fracture patients with osteoporosis in the US.

Osteoporosis is a condition marked by low bone mineral density and the deterioration of bone tissue. One of the main clinical and economic consequences of osteoporosis is skeletal fractures. To assess the healthcare and work loss costs of US patients with non-vertebral (NV) osteoporotic fractures. Privately insured (aged 18-64 years) and Medicare (aged >/=65 years) patients with osteoporosis (ICD-9-CM code: 733.0x) were identified during 1999-2006 using two claims databases. Patients with an NV fracture (femur, pelvis, lower leg, upper arm, forearm, rib or hip) were matched randomly on age, sex, employment status and geographic region to controls with osteoporosis and no fractures. Patient characteristics and annual healthcare costs were assessed over the year following the index fracture for privately insured (n = 4764) and Medicare (n = 48 742) beneficiaries (Medicare drug costs were estimated using multivariable models). Indirect (i.e. work loss) costs were calculated for a subset of privately insured, employed patients with available disability data (n = 1148). All costs were reported in $US, year 2006 values. In Medicare, mean incremental healthcare costs per NV fracture patient were $US13 387 ($US22 466 vs $US9079; p < 0.05). The most expensive patients had index fractures of the hip, multiple sites and femur (incremental costs of $US25 519, $US20 137 and $US19 403, respectively). Patients with NV non-hip (NVNH) fractures had incremental healthcare costs of $US7868 per patient ($US16 704 vs $US8836; p < 0.05). Aggregate annual incremental healthcare costs of NVNH patients in the Medicare research sample (n = 35 933) were $US282.7 million compared with $US204.1 million for hip fracture patients (n = 7997). Among the privately insured, mean incremental healthcare costs per NV fracture patient were $US5961 ($US11 636 vs $US5675; p < 0.05). The most expensive patients had index fractures of the hip, multiple sites and pelvis (incremental costs of $US13 801, $US9642 and $US8164, respectively). Annual incremental healthcare costs per NVNH patient were $US5381 ($US11 090 vs $US5709; p < 0.05). Aggregate annual incremental healthcare costs of NVNH patients in the privately insured sample (n = 4478) were $US24.1 million compared with $US3.5 million for hip fracture patients (n = 255). Mean incremental work loss costs per NV fracture employee were $US1956 ($US4349 vs $US2393; p < 0.05). Among patients with available disability data, work loss accounted for 29.5% of total costs per NV fracture employee. The cost burden of NV fracture patients to payers is substantial. Although hip fracture patients were more costly per patient in both Medicare and privately insured samples, NVNH fracture patients still had substantial incremental costs. Because NVNH patients accounted for a larger proportion of the fracture population, they were associated with greater aggregate incremental healthcare costs than hip fracture patients.

Analytic models to identify patients at risk for prescription opioid abuse.

OBJECTIVE: To assess the feasibility of using medical and prescription drug claims data to develop models that identify patients at risk for prescription opioid abuse or misuse. STUDY DESIGN: Deidentified prescription drug and medical claims for approximately 632,000 privately insured patients in Maine from 2005 to 2006 were used. Patients receiving prescription opioids were divided into 2 mutually exclusive groups, namely, prescription opioid abusers and nonabusers. METHODS: Potential risk factors for prescription opioid abuse were incorporated into logistic models to identify their effects on the probability that a prescription opioid user was diagnosed as having prescription opioid abuse. Different models were based on data available to prescription monitoring programs and managed care organizations. Best-fitting models were identified based on statistical significance (P