Clinical Trajectories, Healthcare Resource Use, and Costs of Diabetic Nephropathy Among Patients with Type 2 Diabetes: A Latent Class Analysis.

INTRODUCTION: Patients with type 2 diabetes mellitus (T2DM) are clinically heterogeneous in terms of disease severity, treatment, and comorbidities, potentially resulting in differential diabetic nephropathy (DN) progression courses. In this exploratory study we used latent class analysis (LCA) to identify patient groups with distinct clinical profiles of T2DM severity and explored the association between disease severity, DN progression or reversal, and healthcare resource use (HRU) and costs. METHODS: Latent class analysis was used to group adults with ≥ 2 medical claims with a diagnosis of T2DM and ≥ 2 urine albumin tests within the Truven MarketScan database (2004-2014), based on T2DM-related complications, comorbidities, and therapies. DN severity categories (normoalbuminuria, moderately increased albuminuria, and severely increased albuminuria) were determined based on urine albumin measure. The risks of DN progression and reversal (change to a more/less severe DN category) were compared among all identified latent classes using Kaplan-Meier analyses and log-rank tests. All-cause and DN-related costs and HRU were assessed and compared during the study period among the identified latent classes. RESULTS: Four clinically distinct profiles were identified among the 23,235 eligible patients: low comorbidity/low treatment (46.5%), low comorbidity/high treatment (29.0%), moderate comorbidity/high insulin use (9.7%), and high comorbidity/moderate treatment (14.8%). The 5-year DN progression rates for these clinically distinct profiles were 11.8, 18, 16.5, and 27.7%, respectively. Compared with the low comorbidity/low treatment group, all other groups were associated with an increased risk of DN progression (all p < 0.001). Increasing comorbidity was significantly associated with higher all-cause and DN-related HRU and costs, primarily driven by higher pharmacy and inpatient costs. CONCLUSION: Patients with T2DM who have more comorbidities experienced higher rates of DN progression and HRU and incurred higher healthcare costs compared with patients with low comorbidity profiles. Future prospective studies are needed to confirm the significance of these groups on DN progression, HRU, and costs. FUNDING: Takeda Development Center Americas, Inc.

Healthcare Resource Use, Costs, and Disease Progression Associated with Diabetic Nephropathy in Adults with Type 2 Diabetes: A Retrospective Observational Study.

INTRODUCTION: Diabetic nephropathy (DN) is a progressive kidney disease resulting as a complication of diabetes mellitus. This study evaluated the disease progression and economic burden of DN among commercially insured patients with type 2 diabetes in the USA. METHODS: The research design was a retrospective observational study based on healthcare claims data. The Truven MarketScan Databases (2004-2014) were queried for adults with type 2 diabetes with at least one urine albumin test (index, randomly selected) after diagnosis and at least one test after the index. On the basis of the index test, patients were classified into normoalbuminuria, microalbuminuria, or macroalbuminuria groups. Nephropathy-related treatment use was measured in the 6 months after the index, disease progression was assessed from the index to the end of data availability, and annual all-cause and nephropathy-related costs and healthcare resource use (HRU) were assessed up to 2 years from the index. Outcomes were compared between any two groups, controlling for baseline demographics. RESULTS: A total of 23,235 patients were identified and classified into normoalbuminuria (N = 18,409), microalbuminuria (N = 3863), or macroalbuminuria (N = 963) groups. Patients with albuminuria were more likely to be older, male, and have a higher burden of baseline comorbidities and HRU. Within 6 months following the index, 12-20% of patients with albuminuria were not treated with any relevant recommended treatment. Compared to the normoalbuminuria group, patients with macroalbuminuria had a significantly greater risk of disease progression (hazard ratio [HR] = 1.44), and both albuminuria groups were more likely to require dialysis (HR = 4.23 and 40.14 for micro- and macroalbuminuria, respectively; all p < 0.05). Annual all-cause (2016 US dollars, $3580 and $12,830 higher for micro- and macroalbuminuria vs. normoalbuminuria, respectively) and nephropathy-related ($362 and $3716) costs increased significantly with increasing nephropathy severity, consistent with the trend in increased HRU. CONCLUSIONS: Diabetic nephropathy may be undertreated or inappropriately treated. It was also associated with significantly higher costs, HRU, and risk of disease progression among commercially insured patients with type 2 diabetes in the USA. FUNDING: Takeda Development Center Americas, Inc.

Evaluation of patients with type 2 diabetes mellitus receiving treatment during the pre-diabetes period: Is early treatment associated with improved outcomes?

AIM: This study evaluates the association of pretreatment with oral antidiabetics (OADs) on clinical outcomes and health resource utilization among commercially insured type II diabetes mellitus (T2DM) patients in the United States. METHODS: Using administrative data (Truven MarketScan® Research Databases), patients diagnosed with T2DM between 2007 and 2014 with ⩾6months continuous enrolment pre- and post-diagnosis were evaluated. Pretreatment was defined as OAD use at least 3months prior to T2DM diagnosis. Time-to-insulin initiation and healthcare costs were compared by OAD pretreatment status. RESULTS: Of the 866,605 patients studied, 241,856 (27.9%) were pretreated prior to T2DM diagnosis. Mean follow-up was 2.9years for pretreatment and 3.1years for those without pretreatment. Monthly diabetes-related pharmacy costs were significantly higher among pretreated patients ($66 versus $36, p<0.0001), as were overall monthly pharmacy costs ($255 versus $198, p<0.0001). Pretreated patients had lower mean monthly costs, both total ($625 versus $671, p<0.0001) and diabetes-related ($207 versus $214, p=0.0012). After multivariable adjustment, mean monthly diabetes-related total healthcare costs were higher among pretreated patients (+$60) but total all-cause monthly healthcare costs were significantly lower (-$354) (both p<0.05). Pretreatment was associated with a lower insulin initiation probability for 2years, after which probability was similar; the adjusted hazard ratio for pretreatment in a time-to-insulin model was 0.96 (95% CI, 0.94-0.97). CONCLUSIONS: Pretreatment with OADs is associated with a modest delay in initiating insulin therapy and lower total healthcare costs. The clinical and pharmacoeconomic benefits of pretreatment should be elucidated in a prospective study.

Cost-effectiveness of tacrolimus ointment versus pimecrolimus cream in adults with atopic dermatitis.

BACKGROUND: Tacrolimus 0.1% and pimecrolimus 1.0% are used for short-term and noncontinuous treatment of atopic dermatitis (AD) in patients unresponsive to conventional therapies. OBJECTIVE: To assess the cost-effectiveness of tacrolimus versus pimecrolimus in adults with AD. METHODS: Using a Markov cohort model, the authors projected clinical and economic outcomes over six weeks in adults receiving tacrolimus versus pimecrolimus. Cost-effectiveness was assessed in terms of the ratio of the expected cost of AD-related care to the expected number of days with resolved AD. RESULTS: Patients receiving tacrolimus had an estimated 4.9 fewer days with active AD over six weeks (30.0 versus 34.9 for pimecrolimus). Expected costs (per patient) of AD-related care also were lower for tacrolimus patients ($501.27 versus $546.14, respectively). LIMITATION: While pimecrolimus is indicated for use solely in patients with mild-to-moderate AD, the trial on which this study was based included some patients with severe AD. CONCLUSION: In adults with AD, tacrolimus 0.1% may yield better clinical outcomes and lower costs of care than pimecrolimus 1.0%.

Solifenacin for overactive bladder: patient-reported outcomes from a large placebo-controlled trial.

OBJECTIVE: Overactive bladder (OAB) is a prevalent, chronic condition that can negatively affect health-related quality of life (HRQL). Treatment goals are to improve symptoms and HRQL. We assessed the efficacy of solifenacin in OAB patients using several patient-reported outcome (PRO) measures, with a focus on urgency severity. Results for the primary endpoint, reductions in daily urgency episodes, and other bladder-diary variables have been recently reported. MATERIALS AND METHODS: In this 12-week multicenter trial, 739 patients (aged >or= 18 years) were randomized to flexibly dosed solifenacin (5/10 mg) or placebo. Prespecified secondary PRO measures included the Indevus Urgency Severity Scale (IUSS), Urgency Perception Scale (UPS), Patient Perception of Bladder Condition (PPBC), and Overactive Bladder Questionnaire (OAB-q). Appropriate statistical tests compared treatment-group differences in continuous and categorical data. RESULTS: In the full analysis set, patients who received solifenacin (n = 357) versus placebo (n = 350) showed significant improvements on the IUSS and UPS; treatment-group differences were 0.4 (P < 0.0001) and 0.2 (P = 0.0018), respectively. On the PPBC, significantly more patients taking solifenacin (66%) than placebo (48%) perceived fewer bladder-related problems (P < 0.0001) by week 12. On the OAB-q, solifenacin was superior to placebo for the Symptom Bother and total HRQL scales and for 3 of the 4 HRQL domains at study end (P

Estimating the prevalence and economic burden of overactive bladder among Medicare beneficiaries prior to Medicare Part D coverage.

OBJECTIVE: The goal of this study is to provide annual estimates for the treated prevalence and expenditures attributable to overactive bladder (OAB) in the elderly prior to Medicare Part D drug coverage. RESEARCH DESIGN AND METHODS: All Medicare claims were extracted for beneficiaries over 65 with continuous coverage for Medicare Parts A and B during 2003-2004. Two OAB definitions were created: (1) the base case included diagnosis codes that narrowly defined OAB, and (2) the sensitivity variant included additional codes indicative of OAB. Descriptive comparisons of baseline characteristics, annual expenditures, and events and procedures were performed for OAB vs. non-OAB subjects meeting the inclusion criteria. CMS expenditures (2004 US dollars) for individuals were totaled and multiple regression techniques were used to estimate costs attributable to OAB after adjusting for demographic characteristics and comorbid conditions. RESULTS: The prevalence of subjects with an OAB diagnosis ranged from 8.8 to 13.6% for the base and sensitivity definitions, respectively. While mean total annual expenditures ranged from $9331 to $9655, mean annual expenditures attributable to OAB ranged from $825 to $1184 per subject (9-12% of total medical expenditures for OAB subjects), with aggregate total OAB-attributable expenditures of $1.8-3.9 billion per year. CONCLUSIONS: The treated prevalence of individuals seeking treatment for OAB in the elderly Medicare population is comparable to some common chronic conditions in that population, and OAB-attributable CMS expenditures are considerable. However, due to study limitations this is a conservative estimate of the direct cost of OAB in the elderly population. The reported estimates exclude pharmacy and out-of-pocket costs, are extrapolated to only two-thirds of the elderly Medicare population, and do not include expenditures by Medicaid for long-term care. Additionally, claims data limits detection of chronic conditions to patients who receive treatment or consultation for OAB; diagnosis codes used were based on expert opinion rather than a review of medical records to identify OAB patients; and long-term care costs are not included.

The economic impact of aspergillosis: analysis of hospital expenditures across patient subgroups.

OBJECTIVE: To measure the impact of invasive aspergillosis infection on US hospital costs and financial performance across different patient populations. METHODS: Hospital discharge data for patients with a primary or secondary diagnosis of aspergillosis were extracted from the 2003 Nationwide Inpatient Sample (NIS) and the fiscal year 2003 (FYO3) Medicare Provider Analysis and Review (MedPAR) file. The data on patient demographics, length of stay (LOS), hospital charges, estimated costs, and reimbursement levels were reported. After controlling for comorbidities, operative procedures, and diagnosis-related group (DRG) assignment, the clinical and economic outcomes were compared for patients with and without aspergillosis. RESULTS: The NIS contains a total of over 38 million projected hospital discharges. From these, 10400 aspergillosis cases were identified across 171 DRGs, resulting in a US incidence rate of 36 per million per year. The mean age of aspergillosis patients was 55.6 years, with 53.4% male and 67.9% Caucasian. The median (mean) LOS per aspergillosis patient was 10 (17.7) days, with a median (mean) total hospital charge (THC) of $44,845 ($96,731). Among the patient subgroups analyzed, the median (mean) THC per patient ranged from $47,252 ($82,946) for HIV to $413,200 ($442,233) for bone marrow transplant (BMT). When compared to the non-aspergillosis patient population, the data showed a significant increase in LOS, THC, and hospital costs. Furthermore, the higher hospital costs associated with aspergillosis patients were not matched by similar increases in reimbursements, resulting in a greater financial loss for hospitals. The mean reimbursement-to-cost ratio for aspergillosis cases across the DRGs analyzed was 0.80. CONCLUSIONS: Aspergillosis affects a wide range of patient groups and has a negative economic impact across many DRGs. Improved prevention, diagnosis, and patient management strategies can help mitigate these effects on hospital financial performance.

Impact of solifenacin on quality of life, medical care use, work productivity, and health utility in the elderly: an exploratory subgroup analysis.

BACKGROUND: Overactive bladder (OAB) is a common problem among the elderly and a financial burden to society. The prevalence of OAB increases with age and affects > or = 25% of people aged > or = 65 years. OBJECTIVE: The goal of this exploratory subgroup analysis of the VESIcare Efficacy and Research Study US (VERSUS) was to assess changes in health-related quality of life (HRQoL), medical care resource utilization, work and activity impairment, and health utility among elderly patients with OAB who continued to have urgency symptoms with tolterodine and were willing to try solifenacin. METHODS: This was a 12-week, multicenter, prospective, open-label, noncomparative, flexible-dosing study designed to assess the efficacy and tolerability of solifenacin. Patients who received tolterodine 4 mg/d for > or = 4 weeks but continued to experience urgency symptoms (> or = 3 urgency episodes/24 hours) were enrolled. This exploratory analysis describes results from 2 elderly cohorts (patients 65 to 74 years and > or = 75 years of age). After a washout period of > or = 14 days, patients began treatment with solifenacin 5 mg/d with dosing adjustments allowed at week 4 (to 10 mg/d) and at week 8 (back to 5 mg/d for patients whose dose was increased to 10 mg/d at week 4). Outcomes were assessed using the OAB-q (a questionnaire specific to OAB and HRQoL), the Work Productivity and Activity Impairment-Specific Health Problem index, the Medical Care Use Index, and the Health Utilities Index Mark 2 and Mark 3 (HUI2/3), administered at the prewashout and week-12 visits. RESULTS: The subgroup analysis included 108 patients 65 to 74 years of age and 86 patients > or = 75 years of age. Patients in both age groups experienced significant improvement in HRQoL (P < 0.001), as well as significant reductions in nonprotocol-related office visits (P < 0.001) and activity impairment (P < 0.025). A significant reduction in the use of pads/diapers was reported for patients 65 to 74 years of age (P < 0.018), and patients in this age group who were working reported significantly less impairment related to OAB while working during solifenacin treatment than during tolterodine treatment (P < 0.042). No significant differences in HUI2/3 scores were observed in either of the elderly subgroups. CONCLUSIONS: Overall, solifenacin was found to improve symptom bother, HRQoL, work productivity, activity participation, and reduced medical care resource utilization in these elderly subjects with OAB who continued to have urgency symptoms with tolterodine and were willing to try solifenacin. This was an exploratory subgroup analysis of an open-label, noncomparative study; further research is needed to confirm these results.

Efficacy of solifenacin in patients previously treated with tolterodine extended release 4 mg: results of a 12-week, multicenter, open-label, flexible-dose study.

OBJECTIVE: This study evaluated the use of solifenacin in patients experiencing residual urgency symptoms during treatment with tolterodine extended release (ER) 4 mg for overactive bladder (OAB). METHODS: This was a 12-week, multicenter, openlabel, flexible-dose study of the efficacy, tolerability, and effects on health-related quality of life (HRQL) of solifenacin in patients aged >or=18 years who had symptoms of OAB for >or=3 months, had been treated with tolterodine ER 4 mg for >or=4 weeks, and wished to switch therapy because of a lack of sufficient subjective improvement in urgency. At baseline (before washout of tolterodine), patients had to have >or=3 urgency episodes/24 hours. After >or=14 days' washout of tolterodine, all patients received oral solifenacin 5 mg/d, with the option of a dose increase to 10 mg at weeks 4 and 8. On 3 consecutive days before the prewashout, postwashout (no drug treatment for OAB), and week 4, 8, and 12 visits (during and at the end of treatment with solifenacin), patients used a bladder diary to document daily symptoms of urgency, urge incontinence, frequency, nocturia, and nocturnal voids. Changes in these measures at study end were compared with prewashout and postwashout values. The Patient Perception of Bladder Condition (PPBC) and Overactive Bladder Questionnaire (OAB-q) were used to assess patient-reported outcomes at prewashout, postwashout, and week 12. Tolerability was evaluated based on the nature, frequency, and severity of observed or reported adverse events (AEs). RESULTS: Of 606 patients screened, 441 received study medication (mean [SD] age, 61.4 [13.8] years; 88.9% white; 88.2% female). Diary-documented urgency changed from a mean of 6.0 episodes/24 hours at prewashout to 2.6 episodes/24 hours at study end, a mean decrease of 3.4 episodes/24 hours (95% CI, -3.8 to -3.0; P < 0.001). The frequency of all other diary variables was also significantly reduced from prewashout to study end (P < 0.001). The mean PPBC score changed from 4.2 points at prewashout to 3.0 points at study end, a mean improvement of 1.2 points (95% CI, -1.3 to -1.1; P < 0.001). Changes in all OAB-q scales and domains (symptom bother, coping, concern, sleep, social interaction, and total HRQL) from prewashout and postwashout to study end were also statistically significant (P < 0.001). Treatment-emergent AEs were mainly mild or moderate (237/261 [90.8%]) and led to few discontinuations (16/441 [3.6%]). Treatment-emergent AEs included anticholinergic AEs such as dry mouth (77 [17.5%]), constipation (51 [11.6%]), and blurred vision (10 [2.3%]). CONCLUSIONS: Among these patients with residual urgency after treatment with tolterodine ER 4 mg, solifenacin was associated with significant improvements in urgency and other diary-documented symptoms of OAB. Patients receiving solifenacin also had significant improvements in HRQL and the perceived bother of OAB.

Cost-effectiveness analysis of antifungal prophylaxis in patients undergoing hematopoietic stem cell transplantation.

BACKGROUND: Micafungin sodium is indicated for the prophylaxis of Candida infections in patients undergoing hematopoietic stem cell transplantation (HSCT). One Phase III, multi-institutional, randomized, doubleblind comparative trial involving 882 adult and pediatric patients found that micafungin was more effective, in terms of significantly lower rates of systemic fungal infections and empiric antifungal therapy (AFT), than fluconazole as antifungal prophylaxis during the neutropenic phase following HSCT. Thus, despite the higher cost of micafungin versus fluconazole, micafungin prophylaxis may be associated with reduced costs. OBJECTIVE: The aim of this analysis was to determine the cost-effectiveness of micafungin prophylaxis compared with fluconazole prophylaxis in patients undergoing HSCT. METHODS: Efficacy data were taken from the clinical study. The economic analysis was conducted from the hospital perspective, using costs incurred from admission through discharge. Each of the patients was assigned costs and effectiveness based on outcomes data from the clinical study. Published literature was used to estimate hospital costs associated with HSCT and prophylaxis, empiric AFT, and treatment of a probable or proven Candida or Aspergillus infection. Mean costs and effectiveness were calculated in each treatment group. To test the variability of the results using repeated sampling, a bootstrapping analysis was also conducted, with 1,000 simulations of random samples of 100 patients from each treatment group. If appropriate to describe the results, incremental cost effectiveness ratios were calculated, and sensitivity analyses were conducted by varying components of cost. RESULTS: This analysis included data from 882 patients (527 males, 355 females; micafungin, 425 patients, mean age, 43.2 years [range, 0.6-73.0 years]; fluconazole, 457 patients, mean age, 41.9 years [range, 0.6-71.0 years]). Total hospital costs per patient were USD121,098 and USD124,957 in micafungin and fluconazole recipients, respectively-a difference of USD3,859. The bootstrapping analysis found that micafungin prophylaxis was cost-saving in 72.4% of the samples compared with 9.2% with fluconazole prophylaxis. Sensitivity analyses on estimated hospital costs found that micafungin was a cost-effective therapy. CONCLUSION: In this analysis of data from a clinical study in adults and children undergoing HSCT, micafungin prophylaxis was associated with reduced hospital costs, and resultant total patient costs, compared with fluconazole prophylaxis.

Impact of solifenacin on resource utilization, work productivity and health utility in overactive bladder patients switching from tolterodine ER.

OBJECTIVE: Assess changes in resource utilization, work and activity impairment, and health utility among OAB patients continuing to have urgency symptoms with tolterodine ER 4 mg and willing to try solifenacin 5/10 mg. RESEARCH DESIGN AND METHODS: This was an open-label, non-comparative, flexible-dosing, multicenter, 12-week study assessing the efficacy and safety of solifenacin 5/10 mg/day. Patients receiving tolterodine ER 4 mg/day for >/=4 weeks but continuing to experience residual urgency symptoms (>/=3 urgency episodes/24 h) were enrolled into the study. After a 14-day washout, patients began treatment with solifenacin 5 mg/day with dosing adjustments allowed at Weeks 4 and 8. MAIN OUTCOME MEASURES: Outcomes were assessed using the Work Productivity and Activity Impairment Questionnaire - Specific Health Problem (WPAI-SHP), Health Utilities Index (HUI), and a resource utilization questionnaire administered at Pre-Washout and Week 12. RESULTS: Patients (n=440) reported significantly fewer physician office visits (p<0.0001), UTIs (p<0.0001), and pads/diapers (p=0.0009) during the study period while receiving solifenacin 5/10 mg/day, compared with the Pre-Washout period when receiving tolterodine ER 4 mg/day. After 12 weeks of treatment with solifenacin 5/10 mg/day, patients reported a reduction in work time missed (p=0.0017), less impairment while working (p<0.0001), less overall work impairment (p<0.0001) and a reduction in activity impairment (p<0.0001) compared to Pre-Washout. There was no significant difference in health utility scores. Treatment-emergent adverse events were mostly anticholinergic in nature, and were mild to moderate in severity. CONCLUSION: Overall, solifenacin 5/10 mg/day improved work productivity, activity participation, and reduced medical care use in OAB patients who continued to have urgency symptoms with tolterodine ER 4 mg/day and wished to switch to solifenacin 5/10 mg. This was an open-label, non-comparative study; therefore, further research is needed to confirm these results.

The impact of esophageal candidiasis on hospital charges and costs across patient subgroups.

OBJECTIVE: Assess the impact of esophageal candidiasis on US hospital inpatient charges, length of stay (LOS), and costs across clinically relevant subgroups. METHODS: Total hospital charge (THC) and LOS data extracted from the 2005 National Inpatient Sample (NIS) were compared for patients with and without esophageal candidiasis within the top 20 most commonly assigned Diagnosis Related Groups (DRGs) for the disease. Total hospital costs were estimated using hospital charges in the 2005 Medicare Provider Analysis and Review (MEDPAR) file and hospital cost-to-charge ratios published in the Center for Medicare and Medicaid Service's (CMS) 2005 Inpatient Prospective Payment System Standardization File. RESULTS: Across 274 DRGs, 45 727 esophageal candidiasis patients were identified. Mean age was 50.8 years; 52.5% were female, 59.3% Caucasian. Median LOS was 7 days; median THC was $25 649. Of all esophageal candidiasis cases identified, 65% fell into the top 20 most commonly assigned DRGs. Within this subset, HIV-related DRGs accounted for 22% of the esophageal candidiasis cases. The difference in mean THC and LOS for esophageal candidiasis patients in HIV-related DRGs was not significant. However, total hospital costs were higher for esophageal candidiasis patients in this subset ($11 886 vs. $10 534, p < 0.01). The remaining 78% of esophageal candidiasis cases were assigned to 19 non-HIV-related DRGs. Mean LOS, THC, and total hospital costs were significantly higher for esophageal candidiasis patients within these 19 non-HIV-related DRGs, (8.4 vs. 6.1; $35 704 vs. $23 874, and $10 917 vs. $7474, p < 0.01 in all cases). CONCLUSIONS: Esophageal candidiasis affects a wide range of patient groups; it increases LOS and total charges within non-HIV-related hospitalizations. Although the costs presented in this study are estimates, they do suggest a significant increase in cost among esophageal candidiasis cases. Future studies on treatment and preventive care strategies for esophageal candidiasis should not be limited to HIV patients, but instead performed across a wider range of disease settings.

A systems approach to identifying inappropriate use of controlled substances: the need for balance.

BACKGROUND: The diversion, abuse, and inappropriate use of controlled substances remain of concern among health care practitioners, insurers, and policy makers in the United States. The principle of "balance" represents a need to establish a system of control to prevent abuse, trafficking, and diversion of controlled substances, while ensuring their medical availability for legitimate patients. ADMINISTRATIVE DATABASES TO STUDY OUTCOMES AND QUALITY OF CARE: Some models employ pattern recognition within administrative health databases, for example, to examine outcomes and quality of medical care and monitor fraudulent behaviors and inappropriate medical care. Patients' use of resources or variations in practitioners' practice patterns can be examined. A SYSTEMS APPROACH TO ADDRESS INAPPROPRIATE USE OF CONTROLLED SUBSTANCES: A systems approach would require collaboration with medical and pharmacy directors, systems analysts, coding experts, legal experts, and clinicians to develop the claims-based model. Once a patient and/or practitioner with possible diversion or abuse are identified, a second step is required to distinguish inappropriate and appropriate behaviors and medical care. CONCLUSION: Programs to detect misuse of controlled substances must be validated through clinical research, and a consensus should be reached as to what constitutes a breach of accepted medical practice.

Identifying controlled substance patterns of utilization requiring evaluation using administrative claims data.

OBJECTIVES: To develop a systems approach to identify, for further evaluation, patients with potential controlled substance misuse or mismanagement using software queries applied to administrative health claims data. STUDY DESIGN: Retrospective validation of the system using insurance claims. PATIENTS AND METHODS: Data from administrative health claims databases representing nearly 7 million individuals younger than 65 years were used by multidisciplinary expert panels to develop and validate controlled substance patterns of utilization requiring evaluation (CS-PURE) criteria. RESULTS: Thirty-four CS-PURE queries were developed in SAS and applied to administrative claims records to identify patients with potential controlled substance misuse or mismanagement. From these, we identified 10 CS-PURE with the highest expert agreement that intervention was warranted. Expert panel agree, ment that CS-PURE correctly identified cases ranged from 48% to 100%, with at least 50% agreement in 9 of 10 CS-PURE. The prevalence rates for CS-PURE ranged from 0.001% to 0.252%. This translates to identifying between 5 and 1116 patients for individual CS-PURE in a 500 000-member health plan. CONCLUSIONS: We developed and empirically validated a group of queries using CS-PURE to identify patients with potential controlled substance misuse or mismanagement that would warrant further evaluation by the treating physician, a quality assurance function, or the medical director. Claims-based CS-PURE identification is generalizable to most health insurers with access to medical and pharmaceutical claims records. Although CS-PURE are not direct measures of misuse, they can direct attention to potential problems to determine if intervention is needed.

Opioid use and health care charges at the end of life in patients with metastatic cancer.

Opioid use and health care charges during the final year of life in patients with metastatic cancer who received controlled-release oxycodone (CRO), transdermal fentanyl (TF), or controlled-release morphine sulfate (CRM) were examined in the following study. A total of 704 patients were identified who met study entry criteria; CRO, TF, or CRM was the first-received long-acting opioid (LAO) during the last year of life for 36% (N = 250), 29% (N = 203), and 36% (N = 251) of study subjects, respectively. On average, patients initiated LAO therapy three to four months before death. One-half of patients received less than 60 days of LAO therapy. Mean total health care charges in the final year of life were dollars 84,572 for patients receiving CRO, dollars 90,935 for patients receiving TF, and dollars 76,446 for patients receiving CRM. Patients receiving TF started LAO therapy closer to their date of death, and had significantly higher hospitalization charges than did patients receiving CRO and CRM.

Therapy switching in patients receiving long-acting opioids.

BACKGROUND: Patterns of therapy switching in patients receiving long-acting opioids have not been well documented. OBJECTIVE: To compare therapy switching among patients beginning treatment with controlled-release (CR) oxycodone, transdermal fentanyl, or CR morphine sulfate. METHODS: Using a US healthcare claims database, we identified patients beginning treatment with CR oxycodone, transdermal fentanyl, or CR morphine sulfate between July 1, 1998, and December 31, 1999. We compiled claims for each patient for 6 months following therapy initiation and compared the incidence of therapy switching among the 3 groups. We also estimated total healthcare charges for patients who switched therapy versus those who did not. RESULTS: We identified 1931, 668, and 449 patients beginning therapy with CR oxycodone, transdermal fentanyl, and CR morphine sulfate, respectively; 16.7%, 25.0%, and 35.9%, respectively, had cancer. For patients without cancer, rates of therapy switching at 6 months were 10.6% (CR oxycodone), 19.0% (transdermal fentanyl), and 26.0% (CR morphine sulfate); for those with cancer, rates were 23.8%, 24.6%, and 29.8%, respectively. Multivariate hazard ratios (vs CR morphine sulfate) for therapy switching in patients without cancer were 0.36 (95% CI, 0.27 to 0.47) for CR oxycodone and 0.69 (0.51 to 0.94) for transdermal fentanyl; for those with cancer, corresponding hazard ratios were 0.72 (0.50 to 1.03) and 0.76 (0.50 to 1.16). Total healthcare charges were significantly (p < 0.01) higher for patients who switched therapy than those who did not (23,965 US dollars vs 14,299 US dollars in pts. without cancer; 58,259 US dollars vs 39,618 US dollars for those with cancer). CONCLUSIONS: Patients without cancer who receive CR oxycodone or transdermal fentanyl are less likely to switch therapy than those receiving CR morphine sulfate. Total healthcare charges are higher for patients who switch therapy.

Development of a metric for a day of manageable pain control: derivation of pain severity cut-points for low back pain and osteoarthritis.

The objective of this study was to adapt the concept of 'episode-free day', a metric for measuring symptom relief in daily units, to the clinical outcome literature for persistent pain. The episode-free day metric is widely used in other medical literature, but no analogous measure exists in pain literature. Prior focus groups with this population suggested that a 'Day of Manageable Pain Control' was an appropriate name for the metric. In the present study, in order to derive a statistical criterion for 'Manageable Day', we used Serlin et al.'s (Pain 61 (1995) 277) cut-point derivation method to derive a single cut-point on a 0-10 scale of average pain that divided groups with significant persistent pain optimally on pain-related functional interference. Participants were 194 patients with moderate-severe low back pain (n=96) or osteoarthritis (n=98). For both patient samples, '5' was the cut-point that optimally distinguished groups on pain-related interference. '5-8' and '5-7' were double cut-point solutions that optimally divided LBP and OA samples into three categories (e.g. lowest, medium and highest average pain), respectively. Derived cut-points were confirmed using a variety of measures of functional disability. Together with research that showed that average pain ratings of approximately 5 and below permit increased function and quality of life in patients with moderate to severe low back pain and osteoarthritis, our findings provide support for the use of 0-5 on a 0-10 numeric average pain severity scale as one possible criterion for a Manageable Day.

Care management for persistent pain: an introduction.

Persistent pain is a frequently occurring condition with significant economic, clinical, and humanistic implications, for both individuals and society. Current literature, however, points to unresolved issues with regard to its identification, assessment, diagnosis, and treatment, and a number of suggestions have been made for improving the quality of care for pain sufferers. Because persistent pain shares many of the salient features of other chronic conditions such as diabetes and congestive heart failure, it is reasonable to believe that the adoption of a coordinated approach to care management could substantially improve the quality of care. Several strategies--including identification, appropriate referral, education, and planning--can and should be implemented to offer comprehensive, individualized treatment alternatives that are not currently available and that improve patient outcomes, including quality of life.