Budget impact of lasmiditan for the acute treatment of migraine in the United States.

BACKGROUND: Three novel acute treatments for migraine-lasmiditan, ubrogepant, and rimegepant-were approved by the FDA in 2019 and 2020 for adults with migraine with and without aura. American Headache Society guidance recommends that these novel acute treatments be considered for patients who are contraindicated to or fail to respond or tolerate oral triptans, the current standard of acute care. OBJECTIVE: To estimate, from a US commercial plan perspective, the budget impact of adding lasmiditan as an option to a formulary that already includes ubrogepant and rimegepant. METHODS: Epidemiologic data were drawn from US Census data, the American Migraine Prevalence and Preventive study, and the first wave of the OVERCOME US survey, a web-based survey that included 21,000 patients with migraine. A model with a 3-year time horizon was built assuming that demand for the novel acute treatments would not vary based on whether lasmiditan is included in the formulary. The model examined a variety of populations, in particular beneficiaries with previous use of 1 or more oral triptans or contraindicated to triptans and beneficiaries with previous use of 2 or more oral triptans or contraindicated to triptans. Primary outcomes were the incremental differences in total cost and average cost per member per month (PMPM) between scenarios with and without lasmiditan. One-way sensitivity analyses with model parameters that were varied by plus or minus 15% were conducted to assess the effect of key parameters on the incremental total cost over 3 years. RESULTS: The addition of lasmiditan to a formulary that already includes ubrogepant and rimegepant resulted in a total savings of -$927,657 (-1.5% compared with the scenario without lasmiditan) over a 3-year time horizon in the population with previous history of using 1 or more oral triptans or contraindicated to a triptan. In the population with previous history of using 2 or more oral triptans or contraindicated, the addition of lasmiditan resulted in a total budget impact of -$466,518 (-1.3%) over a 3-year time horizon. Most of the cost savings was attributable to reductions in drug acquisition cost. Savings in total costs resulted in average incremental cost per PMPM of -0.03 and -$0.01, respectively. CONCLUSIONS: The addition of lasmiditan to the formulary as a novel acute treatment option for migraine alongside ubrogepant and rimegepant resulted in lower budget impact on a 3-year time horizon from a US commercial payer's perspective. This result is important to US commercial payers as they seek to incorporate the emerging novel acute treatments for migraine into their benefit designs. DISCLOSURES: This work was funded by Eli Lilly and Company. Milev and Sun are employed by Evidera, which received funding from Eli Lilly and Company for work on this project. Pohl, Mason, Njuguna, and Loo are employees and stockholders of Eli Lilly and Company.

One-Year Effect of the Medicare Annual Wellness Visit on Detection of Cognitive Impairment: A Cohort Study.

OBJECTIVES: To examine the effect of the Medicare Annual Wellness Visit (AWV) on the detection of cognitive impairment and on follow-up cognitive care for older adults. DESIGN: Retrospective matched-cohort study. SETTING: United States. PARTICIPANTS: A 5% random sample of fee-for-service Medicare beneficiaries continuously enrolled for 12 months before and after an index ambulatory visit occurring from 2011 to 2013 with no claims evidence of cognitive impairment before index. MEASUREMENTS: Outcomes include 12-month post-index visit claims-based measurements of cognitive impairment, including new Alzheimer's disease and related dementia (ADRD) diagnoses; medications for ADRD; and cognitive care-related diagnostic examination such as neurobehavioral testing, brain imaging, and blood tests for thyroid-stimulating hormone (TSH), serum B12, folate, and syphilis. We also measured changes in burden of anticholinergic medication. RESULTS: There were no clinically relevant differences between the AWV and control groups in the rates of incident ADRD diagnoses (6.16% vs 6.86%, p<.001) and initiation of ADRD medications (1.00% vs 1.08%, p=.15), although there were differences favoring the AWV group in rates of TSH (39.80% vs 28.36%, p<.001), B12 (9.41% vs 6.97%, p<.001), folate (4.76% vs 3.72%, p<.001), and neurobehavioral (0.75% vs 0.55%, p<.001) testing. CONCLUSIONS: Although the AWV is correlated with an increase in some measures of cognitive care, such as laboratory testing for reversible causes of cognitive impairment, it does not appear to substantially increase recognition of undetected ADRD.

Analysis of the psychological impact of cancer-related symptoms on patients with non-small cell lung cancer.

BACKGROUND: Patients with non-small cell lung cancer (NSCLC) experience adverse physical symptoms because of cancer, cancer treatment, and comorbidities. The relations among Cancer-Related Symptoms, Functional Impairment, and Psychological Symptoms in patients with NSCLC is not well understood. METHODS: Retrospective analysis of patient-reported symptoms with the 38-item Patient Care Monitor survey, collected in routine clinical care for 1138 patients with NSCLC at eight US community oncology practices. Study sample was randomly split, and structural equation models examined the direct and mediated effects of Cancer-Related Symptoms and Functional Impairment on symptoms of acute distress (Distress) and depression (Despair) in the training sample. The training model was cross validated in testing sample. Results are presented for the full model using the entire sample. RESULTS: Patients were 48.3% female, with mean age of 66.0 years. The most common comorbidities were anemia (60.8%) and respiratory disease (24.5%). Severity of Cancer-Related Symptoms was strongly and positively related to Functional Impairment and Psychological Symptoms in both training and testing models. The modeled effect of Functional Impairment on Distress and Despair was significant in the overall model using the total sample, and significant or near-significant in the training and testing models. The mediated effect of Cancer-Related Symptoms by Functional Impairment tended to be weaker than its direct modeled effect on Distress and Despair. CONCLUSIONS: Despite prior research suggesting that Functional Impairment plays a larger role than symptom burden in depression in NSCLC, the independent modeled effects of Functional Impairment were no greater than the direct modeled effects of Cancer-Related Symptoms. Copyright © 2016 John Wiley & Sons, Ltd.

Treatment patterns and cost-effectiveness of first line treatment of advanced non-squamous non-small cell lung cancer in Medicare patients.

AIM: To assess the cost-effectiveness of first-line pemetrexed/platinum and other commonly administered regimens in a representative US elderly population with advanced non-squamous non-small cell lung cancer (NSCLC). MATERIALS AND METHODS: This study utilized the Surveillance Epidemiology and End Results (SEER) cancer registry linked to Medicare claims records. The study population included all SEER-Medicare patients diagnosed in 2008-2009 with advanced non-squamous NSCLC (stages IIIB-IV) as their only primary cancer and who started chemotherapy within 90 days of diagnosis. The study evaluated the four most commonly observed first-line regimens: paclitaxel/carboplatin, platinum monotherapy, pemetrexed/platinum, and paclitaxel/carboplatin/bevacizumab. Overall survival and total healthcare cost comparisons as well as incremental cost-effectiveness ratios (ICERs) were calculated for pemetrexed/platinum vs each of the other three. Unstratified analyses and analyses stratified by initial disease stage were conducted. RESULTS: The final study population consisted of 2,461 patients. Greater administrative censorship of pemetrexed recipients at the end of the study period disproportionately reduced the observed mean survival for pemetrexed/platinum recipients. The disease stage-stratified ICER analysis found that the pemetrexed/platinum incurred total Medicare costs of $536,424 and $283,560 per observed additional year of life relative to platinum monotherapy and paclitaxel/carboplatin, respectively. The pemetrexed/platinum vs triplet comparator analysis indicated that pemetrexed/platinum was associated with considerably lower total Medicare costs, with no appreciable survival difference. LIMITATIONS: Limitations included differential censorship of the study regimen recipients and differential administration of radiotherapy. CONCLUSIONS: Pemetrexed/platinum yielded either improved survival at increased cost or similar survival at reduced cost relative to comparator regimens in the treatment of advanced non-squamous NSCLC. Limitations in the study methodology suggest that the observed pemetrexed survival benefit was likely conservative.

Comparison of demographics, treatment patterns, health care utilization, and costs among elderly patients with extensive-stage small cell and metastatic non-small cell lung cancers.

BACKGROUND: Limited data exist regarding real-world treatment patterns, resource utilization, and costs of extensive-stage small cell lung cancer (esSCLC) among elderly patients in the United States. While abundant data are available on treatment patterns in metastatic non-small cell lung cancer (mNSCLC), to our knowledge no data exist comparing costs and resource use between patients with esSCLC or mNSCLC. METHODS: We retrospectively analyzed administrative claims data (2000-2008) of patients aged ≥65 years from the linked Surveillance, Epidemiology and End Results (SEER)-Medicare database. Patients were selected on the basis of having newly diagnosed esSCLC (n=5,855) or mNSCLC (n=24,090) during 1/1/2000-12/31/2005, and were required to have received cancer-directed therapy. Survival and other measures were compared between esSCLC and mNSCLC patients using Kaplan-Meier log-rank and univariate chi-square and t-tests. Study measures were followed from first diagnosis date of either esSCLC or mNSCLC until the earlier of death or end of the database. RESULTS: Survival between the cohorts did not differ significantly: mean of 10.4 months for esSCLC patients versus 11.1 months for mNSCLC; median survival was 7.4 months versus 5.9 months. A higher percentage of mNSCLC patients (vs. esSCLC) received radiation therapy (75.6% vs. 65.4%; P < 0.001) and surgery (13.6% vs. 7.8%; P < 0.001) during the metastatic disease period. Conversely, a higher percentage of esSCLC patients than mNSCLC patients received chemotherapy (85.5% vs. 60.3%; P < 0.001), red blood-cell transfusion (20.7% vs. 10.9%; P < 0.001), platelet transfusion (5.6% vs. 1.8%; P < 0.001), and growth-factor support (59.0% vs. 39.5%; P < 0.001). esSCLC patients incurred higher lifetime disease-related costs ($44,167 vs. $37,932; P < 0.001) and all-cause costs ($70,549 vs. $67,176; P < 0.001) than mNSCLC patients. CONCLUSIONS: Lifetime total and disease-related costs per patient were high. Increased use of chemotherapy, supportive care therapies (including growth factors), and disease-related hospitalizations were observed in esSCLC patients as compared with mNSCLC patients. Disease-related and all-cause costs for esSCLC also exceeded those of mNSCLC, except for hospice and skilled nursing services. Survival and per-patient costs for both groups underscore the unmet medical need for more effective therapies in patients with esSCLC or mNSCLC.

Survival patterns in United States (US) medicare enrollees with non-CML myeloproliferative neoplasms (MPN).

PURPOSE: Non-CML myeloproliferative neoplasms (MPN) include essential thrombocythemia (ET), polycythemia vera (PV), and myelofibrosis (MF). Reported median overall survival (OS) ranges from a few to several years for MF, a decade or more for ET and PV. The study objective was to compare US survival rates of ET, PV, and MF patients with matched non-MPN/non-cancer controls in a nationally representative database. PATIENTS AND METHODS: Data were taken retrospectively from the Survey, Epidemiology, and End Results (SEER)-Medicare linked database. Medicare enrollees with a new SEER MPN diagnosis between Jan 1, 2001 and Dec 31, 2007 were eligible. First MPN diagnosis was required at or after Medicare enrollment to allow for continuous follow-up. Non-MPN/non-cancer control groups were selected from Medicare separately for each MPN subtype and demographically matched to cases at a ratio of 5:1. Survival was determined starting from the case diagnosis date using the Kaplan-Meier method. RESULTS: A total of 3,364 MPN patients (n = 1,217 ET; 1,625 PV; 522 MF) met the inclusion criteria and were matched to controls. Mean age was 78.4, 76.1, and 77.4 years for ET, PV, and MF, respectively, and percent female was 63, 50, and 41. Median OS was significantly (p<0.05) lower for MPN cases vs. controls (ET: 68 vs. 101 months; PV: 65 vs. 104; MF: 24 vs. 106). CONCLUSIONS: In the US Medicare population, survival in MF patients was worse than that of patients with ET or PV and significantly worse than matched controls. Survival of patients with ET or PV was substantially inferior to matched controls. These findings have implications for the clinical management of MPN patients and underscore the need for effective therapies in all MPN subtypes.

Prospective observational comparison of clinical outcomes between african-american and caucasian patients receiving second-line treatment with pemetrexed for advanced non-small-cell lung cancer.

INTRODUCTION: This prospective observational study evaluated the effect of race on disease control rate (DCR), progression-free survival (PFS), and overall survival (OS) in patients with NSCLC treated with second-line pemetrexed. PATIENTS AND METHODS: Eligibility criteria included stage IIIB or IV NSCLC patients receiving single-agent pemetrexed for second-line therapy in routine clinical practice. Noninferiority was evaluated using logistic regression analysis of DCR, controlling for predefined covariates. Noninferiority was considered if the upper 95% confidence bound on the adjusted odds ratio (OR) for Caucasian vs. African-American individuals was less than 1.78, corresponding to a difference in proportion of 14% assuming Caucasian individuals to have a DCR of approximately 50%. The bound was chosen to be half of the anticipated difference between treatment and no second-line treatment. PFS and OS were estimated using the Kaplan-Meier method. Tools were used to measure functional status and symptom burden. RESULTS: The unadjusted DCR was 43.7% (117/268) for Caucasian and 45.0% (27/60) for African-American individuals (unadjusted OR, 0.95; 95% confidence interval [CI], 0.54-1.66). The adjusted OR in the final logistic regression model was 0.82 (95% CI, 0.43-1.58). This upper 95% confidence bound was within the prespecified acceptable bound of 1.78. Median PFS times (months) were 2.7 (95% CI, 2.4-3.4) for Caucasian and 3.0 (95% CI, 2.3-4.7) for African-American individuals (P = .91). Median OS times (months) were 6.7 (95% CI, 5.7-7.9) for Caucasian and 6.9 (95% CI, 4.5-8.9) for African-American individuals (P = .92). Baseline and functional status after baseline assessment and mean symptom burden did not differ substantially among races. CONCLUSION: African-American race was not considered to be a significant predictor of disease control after second-line treatment with pemetrexed.

Perspectives of quality care in cancer treatment: a review of the literature.

BACKGROUND: Approximately 1.7 million Americans are diagnosed with cancer annually. There is an increasing demand for high-quality cancer care; however, what constitutes quality care is not well defined. There remains a gap in our knowledge regarding the current perceptions of what defines quality care. OBJECTIVE: To review the current understanding and perspectives of key stakeholders regarding quality cancer care for adult patients with cancer who are receiving chemotherapy-based treatment regimens. METHODS: This systematic qualitative literature review involved a search of MEDLINE and PubMed databases for articles that were published between January 2009 and May 2013 using a predefined search strategy with specific Medical Subject Headings terms encompassing 3 core concepts-cancer, chemotherapy, and quality of healthcare. Articles were eligible to be included if they focused on adult cancers, discussed quality indicators of cancer care or quality of care in the article's body, discussed treating cancer with chemotherapy, were conducted in the United States and with US respondents, and reported data about cancer quality that were obtained directly from stakeholders (eg, patients, caregivers, providers, payers, other healthcare professionals). Thematic analyses were conducted to assess the perspectives and the intersection of quality care issues from each stakeholder group that was identified, including patients, providers, and thought leaders. RESULTS: The search strategy identified 542 articles that were reviewed for eligibility. Of these articles, 15 were eligible for inclusion in the study and reported perspectives from a total of 4934 participants. Patients with cancer, as well as providers, noted information needs, psychosocial support, responsibility for care, and coordination of care as important aspects of quality care. Providers also reported the importance of equity in cancer care and reimbursement concerns, whereas patients with cancer considered the timeliness of care an important factor. The perspectives of thought leaders focused on barriers to and facilitators of quality care. CONCLUSION: Thematic elements related to cancer quality were relatively consistent between patients and providers; no additional information was found regarding payer perspectives. The perspectives of these groups are important to consider as quality initiatives are being developed.

Healthcare costs and workloss burden of patients with chemotherapy-associated peripheral neuropathy in breast, ovarian, head and neck, and nonsmall cell lung cancer.

Objective. Chemotherapy-associated peripheral neuropathy (CAPN) is a painful side-effect of chemotherapy. This study assesses healthcare and workloss costs of CAPN patients with breast, ovarian, head/neck, or non-small cell lung cancer (NSCLC) from a third-party payor/employer perspective. Research Design and Methods. Patients with qualifying tumors, and claims for chemotherapy and services indicative of peripheral neuropathy (PN) within 9-months of chemotherapy (cases) were identified in a administrative claims database. Cases were matched 1 : 1 to controls with no PN-related claims based on demographics, diabetes history and propensity for having a diagnosis of PN during the study period (based on resource use and comorbidities in a 3-month baseline period). Average all-cause healthcare costs, resource use and workloss burden were determined. Results. Average healthcare costs were $17,344 higher for CAPN cases than their non-CAPN controls, with outpatient costs being the highest component (with cases having excess costs of $8,092). On average, each CAPN case had 12 more outpatient visits than controls, and spent more days in the hospital. Workloss burden was higher for cases but not statistically different from controls. Conclusion. This study establishes that breast, ovarian, head/neck, or NSCLC patients with CAPN have significant excess healthcare costs and resource use.

Factors Associated with Persistence with Teriparatide Therapy: Results from the DANCE Observational Study.

Purpose. Determine patient-reported reasons for discontinuation with teriparatide. Methods. Patients taking teriparatide in a multicenter, prospective, and observational study were given three questionnaires: baseline, follow-up questionnaire 1 (QF1, 2 to 6 months), and follow-up questionnaire 2 (QF2, 12 months). Discontinuation reported at QF1 and QF2 was defined as "early" and "late," respectively, and remaining patients were considered persistent. Cochran-Armitage trend test was used to identify factors associated with discontinuation. Results. Side effects, concern about improper use, injection difficulties, and several patient-perceived physician issues were associated with early discontinuation. Low patient-perceived importance of continuing treatment, side effects, difficulty paying, and low patient-perceived physician knowledge were associated with late discontinuation. The most common specific reasons selected for discontinuing treatment were "concerns about treatment outweighing the benefits" (n = 53) and "difficulty paying" (n = 47). Conclusions. Persistence with teriparatide is dependent on managing side effects, addressing financial challenges, proper training, and obtaining support from the healthcare provider.

Evaluation of the Reliability of Electronic Medical Record Data in Identifying Comorbid Conditions among Patients with Advanced Non-Small Cell Lung Cancer.

Background. Traditional methods for identifying comorbidity data in EMRs have relied primarily on costly and time-consuming manual chart review. The purpose of this study was to validate a strategy of electronically searching EMR data to identify comorbidities among cancer patients. Methods. Advanced stage NSCLC patients (N = 2,513) who received chemotherapy from 7/1/2006 to 6/30/2008 were identified using iKnowMed, US Oncology's proprietary oncology-specific EMR system. EMR data were searched for documentation of comorbidities common to advanced stage cancer patients. The search was conducted by a series of programmatic queries on standardized information including concomitant illnesses, patient history, review of systems, and diagnoses other than cancer. The validity of the comorbidity information that we derived from the EMR search was compared to the chart review gold standard in a random sample of 450 patients for whom the EMR search yielded no indication of comorbidities. Negative predictive values were calculated. Results. The overall prevalence of comorbidities of 22%. Overall negative predictive value was 0.92 in the 450 patients randomly sampled patients (36 of 450 were found to have evidence of comorbidities on chart review). Conclusion. Results of this study suggest that efficient queries/text searches of EMR data may provide reliable data on comorbid conditions among cancer patients.

A review and characterization of the various perceptions of quality cancer care.

BACKGROUND: It is important to maintain high-quality cancer care while reducing spending. This requires an understanding of how stakeholders define "quality." The objective of this literature review was to understand the perceptions patients, physicians, and managed care professionals have about quality cancer care, especially chemotherapy. METHODS: A computerized literature search was conducted for articles concerning quality cancer care in patients who received chemotherapy. Among >1100 identified sources, 25 presented interviews/survey results from stakeholders. RESULTS: Patients defined quality cancer care as being treated well by providers, having multiple treatment options, and being part of the decision-making process. Waiting to see providers, having problems with referrals, going to different locations for treatment, experiencing billing inaccuracies, and navigating managed care reimbursement negatively affected patients' quality-of-care perceptions. Providers perceived quality cancer care as making decisions based on the risks-benefits of specific chemotherapy regimens and patients' health status rather than costs. Providers objected to spending substantial time interacting with payers instead of delivering care to patients. Payers must control the costs of cancer care but do not want an adversarial relationship with providers and patients. Payers' methods of managing cancer more efficiently involved working with providers to develop assessment and decision-assist tools. CONCLUSIONS: Delivering quality cancer care is increasingly difficult because of the shortage of oncologists and rising costs of chemotherapy agents, radiation therapy, and imaging tests. The definition of quality cancer care differed among stakeholders, and healthcare reform must reflect these various needs to maintain and improve quality while controlling costs.

Illness-associated productivity costs among women with employer-sponsored insurance and newly diagnosed breast cancer.

OBJECTIVE: Determine lost work time and job attrition for incident breast cancer (BC). METHODS: The cases were employed women, aged 18 to 64, with BC identified by a validated algorithm between 1999 and 2005, from claims (MarketScan) and attendance databases. Controls without cancer were matched 3:1 on age, comorbidity, and index year. RESULTS: First-year mean disability days were 60 (cases, N = 880) versus 5 (controls, N = 2640) (P < 0.001). The first-year disability costs were $4900 for cases versus $385 for controls (P < 0.001). In years 2 through 4, the disability days and associated costs were similar for the cases versus controls. After 4 years, 56.4% of cases were still enrolled in the employer-sponsored insurance programs compared to 6.5% of controls (P < 0.001). CONCLUSIONS: The lost work associated with BC is substantial in the first year after diagnosis. Employee retention is much higher for BC cases versus controls.

A retrospective claims analysis of combination therapy in the treatment of adult attention-deficit/hyperactivity disorder (ADHD).

BACKGROUND: Combination therapy in managing psychiatric disorders is not uncommon. While combination therapy has been documented for depression and schizophrenia, little is known about combination therapy practices in managing attention-deficit/hyperactivity disorder (ADHD). This study seeks to quantify the combination use of ADHD medications and to understand predictors of combination therapy. METHODS: Prescription dispensing events were drawn from a U.S. national claims database including over 80 managed-care plans. Patients studied were age 18 or over with at least 1 medical claim with a diagnosis of ADHD (International Classification of Diseases, Ninth Revision, Clinical Modification [ICD-9-CM] code 314.0), a pharmacy claim for ADHD medication during the study period July 2003 to June 2004, and continuous enrollment 6 months prior to and throughout the study period. Dispensing events were grouped into 6 categories: atomoxetine (ATX), long-acting stimulants (LAS), intermediate-acting stimulants (IAS), short-acting stimulants (SAS), bupropion (BUP), and Alpha-2 Adrenergic Agonists (A2A). Events were assigned to calendar months, and months with combined use from multiple categories within patient were identified. Predictors of combination therapy for LAS and for ATX were modeled for patients covered by commercial plans using logistic regression in a generalized estimating equations framework to adjust for within-patient correlation between months of observation. Factors included age, gender, presence of the hyperactive component of ADHD, prior diagnoses for psychiatric disorders, claims history of recent psychiatric visit, insurance plan type, and geographic region. RESULTS: There were 18,609 patients identified representing a total of 11,886 months of therapy with ATX; 40,949 months with LAS; 13,622 months with IAS; 38,141 months with SAS; 22,087 months with BUP; and 1,916 months with A2A. Combination therapy was present in 19.7% of continuing months (months after the first month of therapy) for ATX, 21.0% for LAS, 27.4% for IAS, 23.1% for SAS, 36.9% for BUP, and 53.0% for A2A.For patients receiving LAS, being age 25-44 or age 45 and older versus being 18-24 years old, seeing a psychiatrist, having comorbid depression, or having point-of-service coverage versus a Health Maintenance Organization (HMO) resulted in odds ratios significantly greater than 1, representing increased likelihood for combination therapy in managing adult ADHD.For patients receiving ATX, being age 25-44 or age 45 and older versus being 18-24 years old, seeing a psychiatrist, having a hyperactive component to ADHD, or having comorbid depression resulted in odds ratios significantly greater than 1, representing increased likelihood for combination therapy in managing adult ADHD. CONCLUSION: ATX and LAS are the most likely drugs to be used as monotherapy. Factors predicting combination use were similar for months in which ATX was used and for months in which LAS was used except that a hyperactive component to ADHD predicted increased combination use for ATX but not for LAS.

Characteristics of patients initiating raloxifene compared to those initiating bisphosphonates.

BACKGROUND: Both raloxifene and bisphosphonates are indicated for the prevention and treatment of postmenopausal osteoporosis, however these medications have different efficacy and safety profiles. It is plausible that physicians would prescribe these agents to optimize the benefit/risk profile for individual patients. The objective of this study was to compare demographic and clinical characteristics of patients initiating raloxifene with those of patients initiating bisphosphonates for the prevention and treatment of osteoporosis. METHODS: This study was conducted using a retrospective cohort design. Female beneficiaries (45 years and older) with at least one claim for raloxifene or a bisphosphonate in 2003 through 2005 and continuous enrollment in the previous 12 months and subsequent 6 months were identified using a collection of large national commercial, Medicare supplemental, and Medicaid administrative claims databases (MarketScan). Patients were divided into two cohorts, a combined commercial/Medicare cohort and a Medicaid cohort. Within each cohort, characteristics (demographic, clinical, and resource utilization) of patients initiating raloxifene were compared to those of patients initiating bisphosphonate therapy. Group comparisons were made using chi-square tests for proportions of categorical measures and Wilcoxon rank-sum tests for continuous variables. Logistic regression was used to simultaneously examine factors independently associated with initiation of raloxifene versus a bisphosphonate. RESULTS: Within both the commercial/Medicare and Medicaid cohorts, raloxifene patients were younger, had fewer comorbid conditions, and fewer pre-existing fractures than bisphosphonate patients. Raloxifene patients in both cohorts were less likely to have had a bone mineral density (BMD) screening in the previous year than were bisphosphonate patients, and were also more likely to have used estrogen or estrogen/progestin therapy in the previous 12 months. These differences remained statistically significant in the multivariate model. CONCLUSION: In this sample of patients enrolled in commercial, Medicare, and Medicaid plans, patients who initiated raloxifene treatment differed from those initiating bisphosphonates. Raloxifene patients were younger, had better overall health status and appeared to be less likely to have risk factors for new osteoporotic fractures than bisphosphonate patients. Differences in the clinical profiles of these agents may impact prescribing decisions. Investigators using observational data to make comparisons of treatment outcomes associated with these medications should take these important differences in patient characteristics into consideration.

Short-term economic impact of body weight change among patients with type 2 diabetes treated with antidiabetic agents: analysis using claims, laboratory, and medical record data.

BACKGROUND: Obesity is highly prevalent among patients with type 2 diabetes. Unfortunately, weight gain may also be a consequence of some antidiabetic medications. Although clinical benefits of weight loss have been established, the economic consequence of weight change among patients with type 2 diabetes is unclear. OBJECTIVES: The objective was to measure 1-year total and diabetes-related health care costs associated with weight change during the preceding 6-month period among type 2 diabetic patients on antidiabetic therapy. METHODS: Administrative claims, electronic laboratory data and medical chart information were abstracted for continuously enrolled adults with type 2 diabetes from an health maintenance organization (HMO) for the period from July 1, 1997 through October 31, 2005. To assess the economic impact of weight change, three regression models were applied to estimate the following: (1) the effect of weight change in general (one-slope model); (2) the different effects of weight gain and no weight gain (two-slope model); and (3) the different effects of weight gain and no weight gain (i.e., no change or weight loss) among obese and non-obese patients (four-slope model). Patients included in the study had a baseline weight measurement and a second weight measurement approximately 6 months later. They were also required to be on at least one antidiabetic drug therapy within 1 month around the baseline weight measurement date (index date). Based on the measured weight change, patients were classified into two groups--weight gainers and non-weight gainer. Total health care cost and diabetes-related cost were measured during the 1-year period following the second weight measurement and were adjusted to 2004 dollars by the medical component of the Consumer Price Index (CPI). Generalized linear models with log link function and gamma distribution were applied to assess the impacts of weight change on the 1-year total health care cost as well as 1-year diabetes-related cost. All models controlled for patients' baseline demographics, comorbidities, body mass index (BMI), glycosylated hemoglobin (HbA1c), and prior resource utilization. RESULTS: The study included 458 patients, of whom 224 (48.9%) experienced minimum weight gain of 1 pound between the two weight measurements. The average 1-year total health care cost following the second weight measure was $6382 and the diabetes-related cost was $2002. The mean total health care cost was $7260 for the weight-gainers and $5541 for the non-weight gainers (p = 0.046), and the mean diabetes-related cost, respectively, was $2141 and $1869 (p = 0.006). Results from the models showed that one percentage point of weight change was positively associated with a 3.1% ($213, p < 0.01) change in total health care cost. When weight gain and no gain were modeled separately, one percentage point of weight loss was associated with a 3.6% ($256, p < 0.05) decrease in total health care cost and a 5.8% ($131, p < 0.01) decrease in diabetes-related cost. However, one percentage point of weight gain was not associated with significant increase in either total health care or diabetes-related cost. Further, results from the model with interactions between weight change and obesity status revealed that the economic benefit of weight loss was more pronounced in the obese group (BMI > or = 30). Log likelihood ratio tests showed that the one-slope model for total health care cost and the two-slope model for diabetes-related cost are the appropriate models of choice. CONCLUSIONS: Weight loss significantly reduced diabetes-related costs. Controlling for baseline factors in the regression model, the 1-year total health care cost following 1% weight loss (or gain) was $213 cost decrease (or increase). Diabetes-related cost did not appear to be associated with weight gain. Economic benefit of weight loss was evident among type 2 diabetic patients on antidiabetic therapy, especially among obese patients.

Decreased use of clonidine following treatment with atomoxetine in children with ADHD.

The objectives of the present study were to examine clonidine use before and after initiation of atomoxetine in a cohort of children with attention deficit/hyperactivity disorder (ADHD). For this purpose, medical and pharmaceutical claims data for patients from 75 managed health care plans across the United States were extracted to identify a cohort of patients aged 18 years and younger at the time of a first atomoxetine prescription. Clonidine users were characterized on the basis of demographics, comorbid conditions, medication use and provider types, and prescribing patterns before and after the index atomoxetine prescription assessed. Subgroups of patients switching from clonidine to atomoxetine were examined and predictors of ongoing or new clonidine use were assessed. Of patients filling a first prescription for atomoxetine, 9.6% received a prescription for clonidine at some time and 4.3% within the previous 2 months. Children identified with a hyperactive component to their ADHD, those with more complex diagnostic histories, and those with tics and sleep disorders were particularly likely to receive clonidine. More than a third of patients (36.5%) with recent clonidine use subsequently discontinued use, with the pattern of clonidine use before and after atomoxetine use being highly dependent upon the pattern of stimulant prescription. Atomoxetine, in some cases, seems to have replaced clonidine in the treatment of patients with ADHD complicated with comorbid psychiatric disorders. In others, atomoxetine has replaced both stimulant and clonidine in patients previously requiring this combination for the control of symptoms or for the management of stimulant-related adverse effects.

Factors associated with initiation with atomoxetine versus stimulants in the treatment of adults with ADHD: retrospective analysis of administrative claims data.

OBJECTIVE: To determine which factors are associated with use of atomoxetine (ATX) relative to stimulant medications (STIMs) for treatment initiation in adults with attention-deficit/hyperactivity disorder (ADHD). A similar exploratory analysis of the use of ATX versus STIMs in children has been published previously. METHODS: This was an exploratory analysis using a retrospective observational cohort design applied to administrative pharmacy and medical claims from an integrated managed care database. Patients were identified if they had at least 1 administrative claim with a diagnosis for ADHD. Treatment .initiation. was defined as a new prescription for an ADHD medication preceded by 3 months without similar therapy. Two separate analyses were done, one comparing medication starts for ATX with those of any STIM, the other comparing starts of ATX with long-acting stimulants (LA-STIMs). Logistic regression analyses of prior-year administrative claims were used to compare the frequencies of differential predictors of the use of medication. RESULTS: There were 10,359 patients aged >18 years who initiated ATX or a STIM between April and December of 2003 and had at least 1 claim with a diagnosis for ADHD (International Classification of Diseases, Ninth Revision, Clinical Modification codes 314.0x). Approximately one third (28 of 82) of the comparisons related to patient demographics, diagnostic history, and previous treatment history was found to be related to the use of ATX versus STIMs and/or LA-STIMs. Patients were more likely to have received ATX than a STIM if they had prior diagnoses of bipolar disorder (odds ratio [OR] 1.47; 95% confidence interval [CI], 1.16-1.87), alcohol dependence (OR 1.80; 95% CI, 1.26-2.58), anxiety (OR 1.21; 95% CI, 1.05-1.40), previous use of antipsychotic medication (OR 1.55; 95% CI, 1.22-1.96), or previous antidepressant use (OR 1.14; 95% CI, 1.01-1.28). Prior use of behavioral services greater than 12 visits was associated with the use of ATX relative to STIMs (OR 1.46; 95% CI, 1.20-1.77) but not for ATX relative to LA-STIMs. Conversely, ATX was used less often than STIMs for initiation in younger adults aged 18 to 24 years (OR 0.66; 95% CI, 0.58-0.74), female patients (OR 0.89, 95% CI, 0.80-0.99), patients with personality disorders (OR 0.53; 95% CI, 0.34-0.82), and those with prior use of STIMs (OR 0.62; 95% CI, 0.56-0.69). The majority of comparisons (54 of 82) related to demographics, diagnostic history, and previous treatment history did not show statistically significant associations. CONCLUSIONS: During the first year of ATX.s market introduction, some differences in the frequency of various clinical factors were found in adults treated with ATX compared with those patients who received STIMs. This association may suggest that STIMs and ATX are used to address different treatment needs in adults with ADHD. Future studies will need to determine the significance of the practice pattern differences inferred here and if they persist after ATX has been on the market longer.

Prevalence, management and impact of urinary incontinence in the workplace.

BACKGROUND: The few prior studies of urinary symptoms in the workplace have been small investigations of women in specific occupations (e.g. nursing) or industries (e.g. pottery manufacture). In this study, the aims were to describe the prevalence, management and impact of urinary incontinence for a large cross-section of employed women in the USA. METHODS: Five-page questionnaires were mailed to 5130 American households selected from the National Family Opinion survey panel during the spring of 2004. Usable questionnaires were returned by 3364 women in the target age range of 18-60 years. RESULTS: About 37% of the 2326 employed respondents reported urine loss during the last 30 days. The most common strategies for managing incontinence at work included frequent bathroom breaks and wearing pads. The use of urine control methods increased with the severity of urine loss. The effect of incontinence on workplace activities also increased with the severity of urine loss: 88% of employed women with the most severe symptoms reported at least some negative impact on concentration, performance of physical activities, self-confidence or the ability to complete tasks without interruption. CONCLUSION: Urinary incontinence is prevalent among employed women. Those who experience severe symptoms report that it has a negative effect on aspects of work. Programs on the prevalence and impact of urinary incontinence would help educate both employers and employees, and may lead to the development of better management techniques in the workplace.