Impact of universal varicella vaccination on the use and cost of antibiotics and antivirals for varicella management in the United States.

BACKGROUND: Our objective was to estimate the impact of universal varicella vaccination (UVV) on the use and costs of antibiotics and antivirals for the management of varicella among children in the United States (US). METHODS: A decision tree model of varicella vaccination, infections and treatment decisions was developed. Results were extrapolated to the 2017 population of 73.5 million US children. Model parameters were populated from published sources. Treatment decisions were derived from a survey of health care professionals' recommendations. The base case modelled current vaccination coverage rates in the US with additional scenarios analyses conducted for 0%, 20%, and 80% coverage and did not account for herd immunity benefits. RESULTS: Our model estimated that 551,434 varicella cases occurred annually among children ≤ 18 years in 2017. Antivirals or antibiotics were prescribed in 23.9% of cases, with unvaccinated children receiving the majority for base case. The annual cost for varicella antiviral and antibiotic treatment was approximately $14 million ($26 per case), with cases with no complications accounting for $12 million. Compared with the no vaccination scenario, the current vaccination rates resulted in savings of $181 million (94.7%) for antivirals and $78 million (95.0%) for antibiotics annually. Scenario analyses showed that higher vaccination coverage (from 0% to 80%) resulted in reduced annual expenditures for antivirals (from $191 million to $41 million), and antibiotics ($82 million to $17 million). CONCLUSIONS: UVV was associated with significant reductions in the use of antibiotics and antivirals and their associated costs in the US. Higher vaccination coverage was associated with lower use and costs of antibiotics and antivirals for varicella management.

Understanding the evolution of coverage policies for prophylaxis treatments of hemophilia A without inhibitors: a payer Delphi panel.

BACKGROUND: The landscape for hemophilia A prophylaxis is rapidly expanding from factor VIII replacement therapy to include novel treatments such as nonfactor replacement therapies that may enhance coagulation (e.g., emicizumab) or inhibit anticoagulant pathways (e.g., fitusiran and concizumab). For payers, this expansion presents challenges in balancing well-established treatments with new options that cost more and have lesser known real-world safety and efficacy. OBJECTIVE: To evaluate likely coverage practices for hemophilia A prophylaxis therapies among U.S. payers given evolving real-world data on safety and efficacy. METHODS: A 3-round modified Delphi process was conducted with representatives of U.S. commercial health plans who had considerable expertise in managing populations of patients with hemophilia. Round 1 consisted of an online questionnaire; round 2 involved an online discussion about the aggregated results from round 1; and round 3 allowed participants to revise their responses from round 1 based on insights gained during round 2. Questions elicited ratings, rankings, and estimates on access restrictions based on given safety and efficacy information for hemophilia A prophylaxis therapies. Consensus was reached if ≥ 74% of panelists (14 of 19) were within 1 SD of the median group estimate during round 3. RESULTS: 19 Payers participated in the research. Among them, 94% dealt with commercial insurance, 94% with Medicare, and 81% with Medicaid; 79% had spent ≥ 5 years in their current role. Panelists reported limited access restrictions on hemophilia A prophylaxis therapies; the most common restrictions were prior authorization (n = 16, 84%) and quantity level limits (n = 13, 67%). Tiering and step therapy were reported by 7 respondents (39%). Respondents agreed that there was an 80% median likelihood that ≥ 9 additional patients with any safety event (e.g., thrombotic event, death) per year would trigger access restrictions, with the median likelihood of restrictions increasing to 95% for another ≥ 10 patients with safety events per year. Respondents also agreed that > 5 thrombotic events requiring treatment per patient per year would have a 98% median likelihood of leading to access restrictions and that ≥ 5 years of real-world safety and efficacy data would be highly likely (95% median likelihood) to affect coverage decisions. Noncoverage was highly unlikely (ranked fifth or sixth of 6 by 14 respondents), as was no restriction-coverage parity (ranked sixth of 6 by 10 respondents). All else being equal, cost continues to affect access policies, with respondents agreeing that a 13%-30% difference in net cost may lead to preferred formulary treatment for a drug with superior efficacy and noninferior safety, inferior efficacy and noninferior safety, or noninferior efficacy and inferior safety. CONCLUSIONS: Payers prefer treatments with well-understood efficacy, safety, and cost over newer treatments with uncertain long-term effects. Relatively unrestricted access to legacy and new hemophilia A prophylaxis will likely continue unless additional real-world safety concerns or major cost differences emerge. DISCLOSURES: Financial support for this study was provided by Takeda Pharmaceutical Company, which was involved in study concept and design. Graf, Tuly, Harley, and Pednekar are employees of PRECISIONheor, a research consultancy to the health and life sciences industries that was contracted by Takeda to conduct this study and write the manuscript. Batt served as a consultant on this project through PRECISIONheor.

Costs associated with management of cervical human papillomavirus-related conditions.

BACKGROUND: Oncogenic types of human papillomavirus (HPV) have been linked to 99.7% of cervical cancer cases worldwide. METHODS: This retrospective claims-based analysis was conducted to assess patterns of use and costs associated with diagnostic and treatment procedures for disease attributed to HPV performed before the introduction of HPV vaccination (January 1, 2001-May 31, 2006). Percentages of commercially insured health plan enrollees who underwent each procedure of interest were calculated for each year. Annual costs (combined patient and health plan-paid amounts) were calculated from qualifying medical claims. Descriptive statistics were used to assess trends in procedure rates and costs. RESULTS: Data for approximately 14.2 million enrollees were obtained. Hysterectomy was the most commonly administered treatment. With the exception of colposcopy with LEEP, all other treatment procedures experienced a decline in rate of use. The most frequently performed diagnostic procedure was colposcopy with endocervical curettage (ECC). With the exception of ECC, rates of diagnostic procedures reached a peak among 20- to 24-year-olds, and followed a downward trend across older groups. Hysterectomy was the most expensive treatment (median $7,383; mean $8,384) per procedure in 2006. CONCLUSION: Results reveal high rates of use and high-associated costs of diagnostic procedures and treatments related to disease attributed to HPV. IMPACT: The data presented may be useful in cost-effectiveness analyses and to guide decision makers evaluating how best to optimize prevention strategies.

Health care costs for patients with cancer at the end of life.

PURPOSE: With rising health care costs in the United States, clearly defined end-of-life (EOL) cancer costs are needed to help health administrators proactively manage this important care. Our objective was to examine EOL health care resource costs among oncology patients in a US commercial insurance population. METHODS: A retrospective claims database affiliated with OptumInsight was analyzed. Included patients had: a medical claim with cancer diagnosis between July 1, 2002, and December 31, 2009; death on or before December 31, 2009; continuous enrollment with medical/pharmacy benefits from diagnosis until death; ≥ 180 follow-up days; and active cancer in the last 6 months before death (MBD). Death was captured from facility discharge codes or Social Security Administration death files. Costs were determined by summing paid amounts on all services utilized within the last 6 MBD: cancer-related inpatient (IP) stays, cancer- related hospice care, and cancer-related outpatient (OP) services (ie, chemotherapy, erythropoiesis-stimulating agents, granulocyte colony-stimulating factors, radiation, cancer-related office or emergency room visits, cancer-related hospital OP procedures, and other services with cancer diagnosis). RESULTS: A total of 28,530 patients met inclusion criteria. Mean total cancer-related costs in the last 6 MBD were $74,212 (standard deviation, $112,740), comprising IP costs of $40,702 (55%), OP costs of $30,254 (41%), and hospice costs of $3,256 (4%). OP costs decreased from $6,021 in the sixth MBD to $2,238 in the last MBD, whereas IP care costs increased from $1,785 to $20,559. Hospice utilization increased from 0.7% in the sixth MBD to 35.6% in the last MBD. CONCLUSION: Oncology costs increase in the last 6 MBD largely because of increased IP costs, whereas OP costs decrease.

Treatment outcomes with methylphenidate formulations among patients with ADHD: retrospective claims analysis of a managed care population.

OBJECTIVE: Describe treatment patterns, resource use, and predictors of methylphenidate (MPH) switch among children (6-12 years), adolescents (13-17 years), and adults (≥ 18 years) with attention-deficit/hyperactivity disorder (ADHD). METHODS: This retrospective U.S. managed care database study used medical, pharmacy, and enrollment data to examine treatment patterns among patients with ≥ 1 ADHD diagnosis code (ICD-9 314.00-314.9), MPH pharmacy claims during 01/01/2004-09/30/2006, and no ADHD pharmacy claims in prior 6 months. Patients were followed for 1 year for dosage change, switch (change to non-MPH treatment), augmentation, persistence (number days on index medication) and adherence (days supplied/days persistent). End points were assessed by age group and MPH formulation. Cox proportional hazards modeling was conducted to determine predictors of MPH switch. RESULTS: Among 23,860 MPH users, 51.4% had a dosing change, 14% switched to a non-MPH agent, and 4% augmented MPH therapy. Among those prescribed long-acting (LA) MPH (N = 14,681), switching rates were 14% for children, 13% for adolescents, and 16% for adults. Augmentation rates for LA MPH were <5%. Overall, 53% of patients were adherent with mean persistence of 219 days. For the subgroup of patients prescribed LA MPH (n = 14,681), adherence ranged from 49% (adolescents) to 59% (children); persistence varied between 183 days (adults) to 256 days (children). During the 1-year follow-up, office/clinic visits were the major driver of health care resource use in MPH patients (mean 9.7 visits/patient). Patients with psychiatric comorbidity utilized significantly greater services. Predictors of MPH switch included psychiatric comorbidity (hazards ratio [HR] 1.37; 95% confidence interval [CI] = 1.26-1.48; p < 0.0001) and specialty prescribers (HR 1.19, 95% CI = 1.04-1.35; p = 0.011). Potential limitations of this study include use of claims data for definition of drug usage; inclusion of medications approved for use in ADHD; assessment of switching that may not have captured short-term augmentation; absence of economic, clinical and other variables from the claims dataset that may have influenced treatment selection, and outcomes. The 6-month baseline period to determine newly treated patients may not guarantee exclusion of all previously treated patients who restart therapy after an extended period. CONCLUSIONS: Children exhibited the highest persistence of MPH users. ADHD patients on MPH therapy with a psychiatric comorbidity may require additional follow-up to help improve adherence and reduce health care resource use.

A comparison of mortality and costs associated with FOLFOX versus FOLFIRI in stage IV colorectal cancer.

OBJECTIVE: To examine cost and mortality among stage IV colorectal cancer (CRC) patients treated with 5-fluorouracil (5FU)/leucovorin/oxaliplatin (FOLFOX) or 5FU/leucovorin/irinotecan (FOLFIRI). METHODS: Adult CRC patients newly treated with FOLFOX or FOLFIRI were identified from a large database using medical and pharmacy claims for services delivered January 1, 2002 through December 31, 2005. Cancer stage for a subset of patients was abstracted from medical records. Outcomes were annualized costs calculated for 4 years of observation, and deaths as recorded by the National Death Index. Cost was analyzed using generalized linear modeling; mortality was modeled using Cox proportional hazards analysis. RESULTS: Unadjusted annualized median and mean costs were $134,401 and $152,213, respectively, for the FOLFOX cohort (n = 41) and $103,150 and $107,994 for the FOLFIRI cohort (n = 86). Death occurred among five (12%) FOLFOX and 42 (53%) FOLFIRI patients. Adjusted analysis revealed no significant difference in cost between cohorts, even after adjusting for reduced irinotecan costs due to generic availability. Incremental costs associated with one additional life saved per year were only $1,236 higher for patients treated with FOLFOX compared with FOLFIRI. Cox analysis revealed a significant survival advantage for FOLFOX over FOLFIRI (HR = 5.2; 95% CI: 1.7-15.8). CONCLUSIONS: A significant survival benefit was seen for CRC patients receiving FOLFOX versus FOLFIRI; multivariate analysis revealed no significant cost differences. However, the small sample size may have resulted in lack of adequate power to detect a difference between cohorts. There may be factors influencing mortality that were not included in the multivariate modeling.

Costs and outcomes of noncardioembolic ischemic stroke in a managed care population.

PURPOSE: To evaluate the clinical outcomes and incremental health care costs of ischemic stroke in a US managed care population. PATIENTS AND METHODS: A retrospective cohort analysis was done on patients (aged 18+ years) hospitalized with noncardioembolic ischemic stroke from January 1, 2002, through December 31, 2003, identified from commercial health plan administrative claims. New or recurrent stroke was based on history in the previous 12 months, with index date defined as first date of indication of stroke. A control group without stroke or transient ischemic attack (TIA) was matched (1:3) on age, sex, and geographic region, with an index date defined as the first medical claim during the patient identification period. Patients with atrial fibrillation or mitral value abnormalities were excluded. Ischemic stroke and control cohorts were compared on 4-year clinical outcomes and 1-year costs. RESULTS: Of 2180 ischemic stroke patients, 1808 (82.9%) had new stroke and 372 (17.1%) had a recurrent stroke. Stroke patients had higher unadjusted rates of additional stroke, TIA, and fatal outcomes compared with the 6540 matched controls. Recurrent stroke patients had higher rates of adverse clinical outcomes compared with new stroke patients; costs attributed to recurrent stroke were also higher. Stroke patients were 2.4 times more likely to be hospitalized in follow-up compared with controls (hazard ratio [HR] 2.4, 95% confidence interval [CI]: 2.2, 2.6). Occurrence of stroke following discharge was 21 times more likely among patients with index stroke compared with controls (HR 21.0, 95% CI: 16.1, 27.3). Stroke was also predictive of death (HR 1.8, 95% CI: 1.3, 2.5). Controlling for covariates, stroke patients had significantly higher costs compared with control patients in the year following the index event. CONCLUSION: Noncardioembolic ischemic stroke patients had significantly poorer outcomes and higher costs compared with controls. Recurrent stroke appears to contribute substantially to these higher rates of adverse outcomes and costs.

Burden of illness among patients at high risk versus low risk for major cardiovascular events.

OBJECTIVE: This study was designed to compare the burden of illness (BOI) in patients at high risk versus low risk of developing a major cardiovascular (CV) event. METHODS: This retrospective claims data analysis included commercial health plan members identified with a primary diagnosis on a medical claim for cardiovascular disease (CVD) from January 1, 2001 through December 31, 2002. Patients were categorized as: low risk (LR), high risk (HR), or high risk aged≥55 (HR55), based on the ONTARGET clinical trial. RESULTS: Most patients (85%) were in the LR category (8% in HR55, 7% in HR). A significantly greater proportion of patients in the HR55 group were hospitalized and experienced a greater number of ambulatory visits compared with LR and HR patients. Controlling for covariates, HR55 patients averaged $22,502 in paid healthcare services over 2 years versus $15,645 for HR patients and $11,423 for LR patients (p<0.001). CV-related costs represented about 46% of costs for the HR55 group, versus 41% for the HR group and 31% for the LR group. LIMITATIONS: Claims data are collected for the purpose of payment and not research and the presence of a diagnosis code is not proof of disease, due to possible coding errors or the use of a rule-out criterion. Also, patients who died in the follow-up were not included in the analyses, resulting in lower BOI estimates. Finally, the results of this study reflect treatment of CVD in managed-care settings, and may not be applicable to a different type of population. CONCLUSION: This study demonstrates the high BOI associated with CVD, especially for patients within the high-risk group aged≥55 years. Opportunities exist for reducing costs in this population.

Pharmacological treatment patterns among patients with attention-deficit/hyperactivity disorder: retrospective claims-based analysis of a managed care population.

OBJECTIVE: To develop a descriptive profile of attention-deficit/hyperactivity disorder (ADHD) pharmacological treatment patterns in terms of persistence, adherence, augmentation, switching, and dosing changes; and to assess differences in treatment patterns with regard to ADHD medication type, class, and duration of action. METHODS: This retrospective claims database analysis used medical data, pharmacy data, and enrollment information to examine treatment patterns among patients with at least one claim with a diagnosis code for ADHD and a filled prescription for ADHD medication (index therapy) during the period 01 January 2004 through 30 September 2006. Treatment persistence and adherence (days supplied/days persistent) were calculated. Dose changes, medication switching, and augmentation were analyzed at three levels of comparison: class (stimulant vs nonstimulant [atomoxetine]), drug type (amphetamine vs methylphenidate), and duration of action (short, intermediate, long). Statistical comparisons were made using the chi-square test for proportions and Student's t-test or the F-test from one-way ANOVA for means. RESULTS: Of 60,010 patients meeting eligibility criteria, 58.4% were younger than age 18. Most (78.4%) were prescribed a stimulant as their index therapy. Persistence and adherence were greater for patients on stimulants (vs the nonstimulant), for patients on amphetamines (vs methylphenidates), and for patients on long-acting medications (vs short- and intermediate-acting medications; all p < 0.0001). Index drug dose changes were least likely among individuals taking the nonstimulant (vs stimulants), methylphenidates (vs amphetamines), or intermediate-acting drugs (vs short- and long-acting drugs; all p < 0.0001), and medication switches were more frequent among those on nonstimulants, methylphenidates, or short-acting drugs (all p < 0.0001). Subjects taking long-acting medication were less likely to augment with a drug with a different duration of action than those taking intermediate- or short-acting medication (p < 0.0001). This claims-based study is limited by possible discrepancies between claims and patient behaviors (i.e., a claim for a prescription does not necessarily indicate that the medication was taken as prescribed). CONCLUSIONS: Patients were more stable on treatment compared with their respective comparator groups if their index therapy was a stimulant, long-acting drug, or amphetamine.

Prevalence and cost of HIV-associated weight loss in a managed care population.

OBJECTIVE: To estimate the prevalence of HIV-associated weight loss among HIV patients in a US managed care population, and compare demographic and clinical characteristics of HIV patients with and without evidence of HIV-associated weight loss. RESEARCH DESIGN AND METHODS: A retrospective observational study was conducted using a large, geographically diverse US managed care population to identify commercial enrollees with HIV/AIDS from 1/1/2005-7/31/2007, based on a combination of HIV/AIDS diagnosis codes or antiretroviral treatment. HIV-associated weight loss status was defined according to an algorithm combining evidence for weight loss-associated conditions, anorexia symptoms, and various treatments for weight loss or wasting. Among HIV patients continuously enrolled in the health plan for one year, patient demographics, treatments, and comorbidities were compared between patients with and without evidence for weight loss. RESULTS: A total of 22,535 patients with HIV/AIDS were identified, including 2098 who met the criteria for weight loss (estimated prevalence 9.3%; 95% CI: 8.9% - 9.7%). Among 12,187 continuously enrolled patients with HIV, 1006 (8.3%) had evidence of HIV-associated weight loss. Patients with HIV-associated weight loss were older (44.1 vs. 42.6 years), and more men had HIV-associated weight loss than women (8.8% vs. 5.3%). A number of comorbidities were more common among patients with HIV-associated weight loss. On average, these patients also had more ambulatory (24.0 vs. 13.4), ER (1.4 vs. 0.8), and inpatient visits (0.5 vs. 0.1). Total annual health care costs for patients with HIV-associated weight loss were more than double (mean $45,686 vs. $19,960) the costs for HIV patients without weight loss. CONCLUSIONS: Despite the availability of effective antiretroviral therapy, weight loss remains a problem among patients with HIV. Based on this analysis, almost 1 in 10 managed care patients with HIV have evidence of HIV-associated weight loss. These patients tend to have more comorbidities, use more health care resources, and incur greater costs compared to patients without HIV-associated weight loss. Patients with HIV-associated weight loss were generally sicker than the non-weight loss cohort; thus, the increased costs observed in this population may not be directly or wholly attributable to HIV-associated weight loss. In addition, limitations common to analyses of administrative claims data should be considered when interpreting these results.

Additional stroke-related and non-stroke-related cardiovascular costs and hospitalizations in managed-care patients after ischemic stroke.

BACKGROUND AND PURPOSE: Prior stroke confers an increased risk of future cardiovascular events. Because the incremental economic impact of this added risk is unknown, we assessed the additional cardiovascular costs and hospitalizations associated with ischemic stroke. METHODS: Patients hospitalized for ischemic stroke during 2002 to 2005 were identified from a large US managed-care plan and matched to control patients hospitalized for a noncardiovascular acute event. Cumulative stroke-related and non-stroke-related cardiovascular medical costs were determined for each group. Stroke and nonstroke cardiovascular hospitalization rates were calculated with the Kaplan-Meier method; risk of hospitalization was estimated with a Cox regression model. RESULTS: Stroke patients and matched controls (N=11 883) were identified (mean age approximately 58 years; 47.8% female). Compared with controls, patients hospitalized for ischemic stroke had higher stroke and nonstroke cardiovascular medical costs at 6 months (stroke: $1756 vs $50, P<0.01; nonstroke cardiovascular: $1437 vs $658, P<0.01) and 12 months (stroke: $2109 vs $68, P<0.01; nonstroke cardiovascular: $2203 vs $1167, P<0.01) of follow-up. Among stroke patients, cumulative stroke and nonstroke cardiovascular hospitalization rates were 9.06% and 5.63% at 6 months, respectively, and 21.09% and 22.05% at 36 months, respectively. Stroke patients were at significantly increased risk of repeat stroke hospitalization (hazard ratio=12.55; 95% CI, 10.50 to 15.01) and nonstroke cardiovascular hospitalization (hazard ratio=1.95; 95% CI, 1.77 to 2.14). CONCLUSIONS: After ischemic stroke, patients have significantly greater stroke and nonstroke cardiovascular costs and hospitalizations than do matched controls. Attention to total cardiovascular risk reduction in this population could potentially reduce downstream costs.

Lipid levels and low-density lipoprotein cholesterol goal attainment in diabetic patients: rosuvastatin compared with other statins in usual care.

OBJECTIVE: To compare change in low-density lipoprotein cholesterol (LDL-C) levels and National Cholesterol Education Program (NCEP) Adult Treatment Panel III LDL-C goal attainment in diabetic patients treated with rosuvastatin versus other statins in a large, managed care health plan. RESEARCH DESIGN AND METHODS: This retrospective cohort analysis used medical and pharmacy claims linked to laboratory results from a commercial/MedicareAdvantage health plan. Study participants were >or= 18 years of age, had a diagnosis of diabetes, were newly treated with statins from 8/1/03 to 2/28/05, and were considered at high risk for cardiovascular events as defined by NCEP guidelines. Subjects were continuously enrolled for 12 months pre-index and >or= 30 days post-index, with variable follow-up until therapy discontinuation or end of health plan eligibility. MAIN OUTCOME MEASURES: Change in LDL-C from baseline, and attainment of NCEP LDL-C goal among patients not at goal before starting therapy. RESULTS: A total of 3337 adult patients with diabetes were identified with new use of statin therapy during the identification period. A total of 9% (n = 301) started on rosuvastatin, 49.4% (n = 1,649) on atorvastatin, 20.7% (n = 690) on simvastatin, 7.0% (n = 234) on pravastatin, 11.7% (n = 391) on lovastatin and 2.2% (n = 72) on fluvastatin. After controlling for covariates, rosuvastatin patients experienced a significantly greater decrease in LDL-C from baseline (38.7%) than patients taking atorvastatin (34.2%) (p = 0.05), simvastatin (31.5%), pravastatin (24.2%), fluvastatin (26.3%) or lovastatin (24.9%) (p < 0.0001). Rosuvastatin users were significantly more likely to attain LDL-C goal than those taking the other statins (odds ratio: 0.44, 0.28, 0.14, 0.14, 0.19, respectively; p < 0.001). Predicted percent attaining goal was significantly greater for those taking rosuvastatin (87.3%) than for those taking atorvastatin (76.9%), simvastatin (68.7%), pravastatin (55.0%), lovastatin (55.3%) or fluvastatin (61.3%) (p < 0.001). CONCLUSION: For diabetic patients, rosuvastatin is more effective at reducing LDL-C levels and attaining NCEP ATP III LDL-C goal than other statins in real-world clinical practice.

Low-density lipoprotein cholesterol (LDL-C) levels and LDL-C goal attainment among elderly patients treated with rosuvastatin compared with other statins in routine clinical practice.

BACKGROUND: Reducing low-density lipoprotein cholesterol (LDL-C) levels lowers the risk of consequences of cardiovascular disease. Research has confirmed these benefits in elderly patients. The 3-hydroxy-3-methylglutaryl coenzyme A inhibitors (ie, statins) have long-standing proven efficacy in reducing levels of LDL-C and total cholesterol. OBJECTIVE: The goal of this study was to compare change in LDL-C from baseline and National Cholesterol Education Program (NCEP) Adult Treatment Panel (ATP) III LDL-C goal attainment in a population of elderly patients (aged > or =65 years) treated with rosuvastatin versus other statins in routine clinical practice. METHODS: This was a retrospective cohort analysis using medical and pharmacy claims data linked to clinical laboratory results from a large managed care health plan of commercial and Medicare Advantage members in the United States. Included were members aged > or =65 years who were newly treated with statins (index date) from August 1, 2003, through February 28, 2005. All subjects were continuously enrolled for 12 months preindex and > or =30 days postindex, with variable follow-up until therapy discontinuation or end of health plan eligibility. Based on NCEP ATP III guidelines, patients were grouped into risk categories with associated LDL-C goals. The primary outcomes were change in LDL-C from baseline and attainment of NCEP ATP III LDL-C goal among patients not at goal before starting therapy. Generalized linear modeling was used to assess percent change in LDL-C from baseline, controlling for covariates (including age, sex, NCEP risk level, medication possession ratio, preindex LDL-C value, days from index date to postindex LDL-C value, and number of preindex office visits for dyslipidemia). In the subset of patients not at goal before starting therapy, logistic regression was used to estimate the odds of individual patients on other statins reaching goal as compared with rosuvastatin and to produce predicted percent attaining LDL-C goal on individual statins. RESULTS: Of the 2227 elderly new users of statin therapy, 8.0% started on rosuvastatin, 38.9% started on atorvastatin, 3.0% on fluvastatin, 31.0% on lovastatin, 5.5% on pravastatin, and 13.6% on simvastatin. Females comprised 57.7% of the population, and the mean (SD) age was 73 (5.8) years (range, 65-94 years). The mean (SD) doses of rosuvastatin, atorvastatin, fluvastatin, lovastatin, pravastatin, and simvastatin were 10.65 (4.59), 16.0 (12.78), 66.31 (23.56), 27.38 (14.07), 32.86 (16.46), and 28.1 (26.2) mg, respectively. After controlling for covariates, rosuvastatin-treated patients had a 35.8% decrease in LDL-C from baseline, which was significantly greater compared with patients in the atorvastatin, fluvastatin, lovastatin, pravastatin, and simvastatin (29.3%, 21.9%, 22.5%, 22.0%, and 24.9%, respectively; P < 0.05) groups. Atorvastatin (odds ratio [OR], 0.25; 95% CI, 0.12-0.52), fluvastatin (OR, 0.05; 95% CI, 0.02-0.14), lovastatin (OR, 0.10; 95% CI, 0.05-0.20), pravastatin (OR, 0.08; 95% CI, 0.03-0.20), and simvastatin (OR, 0.14; 95% CI, 0.06-0.30) were less likely to attain LDL-C goal compared with rosuvastatin (all, P < 0.001). Predicted percent attaining goal was 93.6% among rosuvastatin users, significantly greater than users of atorvastatin, fluvastatin, lovastatin, pravastatin, and simvastatin (81.2%, 55.8%, 66.8%, 64.1%, and 72.8%, respectively; P < 0.05). CONCLUSION: In this elderly patient population, rosuvastatin was a more effective treatment for reducing LDL-C levels and attaining NCEP ATP III LDL-C goals than the other statins.

Influence of medication choice and comorbid diabetes: the cost of bipolar disorder in a privately insured US population.

BACKGROUND: Bipolar disorder is the most expensive mental disorder for US employer health plans. No published studies have examined the impact of comorbid diabetes on the cost of treating bipolar disorder. The objectives of this work were to determine the direct costs incurred by patients with bipolar disorder in a US managed care plan, and to examine the influence (1) of drug therapy regimen on bipolar-related costs, and (2) of diabetes on bipolar-related and all-cause costs. METHODS: A retrospective analysis of claims in a US private insurance database from January 1, 1999 through December 31, 2002 was performed. The database included at least 4.7 million enrollees each year. Diagnosis codes were used to identify patients with bipolar disorder; patients with diabetes were identified using diagnosis codes and medication use. RESULTS: From 1999-2002, treated bipolar disorder was identified in 262 (33.9) [mean (standard deviation)] cases per 100,000 enrollees. Among patients with bipolar disorder in this cohort, between 6.3 and 7.4% were treated for diabetes each year. Among patients with newly treated bipolar disorder, 61.8% received initial therapy with only mood stabilizers, 24.3% received only atypical antipsychotics, and 13.9% received both. Mean all-cause cost for patients with bipolar disorder was US$2,690 in the 6 months before the first bipolar-related claim, and US$6,826 in the following year. Of the latter cost, bipolar-related cost was US$1,272. Patients with comorbid diabetes had much higher all-cause cost (US$11,317) than those without diabetes in the year following the first bipolar-related claim, but only slightly higher bipolar-related cost (US$1,349). Among newly treated bipolar disorder patients, all-cause and bipolar-related cost in the year after diagnosis was lowest in patients receiving only mood stabilizers. Ordinary least squares regression analysis found that treatment with mood stabilizers only was associated with 41% lower bipolar-related cost than treatment with atypical antipsychotics only (P < .001). Significant individual associations were also found between bipolar-related cost and bipolar disorder I diagnosis, severe bipolar disorder and comorbid personality disorders (P < .001 for each) but not comorbid diabetes (P = .27). CONCLUSIONS: These results suggest that patients with bipolar disorder who receive only mood stabilizer therapy incur lower bipolar-related and all-cause cost than those receiving only atypical antipsychotics. In contrast to that for all-cause cost, comorbid diabetes had little impact on direct costs related to treating bipolar disorder itself.

A comparison of comorbidity measurements to predict healthcare expenditures.

OBJECTIVE: To compare the performance of the Elixhauser, Charlson, and RxRisk-V comorbidity indices and several simple count measurements, including counts of prescriptions, physician visits, hospital claims, unique prescription classes, and diagnosis clusters. STUDY DESIGN: Each measurement was calculated using claims data during a 1-year period before the initial filling of an antihypertensive medication among 20 378 members of a managed care organization. The primary outcome variable was the log-transformed sum of prescription, physician, and hospital expenditures in the year following the prescription encounter. METHODS: In addition to descriptive statistics and Spearman rank correlations between measurements, the predictive performance was determined using linear regression models and corresponding adjusted R(2) statistics. RESULTS: The Charlson index and the Elixhauser index performed similarly (adjusted R(2) = 0.1172 and 0.1148, respectively), while the prescription claims-based RxRisk-V (adjusted R(2) = 0.1573) outperformed both. An age- and gender-adjusted regression model that included a count of diagnosis clusters was the best individual predictor of payments (adjusted R(2) = 0.1814). This outperformed age- and gender-adjusted models of the number of unique prescriptions filled (adjusted R(2) = 0.1669), number of prescriptions filled (R(2) = 0.1573), number of physician visits (adjusted R(2) = 0.1546), logtransformed prior healthcare payments (adjusted R(2) = 0.1359), and number of hospital claims (adjusted R(2) = 0.1115). CONCLUSION: Simple count measurements appear to be better predictors of future expenditures than the comorbidity indices, with a count of diagnosis clusters being the single best predictor of future expenditures among the measurements examined.

Persistence with COX-2 inhibitors in managed care: an analysis of claims data.

Drug tolerability strongly influences patients' persistence with treatment. In this study, patterns of medication persistence with cyclooxygenase 2 (COX-2)-specific inhibitors and nonspecific nonsteroidal anti-inflammatory drugs (NSAIDs) were compared in a managed care setting. Pharmacy, enrollment, and medical claims data from 19 health plans were used to match subjects newly treated with celecoxib, rofecoxib, ibuprofen, naproxen, or diclofenac between July 1, 1999 and June 30, 2000. By using multiple regression analysis, users of COX-2-specific inhibitors were found to be 56.8% less likely to discontinue medication use and 60.3% less likely to switch treatment than were users of nonspecific NSAIDs (P < .001). Celecoxib users were 4.6% less likely to discontinue treatment than were rofecoxib users (P < .001). The greater persistence observed among users of COX-2 inhibitors might reflect improved treatment efficacy and patient satisfaction.

Treatment compliance and dosage administration among rheumatoid arthritis patients receiving infliximab, etanercept, or methotrexate.

OBJECTIVE: To examine treatment compliance and dosage administration associated with infliximab, etanercept, and methotrexate therapy for rheumatoid arthritis (RA). STUDY DESIGN: Retrospective analysis using administrative and claims data from a large US health plan. PATIENTS AND METHODS: Patients were Medicare or commercial enrollees in a health plan with a pharmacy benefit and had a diagnosis of RA. The first (index) claim for infliximab, etanercept, or methotrexate occurred between July 1, 1998, and December 31, 2000. Continuous enrollment in the plan was required from 182 days before to 365 days after the index claim. Treatment groups were compared according to compliance (defined as the actual number of therapy administrations or filled prescriptions divided by the expected number) and changes in dosage administration over time. The costs of infliximab therapy also were explored. RESULTS: A total of 2662 patients (infliximab = 141; etanercept = 853; and methotrexate = 1668) were included in the analyses. Infliximab patients were older and more likely to have a Medicare benefit. In addition, infliximab patients had more comorbidities and had greater medical costs preceding the index claim. Compliance with at least 80% of the expected dosages was significantly lower for etanercept (odds ratio [OR] 0.462; 95% confidence interval [CI] 0.290-0.736) and methotrexate (OR 0.385; 95% CI 0.245-0.604) patients than infliximab patients. Methotrexate patients had the largest dosage increases (61.6%), followed by infliximab (37.4%) and etanercept (7.4%) patients. Assuming 6.5 dosages per year, the annual cost of infliximab was dollars 10446 to dollars 12363, or dollars 1887 to dollars 1902 per administration, depending on site of service. CONCLUSIONS: Compliance is higher with infliximab compared with etanercept or methotrexate; whereas, fewer etanercept patients change dosages. The cost of infliximab was lower than expected based on previous predictions, even with a 37% increase in dosage.

The prevalence of cardiorenal risk factors in patients prescribed nonsteroidal anti-inflammatory drugs: data from managed care.

BACKGROUND: Nonsteroidal anti-inflammatory drugs (NSAIDs) have been shown to cause abnormalities in renal function. This is an important concern in patients with cardiorenal risk factors, including hypertension, congestive heart failure, edema, renal impairment, and advanced age. OBJECTIVES: The goals of this study were to determine the prevalence of cardiorenal risk factors in patients with rheumatoid arthritis (RA) or osteoarthritis and ascertain whether these risk factors are associated with prescribing patterns of cyclooxygenase (COX)-2-selective inhibitors and other NSAIDs. METHODS: This was a retrospective, longitudinal claims analysis using data from 19 large independent-practice-model managed care health plans in the United Stated. Three cohorts were identified based on claims for celecoxib, rofecoxib, or other NSAIDs from October 1, 1999, through September 30, 2000. Logistic regression models were used to explore whether baseline cardiorenal risk factors were related to choice of therapy. RESULTS: A total of 77,552 patients received celecoxib (n = 6779 [8.74%]), rofecoxib (n = 7189 [9.27%]), or other NSAIDs (n = 63,584 [81.99%]). Patients prescribed COX-2-selective inhibitors were older than those receiving other NSAIDs and had a diagnosis of RA more often. Overall, 42% of patients had >or=1 cardiorenal risk factor, and approximately one third had hypertension. Cardiorenal risk factors were not related to physicians' prescribing of celecoxib or rofecoxib, but the presence of any cardiorenal risk factor was associated with an increase in the use of COX-2-selective inhibitors compared with other NSAIDs, from 12% for cerebrovascular disease (point estimate, 1.124; P<0.001) to 74% for chronic renal failure/nephritis (point estimate, 1.738; P=0.025). RA and advanced age were associated with the use of celecoxib rather than rofecoxib. CONCLUSIONS: The prevalence of cardiorenal risk factors was found to be similar in patients prescribed celecoxib or rofecoxib for arthritis. Patients with these risk factors were more likely to receive a COX-2-selective inhibitor than other NSAIDs.