Burden of illness among patients with fragile X syndrome (FXS): a Medicaid perspective.

BACKGROUND: Fragile X syndrome (FXS) is an inherited intellectual disability that imposes a substantial clinical and humanistic burden on patients and caregivers. This study aimed to quantify the incremental burden of illness following FXS diagnosis in Medicaid populations. METHODS: A retrospective matched-cohort study was conducted using FL, NJ, MO, IA, and KS Medicaid claims (1997-2012). Patients with FXS were matched 1:5 to a comparison group without FXS, based on age, gender, state, and continuous Medicaid coverage. Healthcare resource utilization and costs were compared among cohorts over 1 year following first diagnosis. RESULTS: Overall, 697 patients with FXS were matched to 3485 non-FXS patients. Median age was 12.0 years; 82% were male. Newly diagnosed FXS patients were younger (median age: 7.0 years). During the follow-up, patients with FXS had significantly higher medication use, medical procedure use, medical specialist visits, and associated costs than the non-FXS comparison group. One-fourth of FXS patients filled prescriptions for stimulants, antipsychotics, or anticonvulsants; 25% of patients with FXS had speech and language therapy and 39% had physical therapy (versus 9%, 4% and 8%, respectively, for the comparison group). At least 44% of FXS patients visited a neurologist, cardiologist, otolaryngologist, or gastroenterologist; 92% of patients with FXS had an outpatient visit, 35% had an emergency room visit, and 34% used home services (compared to 31%-32%, 64%, 27%, and 10%, respectively, for the comparison group) (all p < 0.05). Patients with FXS had an incremental annual total healthcare cost of $33,409 (2012$) per person relative to the comparison group, while newly diagnosed FXS patients had incremental total annual healthcare costs of $17,617 (2012$) per person. CONCLUSIONS: Both established and newly diagnosed FXS were associated with significantly increased use of multiple medications and medical services, and increased healthcare costs. Treatments that could help reduce this disease burden are urgently needed.

Impact of low-grade adverse events on health-related quality of life in adult patients receiving imatinib or nilotinib for newly diagnosed Philadelphia chromosome positive chronic myelogenous leukemia in chronic phase.

OBJECTIVE: Chronic myeloid leukemia (CML) treatment relies on tyrosine kinase inhibitors (TKIs), but their use can be associated with low-grade adverse events (AEs). This analysis aimed to identify the low-grade AEs which significantly impact the Health Related Quality of Life (HRQoL) of CML patients in chronic phase (CP) and to compare the incidence of such AEs among nilotinib- and imatinib-treated patients. RESEARCH DESIGN AND METHODS: Data from the 48 month ENESTnd trial were used (N = 593 patients). HRQoL was assessed using generic (SF-36) and leukemia-specific (FACT-Leu) HRQoL surveys. AEs were categorized into 26 system organ classes. RESULTS: In the adjusted regression model, five low-grade AE categories - gastrointestinal disorders, blood and lymphatic system disorders, general disorders and administration site conditions, musculoskeletal disorders, and psychiatric disorders - significantly impaired at least one HRQoL score. The incidence rate of these five AE categories was either significantly lower for nilotinib than imatinib or not different between the two drugs. The AE categories with lower incidence for both nilotinib 300 mg BID and 400 mg BID versus imatinib 400 mg daily were gastrointestinal, blood and lymphatic system, and musculoskeletal; nilotinib 300 mg BID had lower incidence than imatinib for general disorders. LIMITATIONS: Low-grade AEs were grouped and analyzed by system organ class category, so the effect of some rare individual AEs on HRQoL may have been missed. CONCLUSIONS: The impact of low-grade AEs on HRQoL should be taken into account, along with other factors, when selecting the optimal treatment for patients newly diagnosed with CML-CP.

Pulmonary medication adherence and health-care use in cystic fibrosis.

BACKGROUND: Poor treatment adherence is common in cystic fibrosis (CF) and may lead to worse health outcomes and greater health-care use. This study evaluated associations of adherence to pulmonary medications, age, health-care use, and cost among patients with CF. METHODS: Patients with CF aged ≥ 6 years were identified in a national commercial claims database. A 12-month medication possession ratio (MPR) was computed for each pulmonary medication and then averaged for a composite MPR (CMPR) for each patient. The CMPR was categorized as low (< 0.50), moderate (0.50-0.80), or high (≥ 0.80). Annual health-care use and costs were measured during the first and second year and compared across adherence categories by multivariable modeling. RESULTS: Mean CMPR for the sample (N = 3,287) was 48% ± 31%. Age was inversely related to CMPR. In the concurrent year, more CF-related hospitalizations were observed among patients with low (event rate ratio [ERR], 1.35; 95% CI, 1.15-1.57) and moderate (ERR, 1.25; 95% CI, 1.05-1.48) vs high adherence; similar associations were observed for all-cause hospitalizations and CF-related and all-cause acute care use (hospitalizations + ED) in the concurrent and subsequent year. Rates of CF-related and all-cause outpatient visits did not differ by adherence. Low and moderate adherence predicted higher concurrent health-care costs by $14,211 ($5,557-$24,371) and $8,493 (-$1,691 to $19,709), respectively, compared with high adherence. CONCLUSIONS: Worse adherence to pulmonary medications was associated with higher acute health-care use in a national, privately insured cohort of patients with CF. Addressing adherence may reduce avoidable health-care use.

Study of imatinib treatment patterns and outcomes among US veteran patients with Philadelphia chromosome-positive chronic myeloid leukemia.

PURPOSE: This study investigated the treatment patterns and outcomes for US veteran patients with chronic myeloid leukemia-chronic phase (CML-CP) initiated on imatinib (IM). PATIENTS AND METHODS: Patients (age≥18 years) with at least one CML diagnosis (International Classification of Diseases, Ninth Edition Clinical Modification: 205.1x) during the period January 1, 2000, to June 30, 2011, and initiated on IM as first-line therapy were identified in the VISN 16 data warehouse (N=137). Accelerated and blastic phases (AP/BP) were identified on the basis of WHO classification using complete blood count (CBC) data. Rates of IM dose adjustment, discontinuation, and switching to another drug therapy were estimated. Time to discontinuation, progression to AP/BP, and survival were assessed using Kaplan-Meier analysis (KM). RESULTS: During follow-up, 19.0% of patients had at least one dose increase; of these, 19.2% switched to another therapy. Dose reductions occurred in 25.6% of patients. Among patients who discontinued IM (n=74; 54.0%), whereas 16.2% switched to other therapies, 27.0% neither restarted IM nor switched to other therapies. KM showed that 25.6% and 42.4% of patients discontinued IM treatment by year 1 and 2, and 8.1% and 16.0% demonstrated disease progression by year 1 and 2, respectively. Among patients who experienced disease progression (n=28), 32.1% continued IM postprogression, 32.1% discontinued IM before progression, 28.6% discontinued IM postprogression without switching, and 7.1% switched to other therapies postprogression. The mortality rates were 3.0% and 9.5% after IM initiation, and 21.7% and 42.7% after disease progression by year 1 and 2, respectively. CONCLUSION: In this veteran population, a substantial number of IM-treated patients, including those with disease progression, either discontinued or interrupted IM use without switching to other therapies.

Serum urate and incidence of kidney disease among veterans with gout.

OBJECTIVE: To study the association between serum urate level (sUA) and the risk of incident kidney disease among US veterans with gouty arthritis. METHODS: From 2002 through 2011 adult male patients with gout who were free of kidney disease were identified in the data from the Veterans Administration VISN 16 database and were followed until incidence of kidney disease, death, or the last available observation. Accumulated hazard curves for time to kidney disease were estimated for patients with average sUA levels > 7 mg/dl (high) versus ≤ 7 mg/dl (low) based on Kaplan-Meier analyses; and statistical comparison was conducted using a log-rank test. A Cox proportional hazard model with time-varying covariates was used to estimate the unadjusted and adjusted hazard ratios for kidney disease. RESULTS: Eligible patients (n = 2116) were mostly white (53%), with average age 62.6 years, mean body mass index 31.2 kg/m(2), and high baseline prevalence of hypertension (93%), hyperlipidemia (67%), and diabetes (20%). Mean followup time was 6.5 years. The estimated rates of all incident kidney disease in the overall low versus high sUA groups were 2% versus 4% at Year 1, 3% versus 6% at Year 2, and 5% versus 9% at Year 3, respectively (p < 0.0001). After adjustment, high sUA continued to predict a significantly higher risk of kidney disease development (HR 1.43, 95% CI 1.20-1.70). CONCLUSION: Male veterans with gout and sUA levels > 7 mg/dl had an increased incidence of kidney disease.

Treatment patterns and economic burden of metastatic and recurrent locally-advanced head and neck cancer patients.

OBJECTIVE: To characterize treatment patterns and measure the economic burden associated with metastatic (mHNC) and recurrent, locally-advanced head and neck cancer (rHNC). METHODS: Administrative claims from Medicare- and privately-insured individuals during 2004-2008 were used in this retrospective database study of patients with advanced HNC. Patients diagnosed with HNC were matched 1:1 to cancer-free controls to measure the incremental economic burden of HNC. Outcomes of interest were measured during the 6 months following the date of a secondary tumor diagnosis for metastatic patients or the date of a diagnosis indicating rHNC. To assess treatment patterns, HNC patients were evaluated for the use frequency of treatments (radiotherapy, chemotherapy and surgery). Costs were reported in 2008 US$ from a third-party payer perspective and were analyzed using generalized linear models and two-part regression models adjusting for differences in age and baseline Charlson Comorbidity Index (excluding cancer diagnoses) between the HNC and control cohorts. Components of cost included inpatient, outpatient and other medical services as well as pharmacy costs. RESULTS: The mHNC cohort consisted of 1042 patients and the rHNC cohort included 324 patients. The most common treatments for mHNC patients were supportive care (90.2%), radiation therapy (48.5%), surgery (41.9%) and chemotherapy (38.3%). Patients with rHNC frequently received HNC-related supportive care (71.0%), radiation therapy (67.9%) and chemotherapy (27.2%); HNC-related surgery was infrequent (12.7%) during the study period. The 6-month incremental adjusted total costs were $60,414 per patient for mHNC and $21,141 per patient for rHNC (p<0.0001). Approximately 46-58% of the incremental cost was attributable to outpatient visits, 27-37% to inpatient costs and 11-13% to pharmacy, depending on the HNC cohort. LIMITATIONS: The identification of mHNC/rHNC was based on diagnosis codes and treatment patterns with the limitation of the claims database. CONCLUSIONS: Metastatic and recurrent, locally-advanced HNC patients frequently receive cancer-related treatments and incur substantial economic burden.

Persistence with nebivolol in the treatment of hypertension: a retrospective claims analysis.

OBJECTIVE: Examine drug persistence by evaluating the hazard of discontinuation and of switching to different antihypertensive drugs in patients initiating treatment with a recently approved ß-blocker, nebivolol, versus other ß-blockers. METHODS: This retrospective analysis included all patients diagnosed with hypertension in the MarketScan Database (January 2007 - December 2008) with at least two medical claims and no prior ß-blocker prescriptions within 6 months of the initial prescription date. Multivariate Cox proportional hazard models (adjusted for baseline differences in demographics, previous use of other antihypertensive medications, initial doses and supply of medication, and number of distinct prescriptions at baseline) were used to assess the hazard of discontinuation, defined as the first prescription gap of ≥30 days, and to assess the hazard of switching to another antihypertensive drug, defined as a prescription fill for another antihypertensive drug within 15 days before and 30 days after discontinuation of the initial ß-blocker. RESULTS: Of the 173,200 patients included in the study population, the adjusted hazard of discontinuation for nebivolol-initiated patients was 8-20% lower than that of patients who initiated treatment with atenolol (hazard ratio [HR] 0.82, p < 0.001), metoprolol (HR 0.91, p < 0.001), carvedilol (HR 0.92, p < 0.001), or other ß-blockers (HR 0.80, p < 0.001). The adjusted hazard of nebivolol-treated patients switching to a different antihypertensive medication was 12-22% lower than that of the other four ß-blocker cohorts (atenolol: HR 0.80, p < 0.001; metoprolol: HR 0.86, p < 0.001; carvedilol: HR 0.88, p < 0.001; other ß-blockers: HR 0.78, p < 0.001). Sensitivity analyses defined discontinuation as prescription gaps of ≥45 days and ≥60 days and showed a lower hazard of discontinuation among patients initiating nebivolol than among patients initiating all other drug cohorts (p < 0.001). LIMITATIONS: Comparisons of non-randomized treatment groups may be confounded by unobserved differences in patients' baseline characteristics. CONCLUSIONS: Initiation with nebivolol was associated with greater persistence than initiation with atenolol, carvedilol, metoprolol, or other ß-blockers.

Hypoglycemia, treatment discontinuation, and costs in patients with type 2 diabetes mellitus on oral antidiabetic drugs.

OBJECTIVE: To investigate the rate and impact of hypoglycemic events among patients with type 2 diabetes mellitus (T2DM) receiving different classes of oral antidiabetic drugs (OADs). RESEARCH DESIGN AND METHODS: Adult patients with T2DM were extracted from the Ingenix IMPACT claims database. The mean number of health care visits due to hypoglycemic events per patient-year was estimated. Multivariate regression models were used to: 1) assess the risk factors for experiencing a hypoglycemic event; 2) assess the effect of experiencing hypoglycemic events on antidiabetic treatment discontinuation; and 3) compare 12-month post-index date costs between patients with and without hypoglycemic events. RESULTS: 212 061 patients with T2DM were included in the analysis. The estimated frequency of hypoglycemia-related health care visits was 0.054 per patient-year. Insulin use was associated with increased risk of developing hypoglycemia, followed by use of sulfonylureas and other OADs (eg, meglitinide and α-glucosidase inhibitors). The impacts of thiazolidinediones, metformin, and dipeptidyl peptidase-4 on hypoglycemia risk were relatively small. Having a hypoglycemic event was associated with significantly increased risk of antidiabetic treatment discontinuation. Patients with hypoglycemia showed significantly higher annual all-cause and diabetes-related health care costs than patients without hypoglycemia (adjusted Δ = +$5024 and +$3747, respectively; both P < 0.0001). CONCLUSION: Different OAD classes were associated with different levels of risk for hypoglycemic events. Hypoglycemia was associated with a higher risk of antidiabetic treatment discontinuation and significantly increased health care costs.

Cost-effectiveness analysis of roflumilast/tiotropium therapy versus tiotropium monotherapy for treating severe-to-very severe COPD.

OBJECTIVE: To conduct a cost-effectiveness analysis comparing roflumilast/tiotropium therapy vs tiotropium monotherapy in patients with severe-to-very severe COPD. METHODS: The economic evaluation applied a disease-based Markov cohort model with five health states: (1) severe COPD, (2) severe COPD with a history of severe exacerbation, (3) very severe COPD, (4) very severe COPD with a history of severe exacerbation, and (5) death. Within a given health state, a patient may have a mild/moderate or severe exacerbation or die. Data from roflumilast clinical trials and published literature were used to populate model parameters. The model calculated health outcomes and costs for roflumilast/tiotropium therapy vs tiotropium monotherapy over a 5-year horizon. Incremental cost and benefits were then calculated as cost-effectiveness ratios, including cost per exacerbation avoided and cost per quality adjusted life year ($/QALY). RESULTS: Over a 5-year horizon, the estimated incremental costs per exacerbation and per severe exacerbation avoided were $589 and $5869, respectively, and the incremental cost per QALY was $15,815. One-way sensitivity analyses varying key parameters produced an incremental cost per QALY ranging from $1963-$32,773. LIMITATIONS: A number of key parameters used in the model were obtained from studies in the literature that were conducted under different contexts. Specifically, the relative risk estimate for severe COPD patients originates from a small trial not designed to demonstrate the impact of roflumilast on frequency of exacerbations. In addition, the model extrapolates the relative risk estimates over periods of 5-30 years, even though the estimates were only observed in trials that spanned less than a year. CONCLUSIONS: The addition of roflumilast to tiotropium is cost-effective for the treatment of severe to very severe COPD patients.

Comparison of skeletal complications and treatment patterns associated with early vs. delayed zoledronic acid therapy in multiple myeloma.

BACKGROUND: This study retrospectively compared the risks of skeletal-related events (SREs) and zoledronic acid (ZOL) treatment discontinuation associated with early vs. delayed ZOL therapy for patients with symptomatic multiple myeloma (MM). PATIENTS AND METHODS: Data were collected from a physician-administered medical chart review among US patients with a confirmed diagnosis of symptomatic MM treated after 01/01/2002. Early and delayed ZOL therapy were defined, respectively, as initiating ZOL ≤ 60 days (N = 126) vs. > 60 days (N = 186) after the first symptomatic MM diagnosis. Kaplan-Meier analysis with a log-rank test was performed to compare the risk of SREs between the cohorts. Cox proportional hazard modeling compared the risk of SREs associated with early vs. delayed ZOL treatment, controlling for demographic factors, stage of MM, bone health status, and presence of major comorbidities at diagnosis. Time to ZOL discontinuation was evaluated using the Kaplan-Meier method, following patients from the date of ZOL initiation. RESULTS: Time to the first SRE was significantly longer for patients who received early treatment with ZOL (P = .005). At 2 years after diagnosis, the SRE-free rate was 74.6% vs. 56.5% in the early vs. delayed treatment group, respectively. Early ZOL therapy was associated with a significantly lower risk of any SRE (hazard rate [HR] = .625 vs. delayed ZOL therapy; P = .029). At 2 years from ZOL therapy initiation, rates of ZOL discontinuation were 9.6% vs. 16.4% among patients with early vs. delayed therapy, respectively (P < .05). CONCLUSION: Early treatment with ZOL was associated with significantly reduced risks of SREs and with better treatment persistence compared with delayed treatment.

Economic impact of therapeutic substitution of a brand selective serotonin reuptake inhibitor with an alternative generic selective serotonin reuptake inhibitor in patients with major depressive disorder.

BACKGROUND: To reduce pharmacy costs, managed care organizations encourage therapeutic substitution from brand to a generic product. However, little is known about whether these cost-containment strategies can also potentially lower total expenditures for payers in treatment of major depressive disorder (MDD). OBJECTIVE: To compare economic outcomes of patients with MDD who were switched from a brand selective serotonin reuptake inhibitor (SSRI) to an alternative generic SSRI for nonmedical reasons versus patients who continued on the brand SSRI. METHODS: Adult MDD patients in the Ingenix Impact Database (2003-2007) were considered "switchers" if they received treatment with a brand SSRI and were later switched to an alternative generic SSRI for nonmedical reasons. Patients who remained on the brand SSRI (nonswitchers) were matched 1:1 with switchers. All-cause, mental health-related, and MDD-related rates of hospitalizations/emergency department (ED) visits and costs over 6 months were compared both descriptively and by using adjusted regression models. A subgroup analysis on patients who were switched from escitalopram (Lexapro) to an alternative generic SSRI was also performed. RESULTS: The study included 4449 matched pairs. Compared with nonswitchers, switchers had higher risk of all-cause, mental health-related, and MDD-related use of hospitalizations/ED visits (OR 1.15, 1.34, and 1.54, respectively; all p < 0.01) and higher risk-adjusted mental health-related and MDD-related medical costs ($219 and $222, respectively; both p < 0.05). Subgroup analysis on escitalopram showed similar results; switchers experienced higher risk of any-cause, mental health-related, and MDD-related use of hospitalizations/ED visits (OR 1.21, 1.41, and 1.53, respectively; all p < 0.01) and higher risk-adjusted MDD-related medical costs ($151; p < 0.05). CONCLUSIONS: Compared with patients who continued on their patented SSRIs, patients who switched to a generic SSRI incurred more resource use of hospitalizations/ED visits and higher MDD-related health-care costs. The effects of therapeutic substitution should be carefully examined, because use of generic alternatives may not be a cost-saving strategy when total health-care costs are considered.

Societal cost of rheumatoid arthritis patients in the US.

OBJECTIVE: To estimate comprehensive cost of rheumatoid arthritis (RA) patients to society and individual stakeholders, including patients/employees, employers, family members/caregivers, and government. RESEARCH DESIGN AND METHODS: Administrative claims databases covering privately insured and Medicare and Medicaid beneficiaries in the US were used to compute the excess payer and beneficiary-paid costs per patient with RA compared with matched controls. Similarly, per-person excess costs for caregivers and uninsured patients with RA were estimated. Costs were estimated for other burdens, including costs of work-loss to employers, adaptations to home and work environments, lost on-the-job productivity, informal and hired care/household help, and job turnover costs. Intangible costs associated with quality-of-life deterioration were estimated based on legal system jury awards, whereas costs for premature mortality were based on lifetime earnings data. Per-capita cost estimates were weighted by the relevant population to estimate societal costs. Because data were incomplete, several assumptions were required; these assumptions could lead to an over- or under-estimation of cost burdens. RESULTS: Annual excess health care costs of RA patients were $8.4 billion, and costs of other RA consequences were $10.9 billion. These costs translate to a total annual cost of $19.3 billion. From a stakeholder perspective, 33% of the total cost was allocated to employers, 28% to patients, 20% to the government, and 19% to caregivers. Adding intangible costs of quality-of-life deterioration ($10.3 billion) and premature mortality ($9.6 billion), total annual societal costs of RA (direct, indirect, and intangible) increased to $39.2 billion. CONCLUSIONS: Societal costs of RA in the US are $19.3 billion and $39.2 billion (in 2005 dollars) without and with intangible costs, respectively. This study was one of the first to attempt to quantify the comprehensive burdens of RA. Despite several assumptions made in areas in which few data exist, the findings generate useful insights into the full burden of RA.

Employees with overactive bladder: work loss burden.

OBJECTIVE: This study assessed the indirect work loss costs to employers as the result of employees with overactive bladder (OAB). METHODS: Study samples were drawn from an administrative database of 1.2 million beneficiaries, including medical and disability claims (1999-2002). OAB employees were compared with matched employees without OAB. RESULTS: OAB was associated with higher annual occurrences of work loss (P < 0.01). Employees with OAB had 2.2 excess work loss days as the result of medically related absenteeism and 3.4 excess days as the result of disability compared with employees without OAB (P < 0.01 for both comparisons). Employees with OAB had increased risk of disability (P < 0.01), and female employees with OAB had a higher risk of disability than male employees (P < 0.01). CONCLUSIONS: This study found that OAB was associated with work loss costs to employers resulting from increased number of employee sick days and increased risk of employee disability.

Economic implications of treatment-resistant depression among employees.

BACKGROUND: Conservative estimates indicate between 10% and 20% of all individuals with major depressive disorders (MDDs) fail to respond to conventional antidepressant therapies. Amongst those with MDD, individuals with treatment-resistant depression (TRD) have been found to be frequent users of healthcare services and to incur significantly greater costs than those without TRD. Given the prevalence of the disorder, it is understandable that MDDs are responsible for a significant amount of both direct and indirect healthcare costs. OBJECTIVE: To provide empirical findings for employees likely to have TRD based on analysis of employer claims data, in the context of previous research. METHODS: We conducted a claims data analysis of employees of a large national (US) employer. The data source consisted of medical, pharmaceutical and disability claims from a Fortune 100 manufacturer for the years 1996-1998 (total beneficiaries >100000). The employee sample included individuals with medical or disability claims for MDDs (n = 1692). A treatment pattern algorithm was applied to classify MDD patients into TRD-likely (n = 180) and TRD-unlikely groups. Treated prevalence of select comorbid conditions and the patient costs (direct and indirect) from the employer perspective by condition were compared among TRD-likely and TRD-unlikely employees, and with a 10% random sample of the overall employee population for 1998. RESULTS: The average annual cost of employees considered TRD-likely was dollars US 14490 per employee, while the cost for depressed but TRD-unlikely employees was dollars US 6665 per employee, and dollars US 4043 for the employee from the random sample. TRD beneficiaries used more than twice as many medical services compared with TRD-unlikely patients, and incurred significantly greater work loss costs. CONCLUSION: TRD has gained increasing recognition due to both the clinical challenges and economic burdens associated with the condition. TRD imposes a significant economic burden on an employer. TRD-likely employees are more likely to be treated for selected comorbid conditions and have higher medical and work loss costs across all conditions.

Economic impact of olanzapine plus fluoxetine combination therapy among patients treated for depression: a pilot study.

Individuals with treatment-resistant depression (TRD) utilize more health care services and are significantly more costly. Drug treatments for TRD may include concomitant administration of multiple antidepressants or augmentation with mood stabilizers or antipsychotic agents. An augmentation strategy currently under investigation is the use of an olanzapine plus fluoxetine combination (OFC) therapy. The objectives for this pilot study were to use claims data to: (1) describe the extent of current use of OFC in patients with depressive disorders, and (2) compare health care utilization patterns and medical costs of patients receiving fluoxetine therapy before and after the initiation of olanzapine treatment. Data source consisted of medical, pharmaceutical, and disability claims from a Fortune 100 manufacturer from 1996 to 1998 (N>100,000). The sample included individuals with medical or disability claims for major depressive disorders treated with OFC (nOFC=36). Resource utilization and costs were compared for fluoxetine patients before and after the initiation of olanzapine treatment. Eleven percent of patients on combination therapy received olanzapine and fluoxetine. For patients on fluoxetine, there was a statistically significant reduction in health care utilization, and overall medical costs (20%), following initiation of olanzapine therapy. Overall, it appears the addition of olanzapine to ongoing fluoxetine therapy is effective in reducing outpatient, office, and inpatient utilization, as well as medical costs of patients treated for depression. Further research is needed to investigate combination therapy more fully.

Attention-deficit/hyperactivity disorder: increased costs for patients and their families.

OBJECTIVE: To estimate the direct (medical and prescription drug) and indirect (work loss) costs of children treated for attention-deficit/hyperactivity disorder (ADHD) and their family members. METHOD: The data source was an administrative database from a national, Fortune 100 manufacturer that included all medical, pharmaceutical, and disability claims for beneficiaries (n > 100,000). The analysis involved four samples. The ADHD patient sample included individuals age 18 or younger with at least one ADHD claim during the study period (1996-1998). Resource utilization of ADHD patients was contrasted with a matched control sample of patients who did not have claims for ADHD. The ADHD and non-ADHD family samples included non-ADHD family members of ADHD patients and their matched controls. RESULTS: The annual average expenditure (direct cost) per ADHD patient was $1,574, compared to $541 among matched controls. The annual average payment (direct plus indirect cost) per family member was $2,728 for non-ADHD family members of ADHD patients versus $1,440 for family members of matched controls. Both patient and family cost differences were significant at the 95% confidence level. CONCLUSIONS: ADHD imposes a significant financial burden regarding the cost of medical care and work loss for patients and family members.

Identification of a claims data "signature" and economic consequences for treatment-resistant depression.

BACKGROUND: Major depressive disorder (MDD) is a debilitating condition with significant economic consequences. Conservative estimates indicate that between 10% and 20% of all individuals with MDD are treatment resistant. The objectives for this study were (1) to use current treatment strategies identified in the literature to evaluate the validity of studying treatment-resistant depression (TRD) using claims data and (2) to estimate cost differences between TRD-likely and TRD-unlikely patients identified by use of treatment patterns. METHOD: The data source consisted of medical, pharmaceutical, and disability claims from a Fortune 100 manufacturer for 1996 through 1998 (N = 125,242 continuously enrolled beneficiaries between the ages of 18 and 64 years). The sample included individuals with medical or disability claims for MDD (NMDD = 4186). A treatment pattern algorithm was applied to classify adult MDD patients into TRD-likely (NTRD = 487) and TRD-unlikely groups. Resource utilization and costs were compared among TRD-likely and TRD-unlikely patients and a random sample of average beneficiaries (i.e., 10% of all beneficiaries) for 1998. RESULTS: Consistent with the epidemiologic literature, the algorithm classified 12% of the MDD sample as TRD-likely. Mean annual costs were $10,954 for TRD-likely patients, $5025 for TRD-unlikely patients, and $3006 for average beneficiaries. TRD-likely patients used almost twice as many medical services as did TRD-unlikely patients and incurred significantly greater indirect costs (p < .0001). CONCLUSION: It is feasible to use an administrative dataset to develop a claim-based treatment algorithm to identify TRD-likely patients. Resource utilization by TRD-likely patients was substantial, not only for direct treatment of depression but also for treatment of comorbid medical conditions. Additionally, TRD imposed on employers substantial indirect costs resulting from high rates of depression-associated disability.