Treatment persistence among patients with rheumatoid disease (RA, AS, PsA) treated with subcutaneous biologics in Germany.

Patients with rheumatoid arthritis (RA), ankylosing spondylitis (AS), and psoriatic arthritis (PsA) are frequently treated with subcutaneous biologic therapies when disease progresses or when response to synthetic disease-modifying antirheumatic drugs (DMARDs) is inadequate. This study analyzed treatment persistence and treatment patterns for RA, AS, and PsA patients in Germany initiating subcutaneous biologic therapies with and without prior DMARDs use. A retrospective cohort study was conducted using the Electronic Medical Record database of IMS Disease Analyzer, Germany. Patients who were ≥18 years old; had at least one ICD-10 diagnosis code of RA, AS, or PsA during the study period; and had exposure to a subcutaneous biologic agent between January 1, 2009 and June 30, 2012 were selected. Patients were required to have continuous observation ≥12 months prior to and after index medication date. Persistence was defined as consecutive days from treatment initiation until treatment discontinuation (≥60-day lapse in medication coverage). Patients were stratified by pre-index use of DMARDs. Kaplan-Meier analysis was conducted to assess time to discontinuation, and logistic regression was conducted to identify characteristics associated with persistence. A total of 576 RA, 108 AS, and 197 PsA patients without biologic experience during the pre-index period were selected. The percentages of RA, AS, and PsA patients persistent ≥12 months were 51.9, 48.1, and 57.9 %, respectively. Median persistent time over 12 months was 365.0 days for RA (mean 245.9 days), 281.0 for AS (mean 228.5), and 365.0 for PsA (mean 264.1). In the RA cohort, a significantly higher proportion of those with pre-index DMARD use were persistent compared to those without pre-index DMARD (56.1 vs. 33.3 %, p = 0.0001). No significant differences were observed for the AS and PsA cohorts. Multivariate analyses confirmed that DMARD-experienced patients were 2.45 times more likely to be persistent with subcutaneous biologic therapy in the RA cohort. Switching between subcutaneous biologics occurred in <10 % of patients in all three cohorts. In the subpopulations with at least two prescriptions for the index subcutaneous biologic and who remained persistent on the index subcutaneous biologic, dose escalation of ≥50 % occurred in 50, 60, and 49 % in the RA, AS, and PsA cohorts, respectively. Among RA, AS, and PsA patients newly initiating subcutaneous biologic agents in Germany, persistence at 12 months is relatively low (48-58 %). For the RA cohort, patients with pre-index DMARD use are more persistent than patients without. The majority of patients do not switch between subcutaneous biologics. A notable proportion of patients who remained persistent on their index subcutaneous biologic had a dose escalation. There are opportunities to improve outcomes of patient with rheumatoid disease through improved medication persistence.

The disease burden of pertussis in adults 50 years old and older in the United States: a retrospective study.

BACKGROUND: While the incidence of pertussis has increased in adolescents and adults in recent years in the U.S., little is known about the incidence and economic burden of pertussis in older adults. This study provides evidence of the incidence of pertussis and direct medical charges associated with pertussis episodes of care (PEOCs) in adults aged 50 years and older in the U.S. METHODS: PEOCs were divided into periods before and after the initial pertussis diagnosis was made (i.e., the index date) to capture any conditions immediately preceding the pertussis diagnosis that may have represented misdiagnoses and subsequent conditions that may have represented sequelae. Data were extracted from IMS's recently acquired SDI databases of longitudinal, patient-level practitioner claims and hospital operational billing records collected from private practitioners and hospitals, respectively, across the U.S. Patients 50 years and older with one or more ICD-9-CM diagnoses for pertussis/whooping cough and/or a laboratory test positive for Bordetella pertussis between 1/1/2006 and 10/31/2010 were eligible for study inclusion. Resource utilization and charges (i.e., unadjudicated claims) associated with the patient's physician and hospital care were analyzed. The nationally projected incidence of pertussis was estimated using a subsample of patients with the required data necessary for projection. RESULTS: Estimated incidence of diagnosed pertussis ranged from 2.1-4.6 cases per 100,000 people across the two age groups (50-64 and [greater than or equal to] 65) during the years 2006 to 2010. The analysis of charges included 5,748 patients [greater than or equal to] 50 years of age with pertussis. Average charges across the entire episode of care were $1,835 and $14,428 per patient in the outpatient and inpatient settings, respectively. The average number of outpatient (i.e., private practitioner) visits was 2 per patient in both the pre-index and post-index periods. CONCLUSIONS: In the U.S., the incidence of diagnosed pertussis in adults 50 years and older has increased between 2006 and 2010. Healthcare utilization and charges associated with pertussis are substantial, suggesting the need for additional prevention and control strategies and a higher degree of clinical awareness on the part of health care providers. Additional research regarding pertussis in older populations is needed to substantiate these findings.

Synchronization of administrations of chemotherapy and erythropoiesis-stimulating agents and frequency of associated healthcare visits.

PURPOSE: The erythropoiesis-stimulating agents (ESAs), darbepoetin alfa (DA), and epoetin alfa (EA) differ with respect to dosing schedule in chemotherapy-induced anemia. DA can be administered less frequently than EA, which may increase synchronicity between chemotherapy and ESA schedules. This study compared DA and EA with respect to frequency of synchronization and frequencies of total and ESA healthcare visits in current clinical practice. METHODS: A retrospective analysis of ESA utilization during ESA episodes of care was conducted on all cancer patients identified in the SDI health oncology electronic medical records database who underwent chemotherapy and received ESA therapy from July 1, 2007 to March 31, 2010 (n = 6522 DA, n = 3,439 EA). RESULTS: The frequency of synchronization (chemotherapy and ESA therapy on the same day) was higher with DA (67 %) than EA (58 %) (p < 0.001). The odds that an ESA administration was synchronized with chemotherapy were higher with DA compared with EA (odds ratio = 1.46, 95 % CI: 1.37, 1.54). Compared with EA, DA patients had 2.3 fewer visits with an ESA administration (p < 0.001) and 3.0 fewer total visits (p < 0.001). CONCLUSIONS: Compared with patients receiving EA, DA patients were more likely to have an ESA administration on the same healthcare visit as chemotherapy and had fewer visits for any cause or for ESA administration. These results suggest that through greater synchronization of ESA and chemotherapy administrations, DA may reduce patient and practice burden and healthcare utilization.

Effect of reimbursement changes on erythropoiesis-stimulating agent utilization and transfusions.

Cancer patients frequently develop chemotherapy-induced anemia, which can be treated with erythropoiesis-stimulating agents. These agents have shifted the standard of chemotherapy-induced anemia treatment away from the previous mainstay of red blood cell transfusions. In July 2007, the Centers for Medicare and Medicaid Services issued a National Coverage Decision restricting reimbursement for erythropoiesis-stimulating agents to those chemotherapy patients who have hemoglobin levels <10 g/dL at initiation of therapy. This decision was hypothesized to place a greater reliance on transfusions for chemotherapy-induced anemia treatment. This observational study examined transfusions and erythropoiesis-stimulating agent utilization rates within defined episodes of chemotherapy care using electronic medical records from seven practices consisting of 39 sites of care across seven states. We compared the frequency of myelosuppressive chemotherapy treatment, erythropoiesis-stimulating agent administrations, and red blood cell transfusions before and after the National Coverage Decision in oncology patients with chemotherapy-induced anemia. Although exposure to myelosuppressive chemotherapy was not different, erythropoiesis-stimulating agent administrations significantly decreased and blood transfusions significantly increased after implementation of the National Coverage Decision. The 31% increase in transfusions for patients aged 65 years and older was significant (P = 0.007) and higher than the 8% increase for patients younger than 65 years (P = 0.358). Changes in practice patterns for chemotherapy-induced anemia treatment that followed the Centers for Medicare and Medicaid Services reimbursement decision for erythropoiesis-stimulating agents seem to be impacting practice patterns. Further research is necessary to determine whether these changes represent a widespread and durable shift in patient treatment.

Switching from atorvastatin to simvastatin in patients at high cardiovascular risk: effects on low-density lipoprotein cholesterol.

Since generic simvastatin became available in the United States in 2006, approximately one million patients have switched from atorvastatin to simvastatin. We examined the association between switching from atorvastatin to simvastatin and changes in low-density lipoprotein cholesterol (LDL-C) levels in clinical practice. We compared atorvastatin-treated patients at high cardiovascular risk who switched to simvastatin between June 2006 and July 2007 with randomly selected matched patients who remained on atorvastatin and evaluated changes in LDL-C and percentage of patients reaching LDL-C less than 100 mg/dL. Of patients who switched from atorvastatin to simvastatin, the majority were excluded as a result of lack of LDL-C measurements, leaving 383 patients in the analysis. Among these, 122 (31.9%) switched to a simvastatin dose that was less than therapeutically equivalent to their prior atorvastatin dose. Compared with control subjects, switched patients were less likely to reach an LDL-C less than 100 mg/dL (68.4% versus 74.0%; odds ratio, 0.76; 95% confidence interval, 0.59-0.99; P = 0.041) and had higher measured LDL-C (91.4 versus 87.2 mg/dL; P = 0.009). Switched patients who were not prescribed a higher milligram dose of simvastatin were significantly less likely to reach an LDL-C less than 100 mg/dL (62.3% versus 74.0%; odds ratio, 0.55; 95% confidence interval, 0.36-0.84; P = 0.006) and had higher LDL-C (95.1 versus 87.2 mg/dL; P = 0.002) than control subjects. A large proportion of patients who switch from atorvastatin to simvastatin are prescribed doses that are not therapeutically equivalent, and these patients were significantly less likely to meet LDL-C treatment goals compared with patients who remained on atorvastatin.

Medication adherence, hospitalization, and healthcare resource utilization and costs in patients with pulmonary arterial hypertension treated with endothelin receptor antagonists or phosphodiesterase type-5 inhibitors.

Adherence to therapy for pulmonary arterial hypertension is essential to optimize patient outcomes, but data on real-world adherence to different pulmonary arterial hypertension drug classes are limited. This retrospective database analysis evaluated relationships between adherence, hospitalization, and healthcare costs in pulmonary arterial hypertension patients treated with endothelin receptor antagonists or phosphodiesterase type-5 inhibitors. From the IQVIA Adjudicated Health Plan Database, patients with pulmonary arterial hypertension were identified based on diagnostic codes and prescriptions for endothelin receptor antagonists (ambrisentan, bosentan, macitentan) or phosphodiesterase type-5 inhibitors (sildenafil, tadalafil) approved for pulmonary arterial hypertension. Patients were assigned to the class of their most recently initiated (index) pulmonary arterial hypertension therapy between 1 January 2009 and 30 June 2015. Medication adherence was measured by proportion of days covered; patients with proportion of days covered ≥80% were considered adherent. The proportion of adherent patients was higher for endothelin receptor antagonists (571/755; 75.6%) than for phosphodiesterase type-5 inhibitors (970/1578; 61.5%; P < 0.0001). In both groups, hospitalizations declined as proportion of days covered increased. Among adherent patients, those on endothelin receptor antagonists had a significantly lower hospitalization rate than those on phosphodiesterase type-5 inhibitors (23.1% versus 28.5%, P = 0. 0218), fewer hospitalizations (mean (standard deviation) 0.4 (0.8) versus 0.5 (0.9); P = 0.02), and mean hospitalization costs during the six-month post-index ($9510 versus $15,726, P = 0.0318). Increasing adherence reduced hospitalization risk more for endothelin receptor antagonists than for phosphodiesterase type-5 inhibitors (hazard ratio 0.176 versus 0.549, P = 0.001). Rates and numbers of rehospitalizations within 30 days post-discharge were similar between groups. Mean total costs were higher with endothelin receptor antagonists than phosphodiesterase type-5 inhibitors in all patients ($91,328 versus $72,401, P = 0.0003) and in adherent patients ($88,867 versus $56,300, P < 0.0001), driven by higher drug costs.

The importance of clinical variables in comparative analyses using propensity-score matching: the case of ESA costs for the treatment of chemotherapy-induced anaemia.

BACKGROUND: The erythropoiesis-stimulating agents (ESAs) epoetin alfa (EA) and darbepoetin alfa (DA) have comparable efficacy in treating chemotherapy-induced anaemia (CIA). Therapy choice depends on many factors, including cost. Previous estimates of ESA cost differences have been derived from claims data. These data lack clinical variables, such as baseline haemoglobin (Hb) level, which are likely to influence choice of ESA, dosing and costs. We estimated cost differences between DA and EA in patients with cancer receiving chemotherapy, using a propensity-score matched analysis of baseline patient characteristics with and without Hb values to assess the effect of this clinical variable on ESA cost estimates. METHODS: Data were extracted from electronic medical records in two US databases between January 2004 and December 2006. The study sample included 6743 patients receiving chemotherapy, with one or more visits during the study period, who received an ESA during a chemotherapy episode. Episodes of chemotherapy care were constructed using a 90-day gap in administration to identify the start and end. Patients receiving both DA and EA during their initial chemotherapy episode or with missing data were excluded, representing 42% of patients with CIA receiving an ESA. Drug costs were calculated from the cumulative dose multiplied by 106% of the average sales price (ASP) for DA or EA. Two propensity-score matches were conducted: first using variables available in administrative billing claims systems, then adding the baseline Hb test result. Regression-adjusted cost differences were estimated with and without baseline Hb, using generalized linear models. RESULTS: Using baseline Hb levels resulted in a better match of the baseline characteristics for the EA and DA treatment groups than the original sample or the matched sample without Hb variables. Mean ESA costs (year 2007 values) for the original sample were $US4171 for EA and $US3811 for DA (mean difference $US360; p < 0.001, standard error [SE] $US99). With propensity-score matching without Hb variables, mean estimated costs were $US3836 for EA and $US3599 for DA (mean difference $US237; p = 0.053, SE $US123). With propensity-score match including Hb variables, mean costs were $US3965 for EA and $US3536 for DA (mean difference $US429; p = 0.001, SE $US125). Cost differences in sensitivity analyses ranged between $US102 (p = 0.201) and $US261 (p = 0.003). CONCLUSIONS: Addition of baseline Hb level as a variable in propensity score and ESA cost models affects ESA treatment cost estimates in patients with cancer receiving chemotherapy. Cost comparisons based on observational data should use analytical methods that account for differences in clinical variables between treatment groups.

Medication Utilization Patterns and Hypertension-Related Expenditures among Patients Who Were Switched from Fixed-Dose To Free-Combination Antihypertensive Therapy.

Using a retrospective cohort study of medical and pharmacy claims data, we evaluated medication compliance, persistence, and hypertension-related expenditures among patients who were switched from fixed-dose combination (FDC) to free-combination (FC) antihypertensive therapy. An example of a fixed-dose combination product for hypertension would be a valsartan/HCT tablet, and a free-combination product would be a valsartan tablet plus a diuretic tablet.The 7,224 patients identified from January 2003 to December 2005 were matched, in a 1:1 ratio, by propensity scores to controls who remained on their FC antihypertensive medications. Compliance, defined as a medication-possession ratio, was measured over 12 months. Persistence was measured as the percentage of patients who did not experience a lapse in therapy of more than 30 days since their last prescription refill.The patients continuing with FDC therapy had better persistence (42.5% higher; P < 0.002) and compliance (22.1% higher; P < 0.001), compared with patients who were switched to FC therapy. The 22.1% higher compliance rate for patients continuing the FDC regimen was associated with significantly lower expenditures for hypertension-related health care (P < 0.001) and an estimated 5% reduction in hypertension-related expenditures.

Estimation of Missed Statin Prescription Use in an Administrative Claims Dataset.

BACKGROUND: Nonadherence to statin medications is associated with increased risk of cardiovascular disease and poses a challenge to lipid management in patients who are at risk for atherosclerotic cardiovascular disease. Numerous studies have examined statin adherence based on administrative claims data; however, these data may underestimate statin use in patients who participate in generic drug discount programs or who have alternative coverage. OBJECTIVE: To estimate the proportion of patients with missing statin claims in a claims database and determine how missing claims affect commonly used utilization metrics. METHODS: This retrospective cohort study used pharmacy data from the PharMetrics Plus (P+) claims dataset linked to the IMS longitudinal pharmacy point-of-sale prescription database (LRx) from January 1, 2012, through December 31, 2014. Eligible patients were represented in the P+ and LRx datasets, had ≥1 claim for a statin (index claim) in either database, and had ≥ 24 months of continuous enrollment in P+. Patients were linked between P+ and LRx using a deterministic method. Duplicate claims between LRx and P+ were removed to produce a new dataset comprised of P+ claims augmented with LRx claims. Statin use was then compared between P+ and the augmented P+ dataset. Utilization metrics that were evaluated included percentage of patients with ≥ 1 missing statin claim over 12 months in P+; the number of patients misclassified as new users in P+; the number of patients misclassified as nonstatin users in P+; the change in 12-month medication possession ratio (MPR) and proportion of days covered (PDC) in P+; the comparison between P+ and LRx of classifications of statin treatment patterns (statin intensity and patients with treatment modifications); and the payment status for missing statin claims. RESULTS: Data from 965,785 patients with statin claims in P+ were analyzed (mean age 56.6 years; 57% male). In P+, 20.1% had ≥ 1 missing statin claim post-index; 13.7% were misclassified as nonstatin users; and 14.9% were misclassified as new statin users. MPR was higher in the augmented P+ dataset versus the P+ dataset alone for all patients (79.4% vs. 76.7%, P < 0.001) and new users (61.4% vs. 58.7%, P < 0.001). Similarly, mean PDC was higher in the P+ dataset augmented with LRx versus the P+ dataset alone for all patients (76.0% vs. 74.0%, P < 0.001) and new users (58.5% vs. 56.5%, P < 0.001). Most patients received moderate-intensity statins; few changes in dose, intensity, or discontinuation of statins were observed when the P+ dataset was augmented. The most common reasons for missing data were payment by an alternate third-party program (66.3%) and use of cash, coupon, or discount cards (18.7%). CONCLUSIONS: Augmenting commercial claims data with point-of-sale data provides a more accurate assessment of statin use than claims data alone. DISCLOSURES: This study was funded by Amgen, which contributed to data interpretation and manuscript preparation. Wade, Hill, and De are employees of QuintilesIMS, which received funding from Amgen for work on this study. Patel and Harrison are employees of Amgen and own Amgen stock/stock options. Study concept and design were contributed by Wade, Hill, Patel, and Harrison. De took the lead in data collection, along with the other authors, and all authors contributed to data analysis. The manuscript was written and revised by all the authors.

Functional impairment, healthcare costs and the prevalence of institutionalisation in patients with Alzheimer's disease and other dementias.

INTRODUCTION: The progressive decline in functional status for patients with Alzheimer's disease and other dementias (ADOD) is well documented. However, there is limited information on the economic benefits of interventions improving functional status in an ADOD population. This study estimated the relationship between the degree of functional impairment in patients with ADOD and their healthcare costs and prevalence of institutionalisation. METHODS: Retrospective cross-sectional analyses of the Medicare Current Beneficiary Survey (MCBS) were performed. A nationally representative sample of Medicare beneficiaries with ADOD was identified from the 1995-8 waves of the MCBS (n = 3138): 34% in the community, 57% institutionalised and 9% residing in both settings during the year. Three measures of functioning were used: the number of activities of daily living (ADLs) and independent ADLs (IADLs) impaired; an index summarising number and severity of ADL and IADL impairments; and the Katz Index of ADLs. Healthcare costs included costs for all healthcare services received in all settings, regardless of whether they were covered by insurance or paid out of pocket. The relationships between each measure of impairment and healthcare costs and prevalence of institutionalisation were estimated using linear and logistic regression. RESULTS: Healthcare costs (1995-8 values) for all ADOD patients increased by 1,958 US dollars (p < 0.001) for each additional ADL impairment and 549 US dollars (p = 0.073) for each additional IADL impairment. For community-dwelling ADOD patients, healthcare costs increased by 1,541 US dollars (p < 0.001) for each additional ADL and 714 US dollars (p = 0.022) for each additional IADL. Costs also increased by severity on the summary index and the Katz Index. Odds of institutionalisation also increased by the three measures of functional impairment. CONCLUSION: Although relationships between function and costs have been described previously, the exact nature of these relationships has not been investigated solely in patients with dementia. The data from this study suggest a strong relationship between functional impairment and healthcare costs, specifically in patients with dementia. Even IADL impairments, which are common in mild to moderate dementia, may significantly raise costs. The results suggest that therapies and care management that improve functioning may possibly reduce other healthcare costs.

Improving Medication Adherence and Health Care Outcomes in a Commercial Population through a Community Pharmacy.

The aim was to evaluate the impact of a multifaceted set of medication management interventions offered by a community pharmacy on adherence, health care utilization, and costs within a commercial population. Patients initiating therapy within 16 drug classes from February 7, 2013, to October 6, 2013, were offered various adherence interventions by Walgreens pharmacy. Patients were linked deterministically to IMS medical and prescription databases for 6-month pre- and post-index data analysis. Walgreens patients (intervention) were matched to patients using other pharmacies (control) on drug class, index date, baseline demographics, clinical factors, utilization, and costs. Outcomes were evaluated at the intent-to-treat level using post-index differences and generalized estimating equations (GEE) regression model. Paired t tests (continuous variables) and McNemar's test (dichotomous variables) were used to determine the significance of estimated model coefficients at α = 0.05. The groups (n = 72,410 each) had similar age (47.1 vs. 45.7 years), sex (41.2% vs. 40.2% male), and disease burden (0.52 vs. 0.40 mean Charlson comorbidity index). In the 6-month post-index period, the intervention group had 3.0% greater medication adherence, 1.8% fewer hospital admissions, 2.7% fewer emergency room (ER) visits, and 0.53 fewer mean outpatient visits compared to the control group (all P < 0.0001). The intervention group incurred significantly lower GEE-adjusted pharmacy costs (-$92), outpatient costs (-$120), ER costs (-$38), and total health care costs (-$226.07) (all P < 0.0001), and higher inpatient costs ($86, P < 0.004) per patient. A multifaceted set of medication management interventions offered by a community pharmacy were associated with patients in a commercial population having significantly higher medication adherence and lower health care utilization and costs.

Patterns of healthcare utilization and costs for vascular dementia in a community-dwelling population.

BACKGROUND: While vascular dementia (VaD) is the second most prevalent dementia diagnosis, little is known about healthcare use and costs for VaD. PURPOSE: This study compares the healthcare use and costs of community-dwelling patients with VaD to patients with Alzheimer's disease (AD), other dementias (OD), cerebrovascular disease without dementia (CVD), and patients without dementia or cerebrovascular disease (controls). METHODS: Using diagnoses codes from medical claims and encounter records, 678 VaD, 1,722 AD, 957 OD, 2,718 CVD, and 14,023 controls were identified from patients enrolled in a 100,000-member group practice Medicare HMO during 1999-2002. Annual healthcare use and costs of the study groups were compared, using regression analysis to control for patient characteristics. RESULTS: VaD patients had the highest annual costs, dollars 14,387, followed by dollars 10,716 for OD, dollars 8,254 for CVD, and dollars 7,839 for AD, and dollars 5,494 for controls (p<0.0001 for all comparisons to VaD). Despite higher total direct costs, VaD patients had lower costs for physician visits and prescription drugs compared with all study groups except OD. In contrast, CVD patients had the highest costs for these services. Moreover, hospital admissions for VaD were nearly twice those for CVD, and hospital days for VaD nearly three times those for CVD, despite the high prevalence of cardiovascular conditions for both VaD and CVD. CONCLUSIONS: VaD patients had higher healthcare costs compared to all other patient groups. The substantially higher costs for VaD compared to CVD and the differences in use of healthcare services by VaD compared to CVD suggest that dementia, not cerebrovascular disease, is a major source of the cost differences. Lower costs for physician visits and prescription drugs for VaD suggest possible opportunities for improving ambulatory care and preventing high-cost hospitalizations.

Economics of dementia and pharmacoeconomics of dementia therapy.

BACKGROUND: The economic impact of dementia is not well appreciated, even though Alzheimer's disease and related dementias were the third most expensive health condition in the United States in 2000. In 1997, the cost of managing patients with Alzheimer's disease and other dementias was estimated at US dollar 100 billion. Direct medical costs are compounded by indirect costs of care, including unpaid care and loss of earnings. OBJECTIVE: The aim of this review was to examine studies of the economic impact of approved treatments for dementia therapy. METHODS: Searches of the MEDLINE database were conducted to identify prospective, randomized trials and retrospective or modeling studies of the economic impact of dementia medications, as well as analyses of managed care data (years 1996-2004; English language; search terms: dementia or Alzheimer's cross-referenced with economic or costs). RESULTS: Only 3 studies directly examined the economic effects of dementia therapy. Two of these demonstrated economic benefits of treatment, whereas the third study concluded that there were no benefits; however, the conclusions of the latter study may have been weakened by such factors as the high rate of attrition and biased selection of study participants. Modeling studies and analyses of managed care data also indicate economic benefits from approved treatments. CONCLUSIONS: Therapies that are efficacious early in the disease can postpone the progression of dementia to more severe stages and may offer economic benefit to patients' families, caregivers, and society.

Impact of donepezil use in routine clinical practice on health care costs in patients with Alzheimer's disease and related dementias enrolled in a large medicare managed care plan: a case-control study.

BACKGROUND: Clinical studies have shown efficacy of cholinesterase inhibitors (eg, donepezil) in mild to moderate Alzheimer's disease (AD). However, there are limited studies examining the impact on health care costs of cholinesterase inhibitors prescribed in routine clinical practice. OBJECTIVE: The purpose of this study was to estimate the impact of donepezil use on health care costs and utilization in patients with mild to moderate AD and related dementias. METHODS: This case-control study was conducted using data from the Health Insurance Plan of Greater New York (New York, New York). Data from patients with predominantly mild to moderate AD and related dementias who were enrolled in this Medicare managed care plan from January 1, 1999, to December 31, 2002, were included. The health care costs and utilization of patients who had received donepezil prescribed in routine clinical practice were compared with those of patients who had never received donepezil or other cholinesterase inhibitors (control group). The 2 study groups were matched for age, sex, number of comorbid conditions, and presence of complications of late-stage dementia. Regression analysis was used to estimate the impact of donepezil use on health care costs and utilization during a 12-month follow-up period, controlling for characteristics associated with the outcomes. The analyses did not use a direct measure of disease severity but instead used proxy measures of severity based on medical conditions associated with late-stage dementia. RESULTS: Data from 687 patients were included in the study. The donepezil group comprised 229 patients (140 women, 89 men; mean age, 79.6 years); the control group, 458 patients (280 women, 178 men; mean age, 80.0 years). The mean costs of medical services per year in the donepezil group were US $2500 (95% CI, $300-$4671) less than those in the control group (P = 0.024). Lower medical costs in the donepezil group ($3325; 95% CI, $1163-$5486; P < 0.003 vs controls) were largely attributable to the lower costs of services performed in the hospital ($2594; 95% CI, $846-$4341; P < 0.004 vs controls) and postacute skilled nursing facility (SNF) ($1012; 95% CI, $444-$1579; P < 0.001 vs controls), which were partially offset by $1241 in higher prescription, physician's office, and outpatient hospital costs. Patients receiving donepezil had shorter mean lengths of stay in the hospital (3.00 vs 5.43 days; 95% CI, 0.66-4.19; P < 0.008) and postacute SNF (0.42 vs 3.40 days; 95% CI, 1.28-4.69; P < 0.001) but a higher mean number of physician's office visits (10.91 vs 7.91 visits; 95% CI, 1.63-4.36; P < 0.001) compared with controls. CONCLUSIONS: In this case-control study in patients with predominantly mild to moderate AD and related dementias, donepezil therapy prescribed in routine clinical practice was associated with reduced health care costs to the Medicare managed care plan studied. The findings support previous pharmacoeconomic studies with larger sample sizes obtained over a longer period of time, and with improved case-matching criteria.

Validation of a brief screen for cognitive impairment (BSCI) administered by telephone for use in the medicare population.

The aim of this research was to examine the validity of a brief screen for cognitive impairment (BSCI) consisting of three questions administered by telephone (delayed recall, frequency of help with planning trips for errands, and frequency of help remembering to take medications). The study design was an age and gender matched case-control study. Seventy managed care members, 35 with dementia (cases) and 35 without dementia (controls), were assessed using BSCI embedded within a longer health assessment questionnaire commonly used in Medicare-managed care. A number of measures were used to examine validity of BSCI, including comparisons of the differences between cases and controls in BSCI scores, comparisons of the correlations between patient scores on BSCI and the Mini Mental Status Exam (MMSE, a common screening test for dementia) and the Alzheimer's Disease Assessment Scale (ADAS, a common dementia assessment test), and comparisons of the areas under the receiver operating characteristic (ROC) curves for the three instruments. BSCI scores for cases and controls were significantly different, as were their scores for the MMSE and ADAS. Scores on BSCI were significantly correlated with scores for the MMSE and ADAS using both the Kendall's tau-b and Spearman rank-order correlation; correlations ranged from 0.654 between BSCI and ADAS to -0.83 for the correlation between BSCI and the MMSE (p < 0.001 for both). The areas under the ROC curves ranged from 0.94 to 0.96 for the three tests, meaning that they were equally accurate in discriminating between demented and nondemented patients. BSCI, a brief telephone screen for cognitive impairment due to dementia, discriminates between demented patients and normal controls as well as two standard tests of dementia, and may be considered a valid screen for dementia. Compared to existing screening tests, it has the additional advantages of extreme brevity, and ease of administration and scoring by lay interviewers via telephone. The use of brief screening instruments for dementia, such as the one validated here, will be increasingly important for the effective management of dementia and other chronic diseases where dementia is a coexisting condition.

The costs of vascular dementia: a comparison with Alzheimer's disease.

OBJECTIVES: To estimate the costs of Medicare patients with vascular dementia (VaD). To compare the costs of VaD to Alzheimer's disease (AD) and controls without dementia. METHODS: The study samples were drawn from community-dwelling patients in a large Medicare managed care organization (MCO) operating in the Northeast region of the USA. Costs for three study groups were contrasted in the study: 240 cases with vascular dementia (VaD), 1,366 cases with Alzheimer's disease (AD), and 19,300 controls without dementia. Costs were estimated from medical and pharmacy claims data. Estimated cost differences are controlled for age, gender, and comorbid conditions using regression analysis. RESULTS: VaD patients accounted for 6% of all dementia patients identified in the health plan. VaD patients had substantially higher prevalence rates for 10 cardiovascular conditions compared with AD patients and controls. Annual costs for VaD patients were US$6,797 greater than AD patients. Compared with controls, costs were US$10,545 higher for VaD patients and US$3,748 higher for AD patients. Higher costs for VaD and AD patients relative to controls were largely attributable to higher inpatient costs. CONCLUSIONS: Annual medical costs for VaD patients were substantially higher than costs for patients with AD and control patients without dementia. The high cost of VaD patients suggests a need to improve medical management and treatment of these patients to optimize patient outcomes and medical costs.

Health care utilization and costs of Alzheimer's disease: the role of co-morbid conditions, disease stage, and pharmacotherapy.

BACKGROUND AND OBJECTIVES: Studies on the relationship between Alzheimer's disease (AD) and health care costs have yielded conflicting results. This study analyzed the relationship between co-morbid conditions and health care utilization and costs for patients with AD and estimated costs by stage of disease and receipt of pharmacotherapy. METHODS: We conducted a retrospective analysis of administrative data for 1,366 patients with AD and 13,660 age-gender matched controls enrolled in a large Medicare managed care organization (MCO). Co-morbid conditions were based on the diagnostic classifications from the Charlson co-morbidity index. Health care costs and utilization for MCO-covered services for cases were compared to controls. We used presence of complications of AD associated with later-stage disease to classify patients as having earlier- or later-stage AD. RESULTS: After controlling for co-morbid conditions, age, and gender, annual costs were $3,805 higher for AD patients, resulting in excess costs of $5 million to the MCO. For seven of the 10 most prevalent co-morbidities for AD patients, adjusted costs were higher for AD patients compared with controls with the same condition. Higher costs were attributable to higher inpatient and skilled nursing facility costs. Costs for patients classified as earlier-stage AD were 44% higher than controls and significantly higher for eight of 10 co-morbid conditions when compared with controls with the same conditions. Costs for AD patients receiving treatment by a cholinesterase inhibitor were $2,408 lower than AD patients not receiving therapy. CONCLUSIONS: Utilization and costs for patients with AD were higher compared to controls and were substantially higher for patients with both AD and co-morbid diseases commonly targeted for disease management. Earlier-stage AD and receipt of pharmacotherapy were associated with lower costs. These findings indicate that better treatment and care management of AD could reduce the costs of co-morbid illnesses commonly suffered by AD patients.

The effect of donepezil therapy on health costs in a Medicare managed care plan.

The objective of this study was to estimate the ramifications of donepezil use on the health care costs of a large Medicare managed care plan. Patients with a diagnosis of Alzheimer's disease or related dementia were identified from the claims-and-encounter records of the plan. Costs for 204 patients identified as having Alzheimer's disease and who were receiving donepezil were compared with a control group of 204 patients with Alzheimer's disease who had matching characteristics, but who were not receiving therapy. After controlling for age, gender, pharmacy benefits, comorbid conditions, and complications of dementia, annual costs for medical services and prescription drugs were found to be $3,891 lower for the study group. Costs were $4,192 lower for patients receiving longer-term therapy (> or = 270 day supply of donepezil) and $3,579 lower for patients receiving shorter-term therapy when compared with controls. By improving cognitive and daily functioning, donepezil may lower costs by improving medical management.

TSAT is a better predictor than ferritin of hemoglobin response to Epoetin alfa in US dialysis patients.

Clinical guidelines recommend concurrent treatment of anemia in end-stage renal disease with erythropoiesis-stimulating agents (ESAs) and iron. However, there are mixed data about optimal iron supplementation. To help address this gap, the relationship between iron markers and hemoglobin (Hb) response to ESA (Epoetin alfa) dose was examined. Electronic medical records of 1902 US chronic hemodialysis patients were analyzed over a 12-month period between June 2009 and June 2010. The analysis included patients who had at least one Hb value during each 4-week interval for four consecutive intervals (k - 2, k - 1, k, and k + 1; k is the index interval), received at least one ESA dose during intervals k - 1 or k, had at least one transferrin saturation (TSAT) value at interval k, and at least one ferritin value during intervals k - 2, k - 1, or k. Effect modification by TSAT and ferritin on Hb response was evaluated using the generalized estimating equations approach. Patients had a mean (standard deviation) age of 62 (15) years; 41% were Caucasian, 34% African American, 65% had hypertension, and 39% diabetes. Transferrin saturation, but not ferritin, had a statistically significant (P < 0.05) modifying effect on Hb response. Maximum Hb response was achieved when TSAT was 34%, with minimal incremental effect beyond these levels. Of the two standard clinical iron markers, TSAT should be used as the primary marker of the modifying effect of iron on Hb response to ESA. Long-term safety of iron use to improve Hb response to ESA warrants further study.

Anemia management trends in hospital-based dialysis centers (HBDCs), 2010 to 2013.

BACKGROUND: Few data have been reported on anemia management practices in hospital-based dialysis centers (HBDCs), which are uniquely different from other freestanding dialysis centers. Examining data from HBDCs would help determine if HBDCs and the general US dialysis population have similar trends related to how anemia is managed in dialysis patients. OBJECTIVE: Given recent changes in the prescribing information of erythropoiesis-stimulating agents (ESAs) and in end-stage renal disease-related health policy and reimbursement, this study describes trends in anemia management practices in HBDCs from January 2010 through March 2013. METHODS: Electronic medical records of 5404 adult hemodialysis patients in 50 US-based HBDCs were analyzed retrospectively. Patients included in the study cohort were aged ≥18 years and had at least 1 hemoglobin (Hb) measurement and 1 dose of an ESA between January 2010 and March 2013. End points included Hb concentration, darbepoetin alfa dosing, epoetin alfa dosing, and iron biomarkers (transferrin saturation and ferritin) and dosing. RESULTS: From 2010 to 2013, mean monthly Hb levels declined from 11.4 to 10.7 g/dL; the percentage of patients with mean monthly Hb levels <10 g/dL increased from 11.3% to 24.4%; and the percentage of patients with mean monthly Hb levels >12 g/dL declined from 30.1% to 11.2%. The median darbepoetin alfa cumulative 4-week dose also declined 38.8%, and the weekly epoetin alfa dose declined 24%. From January 2010 to March 2013, the percentage of patients with transferrin saturation >30% increased from 35.8% to 43.6%, the percentage of patients with ferritin levels >500 ng/mL increased from 62.0% to 77.9%, the percentage of patients with ferritin levels ≥800 ng/mL increased from 28.9% to 47.3%, and the median cumulative 4-week intravenous iron dose increased 50%. CONCLUSIONS: These study results support growing evidence that meaningful changes have occurred over the last 3 years in how anemia is clinically managed in US hemodialysis patients. Study limitations include that changes in patient clinical/demographic characteristics over time were not controlled for and that study findings may not be applicable to HBDCs that have different patient populations and/or do not use an electronic medical record system. Continuing to evaluate anemia management practices in HBDCs would provide additional information on the risks and benefits of anemia care. Consistent with national data, the findings from this study indicate that from 2010 to 2013, HBDCs modified anemia management practices for dialysis patients, as evidenced by reductions in mean monthly Hb levels and ESA dosing and by increases in iron biomarkers and dosing.