Clinical and Economic Outcomes of Ranolazine Versus Conventional Antianginals Users Among Veterans With Chronic Stable Angina Pectoris.

Real-world outcomes in patients with chronic stable angina treated with ranolazine and other antianginal medications as second- or third-line therapy are limited. In a historical cohort study of veterans with chronic stable angina, we compared time with coronary revascularization procedures, hospitalizations, and 1-year healthcare costs between new-users of ranolazine versus conventional antianginals (i.e., calcium channel blockers, ß blockers, or long-acting nitrates) as second- or third-line. Weighted regression models calculated adjusted hazard ratios (HR) at up to 8-year follow-up, and adjusted incremental costs in the first year. Weighted groups comprised 4,699 ranolazine users and 31,815 conventional antianginal users. Percutaneous coronary intervention (PCI) occurred more often in ranolazine users compared with conventional antianginal users (HR 1.16; 95% confidence intervals [CI] 1.08 to 1.25, p <0.001), and coronary artery bypass grafting occurred less often (HR 0.82; 95% CI 0.68 to 1.00, p <0.046). All-cause and atrial fibrillation (AF) hospitalizations were less common with ranolazine users compared with conventional users (all-cause: HR 0.94; 95% CI 0.90 to 0.99, p <0.010; AF:HR 0.74; 95% CI 0.67 to 0.82, p <0.001), and acute coronary syndrome was more common (HR 1.13; 95% CI 1.00 to 1.27, p <0.042). Adjusted 1-year costs were $24,517 in ranolazine users and $24,798 in conventional users (difference, $-280; 95% CI $-1,742 to $1,181, p = 0.71). In conclusion, ranolazine users had lower rates of coronary artery bypass grafting and all-cause and AF hospitalizations, but higher rates of percutaneous coronary intervention and hospitalizations due to acute coronary syndrome compared with conventional antianginal users. Healthcare costs were similar between ranolazine and conventional antianginal users.

Health Care Costs in a Cohort of HIV-Infected U.S. Veterans Receiving Regimens Containing Tenofovir Disoproxil Fumarate/Emtricitabine.

BACKGROUND: Tenofovir disoproxil fumarate (TDF), a key component in many human immunodeficiency virus (HIV) treatment regimens, is associated with increased renal and bone toxicities. The contributions of such toxicities to treatment costs, as well as the relative differences in treatment costs for various TDF/emtricitabine (FTC) regimens, remains unexplored. OBJECTIVE: To estimate and compare mean overall and renal- and bone-specific costs, including total, inpatient, outpatient, and pharmacy costs in patients treated with TDF/FTC+efavirenz (EFV) compared with several non-EFV-containing TDF/FTC regimens. METHODS: We conducted a national cohort study of treatment-naive HIV-infected U.S. veterans who initiated treatment from 2003 to 2015 with TDF/FTC in combination with EFV, elvitegravir/cobicistat, rilpivirine, or ritonavir-boosted protease inhibitors (atazanavir, darunavir, or lopinavir). Outcomes of interest were quarterly total, inpatient, outpatient, and pharmacy costs using data from the Veterans Health Administration (VHA) electronic medical record and Managerial Cost Accounting System (an activity-based accounting system that allocates VHA expenditures to patient encounters). We controlled for measured confounders using inverse probability of treatment (IPT) weights and assessed differences using standardized mean differences (SMDs). For comparisons where SMDs exceeded 0.1 after IPT weighting, we used the more conservative matching weights in sensitivity analyses. For hypothesis testing, we compared IPT-adjusted differences in quarterly costs between treatment groups using Mann-Whitney U-tests and generalized estimating equation (GEE) regression models. RESULTS: Of 33,048 HIV-positive veterans, 7,222 met eligibility criteria, including 4,172 TDF/FTC + EFV recipients; mean (SD) age of the cohort was 50.0 (10.0) years; 96.7% were male; 60.1% were black; and 30.1% were white. Quarterly periods of exposure to EFV-containing regimens were 22,499 and of exposure to non-EFV-containing regimens were 11,633. After IPT weighting, absolute SMDs were < 0.1 except for a few covariates in the rilpivirine comparison. The per-patient adjusted mean total quarterly costs were $7,145 for EFV versus $8,726 for non-EFV (P < 0.001; Mann-Whitney U-test) and the per-patient adjusted mean difference in total quarterly costs was $1,419 lower for EFV versus all non-EFV combined (P < 0.001; GEE model). Corresponding values for outpatient costs ($2,656 vs. $2,942; P < 0.001; difference, -$254; P = 0.001), inpatient costs ($2,009 vs. $2,614; P < 0.001), radiology costs ($213 vs. $276; P < 0.001), and pharmacy costs ($2,480 vs. $3,170; P < 0.001; difference, -$600; P < 0.001) were all lower for EFV versus all non-EFV combined. Findings based on matching weights were qualitatively similar. Contributions of renal and bone costs to the total costs of treatment were very small, ranging between $52 and $94 per patient per quarter for renal outcomes and between $6 and $114 for bone outcomes. CONCLUSIONS: Among 7,222 HIV-treated veterans over an average follow-up of 1.2 years per patient, those patients receiving TDF/FTC + EFV had lower overall health care costs compared with those receiving non-EFV regimens. DISCLOSURES: This study was funded by Bristol-Myers Squibb. Nelson, Ma, Crook, Knippenberg, Nyman, and LaFleur are employees of the University of Utah, which received a grant from Bristol-Myers Squibb to conduct this study. Nyman also discloses honoraria for consulting from Otsuka and for writing a book chapter from Fresenius. La Fleur reports advisory board and consulting fees from Bristol-Myers Squibb outside of this study. Paul and Esker are employees of, and own stock in, Bristol-Myers Squibb.

Long-term cost-effectiveness of initiating treatment for painful diabetic neuropathy with pregabalin, duloxetine, gabapentin, or desipramine.

Painful diabetic neuropathy (PDN) affects nearly half of patients with diabetes. The objective of this study was to compare the cost-effectiveness of starting patients with PDN on pregabalin (PRE), duloxetine (DUL), gabapentin (GABA), or desipramine (DES) over a 10-year time horizon from the perspective of third-party payers in the United States. A Markov model was used to compare the costs (2013 $US) and effectiveness (quality-adjusted life-years [QALYs]) of first-line PDN treatments in 10,000 patients using microsimulation. Costs and QALYs were discounted at 3% annually. Probabilities and utilities were derived from the published literature. Costs were average wholesale price for drugs and national estimates for office visits and hospitalizations. One-way and probabilistic (PSA) sensitivity analyses were used to examine parameter uncertainty. Starting with PRE was dominated by DUL as DUL cost less and was more effective. Starting with GABA was extendedly dominated by a combination of DES and DUL. DES and DUL cost $23,468 and $25,979, while yielding 3.05 and 3.16 QALYs, respectively. The incremental cost-effectiveness ratio for DUL compared with DES was $22,867/QALY gained. One-way sensitivity analysis showed that the model was most sensitive to the adherence threshold and utility for mild pain. PSA showed that, at a willingness-to-pay (WTP) of $50,000/QALY, DUL was the most cost-effective option in 56.3% of the simulations, DES in 29.2%, GABA in 14.4%, and PRE in 0.1%. Starting with DUL is the most cost-effective option for PDN when WTP is greater than $22,867/QALY. Decision makers may consider starting with DUL for PDN patients.

Calculating the Baseline Incidence in Patients Without Risk Factors: A Strategy for Economic Evaluation.

Economic and epidemiological models need various inputs to estimate the occurrence of events in different subsets of the population, such as the incidence of events for patients with risk factors compared with those without. However, the baseline event incidence for patients without risk factors (incidence_no_risk) may not be reported in the literature, therefore the event incidence in the population (incidence_pop) is commonly used in its place as the baseline. However, this is problematic because incidence_pop is a weighted average of a heterogeneous population. We therefore developed a method for deriving the incidence for persons without risk factors (incidence_no_risk) by adjustment of incidence_pop. We calculated incidence_no_risk using the relative risk for events due to risk factors (RR_risk), incidence_pop, and the prevalence of the risk factor (pRF), which are typically available in the literature. Since the incidence for patient with risk factors (incidence_risk) can be expressed as incidence_risk = incidence_no_risk × RR_risk, we found that incidence_no_risk = incidence_pop/((RR_risk × pRF) + (1 - pRF)). We validated the equation by modeling the fracture incidence in high-risk patients in an osteoporosis transition-state model. With incidence_pop used as the baseline fracture incidence, the model overestimated hip fractures in the study population (10.72 fractures/1000 patient-years). After adjustment of incidence_pop using incidence_no_risk as the baseline incidence, the model accurately predicted hip fractures (2.27/1000 patient-years). Therefore, incidence_no_risk can be calculated using this method based on the event incidence for the study population, the relative risk increase associated with the risk factor, and the prevalence of the risk factor.

Healthcare costs and resource utilization of patients with binge-eating disorder and eating disorder not otherwise specified in the Department of Veterans Affairs.

OBJECTIVE: The objective of this study was to compare the one-year healthcare costs and utilization of patients with binge-eating disorder (BED) to patients with eating disorder not otherwise specified without BED (EDNOS-only) and to matched patients without an eating disorder (NED). METHODS: A natural language processing (NLP) algorithm identified adults with BED from clinical notes in the Department of Veterans Affairs (VA) electronic health record database from 2000 to 2011. Patients with EDNOS-only were identified using ICD-9 code (307.50) and those with NLP-identified BED were excluded. First diagnosis date defined the index date for both groups. Patients with NED were randomly matched 4:1, as available, to patients with BED on age, sex, BMI, depression diagnosis, and index month. Patients with cost data (2005-2011) were included. Total healthcare, inpatient, outpatient, and pharmacy costs were examined. Generalized linear models were used to compare total one-year healthcare costs while adjusting for baseline patient characteristics. RESULTS: There were 257 BED, 743 EDNOS-only, and 823 matched NED patients identified. The mean (SD) total unadjusted one-year costs, in 2011 US dollars, were $33,716 ($38,928) for BED, $37,052 ($40,719) for EDNOS-only, and $19,548 ($35,780) for NED patients. When adjusting for patient characteristics, BED patients had one-year total healthcare costs $5,589 higher than EDNOS-only (p = 0.06) and $18,152 higher than matched NED patients (p < 0.001). DISCUSSION: This study is the first to use NLP to identify BED patients and quantify their healthcare costs and utilization. Patients with BED had similar one-year total healthcare costs to EDNOS-only patients, but significantly higher costs than patients with NED.

Cost-effectiveness analysis of fecal microbiota transplantation for recurrent Clostridium difficile infection.

OBJECTIVE: Clostridium difficile infection (CDI) places a high burden on the US healthcare system. Recurrent CDI (RCDI) occurs frequently. Recently proposed guidelines from the American College of Gastroenterology (ACG) and the American Gastroenterology Association (AGA) include fecal microbiota transplantation (FMT) as a therapeutic option for RCDI. The purpose of this study was to estimate the cost-effectiveness of FMT compared with vancomycin for the treatment of RCDI in adults, specifically following guidelines proposed by the ACG and AGA. DESIGN: We constructed a decision-analytic computer simulation using inputs from the published literature to compare the standard approach using tapered vancomycin to FMT for RCDI from the third-party payer perspective. Our effectiveness measure was quality-adjusted life years (QALYs). Because simulated patients were followed for 90 days, discounting was not necessary. One-way and probabilistic sensitivity analyses were performed. RESULTS: Base-case analysis showed that FMT was less costly ($1,669 vs $3,788) and more effective (0.242 QALYs vs 0.235 QALYs) than vancomycin for RCDI. One-way sensitivity analyses showed that FMT was the dominant strategy (both less expensive and more effective) if cure rates for FMT and vancomycin were ≥70% and <91%, respectively, and if the cost of FMT was <$3,206. Probabilistic sensitivity analysis, varying all parameters simultaneously, showed that FMT was the dominant strategy over 10, 000 second-order Monte Carlo simulations. CONCLUSIONS: Our results suggest that FMT may be a cost-saving intervention in managing RCDI. Implementation of FMT for RCDI may help decrease the economic burden to the healthcare system.

Comparing fracture absolute risk assessment (FARA) tools: an osteoporosis clinical informatics tool to improve identification and care of men at high risk of first fracture.

BACKGROUND: Fracture absolute risk assessment (FARA) is recommended for guiding osteoporosis treatment decisions in males. The best strategy for applying FARA in the clinic setting is not known. OBJECTIVES: We compared 2 FARA tools for use with electronic health records (EHRs) to determine which would more accurately identify patients known to be high risk for fracture. Tools evaluated were an adaptation of the World Health Organization's Fracture Risk Assessment Tool used with electronic data (eFRAX) and the Veterans Affairs (VA)-based tool, VA-FARA. METHODS: We compared accuracies of VA-FARA and eFRAX for correctly classifying male veterans who fractured and who were seen in the VA's Sierra Pacific Network in 2002-2013. We then matched those cases to nonfracture controls to compare odds of fracture in patients classified as high risk by either tool. RESULTS: Among 8740 patients, the mean (SD) age was 67.0 (11.1) years. Based on risk factors present in the EHR, VA-FARA correctly classified 40.1% of fracture patients as high risk (33.0% and 34.6% for hip and any major fracture, respectively); eFRAX classified 17.4% correctly (17.4% for hip and 0.2% for any major fracture). Compared with non-high-risk patients, those classified as high risk by VA-FARA were 35% more likely to fracture (95% CI = 23%-47%; P < 0.01) compared with 17% for eFRAX (95% CI = 5%-32%; P < 0.01). CONCLUSIONS: VA-FARA is more predictive of first fracture than eFRAX using EHR data. Decision support tools based on VA-FARA may improve early identification and care of men at risk.

Cost effectiveness of training rural providers to perform joint injections.

OBJECTIVE: Community-based outpatient clinics (CBOCs) have been established by the Department of Veterans Affairs (VA) to provide primary care services to veterans living in remote and rural regions. The objective of this study was to evaluate the cost effectiveness of training rural primary care providers to perform knee injections in CBOCs, thereby avoiding referring the patient to an urban medical center for an injection by rheumatology or orthopedic specialists. METHODS: We developed a decision-analysis model to compare costs and outcomes between rural providers who are trained to perform knee injections versus those who are not trained, therefore requiring a referral to a specialist to provide the injections. The model was run separately using costs from the perspective of the VA as well from the patient's perspective. The effectiveness outcome was quality-adjusted life years (QALYs). Probabilistic sensitivity analyses were performed using 10,000 second-order Monte Carlo simulations. RESULTS: In our base-case analyses, the incremental cost-effectiveness ratio for trained rural providers was $21,190/QALY using costs from the perspective of the VA and $205/QALY using costs from the patient's perspective. Training rural providers was cost effective in 74.4% and 93.6% of 10,000 Monte Carlo simulations at a willingness-to-pay threshold of $50,000/QALY from the perspectives of the VA and the patient, respectively. CONCLUSION: Training rural providers to perform knee injections for patients with knee pain secondary to osteoarthritis appears cost effective using the commonly used threshold of $50,000/QALY if more than 20 such patients per year are seen at rural primary care clinics. These results provide support for our ongoing efforts to implement such a training program.

Patent extension policy for paediatric indications: an evaluation of the impact within three drug classes in a state Medicaid programme.

BACKGROUND: The Food and Drug Administration Modernization Act (FDAMA) of 1997, Best Pharmaceuticals for Children Act (BPCA) of 2002 and Pediatric Research Equity Act of 2007 provide an extended period of 6 months of marketing exclusivity (i.e. patent extension) to prescription drug manufacturers that conduct paediatric studies. Branded drugs in the statin, ACE inhibitor and selective serotonin reuptake inhibitor (SSRI) classes were three of many classes with drugs granted patent extensions. OBJECTIVE: We estimated the cost impact of the 6-month exclusivity extension policy on the Utah Medicaid drug programme by comparing actual costs to projected costs had the 6-month exclusivity extension not been granted for these drugs and thus less expensive generic alternatives been available sooner. Using these results, we then projected the cost impact of this policy on Medicaid programmes in the US during the 18 months following patent expiration. METHODS: The Utah Medicaid prescription claims obtained for statins, ACE inhibitors and SSRIs included reimbursement amount, number of units dispensed, days supplied, date of service and drug strength. Actual expenditures for each drug were calculated for the 6 months before and 12 months after generic availability. The percentage difference between the brand name prescription reimbursement amount to Medicaid in the last 2 months of the 6-month extension and the generic prescription reimbursement amount to Medicaid in the first 2 months following exclusivity expiration was then calculated for each drug. This was done using data from the 5 months surrounding the exclusivity expiration by regressing the log-transformed Utah Medicaid reimbursement amount on an indicator for patent expiration, controlling for number of units, volume of sales, month filled and strength. This was used to estimate what the initial generic prescription price would have been without the 6-month patent extension and what costs would have been in the 18 months following the original expiration date if the patent extension had not been granted. Medicaid rebates were assumed to be 15.1% for branded products and 11% for generics. RESULTS: The 6-month extension policy was estimated to cost Utah's Medicaid $US2.2 (95% CI 1.9, 2.4) million for these three drug classes over the 18 months following the original patent expiration date (year 2007 values). Projected to the US Medicaid population, this cost was $US430 (95% CI 371, 475) million. For the individual drugs that we examined, the percentage cost decrease in reimbursement amount resulting from exclusivity expiration and generic entry ranged from 24.4% (p < 0.001) for enalapril to 3.8% (p = 0.0951) for pravastatin sodium. CONCLUSIONS: Makers of the branded drugs evaluated were given market exclusivity extensions for conducting studies of their medications in children. The costs found in this study are just a small portion of the total paid, which include those born by other payers. Whether the benefits of this policy outweigh these costs is an open question, but these results suggest that the costs to Medicaid and thus taxpayers are substantial.

A review of diabetes treatment adherence and the association with clinical and economic outcomes.

BACKGROUND: The benefits of drug therapy to diabetic patients in terms of glycemic control, microvascular complications, cardiovascular event risk, mortality, and quality of life have been well established by clinical trial data. However, it has been a challenge to quantify the relationship between adherence and outcomes such as glycemic control, disease-related events, hospitalizations, cost, and quality of life. OBJECTIVE: This article provides a comprehensive summary of empirical studies that examine the associations between adherence and glycemic control, health care utilization, quality of life, and mortality in patients with diabetes. It is intended to provide a framework for researchers interested in conducting studies to improve their understanding of the value of medication adherence for patients with diabetes. METHODS: Relevant published articles were identified through searches of the National Center for Biotechnology PubMed database. Medical subject heading (MESH) terms diabetes mellitus, hypoglycemic agents, and insulin, were each combined with the MESH term medication adherence and with the subheadings economics, prevention and control, psychology, statistics and numerical data, therapy, adverse effects, therapeutic use, and administration and dosage, where available. Studies were included if they met the following criteria: (1) analyzed empirical data on some measure of patient adherence to diabetes pharmacotherapy; (2) described methods for measuring patient adherence; (3) evaluated economic, clinical, or humanistic outcomes related to diabetes; and (4) had as a goal of the research to evaluate the link between patient adherence and outcomes (as a primary or secondary objective). The data from the articles meeting these criteria were then abstracted, including mention of the specific interventions being compared, specific methods for measuring adherence, outcomes compared between adherent and nonadherent patients and how these outcomes were measured, and information on variables that were adjusted for in predictive and causal multivariable models. RESULTS: A total of 37 articles that met all 4 criteria in this review underwent data extraction. Of these studies, 22 (59%) used objective measures to assess adherence, with 1 study using pill counts to assess adherence and 21 using either pharmacy claims or similar refill records to assess refill behavior. The remaining 15 (41%) studies used a wide variety of subjective patient-reported adherence assessments. The majority (13/23 [57%]) of the glycemic control studies reported that improved adherence was associated with better glycemic control. The ability to draw a distinction between adherence and glycemic control tended to occur more frequently [7/9 (78%)] among studies that characterized adherence in terms of prescription refills compared with studies that used various constructs for patient-reported adherence measures. CONCLUSIONS: Based on the literature, better adherence was found to be associated with improved glycemic control and decreased health care resource utilization. There was no consistent association between improved adherence and decreased health care costs. Little data were available on the association between adherence and quality of life.

Agreement between pharmacists for problem identification: an initial quality measurement of cognitive services.

BACKGROUND: Recent changes in national reimbursement policies expand the ability of pharmacists to seek reimbursement for cognitive services. The quality of pharmacist-provided cognitive services has, until now, remained unassessed. Pharmacists should demonstrate the quality and value of their work to ensure the continued and expanded acceptance of reimbursement for their services. A preliminary step in assessing quality is to compare agreement between pharmacists for basic problem identification. OBJECTIVE: To quantify agreement between pharmacist reviewers for problem identification among Utah Medicaid recipients. METHODS: Five pharmacists retrospectively reviewed drug regimens, patient characteristics, diagnosis codes, and procedures for 80 Medicaid patients in September 2008 and identified drug-related problems (DRPs) in 15 predetermined categories. Data for each patient were reviewed twice, and each combination of 2 pharmacists reviewed the same 8 patients' information. We calculated a reliability coefficient to compare the number of DRPs identified and used prevalence and bias adjusted kappa (PABAK) to determine interrater reliability for the presence of a specific DRP. RESULTS: Of the 15 DRPs categorized by pharmacist reviewers, 1 (untreated indications) had a PABAK coefficient of 0.20, indicating a relatively low level of agreement between reviewers. All other DRP categories had good to excellent agreement, with PABAK coefficients ranging between 0.43 and 0.98. CONCLUSIONS: Pharmacist reviewers exhibited less variability in DRP identification or categorization than had been expected for most categories. This work supports the conclusion that pharmacists in our center provide a basic and necessary level of quality for problem assessment. Future work is needed to document the impact of this quality on patient outcomes.

Problems in studying the association between race and pain in outcomes research.

Variability in the pain experience and treatment among patients of different races or ethnicities has been well studied over the past half century. Despite a large body of evidence describing these differences, the importance of these differences on health and cost outcomes has not be evaluated by pharmacoeconomists and outcomes researchers. We examined the subject to identify potential reasons for the lack of pharmacoeconomics and outcomes research (PE/OR) evaluations by first, defining PE/OR, second, taking the position that race can be an important modifier of disease outcomes by pointing out some identified differences in drug responses due to biology, and third, describing how PE/OR researchers have looked at race in other disease states. Finally, we propose some theories for the lack of such evaluations in pain outcomes research including the limited availability of race and ethnicity data in secondary datasets, a lack of priority for public and private funding organizations to support this type of research, and the potential biases of researchers and funding organizations.

Prevalence of drug-related problems and cost-savings opportunities in medicaid high utilizers identified by a pharmacist-run drug regimen review center.

BACKGROUND: Despite numerous reports of state Medicaid drug utilization review (DUR) programs, little data are available about the prevalence of drugrelated problems (DRPs) in Medicaid patients. A university-based, pharmacist-run DUR program for high utilizers was created as an alternative to imposition of a statutory limit of 7 medications per month in the Utah Medicaid program in 2002. The DUR program was designed to suggest ways that high-utilizing patients could decrease their total number of medications to 7 or fewer prior to imposition of the 7-medication limit at some time in the future. OBJECTIVE: To describe the experience in 1 Medicaid DUR program and to report the prevalence of DRPs and cost-saving opportunities (CSOs) among a population of Medicaid recipients who were high utilizers of prescription drugs. METHODS: DRPs were identified by 5 clinical pharmacists employed by the Drug Regimen Review Center (DRRC) in Salt Lake City. The purpose of the center was to provide drug therapy review services for a select number of Utah Medicaid recipients (200-300 per month) who exceeded a 7-medication limit during the calendar years 2003 and 2004. RESULTS: Out of 391,890 eligible Medicaid recipients, 242,411 (62%) received at least 1 medication, and 16,958 (4.3%) exceeded the 7-medication limit during the review period. Of those exceeding the limit, the DRRC reviewed a total of 3,706 (21.9%) patients, representing the highest utilizers by volume of medication. The prevalence of DRPs considered clinically important in the review cohort was 79.7% of patients, including therapeutic duplications in 54.6% of patients, dose form optimization in 29.7%, and inappropriate uncoordinated care in 25.3%. The average pharmacy cost per month for patients with at least 1 DRP was 1,081 dollars; by contrast, the average pharmacy cost per month for all other patients receiving at least 1 prescription was 91 dollars. CONCLUSIONS: Approximately 4% of Medicaid recipients exceeded the 7-medication monthly limit. Among the 22% highest utilizers in this group, 48% of nursing home residents and 87% of ambulatory recipients had at least 1 DRP, or an overall rate of 80% of high-use Medicaid recipients or as much as 3.2% of the Medicaid population.

Economic benefits of investigational drug services at an academic institution.

PURPOSE: The drug cost avoidance and revenue associated with the provision of investigational drug services (IDSs) at an academic institution were studied. METHODS: The study protocols and dispensing data for the investigational drug studies conducted at the institution over two fiscal years (2000-01 and 2001-02) were reviewed. Revenue generated was calculated for all studies, and drug cost avoidance was calculated for studies in which patients were likely to have been treated with active drug had they not been included in the study. RESULTS: Of 139 studies in which the IDS was involved, 107 (77%) were eligible for the cost avoidance analysis. The total drug cost avoidance plus revenue over the two fiscal years was $5,300,428. The annualized drug cost avoidance plus revenue was $2.6 million. Cost avoidance varied with the type of study and the disease category involved. CONCLUSION: An IDS accounted for substantial drug cost avoidance over two fiscal years.