Cost-Effectiveness of KTE-X19 for Adults with Relapsed/Refractory B-Cell Acute Lymphoblastic Leukemia in the United States.

INTRODUCTION: Despite currently available treatments for adults with relapsed/refractory acute lymphoblastic leukemia (R/R ALL), survival outcomes remain poor, highlighting the need for new therapeutic strategies. This study estimates the cost-effectiveness of KTE-X19 to treat adults with R/R ALL from a US payer perspective. METHODS: The model had two components: a decision-tree, where pre-infusion costs for patients who ultimately did not receive KTE-X19 are accounted for, followed by a partitioned survival analysis, where all KTE-X19 infused patients would enter the three-state (pre-progression, progressed disease, death) model. Comparators included current standard of care treatments, i.e., blinatumomab (BLIN), inotuzumab ozogamicin (INO), and salvage chemotherapy (CHEMO). Both standard parametric and mixture cure models were used to model survival. Efficacy, safety, healthcare resource utilization, and health state utility inputs were derived from the ZUMA-3 trial (NCT02614066) and literature. Cost inputs were derived from literature or publicly available sources. Outcomes and costs were discounted 3% annually. Results of KTE-X19 versus comparators are reported as total and incremental life-years (LYs), quality-adjusted life-years (QALYs), costs, and resulting incremental cost-effectiveness ratio (ICER). Deterministic and probabilistic sensitivity analyses (PSA) and key scenario analyses were also performed. RESULTS: In the base case, incremental QALYs for KTE-X19 were 2.44, 3.26, and 4.61 versus BLIN, INO, and CHEMO, respectively. Incremental costs were $50,913, $251,532, and $432,027, respectively, resulting in ICERs of $20,843/QALY (versus BLIN), $77,271/QALY (versus INO), and $93,768/QALY (versus CHEMO). Deterministic sensitivity analysis results were most sensitive to subsequent allogeneic stem cell transplant rates and post-progression utilities. PSA found that KTE-X19 is 78.4%, 74.0%, and 75.4% likely to be cost-effective versus BLIN, INO, and CHEMO, respectively. Across most scenarios, at a willingness-to-pay (WTP) threshold of $150,000/QALY, KTE-X19 was cost-effective versus all treatments. CONCLUSIONS: Compared to current options for adults with R/R ALL, KTE-X19 is cost-effective, driven primarily by improved survival.

Several treatments for adults with relapsed/refractory B-cell precursor acute lymphoblastic leukemia (R/R B-ALL) have been approved in the past decade in the US, including blinatumomab (BLIN) and inotuzumab ozogamicin (INO). However, despite the high costs associated with these treatments, survival for patients remains poor. KTE-X19, an autologous anti-CD19 chimeric antigen receptor T-cell (CAR-T) therapy, approved by the Food and Drug Administration in October 2021, has potential to improve survival, but its economic value has not yet been determined. This model comprehensively evaluated the long-term clinical and economic value of KTE-X19 versus current treatments, including BLIN, INO, and salvage chemotherapy (CHEMO). Inputs were derived from key clinical trials, the literature, and other publicly available sources. The model used the perspective of a US third party payer over a patient lifetime. Compared to BLIN, INO and CHEMO, KTE-X19 resulted in improved quality of life as measured with incremental quality-adjusted life years (QALYs) of 2.44 (vs BLIN), 3.26 (vs INO), and 4.61 (vs CHEMO). Treatment with KTE-X19 had incremental costs of $50,913 (vs BLIN), $251,532 (vs INO), and $432,027 (vs CHEMO). KTE-X19 was found to provide good value for money based on incremental cost-effectiveness ratios of $20,843/QALY (vs BLIN), $77,271/QALY (vs INO), and $93,768/QALY (vs CHEMO). These values are well below the commonly accepted thresholds to determine economic value. Results were also found to be robust across sensitivity and scenario analyses.

Assessment of Clonotypic Rearrangements and Minimal Residual Disease in Lymphoid Malignancies.

CONTEXT.­: Measurable (minimal) residual disease (MRD) is an independent prognostic factor for survival outcomes in patients with lymphoid and plasma cell malignancies and has been incorporated into consensus criteria regarding treatment response, strategy, and clinical trial endpoints. clonoSEQ (a next-generation sequencing [NGS]-MRD assay) uses multiplex polymerase chain reaction and NGS to identify clonotypic rearrangements at the immunoglobulin (Ig) H, IgK, IgL, T-cell receptor (TCR)-ß, and TCR-γ loci, as well as translocated B-cell lymphoma 1/IgH and 2/IgH sequences for MRD assessment. Additionally, it can be used to confirm diagnoses of cutaneous T-cell lymphoma (CTCL). OBJECTIVE.­: To review the technical aspects of our experience using the clonoSEQ Assay in routine clinical practice. DESIGN.­: In this single-center experience, 390 patients with lymphoid and plasma cell malignancies were assessed with the NGS-MRD Assay at a central laboratory. RESULTS.­: Median time from arrival of the shipment to initiation of the assay (defined as captured in Adaptive's secure tracking system) was 2.1 hours. Overall, 317 patients had 1 or more samples submitted for sequence identification. Of these, 290 (91.5%) had trackable sequences identified. The median calibration rate of samples by malignancy (where n ≥ 10 samples, excluding CTCL samples) was 88.1%, across a variety of fresh and archived sample sources (177 of 201 samples). TCR-ß and/or TCR-γ clonotypes were identified in 40 of 95 samples (42.1%) from 66 patients with suspected CTCL. CONCLUSIONS.­: This NGS-MRD Assay is a valuable and sensitive tool for monitoring MRD in patients with plasma cell and lymphoid malignancies and assisting in the diagnosis of CTCL.

Incidence and Management of Effusions Before and After CD19-Directed Chimeric Antigen Receptor (CAR) T Cell Therapy in Large B Cell Lymphoma.

In patients with lymphoma, third-space fluid accumulations may develop or worsen during cytokine release syndrome (CRS) associated with chimeric antigen receptor (CAR) T cell therapy. Pre-existing symptomatic pleural effusions were excluded by the ZUMA-1 trial of axicabtagene ciloleucel for large B cell lymphoma (LBCL) and variants. The incidence and management of effusions during CAR T cell therapy for LBCL are unknown. We performed a single-center retrospective study evaluating 148 patients receiving CD19-directed CAR T cell therapy for LBCL between May 2015 and September 2019. We retrospectively identified patients who had radiographic pleural, pericardial, or peritoneal effusions that were present prior to the time of CAR T infusion (pre-CAR T) or that newly developed during the first 30 days after CAR T-cell infusion (post-CAR T). Of 148 patients, 19 patients had a pre-CAR T effusion, 17 patients without pre-existing effusion developed a new infusion after CAR T, and 112 patients had no effusions. Comparing pre-CAR T effusions to new effusions post-CAR T, pre-CAR T effusions were more often malignant (84% versus 12%), persistent beyond 30 days (95% versus 18%), and required interventional drainage after CAR T infusion (79% versus 0%). Compared to patients with no effusion, patients with pre-CAR T therapy effusions had a higher frequency of high-risk baseline characteristics, such as bulky disease and high International Prognostic Index. Similarly, patients with pre-CAR T therapy effusions had a higher rate of toxicity with grade 3 or higher CRS occurring in 32% of patients. On multivariate analysis adjusting for age, Eastern Cooperative Oncology Group status, bulky disease, albumin, and lactate dehydrogenase, a pre-CAR T therapy effusion was associated with reduced overall survival (hazard ratio, 2.34; 95% confidence interval, 1.09 to 5.03; P = .03). Moreover, there was higher non-relapse mortality (11% versus 1%; P = .005). Post-CAR T effusions were not associated with significant difference in survival. Effusions commonly complicate CAR T cell therapy for lymphoma. Malignant effusions that occur prior to CAR T therapy are frequently persistent and require therapeutic intervention, and patients have a higher rate of toxicity and death. Effusions that newly occur after CAR T therapy can generally be managed medically and tend not to persist.

Cost-effectiveness for KTE-X19 CAR T therapy for adult patients with relapsed/refractory mantle cell lymphoma in the United States.

AIMS: The objective of this study is to estimate the cost-effectiveness of KTE-X19 versus standard of care (SoC) in the treatment of relapsed/refractory (R/R) mantle cell lymphoma (MCL) patients from a US healthcare perspective. MATERIALS AND METHODS: A three-state partitioned-survival model (pre-progression, post-progression, and death) with a cycle length of 1 month was used to extrapolate progression-free and overall survival (OS) over a lifetime horizon. Due to the long tail of the OS curve, OS was modeled applying a mixture-cure methodology, using the assumption that patients whose disease had not progressed after 5 years experienced long-term remission. Population inputs were derived from the ZUMA-2 trial. This was also the source of KTE-X19 efficacy and safety data, while this data was obtained from the literature for SoC. Costs and resource use inputs were derived from the published literature and publicly available data sources. Health state utilities were derived from the ZUMA-2 trial (NCT02601313), applying the US tariff. Adverse event disutilities were derived from the published literature. Costs and health outcomes were discounted at 3% per year. The model estimated expected life years (LY), quality-adjusted life years (QALY), and total costs for KTE-X19 vs SoC. Deterministic and probabilistic sensitivity analyses were performed. RESULTS: Median survival was 9.71 years for KTE-X19 and 2.13 for SoC. Discounted LYs, QALYs, and lifetime costs were 8.99, 7.39, and $693,832 for KTE-X19 vs 4.47, 3.65, and $574,263 for SoC, respectively. The KTE-X19 vs SoC cost per QALY was $31,985. The most influential model parameter was the utility for patients with long-term remission. At a willingness-to-pay threshold of $150,000 per QALY, the probability that KTE-X19 was cost-effective was 99%. CONCLUSION: The treatment of R/R MCL with KTE-X19 presents a potentially cost-effective alternative to the current SoC, deriving its value from incremental survival and health-related quality-of-life benefits.

Recommendations for the assessment and management of measurable residual disease in adults with acute lymphoblastic leukemia: A consensus of North American experts.

Measurable residual disease (MRD) that persists after initial therapy is a powerful predictor of relapse and survival in acute lymphoblastic leukemia (ALL). However, the optimal use of this information to influence therapeutic decisions is controversial. Herein, we comprehensively review the role of MRD assessment in adults with ALL, including methods to quantify residual leukemia cells during remission, prognostic impact of MRD across ALL subtypes, and available therapeutic approaches to eradicate MRD. This review presents consensus statements and provides an evidence-based framework for practicing hematologists and oncologists to use MRD information to make rational treatment decisions in adult patients with ALL.

Chimeric Antigen Receptor T-Cell Therapy.

Patients with relapsed or refractory (R/R) cancers have a poor prognosis and limited treatment options. The recent approval of 2 chimeric antigen receptor (CAR) autologous T-cell products for R/R B-cell acute lymphoblastic leukemia and non-Hodgkin's lymphoma treatment is setting the stage for what is possible in other diseases. However, there are important factors that must be considered, including patient selection, toxicity management, and costs associated with CAR T-cell therapy. To begin to address these issues, NCCN organized a task force consisting of a multidisciplinary panel of experts in oncology, cancer center administration, and health policy, which met for the first time in March 2018. This report describes the current state of CAR T-cell therapy and future strategies that should be considered as the application of this novel immunotherapy expands and evolves.

Measure Accurately, Act Rapidly, and Partner With Patients (MAP) improves hypertension control in medically underserved patients: Care Coordination Institute and American Medical Association Hypertension Control Project Pilot Study results.

Measure Accurately, Act Rapidly, and Partner With Patients (MAP) is an evidence-based protocol implemented to improve hypertension control in a clinic for underserved patients (49.9% Medicaid and 50.2% black). Patients with hypertension seen during the year before intervention and with at least one visit during the 6-month intervention (N = 714) were included. If initial attended blood pressure (BP; standard aneroid manometer) was ≥140/≥90 mm Hg, unattended automated office BP was measured in triplicate and averaged (Measure Accurately) using an Omron HEM-907XL. When automated office BP was ≥140/≥90 mm Hg, Act Rapidly included intensification of antihypertensive medications, assessed by therapeutic inertia. Partner With Patients included BP self-monitoring, reducing pill burden, and minimizing medication costs, which was assessed by systolic BP change per therapeutic intensification. Between baseline and the last study visit, BP control to <140/<90 mm Hg increased from 61.2% to 89.9% (P < .0001). MAP rapidly and significantly improved hypertension control in medically underserved patients, largely as a result of measuring BP accurately and partnering with patients.

Costs of Rapid HIV Screening in an Urban Emergency Department and a Nearby County Jail in the Southeastern United States.

Emergency departments and jails provide medical services to persons at risk for HIV infection and are recommended venues for HIV screening. Our main objective in this study was to analyze the cost per new HIV diagnosis associated with the HIV screening program in these two venues. The emergency department's parallel testing program was conducted at Grady Memorial Hospital in Atlanta, Georgia starting in 2008; the jail's integrated testing program began at the Fulton County (GA) Jail in 2011. The two sites, four miles apart from one another, employed the same rapid HIV test. Ascertainment that cases were new differed by site; only the jail systematically checked identities against health department HIV registries. The program in the emergency department used dedicated HIV test counselors and made 242 diagnoses over a 40-month period at a cost of $2,981 per diagnosis. The jail program used staff nurses, and found 41 new HIV cases over 10.5 months at a cost of $6,688 per new diagnosis. Differences in methods for ascertainment of new diagnoses, previously undiagnosed HIV sero-positivity, and methodologies used for assessing program costs prevent concluding that one program was more economical than the other. Nonetheless, our findings show that testing in both venues yielded many new diagnoses, with the costs within the range reported in the literature.

Factors affecting the unmet demand for pharmacists: state-level analysis.

OBJECTIVE: To describe the relationship between state-level Aggregate Demand Index (ADI) data and market factors reflecting both supply and demand: unemployment rates, pharmacy graduates, community pharmacy prescription growth rates, and Medicare Part D. DESIGN: Cross-sectional time series analysis using state-level data. SETTING: U.S. labor market for pharmacists, from 2001 to 2010. INTERVENTION: Model ADI data for states (dependent variable) against five independent variables: previous year ADI, unemployment rates, pharmacy graduates, prescription growth rates, and Medicare Part D. MAIN OUTCOME MEASURES: Significance and predictive ability of the model, sign of the variables studied, and R2. RESULTS: In the two-way (state and time) fixed-effects model, all variables were significant and R2 was 0.79. Contributions to state-level ADIs were, in rank order, previous year ADI, unemployment rates, pharmacy graduates, and prescription growth rates. The model predicted 2010 ADI values for 44 of 51 states within ±10%. The model depicts the independent contributions of each variable for the short (∼1 year) and longer term. Although the nature of ADI data precludes quantitative predictions about the pharmacist job market, the model results show marketplace directions (up or down) and comparative impacts. CONCLUSION: The model demonstrated that unemployment rates, pharmacy graduates, prescription growth rates, and Medicare Part D contributed significantly to state-level ADIs between 2001 and 2010. The relationships uncovered should be monitored and reexamined as new data emerge in order to anticipate the directions of the pharmacist job market.

Enhancing diabetes care by adding a pharmacist to the primary care team.

PURPOSE: The impact of pharmacist interventions on short-term clinical markers and long-term cardiovascular risk in patients with type 2 diabetes is investigated. METHODS: Selected health outcomes were retrospectively analyzed in 147 adults with type 2 diabetes whose care was managed by a team of providers including a pharmacist (the enhanced care group) and a matched sample of patients (n = 147) managed by a primary care physician only (the control group). All patients received services through the same health maintenance organization (HMO). The primary study endpoints were (1) the changes from baseline to 12-month follow-up in glycosylated hemoglobin (HbA(1c)), low-density lipoprotein cholesterol (LDL-C), and blood pressure (BP) values, (2) rates of attainment of HbA(1c), LDL-C and BP goals, and (3) changes from baseline in predicted 10-year risks of coronary heart disease (CHD) and stroke. RESULTS: During the 12-month study period, the mean HbA(1c) value was decreased from 9.5% to 6.9% in the enhanced care group and from 9.3% to 8.4% in the control group (p < 0.001); patients in the enhanced care group were significantly more likely to attain goals for HbA(1c) (odds ratio [OR], 3.9), LDL-C (OR, 2.0), and BP reduction (OR, 2.0) and three times more likely to attain all three goals (OR, 3.2). The estimated 10-year risk of CHD was decreased from 16.4% to 9.3% with enhanced care versus a reduction from 17.4% to 14.8% with usual care (p < 0.001). CONCLUSION: The addition of a pharmacist to an HMO primary care team improved short-term surrogate markers as well as long-term cardiovascular risk in adult patients with type 2 diabetes.

A Markov model of the cost-effectiveness of pharmacist care for diabetes in prevention of cardiovascular diseases: evidence from Kaiser Permanente Northern California.

BACKGROUND: It has been demonstrated in previous studies that pharmacist management of patients with type 2 diabetes mellitus (T2DM) in the outpatient setting not only improves diabetes-related clinical outcomes such as hemoglobin A1c but also blood pressure (BP), total cholesterol (TC), and quality of life. Improved control of BP and TC has been shown to reduce the risks of cardiovascular disease (CVD), which has placed a heavy economic burden on the health care system. However, no study has evaluated the cost-effectiveness of pharmacist intervention programs with respect to the long-term preventive effects on CVD outcomes among T2DM patients. OBJECTIVES: To (a) quantify the long-term preventive effects of pharmacist intervention on CVD outcomes among T2DM patients using evidence from a matched cohort study in the outpatient primary care setting and (b) assess the relative cost-effectiveness of adding a clinical pharmacist to the primary care team for the management of patients with T2DM based on improvement in CVD risks with the aid of an economic model. METHODS: Clinical data between the periods of June 2007 to February 2010 were collected from electronic medical records at 2 separate clinics at Kaiser Permanente (KP) Northern California, 1 with primary care physicians only (control group) and the other with the addition of a pharmacist (enhanced care group). Patients in the enhanced care group were matched 1:1 with patients in the control group according to baseline characteristics that included age, gender, A1c, and Charlson comorbidity score. The estimated 10-year CVD risk for both groups was calculated by the United Kingdom Prospective Diabetes Study (UKPDS) Risk Engine (version 2) based on age, sex, race, smoking status, atrial fibrillation, duration of diabetes, levels of A1c, systolic BP (SBP) and TC, and high-density lipoprotein cholesterol (HDL-C) observed at 12 months. There was no statistical difference in the baseline clinical inputs to the Risk Engine (A1c [P=0.115], SBP [P=0.184], TC [P=0.055], and HDL-C [P=0.475]) between the 2 groups. A Markov model was developed to simulate the estimated CVD outcomes over 10 years and to estimate cost-effectiveness. The final outcomes examined included incremental cost and effectiveness measured by life years and per quality-adjusted life year gained. Both deterministic sensitivity analysis (SA) and probabilistic SA were conducted to examine the robustness of the results. RESULTS: The estimated risks for coronary heart disease (CHD) and stroke (both nonfatal and fatal) at the end of the follow-up were consistently lower in the enhanced care group compared with the control group, even though baseline risks in both groups were similar. The absolute risk reduction (ARR) between the enhanced care and control groups increased over time. For example, the ARR for nonfatal CHD risk in year 1 was 0.5% (1.2% vs. 0.7%), whereas the ARR increased to 5.5% in year 10 (14.8% vs. 9.3%). Similarly, the ARR between the enhanced care and the control groups was calculated as 0.3% for fatal CHD in year 1 and increased to 4.6% in year 10. Results from the Markov model suggest that the enhanced care group was shown to be a dominant strategy (less expensive and more effective) compared with the control group in the 10-year evaluation period in the base-case (average or mean results) scenario. Sensitivity analysis that took into account the uncertainty in all important variables, such as wage of pharmacists, utility weight (the degree of preference individuals have for a particular health state or condition), response rate to pharmacists' care, and uncertainty associated with the estimated 10 years of CVD risk, revealed that the relative value of enhanced care was robust to most of the variations in these parameters. Notably, the level of cost-effectiveness measured by net monetary value depends on the time horizon adopted by the payers and the magnitude of CVD risk reduction. The enhanced care group has a higher chance of being considered as a cost-effective strategy when a longer time horizon such as a minimum of 4 to 5 years is adopted. CONCLUSIONS: Adding pharmacists to the health care management team for diabetic patients improves the long-term CVD risks. The longer-term CVD risk reductions were shown to be more dramatic than the short-term reduction. A longer time horizon adopted by health plans in managing T2DM patients has a higher probability of making the intervention cost-effective.

A mnemonic for pharmacy students to use in pharmacotherapy assessment.

OBJECTIVE: To introduce pharmacy students to a patient-centered mnemonic to aid them in remembering the most important parameters when assessing a patient's drug therapy and to determine whether use of the device improved students' clinical examination scores. DESIGN: Second-year pharmacy students were randomized to an intervention group or a control group. A 30-minute presentation on the rationale of the mnemonic and how to apply it to clinical scenarios was given to the intervention group and then a case-based multiple-choice clinical examination was administered. Students in the control group completed the same examination first and then were given the mnemonic. ASSESSMENT: Ninety-five students completed the examination. Examination scores of students in the intervention group were 6% higher than those of students in the control group (p = 0.04). A 6-question survey instrument was administered to both groups and the majority of students agreed that they would use the mnemonic when assessing patients during their upcoming practice experiences. One-hundred percent of the students stated that the mnemonic definitely or probably helped them (or would have helped them) think critically when assessing the patient cases. CONCLUSIONS: Pharmacy students who used a mnemonic device for pharmacotherapy assessment exhibited better decision-making skills and made fewer errors than students who did not use the mnemonic.

Diet quality as measured by the healthy eating index and the association with lipid profile in low-income women in early postpartum.

Early postpartum is a critical period that may initiate consumption of an unhealthful diet, which can lead to obesity and adverse lipid profiles. The Healthy Eating Index 2005 (HEI 2005) is a tool that assesses diet quality in terms of adherence to the 2005 Dietary Guidelines for Americans. Previous versions of HEI have shown to be associated with serum lipids. The aim of this research is to evaluate the diet quality of women in early postpartum using the HEI 2005 and to examine the relationship of index scores with serum lipids and anthropometrics. A convenience sample of 125 multiethnic, overweight/obese women in early postpartum was recruited from urban clinics from June 2004 through April 2007. Dietary intake was measured via the average of a 24-hour dietary recall and 2-day food intake records. The HEI 2005 scores were computed to assess diet quality and were compared to anthropometrics and serum lipids. Descriptive statistics, analysis of covariance, and linear regression were utilized. This sample had low mean scores in fruits, total vegetables, whole grains, and oil components. Conversely, participants consumed more than recommended amounts of sodium, saturated fats, and discretionary calories. The HEI 2005 scores inversely predicted body mass index and low-density lipoprotein and total cholesterol, and positively predicted high-density lipoprotein cholesterol. Low-income women in early postpartum exhibited poor diet quality, as indicated by low total index scores. Further studies are warranted to identify appropriate dietary modifications in this population and to confirm the association of diet quality, as assessed by this HEI 2005 index, with lipids and other markers of health.

Development and validation of the eating stimulus index in low-income, minority women in early postpartum.

Dietary modification to achieve weight loss during the postpartum period may be critical for prevention of obesity, particularly in low-income, minority women. The aim of this cross-sectional study was to develop and validate a measure to examine motivations to eat in low-income, minority women during early postpartum. A convenience sample of 179 triethnic women was recruited from the Special Supplemental Program for Women, Infants, and Children clinics from June 2004 to April 2007. Subjects made one visit to a study center where they completed the Eating Stimulus Index and questions regarding individual demographic characteristics including ethnicity, age, income, education, marital status, breastfeeding, and employment status. Weight and height were also measured during this visit and used to calculate body mass index (BMI; calculated as kg/m(2)). An additional sample of 31 women completed the Eating Stimulus Index on two occasions with 2 weeks between to establish test-retest reliability. The factor structure of the scale was examined with principal components analysis. Total scale scores and subscale scores were calculated and Pearson's correlation and multiple regression analysis examined relationships to BMI. Principal component analysis produced an eight-factor structure with loadings >0.40. Cronbach's alpha coefficients for each subscale ranged from .54 to .89. Subscales of Convenience Eating, Emotional Eating, and Dietary Restraint were related to BMI in mothers. African-American, exclusively formula-feeding, and older women were most vulnerable to convenience eating. White women and those with the highest level of education were most vulnerable to emotional eating. The Eating Stimulus Index is a valid and reliable instrument with the ability to discriminate by weight. It can be used to assess motivations to eat in order to facilitate development of tailored weight-loss messages during early postpartum.

Depressive symptoms in patients with type 2 diabetes in the ambulatory care setting: opportunities to improve outcomes in the course of routine care.

OBJECTIVES: To assess the frequency of untreated, self-reported depressive symptoms in a cross section of adult ambulatory patients with type 2 diabetes and to identify demographic and/or clinical characteristics associated with depressive symptoms in study patients. DESIGN: Cross-sectional study. SETTING: Three ambulatory care clinics in the southwestern United States in fall 2005. PATIENTS: 217 primary care patients aged 18 years or older with a diagnosis of type 2 diabetes. INTERVENTION: Administration of the Zung Self-rating Depression Scale (Zung SDS). MAIN OUTCOMES MEASURES: Self-reported data on demographic characteristics and depressive symptoms. Data for insurance, comorbid conditions, and glycosylated hemoglobin (A1C) values were abstracted from patient charts. RESULTS: Depressive symptoms (Zung SDS score > or =50) were identified in 72.1% of patients. Overall, 13% of the patients with a diagnosis of depression (based on patient charts) were not receiving treatment. Factors significantly associated with depressive symptoms were past history of depression (beta= 0.53, P < 0.01), Medicaid insurance (beta= 0.15, P < 0.02), and insulin use (beta= 0.12, P < 0.05). CONCLUSION: The results suggest that possible undetected or untreated depression can be assessed in patients with type 2 diabetes through use of a self-rating scale in the course of routine ambulatory care. Adding the Zung SDS screen to routine care protocols could facilitate improved detection and treatment of comorbid depression in ambulatory patients with type 2 diabetes.

Direct health care costs of 4 common skin ulcers in New Mexico Medicaid fee-for-service patients.

OBJECTIVE: To determine health care costs associated with pressure ulcers, ulcers of the lower limbs, other chronic ulcers, and venous leg ulcers from the New Mexico Medicaid fee-for-service program perspective. DESIGN: Retrospective analysis of claims database MAIN OUTCOME MEASURES: Physician visit, hospital, and prescription costs were determined for New Mexico Medicaid patients with a primary and/or secondary diagnosis of 1 of 4 identified categories of skin ulcers from January 1, 1994, through December 31, 1998. Costs were determined in terms of mean and median annual cost per patient and total costs per year. Zero dollar claims were included within the cost calculations. All costs are expressed in 2000-dollar values. MAIN RESULTS: Mean annual physician visit costs per patient ranged from $71 (standard deviation [SD] = $60) for venous leg ulcers in 1998 to $520 (SD = $1228) for pressure ulcers in 1996. Mean annual hospital costs per patient ranged from $266 (SD = $348) for other chronic ulcers in 1998 to $15,760 (SD = $30,706) for pressure ulcers in 1998. Mean annual prescription costs per patient ranged from $145 (SD = $282) for other chronic ulcers in 1998 to $654 (SD = $1488) for pressure ulcers in 1994. CONCLUSION: The New Mexico Medicaid fee-for-service system incurred a total cost of approximately $11.6 million (in 2000 dollars) from 1994 through 1998 for the treatment of the 4 categories of skin ulcers studied. The data showed that the majority of wounds were coded as pressure ulcers, which had the highest associated costs.