Tafamidis 61 mg Patient Characteristics and Persistency? A Retrospective Analysis of German Statutory Health Insurance Data (IQVIA™ LRx).

INTRODUCTION: Tafamidis is the first drug approved by the European Commission for the treatment of wild-type or hereditary transthyretin amyloid cardiomyopathy (ATTR-CM) in adults to reduce cardiovascular mortality and cardiovascular-related hospitalization. Real-world treatment patterns of tafamidis 61 mg in Germany are not well studied in patients with ATTR-CM. METHODS: This was a non-interventional, retrospective, observational cohort study of adult patients in Germany based on the IQVIA pharmacy claims database (IQVIA™ LRx). Patients included in the analysis were statutory insured and received at least one prescription of tafamidis 61 mg between March 1, 2020 and August 31, 2022. Treatment adherence was analyzed using the modified medical possession ratio (mMPR) and proportion of days covered (PDC). RESULTS: Overall, 1565 adult patients received at least one tafamidis prescription in the study period. Their mean age was 78.3 years, 82.4% were male, and 23.2% were treated by a cardiologist. Persistency rates for patients treated with tafamidis 61 mg were high: 78.0% for 12 months and 65.1% for 24 months after treatment initiation. Patients also had high adherence rate on filling their prescriptions on time: 94.6% and 90.5% of patients had adherence rates of at least 80%, measured by mMPR and PDC, respectively. CONCLUSIONS: In the IQVIA™ LRx database, patients prescribed tafamidis 61 mg in Germany displayed high adherence and persistency rates, which suggest good drug tolerability and ease of use.

Real-World Characteristics of Patients with Wild-Type Transthyretin Amyloid Cardiomyopathy: An Analysis of Electronic Healthcare Records in the United States.

BACKGROUND: Tafamidis was approved for the treatment of hereditary and wild-type transthyretin amyloid cardiomyopathy (ATTRwt-CM) in May 2019, based on findings from the Tafamidis in Transthyretin Cardiomyopathy Clinical Trial (ATTR-ACT). METHODS: This retrospective cohort study evaluated the factors associated with tafamidis prescription after diagnosis of ATTRwt-CM in the real world. Between May 2019 and December 2020, 430 patients with 6 months' database activity were indexed from the de-identified US Optum electronic healthcare records at first diagnosis of ATTRwt-CM or prescription of tafamidis, then followed until last activity or death. Of these, 209 patients were prescribed tafamidis during follow-up, 167 (80%) within 1 month, 98% by 6 months, and 100% by 9 months. Median time from index to tafamidis prescription, calculated using the Kaplan-Meier method, was 5.8 months (95% confidence interval [CI] 2.4-not evaluable). RESULTS: Factors associated with tafamidis prescription in a multivariable Cox proportional hazards regression (hazard ratio [95% CI]) included age ≥ 65 years (2.1 [1.07-4.05]), male sex (1.6 [1.07-2.28]), having heart failure/cardiomyopathy (2.4 [1.54-3.82]), and having had technetium-99m pyrophosphate myocardial scintigraphy (1.7 [1.28-2.28]). CONCLUSIONS: The clinical characteristics of patients with ATTRwt-CM who were prescribed tafamidis in the real world were broadly comparable with those who took part in ATTR-ACT. Further studies are needed to evaluate hereditary and ATTRwt-CM patient populations in the real world and assess the long-term outcomes associated with disease management pathways. CLINICAL TRIALS REGISTRATION: ClinicalTrials.gov identifier: NCT01994889.

Baseline characteristics and secondary medication adherence among Medicare patients diagnosed with transthyretin amyloid cardiomyopathy and/or receiving tafamidis prescriptions: A retrospective analysis of a Medicare cohort.

BACKGROUND: Transthyretin amyloid cardiomyopathy (ATTR-CM) is an underdiagnosed, life-threatening condition that mostly affects older persons. In May 2019, regulatory approval of tafamidis provided the first pharmacologic treatment of ATTR-CM. In the pivotal phase 3 Transthyretin Amyloidosis Cardiomyopathy Clinical Trial (ATTR-ACT), 97.2% of patients were classified as adherent (defined as taking ≥ 80% of scheduled doses). Given its recent approval, there is limited real-world evidence examining patient adherence to tafamidis. OBJECTIVE: To evaluate adherence patterns, demographics, and clinical characteristics of patients in the United States receiving tafamidis prescriptions through Medicare. Secondarily, we aimed to evaluate concomitant medications filled by this patient population. METHODS: We conducted a retrospective cohort study of US Medicare claims data, limited by the Health Insurance Portability and Accountability Act of 1996, in adult patients with an adjudicated pharmacy claim for tafamidis (tafamidis free acid 61-mg capsule once daily or tafamidis meglumine four 20-mg capsules once daily) between May 1, 2019, and June 30, 2021. Gaps in therapy were measured using day gaps between prescription refills and continuous measure of medication gaps. Implementation adherence was assessed through modified medication possession ratio (MPRm), medication refill adherence (MRA), and proportion of days covered (PDC). Patients were grouped based on Medicare coverage. Patients were analyzed by subgroups based on age and at the zip code level, via distressed communities index quartiles and rural-urban tiers. RESULTS: A total of 3,558 patients who received a prescription fill of a tafamidis formulation were identified using Medicare Fee-for-Service (FFS) and Medicare Advantage (MA) claims data from May 1, 2019, to June 30, 2021. The characteristics of this patient population were consistent with published literature, as 98.6% were older than 65 years, 53.4% were between 75 years and 84 years, and 81.5% were male. In the patient population receiving tafamidis refills, adherence was high across all 3 measures, with mean MPRm greater than 90% and mean MRA greater than 80%, across all age groups. Mean PDC adherence rates were 79% or more across all age groups. Concomitant medications were generally indicated for heart failure and thrombosis. Among monotherapy groups with similar demographic makeup, adherence was significantly higher among users of tafamidis free acid vs tafamidis meglumine (P < 0.0001 across all mean adherence measures). CONCLUSIONS: Our results demonstrate that real-world adherence to tafamidis in the Medicare population is high, regardless of age, zip code-level socioeconomic quartile, or geography. Adherence was higher among patients receiving tafamidis free acid, suggesting that the enhanced convenience of a single capsule once daily may positively contribute to adherence among patients with ATTR-CM. DISCLOSURES: Darrin Benjumea is an employee of Genesis Research who has been contracted by Pfizer, Inc., for involvement in this study. Andrew Peterson is an employee of University of the Sciences who has been contracted by Pfizer, Inc., for involvement in this study. Zach Bredl is an employee of Care Journey who has been contracted by Pfizer, Inc., for involvement in this study. Anuja Roy, Nick Marchant, Jose Alvir, Rahul Bhambri, Jason Kemner, and Bhash Parasuraman are employees of Pfizer, Inc., and own stock and/or stock options. This study was supported by Pfizer, Inc.

Baseline Characteristics and Secondary Medication Adherence Patterns Among Patients Receiving Tafamidis Prescriptions: A Retrospective Analysis Using a National Specialty Pharmacy Dispensing Database.

Introduction: Transthyretin amyloid cardiomyopathy (ATTR-CM) is a serious, underrecognized condition, which leads to heart failure and early mortality if left untreated. Until recently, heart transplantation was the only treatment for ATTR-CM. Regulatory approval of tafamidis transformed treatment for patients. In the phase 3 Transthyretin Amyloidosis Cardiomyopathy Clinical Trial (ATTR-ACT), which established the safety and efficacy of tafamidis, medication adherence was high with 97.2% of patients taking ≥80% of scheduled doses. Evidence of real-world adherence to cardiology drugs demonstrates low adherence and suboptimal outcomes; however, real-world adherence to tafamidis has not been investigated. The main objective of this study was to describe adherence patterns of patients filling tafamidis in the Symphony Health database. Methods: This retrospective analysis of the Symphony Health Solutions claims database used secondary adherence measures, including modified medication possession ratio (MPRm), days between fills adherence rate, and compliance rate, to assess adherence patterns of 2020 patients filling tafamidis free acid 61-mg capsules or tafamidis meglumine 4x20-mg capsules from June 1, 2019 to August 31, 2020. Results: Patients receiving a tafamidis formulation had characteristics consistent with the expected patient population; 71.6% were aged 75-84 years, 83.2% were male, and the highest proportion resided in the Northeast region (30.5%) of the United States. Adherence for tafamidis was high, as 75% to 100% of the patients across subgroups met or exceeded the commonly defined adherence threshold of 80%. Median number of refills ordered and received was six refills per patient. Most patients received refills with no gap (n=1633) or a gap <30 days (n=1267/1317 patients). Adherence was high across follow-up time, sex, and age subgroups. Adherence varied by geographic region, with the Northeast being significantly higher than the Midwest (mean MPRm 94.41% vs 88.21%, p=0.0007). Conclusion: These results provide evidence that real-world adherence to tafamidis in patients with ATTR-CM is high.

Cost-effectiveness analysis of treatments for vertebral compression fractures.

BACKGROUND: Vertebral compression fractures (VCFs) can be treated by nonsurgical management or by minimally invasive surgical treatment including vertebroplasty and balloon kyphoplasty. OBJECTIVE: The purpose of the present study was to characterize the cost to Medicare for treating VCF-diagnosed patients by nonsurgical management, vertebroplasty, or kyphoplasty. We hypothesized that surgical treatments for VCFs using vertebroplasty or kyphoplasty would be a cost-effective alternative to nonsurgical management for the Medicare patient population. METHODS: Cost per life-year gained for VCF patients in the US Medicare population was compared between operated (kyphoplasty and vertebroplasty) and non-operated patients and between kyphoplasty and vertebroplasty patients, all as a function of patient age and gender. Life expectancy was estimated using a parametric Weibull survival model (adjusted for comorbidities) for 858 978 VCF patients in the 100% Medicare dataset (2005-2008). Median payer costs were identified for each treatment group for up to 3 years following VCF diagnosis, based on 67 018 VCF patients in the 5% Medicare dataset (2005-2008). A discount rate of 3% was used for the base case in the cost-effectiveness analysis, with 0% and 5% discount rates used in sensitivity analyses. RESULTS: After accounting for the differences in median costs and using a discount rate of 3%, the cost per life-year gained for kyphoplasty and vertebroplasty patients ranged from $US1863 to $US6687 and from $US2452 to $US13 543, respectively, compared with non-operated patients. The cost per life-year gained for kyphoplasty compared with vertebroplasty ranged from -$US4878 (cost saving) to $US2763. CONCLUSIONS: Among patients for whom surgical treatment was indicated, kyphoplasty was found to be cost effective, and perhaps even cost saving, compared with vertebroplasty. Even for the oldest patients (85 years of age and older), both interventions would be considered cost effective in terms of cost per life-year gained.

Does influenza vaccination of older adult Medicare beneficiaries lower treatment costs for acute and chronic respiratory disease?

BACKGROUND: Influenza accounts for a large proportion of hospitalizations and deaths among older adults, resulting in substantial health care expenses. Influenza vaccinations are effective in reducing respiratory infections in younger populations, but it is less certain whether they reduce costs associated with respiratory infections among older adults. OBJECTIVE: The purpose of this study was to determine whether influenza vaccination of older adult Medicare beneficiaries reduced costs associated with acute and chronic respiratory conditions during 3 recent influenza seasons. METHODS: This study analyzed the relationship between influenza vaccination and costs for respiratory conditions among Medicare beneficiaries >or=55 years of age in influenza seasons (October-May) between 2002 and 2005 using data from the Medicare Current Beneficiary Survey. Two-part multiple regressions of vaccination status were estimated on the probability and cost of treating respiratory conditions in each influenza season controlling for influenza risk factors and other covariates. Various sensitivity tests were conducted by type of service, subgroup analysis for specific population risk segments, propensity score-matched comparisons, and difference equations. RESULTS: The study sample included 13,402 Medicare beneficiaries for the 3 influenza seasons examined. Vaccination rates varied between 67.3% and 74.9% over the 3 influenza seasons. In unadjusted comparisons, no significant difference in the cost of treating respiratory conditions was found between vaccinated and unvaccinated beneficiaries in 2002/2003 (-$104), but vaccinated beneficiaries had significantly higher mean cost differentials in the more recent influenza seasons ($258 in 2003/2004, P = 0.012; $254 in 2004/2005, P = 0.003). Based on 2-part multiple regressions of vaccine status over the 3 seasons combined, costs of respiratory conditions were $142 dollars higher on average for vaccinated beneficiaries (P = 0.014). The base regression models showed no significant cost savings from vaccination in any year. Results of 2 of the 54 sensitivity tests that were conducted indicated significant savings from vaccination (inpatient costs for 2002/2003 and difference in total costs for persons unvaccinated in 2002/2003 but vaccinated in 2003/2004). CONCLUSION: In this study of older adults, no significant cost savings were found with influenza vaccines in the 3 influenza seasons examined (2002-2005) when the outcome was measured in terms of differential spending for acute and chronic respiratory conditions.

Cost of routine immunization of young children against rotavirus infection with Rotarix versus RotaTeq.

Using a probabilistic model of the clinical and economic burden of rotavirus gastroenteritis (RVGE), we estimated the expected impact of vaccinating a US birth cohort with Rotarix in lieu of RotaTeq. Assuming full vaccination of all children, use of Rotarix - rather than RotaTeq - was estimated to reduce the total number of RVGE events by 5% and associated costs by 8%. On an overall basis, Rotarix would reduce costs by $77.2 million (95% CI $71.5-$86.5). Similar reductions with Rotarix were estimated to occur under an assumption of incomplete immunization of children.

Impact of methylphenidate formulation on treatment patterns and hospitalizations: a retrospective analysis.

BACKGROUND: While stimulant therapy has been shown to be effective in the treatment of attention-deficit/hyperactivity disorder (ADHD), there is less information concerning differences between alternative stimulant medications. The purpose of this study is to examine how different formulations of methylphenidate (MPH) affect treatment patterns and hospitalizations. METHODS: From a large claims database we retrospectively identified individuals age 6 or older who were diagnosed with ADHD and who received either once daily, extended-release oral system methylphenidate (OROS MPH) (e.g., Concerta) or three-times daily immediate-release generic methylphenidate (TID MPH). There were 5,939 individuals included in the analysis--4,785 who initiated therapy with OROS MPH and 1,154 who initiated therapy with TID MPH. We used Analyses of Covariance (ANCOVAs) to examine differences in treatment patterns between individuals who initiated therapy on OROS MPH and those who initiated therapy on TID MPH. We used logistic and negative binomial multivariate regressions to examine the probability of being hospitalized and the hospital length of stay. RESULTS: Controlling for demographic characteristics, patient general health status, and comorbid diagnoses, significantly fewer individuals who initiated therapy with OROS MPH had a 15-day gap in therapy (85% vs. 97%, p < 0.0001 or a 30-day gap in therapy (77% vs. 95%, p < 0.0001) or switched to another ADHD medication (27% vs. 68%, p < 0.0001). Individuals who initiated therapy with OROS MPH stayed on therapy significantly longer (199 vs. 108 mean days, p < 0.0001) and more individuals received medication for 90% (24% vs. 5%, p < 0.0001), 80% (29% vs. 7%, p < 0.0001), or 75% (30% vs. 7%, p < 0.0001) of the days during the first year post initiation of therapy. Individuals who initiated therapy on OROS MPH were also significantly less likely to be hospitalized (odds ratio = 0.67, p = 0.0454) and stayed, on average, 0.69 fewer days in the hospital (p = 0.0035). CONCLUSION: Results demonstrate that among individuals diagnosed with ADHD who receive either OROS MPH or TID MPH, the use of OROS MPH is associated with fewer gaps in medication, less switches in medication, and more days on intent-to-treat therapy. In addition, use of OROS MPH compared to TID MPH was associated with improved outcomes, as measured by the reduced use of hospitalizations.

Effect of methylphenidate formulation on treatment patterns and use of emergency room services.

PURPOSE: The treatment patterns of and use of emergency room services by patients with attention-deficit/hyperactivity disorder (ADHD) who initiated therapy with thrice-daily, immediate-release (IR) methylphenidate versus once-daily, extended-release (ER) oral system methylphenidate were studied. METHODS: Using a large claims database, patients who were newly initiated on either ER methylphenidate or IR methylphenidate were retrospectively identified. Analysis of covariance was used to examine differences in treatment patterns between individuals who initiated therapy on ER methylphenidate and those who initiated therapy on IR methylphenidate. Multivariate regressions were used to examine the probability of visiting the emergency room and the number of visits to the emergency room. RESULTS: Of the 5939 patients who met the inclusion criteria, 4785 were initiated on ER methylphenidate and 1154 were initiated on IR methylphenidate. Significantly fewer patients initiated on ER methylphenidate had a 15- or 30-day gap in therapy or switched to another ADHD medication (p < 0.0001 for all comparisons). In addition, patients initiated on the ER formulation had a significantly longer duration of therapy than did those who received IR methylphenidate (p < 0.0001). Patients who received initial treatment with ER methylphenidate were also significantly less likely to visit an emergency room (odds ratio, 0.79; p = 0.01) and had, on average, 0.21 fewer visit to the emergency room (p = 0.0101). CONCLUSION: A retrospective analysis of a patient database demonstrated that initial treatment with ER methylphenidate for patients with ADHD was associated with longer treatment periods, fewer switches in therapy, increased patient adherence, and a lower usage rate of emergency room services compared with initial treatment with IR methylphenidate.

Emergency department use and costs for youth with attention-deficit/hyperactivity disorder: associations with stimulant treatment.

OBJECTIVE: To investigate whether, among youth with attention-deficit/hyperactivity disorder (ADHD), stimulant treatment is associated with reduced emergency department (ED) use and medical costs. METHODS: We previously reviewed the complete and detailed school and medical records of all individuals born 1976-1982 in Rochester, Minn, to identify those who met criteria for ADHD between age 5 years and emigration from the area. Stimulant treatment (all start/stop dates, dosages) was also abstracted. This study followed birth cohort members with ADHD in provider-linked billing data from January 1, 1987 (billing data first available), to age 18 for outcomes: ED visits, ED costs, and medical costs. For each outcome, we analyzed associations with 1) any stimulants (yes/no), 2) proportion of follow-up time on stimulants, and 3) among those treated with stimulants, periods on versus off stimulants. RESULTS: Of 313 youth with ADHD, 231 (74%) received any stimulants; treatment duration ranged from 14 days to 11.8 years. Treated and untreated youth were similar with respect to median annual ED visits (0.5 vs 0.5) and medical costs (661 US dollars vs 741 US dollars) (P > .05); however, increasing proportion of follow-up on stimulants was associated with fewer ED visits (P= .02) and higher medical costs (P< .001). The 231 treated youth experienced an average of 3.7 periods on and off stimulants; while receiving stimulants, they exhibited fewer ED visits (P= .02), lower ED costs (P = .03), and higher medical costs (P< .001) compared with periods off stimulants. CONCLUSIONS: Among youth with ADHD, extended stimulant treatment is associated with decreased ED visits and ED costs, but higher total medical costs.

Multicenter, randomized, open-label study of OROS methylphenidate versus atomoxetine: treatment outcomes in African-American children with ADHD.

The Formal Observation of Concerta versUs Strattera (FOCUS) study was conducted to assess, in children with ADHD, treatment outcomes with Concerta [OROS methylphenidate (MPH)], a once-daily controlled-release medication, and Strattera, (atomoxetine), a selective noradrenaline reuptake inhibitor, Because of the lack of data in minority groups treated for ADHD, the present subgroup analysis was conducted to determine the effectiveness and tolerability of ADHD treatments in African-American patients who were randomized to OROS MPH (n=125) or atomoxetine (n=58) during the FOCUS study. At the end of the study, the mean dose of OROS MPH was 32.8 +/- 10.9 mg and that of atomoxetine was 1.1 +/- 0.4 mg/kg. The results demonstrated that both treatments were associated with significant improvements in ADHD symptoms from baseline; however, patients who received OROS MPH demonstrated significantly greater improvements in total ADHD symptoms, inattentiveness and global improvement. The incidence of adverse events was similar in both treatment groups. OROS MPH and atomoxetine are effective and tolerable in the treatment of African Americans with ADHD, and significantly greater treatment responses were observed in patients receiving OROS MPH compared with those receiving atomoxetine over three weeks. Additional studies are needed to evaluate treatment response in this population.

Continuity of methylphenidate treatment for attention-deficit/hyperactivity disorder.

OBJECTIVE: To compare the continuity of methylphenidate hydrochloride (MPH) therapy among youth Medicaid beneficiaries treated for attention-deficit/hyperactivity disorder with immediate-release (IR) or extended-release (ER) MPH formulations. Method An analysis was conducted of statewide California Medicaid claims (2000-2003) focusing on children and adolescents, ages 6 to 17 years, who started ER-MPH or IR-MPH treatment for attention-deficit/hyperactivity disorder. The study cohorts were limited to youth who had not filled a prescription for MPHs, amphetamines, pemoline, or atomoxetine for 6 months preceding the index prescription and remained eligible for Medicaid benefits for the following 12 months. The study groups were compared with respect to background demographic traits and clinical characteristics. Mean and median duration of MPH treatment episodes were defined to terminate if a gap of 30 or more days occurred from the end of the last prescription supply to the start of the next prescription. Survival time ratios were used to assess treatment duration controlling for group differences in background characteristics. RESULTS: As compared with patients initiating IR-MPH treatment, patients initiating ER-MPH treatment had a significantly longer mean estimated duration of treatment (ER-MPH, 140.3 days [95% confidence interval (CI), 136.3-144.4 days] vs IR-MPH, 103.4 days [95% CI, 101.3-103.4 days]). Similar results were found in analyses stratified by patient age, race/ethnicity, and sex. Controlling for group differences in age, sex, race/ethnicity, coprescribed psychotropic medications, other treated mental disorders, case management, managed care participation, and seasonal effects, ER-MPH treatment initiation was associated with an average 37% longer duration of treatment than IR-MPH treatment (survival time ratio, 1.37 [95% CI, 1.32-1.42]). Among patients treated with ER-MPH, treatment initiation with an osmotic release oral system MPH (Concerta) was associated with significantly longer mean duration (147.2 days [95% CI, 142.6-151.7 days]) than treatment initiation with Metadate CD (controlled delivery) (113.0 days [95% CI, 100.9-125.1 days]) or Ritalin LA (long acting) (101.1 days [95% CI, 91.2-111.0 days]), respectively. CONCLUSIONS: Extended-release MPH formulations were associated with greater continuity of MPH treatment than IR formulations in the study population. Initial selection of an ER formulation may help to prolong continuity of MPH therapy among youth Medicaid beneficiaries with attention-deficit/hyperactivity disorder.

Outcomes of OROS methylphenidate compared with atomoxetine in children with ADHD: a multicenter, randomized prospective study.

This community-based study was designed to evaluate treatment outcomes with OROS methylphenidate (MPH) and atomoxetine in children with attentiondeficit/hyperactivity disorder (ADHD), as assessed by physicians and parents in a setting that resembles clinical practice. In a multicenter, prospective, open-label study, children 6 to 12 years of age with ADHD were randomized (2:1, respectively) to 3 weeks of treatment with once-daily OROS MPH or atomoxetine. Investigatorrated measures of symptoms included the ADHD Rating Scale (ADHD-RS) and the Clinical Global Impression-Improvement of Illness scale (CGI-I). Assessments were made at baseline and during a telephone interview in week 1, a clinic visit in week 2, and a final clinic visit in week 3. In total, 1323 patients received OROS MPH (n = 850) or atomoxetine (n = 473). Significant reductions from baseline in investigator-evaluated ADHD-RS scores were observed among patients receiving OROS MPH and those receiving atomoxetine. At the end of the study, mean decreases from baseline ADHD-RS scores were 20.24 for OROS MPH and 16 for atomoxetine (P < .001). Between-treatment differences appeared to increase over time (2.77, 3.44, and 4.24 at weeks 1, 2, and 3, respectively; P < .001). Treatment response (ie, 25% reduction from baseline ADHD-RS scores) was significantly greater at each evaluation for patients taking OROS MPH than for those taking atomoxetine (P < .001). Similar percentages of patients taking OROS MPH (4.8%) and atomoxetine (5.5%) withdrew because of adverse events. Although community-based studies often lack the control of randomized, placebo-controlled trials, these results nevertheless suggest greater ADHD symptom improvement with OROS MPH compared with atomoxetine.

Productivity and medical costs of diabetes in a large employer population.

OBJECTIVE: The purpose of this study was to assess the economic burden of diabetes from an employer's perspective. We analyzed the costs of diabetes, using claims data for an employed population and the prevalence of selected comorbid conditions. RESEARCH DESIGN AND METHODS: The data source is a claims database from a national Fortune 100 manufacturer. It includes medical, pharmacy, and disability claims for all beneficiaries (n >100,000). Both medical and work productivity costs of diabetes patients are compared by age with those of matched control subjects from the overall beneficiary population. Out-of-pocket and intangible costs are excluded. RESULTS: In 1998, the employer's mean annual per capita costs were higher for all diabetes beneficiaries than for control subjects ($7,778 +/- 16,176 vs. $3,367 +/- 8,783; P < 0.0001), yielding an incremental cost of $4,410 +/- 18,407 associated with diabetes. The medical and productivity costs for employees with diabetes were significantly (P < 0.0008) higher than for control subjects. The incremental cost of diabetes among employees ranged from $4,671 (aged 18-35 years) to $4,369 (aged 56-64 years). CONCLUSIONS: Diabetes imposes a significant economic burden on employers, particularly when including productivity costs. Employers should select health plans that provide enriched benefits to diabetes patients, including ready access to medical and pharmacy services as well as aggressive diabetes management programs.