Validity of ICD-10-based algorithms to identify patients with influenza in inpatient and outpatient settings.

PURPOSE: To evaluate the validity of ICD-10-CM code-based algorithms as proxies for influenza in inpatient and outpatient settings in the USA. METHODS: Administrative claims data (2015-2018) from the largest commercial insurer in New Jersey (NJ), USA, were probabilistically linked to outpatient and inpatient electronic health record (EHR) data containing influenza test results from a large NJ health system. The primary claims-based algorithms defined influenza as presence of an ICD-10-CM code for influenza, stratified by setting (inpatient/outpatient) and code position for inpatient encounters. Test characteristics and 95% confidence intervals (CIs) were calculated using test-positive influenza as a reference standard. Test characteristics of alternative outpatient algorithms incorporating CPT/HCPCS testing codes and anti-influenza medication pharmacy claims were also calculated. RESULTS: There were 430 documented influenza test results within the study period (295 inpatient, 135 outpatient). The claims-based influenza definition had a sensitivity of 84.9% (95% CI 72.9%-92.1%), specificity of 96.3% (95% CI 93.1%-98.0%), and PPV of 83.3% (95% CI 71.3%-91.0%) in the inpatient setting, and a sensitivity of 76.7% (95% CI 59.1%-88.2%), specificity of 96.2% (95% CI 90.6%-98.5%), PPV of 85.2% (95% CI 67.5%-94.1%) in the outpatient setting. Primary inpatient discharge diagnoses had a sensitivity of 54.7% (95% CI 41.5%-67.3%), specificity of 99.6% (95% CI 97.7%-99.9%), and PPV of 96.7% (95% CI 83.3%-99.4%). CPT/HCPCS codes and anti-influenza medication claims were present for few outpatient encounters (sensitivity 3%-10%). CONCLUSIONS: In a large US healthcare system, inpatient ICD-10-CM codes for influenza, particularly primary inpatient diagnoses, had high predictive value for test-positive influenza. Outpatient ICD-10-CM codes were moderately predictive of test-positive influenza.

Fournier's gangrene in patients with type 2 diabetes using second-line antidiabetic medications.

Cases of a rare but serious infection called Fournier's gangrene have been reported with sodium-glucose co-transporter-2 inhibitors (SGLT-2i). To evaluate the safety signal in a population of patients with type 2 diabetes, we used administrative claims data from Horizon Blue Cross Blue Shield of New Jersey from 2014 through 2017 to estimate incidence rates of Fournier's gangrene or necrotizing fasciitis of the perineum among patients treated with a second-line antidiabetic drug. We found very low incidence rates of Fournier's gangrene or necrotizing fasciitis. While we found no indication of an increased risk among SGLT-2i users compared with similar patients treated with other second-line antidiabetic medications, the small number of events yielded wide confidence intervals.

Personalizing health care: feasibility and future implications.

Considerable variety in how patients respond to treatments, driven by differences in their geno- and/ or phenotypes, calls for a more tailored approach. This is already happening, and will accelerate with developments in personalized medicine. However, its promise has not always translated into improvements in patient care due to the complexities involved. There are also concerns that advice for tests has been reversed, current tests can be costly, there is fragmentation of funding of care, and companies may seek high prices for new targeted drugs. There is a need to integrate current knowledge from a payer's perspective to provide future guidance. Multiple findings including general considerations; influence of pharmacogenomics on response and toxicity of drug therapies; value of biomarker tests; limitations and costs of tests; and potentially high acquisition costs of new targeted therapies help to give guidance on potential ways forward for all stakeholder groups. Overall, personalized medicine has the potential to revolutionize care. However, current challenges and concerns need to be addressed to enhance its uptake and funding to benefit patients.

Rheumatoid arthritis decision making: many information sources but not all rated as useful.

BACKGROUND: Patients who make high-quality medical decisions are more likely to have better health outcomes. One of the central components to a high-quality decision is the well-informed manner in which it is made. However, there has been little research studying patient behaviors regarding how they seek information about treatments for rheumatoid arthritis (RA). METHODS: We conducted a pilot study surveying beneficiaries of a health plan who had 2 or more visits coded for RA. Of 799 invited subjects, 101 (13%) completed interviews. Participants answered a questionnaire regarding sources of RA treatment information and their usefulness, sociodemographic items, and scales regarding their attitudes toward providers and medicines. Outcomes of interest included the average number of sources described (range, 0-10) and the usefulness for each source (1 "not useful" and 4 "extremely useful"). RESULTS: Methotrexate was the most widely used medication reported. The mean (SD) number of information sources used was 5.0 (2.1). Participants rated the information they used with a mean (SD) score of 2.8 (0.7). We found no strong patient correlates of these outcomes when compared with the aforementioned domains. Of the 98% of the total sample who referred to a rheumatologist for information, 87% rated the source as extremely useful. The Internet was the most frequently used nonprovider source, with 63% of subjects reporting use, and a mean (SD) usefulness rating of 3.0 (1.03). CONCLUSIONS: In this pilot study, participants used many sources of information regarding treatment decisions for RA. Ninety-eight percent of the participants used rheumatologists as a source and found them extremely useful. Of the nonprovider sources, the Internet was most common, and 40% found it very useful.

Comparing pre-gap and gap behaviors for Medicare beneficiaries in a Medicare managed care plan.

OBJECTIVE: To examine the impact of the coverage gap on pharmacy use, expenditures, and out-of-pocket costs for Medicare managed care beneficiaries before and after reaching the gap. STUDY DESIGN: A longitudinal comparison of behaviors for beneficiaries with non-gap coverage before and after reaching the gap. METHODS: Prescription drug use and expenditures were assessed for Medicare beneficiaries who reached the gap, including subsets with one of four chronic disorders (congestive heart failure (CHF), diabetes, dyslipidemia, or hypertension). Differences in pre- and post-prescription use were calculated using generalized estimating equations. Time until the end and start of the gap was estimated using a Cox proportional hazards model. Expenditure data were estimated using bootstrap methods. RESULTS: Roughly a quarter (27.1 percent) of patients reached the gap in 2006, of whom 3.6 percent passed through the gap. The most prevalent disease state was hypertension (58.5 percent). Beneficiaries took an average of 8.1 months to reach the gap. Patients <65 years (HR = 1.42, 95% CI = 1.29 - 1.56) and those with diabetes (HR = 1.19, 95% CI = 1.12 - 1.27) were more likely to reach the gap sooner as compared to older beneficiaries (aged 65 to 74) and those without diabetes. These individuals were more likely to pass through the gap as well. Beneficiaries faced a 60.7 percent increase in out-of-pocket expenditures in the gap phase. Brand-name medication use decreased by 9.3 percent, while generic medication use increased by 7.4 percent. For chronic conditions, however, over 90 percent of individuals continued brand-name medication use in the gap. CONCLUSIONS: Our findings suggest that, in general, beneficiaries take lower-cost generics while in the gap. However, taking brand-name medications is the predominant behavior for beneficiaries with chronic diseases. Health care reform provisions that close the gap over the next ten years may facilitate continuity of medication use while in the gap.

Patient, physician, and payment predictors of statin adherence.

BACKGROUND: Although many patient, physician, and payment predictors of adherence have been described, knowledge of their relative strength and overall ability to explain adherence is limited. OBJECTIVES: To measure the contributions of patient, physician, and payment predictors in explaining adherence to statins. RESEARCH DESIGN: Retrospective cohort study using administrative data. SUBJECTS: A total of 14,257 patients insured by Horizon Blue Cross Blue Shield of New Jersey who were newly prescribed a statin cholesterol-lowering medication. MEASURES: Adherence to statin medication was measured during the year after the initial prescription, based on proportion of days covered. The impact of patient, physician, and payment predictors of adherence were evaluated using multivariate logistic regression. The explanatory power of these models was evaluated with C statistics, a measure of the goodness of fit. RESULTS: Overall, 36.4% of patients were fully adherent. Older patient age, male gender, lower neighborhood percent black composition, higher median income, and fewer number of emergency department visits were significant patient predictors of adherence. Having a statin prescribed by a cardiologist, a patient's primary care physician, or a US medical graduate were significant physician predictors of adherence. Lower copayments also predicted adherence. All of our models had low explanatory power. Multivariate models including patient covariates only had greater explanatory power (C = 0.613) than models with physician variables only (C = 0.566) or copayments only (C = 0.543). A fully specified model had only slightly more explanatory power (C = 0.633) than the model with patient characteristics alone. CONCLUSIONS: Despite relatively comprehensive claims data on patients, physicians, and out-of-pocket costs, our overall ability to explain adherence remains poor. Administrative data likely do not capture many complex mechanisms underlying adherence.

Introduction: landscape of opioid dependence.

BACKGROUND: The use of opioids for chronic noncancer pain increased 222% from 1992 to 2002. Opioid dependence has also increased significantly, leading to a burden on patients, employers, insurers, society, and the entire health care system. It is imperative that opioid dependence is addressed and treated properly, in order to return patients to being productive participants in the workplace and society. OBJECTIVE: To provide an overview of addiction, abuse, and dependence and identify risk factors for addiction. SUMMARY: Studies have shown that intensive use of opioids is associated with increased utilization of costly health care services, prolonged disability, and continued use of opioids, leading to abuse and dependence in many patients. While identifying patients at risk for developing opioid dependence is difficult, there are many risk stratification tools now available to practitioners, including the Opioid Risk Tool (ORT) or Screener and Opioid Assessment for Patients with Pain (SOAPP). Understanding the differences between dependence, addiction, and tolerance is essential to managing patients on opioids. CONCLUSION: It is imperative that patients be properly managed when being treated for pain. Physicians and employers have to be able to identify patients at risk for opioid abuse or exhibiting symptoms of opioid abuse and know how to address their needs.

Patient perspective, complexities, and challenges in managed care.

BACKGROUND: Lack of coordination of care is one of the largest obstacles involved with treating opioid dependence. Physicians also face the challenges of managing comorbidities and dealing with relapse. OBJECTIVE: To examine the clinical, economic, and humanistic factors involved in treating opioid dependence. SUMMARY: Despite the extensive utilization of narcotic analgesics, pain is often uncontrolled. Effective pain management and coordination of care is essential in treating pain patients, as patients who abuse pain medications consume more health care resources than nonabusers. Patients who abuse are 2.3 times more likely to present at the emergency department and 6.7 times more likely to be hospitalized than nonabusers. Managed care organizations are now incorporating integrated approaches to treating pain and substance abuse disorders, realizing that patients must be looked at as a whole, considering alternative and behavioral therapies in addition to pharmacological treatments. They are also able to assess patterns of abuse using pharmacy claims data and alert physicians to potential problems by making use of prescription monitoring programs. Physicians who treat chronic pain must utilize strategies to minimize the risk of developing dependence on opioids, and practitioners treating opioid dependence must employ policies to optimize outcomes. Such strategies include developing pain contracts; performing random urine screenings and pill counts; and setting goals of therapy and re-evaluating patients throughout treatment. Plans must be in place in the event of relapse, as well. CONCLUSION: In order to be successful in managing opioid dependence, physicians, employers, and managed care organizations must work together to provide an integrated approach to treatment.

Risk sharing arrangements for pharmaceuticals: potential considerations and recommendations for European payers.

BACKGROUND: There has been an increase in 'risk sharing' schemes for pharmaceuticals between healthcare institutions and pharmaceutical companies in Europe in recent years as an additional approach to provide continued comprehensive and equitable healthcare. There is though confusion surrounding the terminology as well as concerns with existing schemes. METHODS: A literature review was undertaken to identify existing schemes supplemented with additional internal documents or web-based references known to the authors. This was combined with the extensive knowledge of health authority personnel from 14 different countries and locations involved with these schemes. RESULTS AND DISCUSSION: A large number of 'risk sharing' schemes with pharmaceuticals are in existence incorporating both financial-based models and performance-based/outcomes-based models. In view of this, a new logical definition is proposed. This is "risk sharing' schemes should be considered as agreements concluded by payers and pharmaceutical companies to diminish the impact on payers' budgets for new and existing schemes brought about by uncertainty and/or the need to work within finite budgets". There are a number of concerns with existing schemes. These include potentially high administration costs, lack of transparency, conflicts of interest, and whether health authorities will end up funding an appreciable proportion of a new drug's development costs. In addition, there is a paucity of published evaluations of existing schemes with pharmaceuticals. CONCLUSION: We believe there are only a limited number of situations where 'risk sharing' schemes should be considered as well as factors that should be considered by payers in advance of implementation. This includes their objective, appropriateness, the availability of competent staff to fully evaluate proposed schemes as well as access to IT support. This also includes whether systematic evaluations have been built into proposed schemes.

Association of Potentially Modifiable Diabetes Care Factors With Glycemic Control in Patients With Insulin-Treated Type 2 Diabetes.

Importance: Numerous factors are associated with the ability of patients with type 2 diabetes to achieve optimal glycemic control. However, many of these factors are not modifiable by quality improvement interventions. In contrast, the structure of how diabetes care is delivered, such as whether patients visit an endocrinologist or how prescriptions are filled, is potentially modifiable, yet its associations with glycemic control have not been rigorously evaluated. Objective: To investigate the association of diabetes care delivery with glycemic control in patients with type 2 diabetes using insulin. Design, Setting, and Participants: This retrospective cohort study used baseline claims and laboratory insurer data within a large pragmatic trial to identify individuals with type 2 diabetes using insulin with data for at least 1 hemoglobin A1c (HbA1c) test result from before trial randomization (July 1, 2014, to October 5, 2016) and for key nonmodifiable patient factors as well as diabetes care delivery and behavioral factors measured before the HbA1c test. Analyses were conducted from February 4, 2017, to November 13, 2018. Main Outcomes and Measures: Multivariable modified Poisson regression was used to evaluate the independent associations of nonmodifiable patient factors and potentially modifiable diabetes care delivery and patient behavioral factors with achieving adequate diabetes control (ie, HbA1c level <8%). The extent of measured variation explained in glycemic control by these factors was also explored using pseudo R2 and C statistics. Results: Of 1423 patients included, 565 (39.7%) were women, and the mean (SD) age was 56.4 (9.0) years. In total, 690 (48.5%) had HbA1c levels less than 8%. Age (relative risk [RR] per 1-unit increase, 1.01; 95% CI, 1.00-1.02), persistent use of basal insulin (RR, 1.20; 95% CI, 1.00-1.43), more frequent filling of glucose self-testing supplies (RR, 1.01; 95% CI, 1.01-1.02), visiting an endocrinologist (RR, 1.41; 95% CI, 1.19-1.67), and receipt of insulin prescriptions by mail order (RR, 1.23; 95% CI, 1.03-1.48) were all independently associated with adequate control. Measured potentially modifiable diabetes care factors explained more variation in adequate glycemic control than measured nonmodifiable patient factors (C statistic, 0.661 vs 0.598; pseudo R2 = 0.11 vs 0.04). Conclusions and Relevance: These findings suggest that for patients with type 2 diabetes using insulin, the way in which care is delivered may be more strongly associated with achieving adequate control of HbA1c levels than patient factors that cannot be altered are. Given the potential for intervention, these care delivery factors could be the focus of efforts to improve diabetes outcomes.

Ongoing strategies to improve the management of upper respiratory tract infections and reduce inappropriate antibiotic use particularly among lower and middle-income countries: findings and implications for the future.

Introduction: Antibiotics are indispensable to maintaining human health; however, their overuse has resulted in resistant organisms, increasing morbidity, mortality and costs. Increasing antimicrobial resistance (AMR) is a major public health threat, resulting in multiple campaigns across countries to improve appropriate antimicrobial use. This includes addressing the overuse of antimicrobials for self-limiting infections, such as upper respiratory tract infections (URTIs), particularly in lower- and middle-income countries (LMICs) where there is the greatest inappropriate use and where antibiotic utilization has increased the most in recent years. Consequently, there is a need to document current practices and successful initiatives in LMICs to improve future antimicrobial use.Methodology: Documentation of current epidemiology and management of URTIs, particularly in LMICs, as well as campaigns to improve future antimicrobial use and their influence where known.Results: Much concern remains regarding the prescribing and dispensing of antibiotics for URTIs among LMICs. This includes considerable self-purchasing, up to 100% of pharmacies in some LMICs. However, multiple activities are now ongoing to improve future use. These incorporate educational initiatives among all key stakeholder groups, as well as legislation and other activities to reduce self-purchasing as part of National Action Plans (NAPs). Further activities are still needed however. These include increased physician and pharmacist education, starting in medical and pharmacy schools; greater monitoring of prescribing and dispensing practices, including the development of pertinent quality indicators; and targeted patient information and health education campaigns. It is recognized that such activities are more challenging in LMICs given more limited resources and a lack of healthcare professionals.Conclusion: Initiatives will grow across LMICs to reduce inappropriate prescribing and dispensing of antimicrobials for URTIs as part of NAPs and other activities, and these will be monitored.

An evaluation of the relationship between the implementation of a newly designed prescription drug label at Target pharmacies and health outcomes.

BACKGROUND: Medication errors represent a major public health concern, and inadequate prescription drug labels have been identified as a root cause of errors. A new prescription medication labeling system was implemented by Target pharmacies in May 2005 and aimed to improve health outcomes. OBJECTIVES: To evaluate whether the new Target label influenced patient health services utilization. SUBJECTS: Derived from 2 large health plans. RESEARCH DESIGN AND MEASURES: Using administrative claims, we identified patients with 1 of 9 chronic diseases who filled prescriptions at Target pharmacies and a matched sample who filled prescriptions at other community pharmacies. We stratified our cohort into new and prevalent medication users and evaluated the impact of the Target label on outpatient, emergency department and inpatient health services use. We used linear regression and segmented linear regression to evaluate the new-user and prevalent-user analyses, respectively. RESULTS: Our sample included 23,745 Target pharmacy users and 162,369 matched non-Target pharmacy users. In the new-user analysis, we found no significant change in rates of both outpatient (event rate ratio: 0.53; 95% CI: 0.15-1.86) and inpatient and emergency department (Event rate ratio: 0.88; 95% CI: 0.62-1.24) health services utilization in Target users after implementation when compared with non-Target users. Similarly, in the prevalent user analysis, we found no change in the level or slope of outpatient or emergency/inpatient services in Target users after implementation of the new label when compared with non-Target users. CONCLUSIONS: We found no statistically significant change in health services use attributable to the implementation of the new prescription drug label at Target pharmacies. These findings highlight the challenge of influencing health outcomes with interventions to improve health literacy.

Can improved prescription medication labeling influence adherence to chronic medications? An evaluation of the Target pharmacy label.

BACKGROUND: Prescription medication labels contain valuable health information, and better labels may enhance patient adherence to chronic medications. A new prescription medication labeling system was implemented by Target pharmacies in May 2005 and aimed to improve readability and understanding. OBJECTIVE: We evaluated whether the new Target label influenced patient medication adherence. DESIGN AND PATIENTS: Using claims from two large health plans, we identified patients with one of nine chronic diseases who filled prescriptions at Target pharmacies and a matched sample who filled prescriptions at other community pharmacies. MEASUREMENTS: We stratified our cohort into new and prevalent medication users and evaluated the impact of the Target label on medication adherence. We used linear regression and segmented linear regression to evaluate the new-user and prevalent-user analyses, respectively. RESULTS: Our sample included 23,745 Target users and 162,368 matched non-Target pharmacy users. We found no significant change in adherence between new users of medications at Target or other community pharmacies (p = 0.644) after implementing the new label. In prevalent users, we found a 0.0069 percent reduction in level of adherence (95% CI -0.0138-0.0; p < 0.001) and a 0.0007 percent increase in the slope in Target users (the monthly rate of change of adherence) after implementation of the new label (95% CI 0.0001-0.0013; p = 0.001). CONCLUSIONS: We found no changes in adherence of chronic medication in new users, and small and likely clinically unimportant changes in prevalent users after implementation of the new label. While adherence may not be improved with better labeling, evaluation of the effect of labeling on safety and adverse effects is needed.

Shape it up: a school-based education program to promote healthy eating and exercise developed by a health plan in collaboration with a college of pharmacy.

BACKGROUND: Childhood obesity is an intensifying public health problem that affects millions of U.S. children. Obesity leads to the development of health conditions such as hypertension, diabetes, gastroesophogeal reflux disease, depression, and hypercholesterolemia. The increasing prevalence of these conditions among U.S. children is reflected in increased use of medical services and medications in both childhood and adulthood. OBJECTIVE: To assess the preliminary results of the effectiveness of Shape It Up, a school-based obesity prevention program developed and implemented by the Ernest Mario School of Pharmacy at Rutgers University in conjunction with Horizon Blue Cross Blue Shield of New Jersey, with the goal of using these results to help improve the program. METHODS: Program activities and materials included an interactive workshop, an activity book and family guide, posters, a website, and educational field days. The Shape It Up program not only delivered a positive message about eating healthful food but also modeled fruit and vegetable consumption during the interactive workshops and distributed fruits and vegetables as prizes. During the 2004-2005 and 2005-2006 school years, Shape It Up was delivered to 89,736 children at 257 New Jersey elementary schools. Pre-intervention and post-intervention surveys were administered to a convenience sample of 6,421 students at 49 participating schools. Attitudes were measured using a 6-point Likert-type graphic face scale (smiles positive, frowns negative) and analyzed for statistical significance of pre-intervention to post-intervention change using paired t-tests. RESULTS: After exposure to the Shape It Up program, children reported higher levels of knowledge (P < 0.001) and positive attitudes (P < 0.001) about healthy eating and exercise compared with the baseline survey results. In a question to gauge satisfaction with the program, 54.9% of children surveyed gave the program the highest possible rating, and overall, 91.7% selected 1 of the 3 response categories toward the positive end of the 6-point scale. CONCLUSION: Shape It Up appears to have had a positive impact on children's knowledge and attitudes toward exercise and healthy eating. Additional research employing a comparison group is needed to assess the program's impact.

Actionable Real-World Evidence to Improve Health Outcomes and Reduce Medical Spending Among Risk-Stratified Patients with Diabetes.

BACKGROUND: Type 2 diabetes mellitus (T2DM) is a chronic condition with a high economic burden as well as drug treatments that have not all demonstrated effects on longevity. Managed care organizations want to improve health outcomes in these complex patients but lack actionable evidence to make informed decisions on which therapies are most effective among their members and may also control total health care spending. OBJECTIVE: To produce actionable evidence by identifying antidiabetic treatments that are effective and may reduce total cost of care in various risk groups of patients with T2DM, using insurance claims data that includes medical claims and pharmacy dispensing data among members of Horizon Blue Cross Blue Shield of New Jersey with T2DM. METHODS: We identified patients with T2DM in longitudinal claims data from Horizon between 2014 and 2017 with demographic and enrollment information, inpatient and outpatient diagnoses and procedures, and pharmacy dispensing. Outcomes included myocardial infarction, heart failure (HF), stroke, percutaneous revascularization, health care services utilization, and plan costs (i.e., medical, pharmacy, and total cost of care). After propensity score decile adjustment on over 20 covariates, we evaluated the effectiveness and safety of second-line antidiabetic treatment that included sodium-glucose co-transporter-2 (SGLT-2) inhibitors, sulfonylureas (SUs), dipeptidyl peptidase-4 (DPP-4) inhibitors, and glucagon-like peptide-1 (GLP-1) receptor agonists. RESULTS: Among 115,308 members with T2DM, the most common comorbidities were cardiovascular risk factors, including hyperlipidemia (56%), hypertension (50%), and existing cardiovascular disease (CVD; 55%). Among members receiving dual antidiabetic treatment (n = 20,204), the most prevalent treatments were metformin plus the following second-line medications: SUs (42%), DPP-4 inhibitors (29%), SGLT-2 inhibitors (10%), or GLP-1 receptor agonists (3%). Approximately 20% of members accounted for 79% of total cost of care, with an average of $9,605 per member per year (PMPY). Compared with SU initiation and after propensity score decile adjustment, new users of SGLT-2 inhibitors had a reduced risk for HF hospitalization (HR = 0.35, 95% CI = 0.13-0.89), hypoglycemia, albuminuria, microvascular disease, and metabolic failure. Among SGLT-2 inhibitor initiators with established CVD, the savings in total cost of care compared with SU initiators was $5,520 per member over an average treatment duration of 6 months and an approximate savings of $11,000 PMPY if patients persisted on treatment for 12 months. CONCLUSIONS: In the Horizon membership, we confirmed that SGLT-2 inhibitors reduce HF hospitalizations, resulting in reduced medical spending and savings in total cost of care. Regulatory-grade analytics of local data provided the confidence to encourage increased SGLT-2 inhibitor use to produce better outcomes and save total cost of care despite higher pharmacy spending. DISCLOSURES: This research did not receive outside funding; however, Aetion has since begun a contractual relationship with Horizon Blue Cross Blue Shield of New Jersey. Garry, Petruski-Ivleva, Cheever, and Rajan are employees of and have stock options in Aetion, a company that makes software for the analysis of real-world data. Eapen was an employee of Aetion during the implementation of this study. Rassen is an employee of and has ownership interest in Aetion. Murk is a consultant to Aetion of which he owns equity. Schneeweiss is a consultant to WHISCON and to Aetion, of which he also owns equity. He is the principal investigator of investigator-initiated grants to the Brigham and Women's Hospital from Bayer, Genentech, Boehringer Ingelheim, and Vertex. Gambino is an employee and officer at Horizon Blue Cross and Blue Shield of New Jersey. He was recently appointed to a board observer position at Aetion, as Horizon has small equity interest in Aetion. Jan is an employee of Rutgers State University and Horizon Blue Cross Blue Shield of New Jersey and has no conflict of interest or association with Aetion or any pharmaceutical company. Jang and Rubin are employees of Horizon Blue Cross and Blue Shield of New Jersey and have no conflict of interest or association with Aetion. This work was presented as a poster at AMCP Nexus 2018, October 22-25, 2018, in Orlando, FL; as part of a continuing education session at the AMCP Managed Care & Specialty Pharmacy 2019 Annual Meeting in San Diego, CA, March 25-28, 2019; as invited podium presenter at the Blue Cross Blue Shield 2019 National Summit conference in Grapevine, TX, April 29-May 2, 2019; and was accepted for a podium presentation at the International Society for Pharmacoeconomics and Outcomes Research (ISPOR) 2019 annual conference in New Orleans, LA, May 18-22, 2019, where it won an award for Best Podium Presentation.

Impact of a novel pharmacist-delivered behavioral intervention for patients with poorly-controlled diabetes: The ENhancing outcomes through Goal Assessment and Generating Engagement in Diabetes Mellitus (ENGAGE-DM) pragmatic randomized trial.

BACKGROUND: Many factors contribute to suboptimal diabetes control including insufficiently-intensive treatment and non-adherence to medication and lifestyle. Determining which of these is most relevant for individual patients is challenging. Patient engagement techniques may help identify contributors to suboptimal adherence and address barriers (using motivational interviewing) and help facilitate choices among treatment augmentation options (using shared decision-making). These methods have not been used in combination to improve diabetes outcomes. OBJECTIVE: To evaluate the impact of a telephone-based patient-centered intervention on glycosylated hemoglobin (HbA1c) control for individuals with poorly-controlled diabetes. DESIGN: Two-arm pragmatic randomized control trial within an explanatory sequential mixed-methods design. SUBJECTS: 1,400 participants 18-64 years old with poorly-controlled type 2 diabetes. INTERVENTION: The intervention was delivered over the telephone by a clinical pharmacist and consisted of a 2-step process that integrated brief negotiated interviewing and shared decision-making to identify patient goals and options for enhancing diabetes management. MAIN MEASURES: The primary outcome was change in HbA1c. Secondary outcomes were medication adherence measures. Outcomes were evaluated using intention-to-treat principles; multiple imputation was used for missing values in the 12-month follow-up. We used information from pharmacist notes to elicit factors to potentially explain the intervention's effectiveness. KEY RESULTS: Participants had a mean age of 54.7 years (SD:8.3) and baseline HbA1c of 9.4 (SD:1.6). Change in HbA1c from baseline was -0.79 (SD:2.01) in the control arm and -0.75 (SD:1.76) in the intervention arm (difference:+0.04, 95%CI: -0.22, 0.30). There were no significant differences in adherence. In as-treated analyses, the intervention significantly improved diabetes control (-0.48, 95%CI: -0.91, -0.05). Qualitative findings provided several potential explanations for the findings, including insufficiently addressing patient barriers. CONCLUSIONS: A novel telephone-based patient-centered intervention did not improve HbA1c among individuals with poorly-controlled diabetes, though as-treated analyses suggest that the intervention was effective for those who received it. TRIAL REGISTRATION: ClinicalTrials.gov NCT02910089.

Effectiveness of Targeted Insulin-Adherence Interventions for Glycemic Control Using Predictive Analytics Among Patients With Type 2 Diabetes: A Randomized Clinical Trial.

Importance: Patient adherence to antidiabetic medications, especially insulin, remains poor, leading to adverse outcomes and increased costs. Most adherence interventions have only been modestly effective, partly because they are not targeted to patients who could benefit most. Objective: To evaluate whether delivering more intensive insulin-adherence interventions only to individuals with type 2 diabetes predicted to benefit most was more effective than delivering a lower-intensity intervention to a larger group of unselected individuals. Design, Setting, and Participants: This 3-arm pragmatic randomized clinical trial used data from Horizon, the largest health insurer in New Jersey, on 6000 participants 18 years or older with type 2 diabetes who were receiving basal insulin. Patients were excluded if they were insured by Medicaid or Medicare or had fewer than 3 months of continuous enrollment. The study was conducted from July 7, 2016, through October 5, 2017. Analyses were conducted from February 5 to September 24, 2018. Interventions: Eligible patients were randomized to 3 arms in a 1:1:1 ratio. Randomization was stratified based on baseline availability of 1 or more glycated hemoglobin A1c (HbA1c) test values. All arms were designed to cost the same, and each cohort received a tailored pharmacist telephone consultation varying based on (1) proportion receiving the intervention and (2) intensity, including follow-up frequency and cointerventions. Arm 1 offered a low-intensity intervention to all patients. Arm 2 offered a moderate-intensity intervention to 60% of patients based on their predicted risk of insulin nonadherence. Arm 3 offered a high-intensity intervention to 40% of patients based on glycemic control and predicted risk of insulin nonadherence. Main Outcomes and Measures: The primary outcome was insulin persistence. Secondary outcomes were changes in HbA1c level and health care utilization. Outcomes were evaluated in arms 2 and 3 vs arm 1 using claims data, intention-to-treat principles, and multiple imputation for missing values in the 12-month follow-up. Results: Among 6000 participants, mean (SD) age was 55.9 (11.0) years and 3344 (59.8%) were male. Compared with arm 1, insulin nonpersistence did not differ in arm 2 (relative risk, 0.88; 95% CI, 0.75-1.03) or arm 3 (relative risk, 0.91; 95% CI, 0.77-1.06). Glycemic control was similar in arm 2 and arm 1 (absolute HbA1c level difference, -0.15%; 95% CI, -0.34% to 0.05%) but was better in arm 3 (absolute HbA1c level difference, -0.25%; 95% CI, -0.43% to -0.06%). Total spending and office visits did not differ, but arm 2 (moderate intensity intervention) had more hospitalizations (odds ratio, 1.22; 95% CI, 1.06-1.41) and emergency department visits (odds ratio, 1.38; 95% CI, 1.24-1.53) than did arm 1 (low intensity intervention). Conclusions and Relevance: Compared with an untargeted low-intensity intervention, delivering a highly targeted high-intensity intervention did not improve insulin persistence but modestly improved mean glycemic control. A partially targeted moderate-intensity intervention did not change insulin persistence or HbA1c level but was associated with a small increase in hospitalizations. Trial Registration: ClinicalTrials.gov Identifier: NCT02846779.

Long-term adherence to evidence based secondary prevention therapies after acute myocardial infarction.

BACKGROUND: After acute myocardial infarction (AMI), treatment with beta-blockers and angiotensin-converting enzyme inhibitors (ACEI) is widely recognized as crucial to reduce risk of a subsequent AMI. However, many patients fail to consistently remain on these treatments over time, and long-term adherence has not been well described. OBJECTIVE: To examine the duration of treatment with beta-blockers and ACEI within the 24 months after an AMI. DESIGN: A retrospective, observational study using medical and pharmacy claims from a large health plan operating in the Northeastern United States. SUBJECTS: Enrollees with an inpatient claim for AMI who initiated beta-blocker (N = 499) or ACEI (N = 526) therapy. MEASUREMENT: Time from initiation to discontinuation was measured with pharmacy refill records. Associations between therapy discontinuation and potential predictors were estimated using a Cox proportional hazards model. RESULTS: ACEI discontinuation rates were high: 7% stopped within 1 month, 22% at 6 months, 32% at 1 year and 50% at 2 years. Overall discontinuation rates for beta-blockers were similar, but predictors of discontinuation differed for the two treatment types. For beta-blockers, the risk of discontinuation was highest among males and those from low-income neighborhoods; patients with comorbid hypertension and peripheral vascular disease were less likely to discontinue therapy. These factors were not associated with ACEI discontinuation. CONCLUSION: Many patients initiating evidence-based secondary prevention therapies after an AMI fail to consistently remain on these treatments. Adherence is a priority area for development of better-quality measures and quality-improvement interventions. Barriers to beta-blocker adherence for low-income populations need particular attention.

Opioid drug utilization and cost outcomes associated with the use of buprenorphine-naloxone in patients with a history of prescription opioid use.

BACKGROUND: Management of opioid dependence is associated with many challenges such as the misuse of prescribed treatment and lack of medication adherence that can affect the clinical outcome of the patient. Buprenorphine-naloxone was approved by the U.S. Food and Drug Administration in October 2002 as the first outpatient treatment indicated for opioid dependence. There is only 1 report in the literature on the effectiveness of buprenorphine-naloxone in a real-world setting and no reports on persistence and cost obtained from administrative claims data. OBJECTIVES: To determine (1) the length and cost of therapy with oral buprenorphine-naloxone, and (2) the cost avoidance for opioid dependence as measured by opioid utilization and opioid drug cost obtained from pharmacy claim records. METHODS: The patients for this drug use evaluation (DUE) were identified from a New Jersey managed care organization (MCO) with approximately 1.8 million members with pharmacy benefits who (a) were continuously enrolled from October 1, 2004, through September 30, 2006; (b) had their first buprenorphine-naloxone pharmacy claim during the fixed 6-month initiation period (April 1, 2005, through September 30, 2005); and (c) had at least 1 opioid pharmacy claim in the 6-month pre period preceding the 6-month initiation period. The outcome measures included the number of opioid pharmacy claims, daily dose, days supply, and cost defined as opioid ingredient cost. Member cost share and net plan cost (after subtraction of member cost share) were also measured. The measurement periods for opioid use and cost were the fixed calendar periods for 6 months from October 1, 2004, through March 31, 2005, and for 12 months from October 1, 2005, through September 30, 2006. Persistence in the 12-month follow-up period was defined as a gap of 30 days or less between depletion of the days supply for the preceding pharmacy claim for buprenorphinenaloxone and the date of service (refill date) for the succeeding pharmacy claim for buprenorphine-naloxone. RESULTS: Of the 160 new buprenorphine-naloxone users with continuous pharmacy enrollment for the 2-year period ending September 30, 2006, 84 patients (52.5%) had at least 1 opioid pharmacy claim in the 6-month pre period from October 1, 2004, through March 31, 2005, and were included in this DUE. In the 12-month post period from October 1, 2005, through September 2006, the median length of therapy with buprenorphinenaloxone was 1 month, and the mean length of therapy was 3.5 months. Only 40 patients (47.6%) had a pharmacy claim for buprenorphine-naloxone at month 1 in the 12-month post period. Persistence was 27.4% (n = 23) at 6 months (March 2006) and 20.2% (n = 17) at 12 months (September 2006) in the post period. A total of 24 study patients (28.6%) had no opioid pharmacy claims other than buprenorphine-naloxone in the 12-month post period. Utilization of opioids decreased by 18.8%, from 1.49 opioid pharmacy claims per patient per month (PPPM) in the pre period to 1.21 claims PPPM in the post period (P = 0.031). Excluding the 0.42 buprenorphine-naloxone claims PPPM, opioid utilization decreased by 47.0%, from 1.49 claims PPPM to 0.79 claims PPPM (P < 0.001) in the 12-month post period. Before subtraction of member cost share, the actual drug cost of opioids including buprenorphine-naloxone appeared to be 26.9% lower ($156.24 PPPM) in the post period compared with $213.74 PPPM in the pre period, but the difference was not statistically significant (P = 0.254). Excluding the cost of the buprenorphine-naloxone, actual opioid drug cost decreased 66.5% from $213.74 PPPM pre period to $71.65 PPPM post period (P = 0.047). CONCLUSIONS: Approximately one half of the patients who had a new claim for buprenorphine-naloxone were excluded from this study because there was no utilization of prescription opioids in the 6 months prior to initiation. For patients with documented use of prescription opioids prior to initiation, treatment with buprenorphine-naloxone was associated with a reduction in opioid utilization and cost in the first year of follow-up. Persistence was only 27% at 6 months and 20% at 12 months, and there were no drug cost savings in the follow-up period when the actual cost of the buprenorphine-naloxone therapy was included.

Improving care of patients at-risk for osteoporosis: a randomized controlled trial.

BACKGROUND: Despite accurate diagnostic tests and effective therapies, the management of osteoporosis has been observed to be suboptimal in many settings. We tested the effectiveness of an intervention to improve care in patients at-risk of osteoporosis. DESIGN: Randomized controlled trial. PARTICIPANTS: Primary care physicians and their patients at-risk of osteoporosis, including women 65 years and over, men and women 45 and over with a prior fracture, and men and women 45 and over who recently used > or =90 days of oral glucocorticoids. INTERVENTION: A multifaceted program of education and reminders delivered to primary care physicians as well as mailings and automated telephone calls to patients. OUTCOME: Either undergoing a bone mineral density (BMD) testing or filling a prescription for a bone-active medication during the 10 months of follow-up. RESULTS: After the intervention, 144 (14%) patients in the intervention group and 97 (10%) patients in the control group received either a BMD test or filled a prescription for an osteoporosis medication. This represents a 4% absolute increase and a 45% relative increase (95% confidence interval 9-93%, p = 0.01) in osteoporosis management between the intervention and control groups. No differences between groups were observed in the incidence of fracture. CONCLUSION: An intervention targeting primary care physicians and their at-risk patients increased the frequency of BMD testing and/or filling prescriptions for osteoporosis medications. However, the absolute percentage of at-risk patients receiving osteoporosis management remained low.