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.

Rationale and design of the ENhancing outcomes through Goal Assessment and Generating Engagement in Diabetes Mellitus (ENGAGE-DM) pragmatic trial.

BACKGROUND: Poor glycemic control among patients with diabetes may stem from poor medication and lifestyle adherence or a failure to appropriately intensify therapy. A patient-centered approach could discern the most likely possibility and would then, as appropriate, address patient barriers to non-adherence (using behavioral interviewing methods such as motivational interviewing) or help facilitate choices among treatment augmentation options (using methods such as shared decision-making). OBJECTIVE: To test the impact of a novel telephone-based patient-centered intervention on glycemic control for patients with poorly-controlled diabetes. METHODS/DESIGN: ENGAGE-DM (ENhancing outcomes through Goal Assessment and Generating Engagement in Diabetes Mellitus) is a pragmatic trial of patients with poorly-controlled diabetes receiving treatment with an oral hypoglycemic agent. We randomized 1400 patients in a large health insurer to intervention or usual care. The intervention is delivered over the telephone by a pharmacist and consists of a 2-step process that integrates brief negotiated interviewing and shared decision-making to identify patient-concordant goals and options for enhancing patients' diabetes management. The trial's primary outcome is disease control, assessed using glycosylated hemoglobin values. Secondary outcomes include medication adherence measures, assessed using pharmacy claims data. CONCLUSIONS: This trial will determine whether a novel highly-scalable patient engagement strategy improves disease control and adherence to medications among individuals with poorly-controlled diabetes.

Are new models needed to optimize the utilization of new medicines to sustain healthcare systems?

Medicines have made an appreciable contribution to improving health. However, even high-income countries are struggling to fund new premium-priced medicines. This will grow necessitating the development of new models to optimize their use. The objective is to review case histories among health authorities to improve the utilization and expenditure on new medicines. Subsequently, use these to develop exemplar models and outline their implications. A number of issues and challenges were identified from the case histories. These included the low number of new medicines seen as innovative alongside increasing requested prices for their reimbursement, especially for oncology, orphan diseases, diabetes and HCV. Proposed models center on the three pillars of pre-, peri- and post-launch including critical drug evaluation, as well as multi-criteria models for valuing medicines for orphan diseases alongside potentially capping pharmaceutical expenditure. In conclusion, the proposed models involving all key stakeholder groups are critical for the sustainability of healthcare systems or enhancing universal access. The models should help stimulate debate as well as restore trust between key stakeholder groups.

The impact of reducing cardiovascular medication copayments on health spending and resource utilization.

OBJECTIVES: The aim of this study was to evaluate the impact of reductions in statin and clopidogrel copayments on cardiovascular resource utilization, major coronary events, and insurer spending. BACKGROUND: Copayments are widely used to contain health spending but cause patients to reduce their use of essential cardiovascular medications. Reducing copayments for post-myocardial infarction secondary prevention has beneficial effects, but the impact of this strategy for lower risk patients and other drugs remains unclear. METHODS: An evaluation was conducted of health care spending and resource use by a large self-insured employer that reduced statin copayments for patients with diabetes or vascular disease and reduced clopidogrel copayments for all patients prescribed this drug. Eligible individuals in the intervention company (n = 3,513) were compared with a control group from other companies without such a policy (n = 49,803). Analyses were performed using segmented regression models with generalized estimating equations. RESULTS: Lowering copayments was associated with significant reductions in rates of physician visits (relative change: statin users 0.80; 95% confidence interval [CI]: 0.57 to 0.98; clopidogrel users: 0.87; 95% CI: 0.59 to 0.96) and hospitalizations and emergency department admissions (relative change: statin users 0.90; 95% CI: 0.80 to 0.92; clopidogrel users: 0.89; 95% CI: 0.74 to 0.90) although not major coronary events. Patient out-of-pocket spending for drugs and other medical services decreased (relative change: statin users 0.79; 95% CI: 0.75 to 0.83; clopidogrel users 0.74; 95% CI: 0.66 to 0.82). Providing more generous coverage did not increase overall spending (relative change: statin users 1.03; 95% CI: 0.97 to 1.09; clopidogrel users 0.94; 95% CI: 0.87 to 1.03). CONCLUSIONS: Lowering copayments for statins and clopidogrel was associated with reductions in health care resource use and patient out-of-pocket spending. The policy appeared cost neutral with respect to overall health spending.

Utilization patterns of extended-release naltrexone for alcohol dependence.

OBJECTIVE: The purpose of this retrospective study was to evaluate health plan member utilization patterns of extended-release naltrexone (XR-NTX) and assess the cost of alcohol-related hospitalizations and medical and pharmacy costs. This is the first known study that examined post-XR-NTX therapy outcomes and costs. STUDY DESIGN: Retrospective analysis of claims data. METHODS: A sample of 48 members was identified with continuous pharmacy and medical benefit enrollment between July 1, 2006, and December 31, 2008, and a medical claim for reimbursement code J2315 (naltrexone for extended-release injectable suspension) with a date of service between July 1, 2007, and December 31, 2007. RESULTS: The average duration of XR-NTX therapy was 3 months. Among the 40% of patients who received 3 or more months of therapy, 58% had gaps in therapy. Post-XR-NTX therapy, alcohol-related hospitalization, medical, and pharmacy costs significantly decreased. CONCLUSION: Findings validate that abstinence from alcohol remains an issue after discontinuing therapy. Despite most patients being on therapy for less than 6 months, there were significant reductions in costs for alcohol-related hospitalizations, as well as total medical and total pharmacy costs.

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.

At Pitney Bowes, value-based insurance design cut copayments and increased drug adherence.

To date, there has been little empirical evidence to support the broader use of value-based insurance design, which lowers copayments for services with high value relative to their costs. To address this lack of data, we evaluated the impact of the value-based insurance program of a US corporation, Pitney Bowes. The program eliminated copayments for cholesterol-lowering statins and reduced them for clopidogrel, a blood clot inhibitor. We found that the policy was associated with an immediate 2.8 percent increase in adherence to statins relative to controls, which was maintained for the subsequent year. For clopidogrel, the policy was associated with an immediate stabilizing of the adherence rate and a four-percentage-point difference between intervention and control subjects a year later. Our study thus provides an empirical basis for the use of this approach to improve the quality of health care.

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.

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.

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.

Prescriber compliance with black box warnings in older adult patients.

BACKGROUND: Patients prescribed medications with US Food and Drug Administration-issued black box warnings (BBWs) warrant additional vigilance by prescribers because these drugs can cause serious adverse drug events. Seniors are at greater risk for adverse drug events due to increased medication burden and greater health vulnerability. OBJECTIVE: To improve our understanding of the prescribing and patient-monitoring practices of physicians prescribing medications with a BBW to patients age >or=65 years in an ambulatory care setting. METHODS: A retrospective cohort study of administrative pharmacy and medical claims identified 58,190 patients age >or=65 years in the Horizon Blue Cross Blue Shield of New Jersey beneficiary population with >or=1 claim for >or=1 of the 8 targeted medications between January 1, 2005, and December 31, 2005. Medications included carbamazepine, amiodarone, ketoconazole, loop diuretics, methotrexate, cyclosporine, metformin and combinations, and cilostazol. Patients were followed 12 months from the index prescription date to evaluate prescriber compliance with BBWs using operationalized definitions of compliance. RESULTS: Patients prescribed drugs with a drug-laboratory warning had lower rates of prescriber BBW compliance (0.7%-24.9%) than patients prescribed drugs with a drug-disease warning (84.7%-90.2%). CONCLUSIONS: Administrative claims analysis identified low rates of prescriber compliance with BBWs in managing patients age >or=65 years. Claims analysis may be a cost-effective strategy to monitor prescriber compliance with BBWs in older patients at higher risk.

Measuring concurrent adherence to multiple related medications.

OBJECTIVES: To propose standardized methods for measuring concurrent adherence to multiple related medications and to apply these definitions to a cohort of patients with diabetes mellitus. STUDY DESIGN: Retrospective cohort study of 7567 subjects with diabetes prescribed 2 or more classes of oral hypoglycemic agents in 2005. METHODS: For each medication class, adherence for each patient was estimated using prescription-based and interval-based measures of proportion of days covered (PDC) from cohort entry until December 31, 2006. Concurrent adherence was calculated by applying these 2 measures in the following 3 ways: (1) the mean of each patient's average PDC, (2) the proportion of days during which patients had at least 1 of their medications available to them, and (3) the proportion of patients with a PDC of at least 80% for all medication classes. Because patients taking multiple related medications have distinct patterns of use, the analysis was repeated after classifying patients into mutually exclusive groups. RESULTS: Concurrent medication adherence ranged from 35% to 95% depending on the definition applied. Interval-based measures provide lower estimates than prescription-based techniques. Definitions that require the use of at least 1 drug class categorize virtually all patients as adherent. Requiring patients to have a PDC of at least 80% for each of their drugs results in only 30% to 40% of patients being defined as adherent. The variability in adherence is greatest for patients whose treatment regimen changed the most during follow-up. CONCLUSIONS: The variability in adherence estimates derived from different definitions may substantially impact qualitative conclusions about concurrent adherence to related medications. Because the measures we propose have different underlying assumptions, the choice of technique should depend on why adherence is being evaluated.

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.

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.

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.

Adherence to antidepressant treatment among privately insured patients diagnosed with depression.

BACKGROUND: Antidepressants are effective in treatment of depression, but poor adherence to medication is a major obstacle to effective care. OBJECTIVE: We sought to describe patient and provider level factors associated with treatment adherence. METHODS: This was a retrospective, observational study using medical and pharmacy claims from a large health plan, for services provided between January 2003 and January 2005. We studied a total of 4312 subjects ages 18 or older who were continuously enrolled in the health plan with a new episode of major depression and who initiated antidepressant treatment. Treatment adherence was measured by using pharmacy refill records during the first 16 weeks (acute phase) and the 17-33 weeks after initiation of antidepressant therapy (continuation phase). Measures were based on Health Plan Employer Data and Information Set (HEDIS) quality measures for outpatient depression care. RESULTS: Fifty-one percent of patients were adherent through the acute phase; of those, 42% remained adherent in the continuation phase. Receipt of follow-up care from a psychiatrist and higher general pharmacy utilization (excluding psychotropics) were associated with better adherence in both phases. Younger age, comorbid alcohol or other substance abuse, comorbid cardiovascular/metabolic conditions, use of older generation antidepressants, and residence in lower-income neighborhoods were associated with lower acute-phase adherence. Continuation-phase adherence was lower for HMO participants than for others. CONCLUSION: In an insured population, many patients fall short of adherence to guideline recommended therapy for depression. Information from existing administrative data can be used to predict patients at highest risk of nonadherence, such as those with substance abuse, and to target interventions.

Utilization patterns of second-line antibiotics in a health plan setting.

Increased utilization of second-line antibiotics where first-line agents are appropriate, and the use of antibiotics for viral infections, are leading to the development of resistance. This retrospective study evaluated antibiotic utilization patterns of cephalosporins, macrolides, and quinolones for community-acquired infections in a health plan's patient population. Patients were identified through the health plan's computerized pharmacy claims database. Patients were considered eligible if they had been enrolled with the health plan for at least one year, and had a prescription claim for a cephalosporin, macrolide, or quinolone antibiotic between February 1, 2001 and April 30, 2001. Six hundred fifty patients were randomly selected to undergo chart review. A total of 128 patients (25.2%) from an eligible cohort of 508 health plan members had no documented diagnosis of infection in their chart. Gram staining was checked in 14 patients. Cultures were ordered for only 19 patients. Comparisons were made with regard to first-, second-, and third-line drug use in select documented infections. Of all the patients in the study, only 10.4% (53/508) had chart documentation of previous antibiotic failure. Of the 456 patients who had documentation, 63% had no known antibiotic allergies, and 19% had allergies to penicillin. The results of this study will be used to educate providers and consumers on appropriate antibiotic prescribing.