Disparities in SGLT2 Inhibitor or Glucagon-Like Peptide 1 Receptor Agonist Initiation Among Medicare-Insured Adults With CKD in the United States.

Rationale & Objective: Information regarding disparities in initiating sodium/glucose cotransporter 2 inhibitors (SGLT2i) and glucagon-like peptide 1 receptor agonists (GLP-1RA) in patients with chronic kidney disease (CKD) is limited. We examined sociodemographic and clinical factors associated with the initiation of SGLT2i, GLP-1RA, or second-generation sulfonylureas in a Medicare Fee-For-Service patient population with CKD and type 2 diabetes. Study Design: Retrospective cohort study. Setting & Participants: The 20% random sample of Medicare Fee-For-Service claims, 2012-2018. Exposures: Patients' sociodemographic and clinical factors. Outcomes: Use of SGLT2i, GLP-1RA, or sulfonylureas. Analytical Approach: Patients with a newly initiated prescription of SGLT2i, GLP-1RA, or second-generation sulfonylureas from January 1, 2013, to December 31, 2018, were identified. Multinomial logistic regression model was used to evaluate demographic and clinical factors associated with the initiation of SGLT2i, GLP-1RA, or second-generation sulfonylureas. Results: The study cohort comprised 53,029 adults (aged greater than or equal to 18 years) with CKD and type 2 diabetes, of whom 10.0%, 17.4%, and 72.6% had a first prescription for SGLT2i, GLP-1RA, and sulfonylurea, respectively. Patients aged greater than or equal to 75 years versus those aged 65-74 years had lower odds to start SGLT2i or GLP-1RA compared with sulfonylureas. Black patients were associated with lower odds of initiation of SGLT2i (OR, 0.67; 95% CI, 0.61-0.74) and GLP-1RA (OR, 0.73; 95% CI, 0.68-0.79), compared with White patients. Hispanic and Asian patients had lower odds of initiation of GLP-1RA. Patients with cardiovascular disease or hyperlipidemia had higher odds to start SGLT2i or GLP-1RA. Limitations: CKD and type 2 diabetes diagnosis; CKD stage; and patient clinical status were identified with diagnosis or procedure codes. There is potential for residual confounding with the use of retrospective data. Conclusions: The results of this study identified disparities in the use of SGLT2i and GLP-1RA in patients with CKD. Black and older patients were significantly less likely to be initiated on SGLT2i or GLP-1RA than on second-generation sulfonylureas.

Hypoglycemia Risk With SGLT2 Inhibitors or Glucagon-Like Peptide 1 Receptor Agonists Versus Sulfonylureas Among Medicare Insured Adults With CKD in the United States.

Rationale & Objective: Information on safety issues of newer glucose-lowering medications from a large population perspective in chronic kidney disease (CKD) patients with type 2 diabetes is limited. Our study aimed to examine hypoglycemia risk associated with sodium-glucose cotransporter 2 inhibitors (SGLT2is) and glucagon-like peptide 1 receptor agonists (GLP-1RAs) versus second-generation sulfonylureas in a general population of older patients with CKD and type 2 diabetes, across race, age, sex, and socioeconomic subgroups. Study Design: Retrospective cohort. Setting & Participants: The 20% random sample of Medicare fee-for-service claims, 2012-2018. Exposures: Use of SGLT2is, GLP-1RAs, or sulfonylureas. Outcomes: Hypoglycemic events resulting in health care utilization. Analytical Approach: Cox proportional hazard model evaluated the 90-day risk of hypoglycemia associated with SGLT2is or GLP-1RAs versus sulfonylureas. Results: A total of 18,567 adults (mean age: 73 years) with CKD and type 2 diabetes was included; 14.0% (n = 2,528) had a prescription for a SGLT2i or GLP-1RA, and 86.0% (n = 16,039) with a sulfonylurea. Compared with sulfonylureas, use of SGLT2is or GLP-1RAs was associated with a significantly lower risk of hypoglycemia (adjusted HR, 0.30; 95% CI, 0.14-0.65). Black individuals had higher risk of developing hypoglycemia than White individuals (adjusted HR, 1.55; 95% CI, 1.07-2.26). Low-income subsidy compared to no low-income subsidy status was associated with higher risk of hypoglycemic events. The risk of hypoglycemia also increased with higher comorbid condition score. Limitations: CKD and type 2 diabetes diagnosis, CKD stage, and patient clinical status were identified with diagnosis or procedure codes. There is potential for residual confounding with use of retrospective data. Conclusions: Use of SGLT2is or GLP-1RAs compared with sulfonylureas was associated with a lower risk of hypoglycemia among patients with CKD and type 2 diabetes. Black race was not only associated with lower use of newer agents with demonstrated cardiovascular and kidney benefits and lower hypoglycemia risk, but also with a higher rate of hypoglycemic events as compared with White individuals.

Glucose-Lowering Medication Use in CKD: Analysis of US Medicare Beneficiaries Between 2007 and 2016.

BACKGROUND: Information regarding the use of glucose-lowering medications in patients with chronic kidney disease (CKD) is limited. STUDY DESIGN: Retrospective cohort study. SETTING & PARTICIPANTS: Medicare 5% random sample of patients with CKD with type 2 diabetes, 2007 to 2016. PREDICTORS: Study year, CKD stage, low-income subsidy status, and demographic characteristics (age, sex, and race/ethnicity). OUTCOMES: Trends in use of glucose-lowering medications. ANALYTICAL APPROACH: Yearly cohorts of patients with CKD and type 2 diabetes were created. Descriptive statistics were used to report proportions of patients using glucose-lowering medications. To test overall trends in glucose-lowering medication classes, linear probability models with adjustment for age, sex, race/ethnicity, CKD stage, and low-income subsidy status were used. RESULTS: Metformin use increased significantly from 32.7% in 2007 to 48.7% in 2016. Use of newer classes of glucose-lowering medications increased significantly, including dipeptidyl peptidase 4 inhibitors (5.6%, 2007; 21.7%, 2016), glucagon-like peptide 1 receptor agonists (2.3%, 2007; 6.1%, 2016), and sodium-glucose cotransporter 2 inhibitors (0.2%, 2013; 3.3%, 2016). Newer insulin analogue use increased from 37.2% in 2007 to 46.3% in 2013 and then remained steady. Use of sulfonylureas, thiazolidinediones, older insulins (human regular and neutral protamine Hagedorn), α-glucosidase inhibitors, amylin mimetics, and meglitinides decreased significantly. Insulin was the most highly used single medication class. Insulin use was higher among low-income subsidy than among non-low-income subsidy patients. Combination therapy was less common as CKD stage increased. LIMITATIONS: Patients with CKD and type 2 diabetes and the CKD stages were identified with diagnosis codes and could not be verified through medical record review. Our results may not be generalizable to younger patients with CKD with type 2 diabetes. CONCLUSIONS: Use of metformin and newer glucose-lowering medication classes is increasing in patients with CKD with type 2 diabetes. We anticipate that percentages of patients with CKD using these newer agents will increase.

Translational Effect of Provider-Focused, Multi-State, Multi-Clinic Asthma Care Quality Improvement Program on Patient-Level Health Care Costs.

INTRODUCTION/OBJECTIVES: Enhancing Care for Patients with Asthma (ECPA), a year-long provider-focused, multi-state, multi-clinic quality improvement program, decreased avoidable utilizations among patients with asthma, but its effects on health care expenditures were not determined. This study examined the translational and sustainable effects of improved care through ECPA on individual-level total health care costs due to asthma. METHODS: We conducted a retrospective pretest-posttest quasi-experimental study in which attributed 1683 patients in a 12-month pre-ECPA implementation period served as their own control. We constructed the total annual asthma-related health care costs per patient occurred during pre-ECPA implementation, ECPA implementation, and post-ECPA completion. We used 3-level generalized linear mixed models (GLMMs) to estimate the ECPA effect on the annual health care costs and account for correlation between the repeated outcome measures for each patient and nested clinic. All costs were adjusted for inflation to 2014 U.S. dollars, the last year of program observation. RESULTS: Total asthma-related health care costs among the 1683 included patients decreased from an average of $7033 to $3237 per person-year (pre-ECPA implementation vs implementation). Using the cost data from the 12-month pre-ECPA implementation period as a reference, GLMMs found that the ECPA implementation was associated with a reduction in total annual asthma-related health care costs by 56.4% (95% CI -60.7%, -51.8%). During the 12-months after ECPA completion period, health care costs were also found to be significantly lower, experiencing a 57.3% reduction. CONCLUSIONS: The economic benefits of ECPA provide a justification to adopt this quality improvement initiative to more primary care clinics at a national level.

Reducing potentially preventable health events among patients with asthma through multi-state, multi-center quality improvement program.

INTRODUCTION: Enhancing Care for Patients with Asthma is a multi-state, multi-center quality improvement program developed to augment guideline-based practice among health care providers through Plan-Do-Study-Act cycle. This study examined the association between the implementation of the guideline-based quality improvement program and subsequent changes in asthma-related emergency room visits and hospitalizations. METHODS: This retrospective, interrupted time-series study used administrative claims data from a private insurer that provided coverage to patients receiving care from participating health centers (15 centers in New Mexico, Oklahoma, Texas, and Illinois). The 12-month implementation period started in January 2013 for centers in Cohort 1 and October 2013 for centers in Cohort 2. The claims of 1,828 patients with asthma from January 2012 to May 2015 were analyzed. The data included 12-month pre-program implementation, 12-month program implementation, and 5-month post-program completion periods. RESULTS: The average number of asthma-related emergency room visits and hospitalizations decreased from 2.22 to 1.38 and 1.97 to 1.04 per 100 patients per month, respectively, in the 12-month pre-implementation period as compared to 12-month implementation period. The results of three-level generalized linear mixed models found that during the 12-month implementation period, patients had 37.7% and 47.1% lower rates of emergency room visits and hospitalizations, respectively, compared to the 12-month pre-implementation period (p < 0.001 in both comparisons). CONCLUSIONS: Enhancing Care for Patients with Asthma is an effective quality improvement program that was successfully executed in diverse geographical states and associated with reductions in potentially preventable health events. The findings support the widespread use of the program in other settings.

Enhancing guideline-based asthma care processes through a multi-state, multi-center quality improvement program.

OBJECTIVE: This study investigated the effectiveness of Enhancing Care for Patients with Asthma (ECPA)-a collaborative quality improvement program implemented in 65 community health centers that serve asthma patients in four states-on clinic-based asthma performance measures consistent with national guidelines. METHODS: This study utilized a pretest-posttest quasi-experimental design. Six clinic-based performance measures of each center were collected from a retrospective chart review at time points: before the ECPA implementation; at the end of the 12-month long ECPA program; and 6 months after program completion. The effectiveness of the ECPA was assessed using generalized linear mixed models with a Poisson distribution and log link by evaluating the change in each measure from baseline to program completion, from baseline to 6-month post-program completion and from program completion to 6-month post-program completion. RESULTS: The ECPA implementation was positively associated with improvement in all measures from baseline to program completion: documentation of asthma severity (rate ratio (RR) 1.314; 95% confidence interval (CI) 1.206, 1.432); Asthma Control Test (RR 3.625; 95% CI 3.185, 4.124); pulmonary function testing (RR 1.771; 95% CI 1.527, 2.054), asthma education (RR 2.246; 95% CI 2.018, 2.501), asthma action plan (RR 2.335; 95% CI 2.070, 2.634) and controller medication (RR 1.961; 95% CI 1.504,2.556). Improvement was sustained for all six measures at the 6-month post-program completion time point. CONCLUSION: This study demonstrated the favorable effect of the ECPA program on evidence-based asthma quality measures. This program could be considered a model worth replication on a broader scale.

The Medical Home Model and Pediatric Asthma Symptom Severity: Evidence from a National Health Survey.

The objective was to investigate the association between receiving care under the medical home model and parental assessment of the severity of asthma symptoms. It was hypothesized that parents of children who received care under the medical home model reported less severe asthma symptoms compared with their counterparts, whose care did not meet the medical home criteria. Secondary analyses were conducted using cross-sectional data from the 2011-2012 National Survey of Children's Health. Children with asthma aged 0-17 years were included and classified as receiving care from the medical home if their care contained 5 components: a personal doctor, a usual source of sick care, family-centered care, no problems getting referrals, and effective care coordination. Ordinal logistic regression was used to examine the relationship between parent-rated severity of asthma symptoms (mild, moderate, and severe symptoms) and the medical home. Approximately 52% of 8229 children who reported having asthma received care from the medical home. Only 30.8% of children with severe asthma symptoms received care that met the medical home criteria, compared to 55.7% of children with mild symptoms. After accounting for confounding factors, obtaining care under the medical home model decreased the odds of parent-reported severe asthma symptoms by 31% (adjusted odds ratio 0.69; 95% CI, 0.56-0.85). Study results suggest that the medical home model can reduce parent-rated severity of asthma symptoms. The findings highlight the importance of providing medical home care to children with asthma to improve the outcomes that matter most to children and their families.

Pharmacy Practice in the South Dakota Correctional System: Discovery of an Unconventional Experiential Practice Site.

Pharmacists must be prepared to care for populations where health disparities are greatest and their services can best impact public health needs. Such preparation requires that students have access to practice experiences in underserved environments where pharmacy practice, cultural competence and knowledge of population health are experienced simultaneously. The correctional facility is such a place. The American Society of Health-System Pharmacists recommends that students receive preceptorship opportunities within the correctional system. The occasional collaboration or experiential opportunity, like Kingston's early model, has occurred between health professional schools and correctional facilities. However, to date, the correctional facility-experiential site remains an untapped opportunity, at least in a complete, coordinated, pharmaceutical care, patient management framework. Consequently, a short research study asked: To what extent is there potential for correctional facilities to serve as experiential practice sites for pharmacy students? The research objective was to identify pharmaceutical practices within South Dakota correctional system and compare those practices to the guidelines established by the Association of American College of Pharmacy's as optimal for student training. To understand medical and pharmaceutical practices in SDPS, three South Dakota Adult prison facilities were included in the exploratory study. Data was collected through a mixed methods approach designed to obtain perspectives about the SDPS health care system from individuals representing the numerous job levels and roles that exist within the health care continuum. Interviews and a web-based surveys were used to collect data. A review of a 36-page transcript along with 498 freeform survey comments revealed that while exact themes from the Exemplary Practice Framework may not have been evident, related words or synonyms for patient-centered care, informatics, public health, medication therapy management, and quality improvement appeared with great frequency.

Comprehensive Medication Management and Medication Adherence for Chronic Conditions.

BACKGROUND: The beneficial clinical effects of medication adherence have been consistently reported across most chronic diseases. Medication nonadherence carries significant economic and clinical burden. Medication therapy management (MTM) services aim to optimize pharmacotherapy and improve medication adherence. OBJECTIVE: To evaluate the impact of exposure to face-to-face comprehensive medication management (CMM) services on medication adherence across 4 classes of chronic disease medications: oral diabetes medications, statins, angiotensin-converting enzyme inhibitors (ACEIs) or angiotensin II receptor blockers (ARBs), and beta-blockers. METHODS: Pharmacy claims of continuously enrolled employees of a large Midwest integrated health system were retrieved for the period 2007-2011. Retrospective analysis was used to compare medication adherence measured using proportion of days covered (PDC) in employees who received CMM with employees who did not (control group). The pharmacy MTM program used the Patient-Centered Primary Care Collaborative standard of care. The CMM group's index date was the date of the first CMM visit; the non-CMM group's index date was randomly chosen from all therapeutic class-specific prescription claims dates. For each therapeutic class, patients with at least 1 prescription fill in both the measurement period (365 days post-index) and the baseline period (365 days pre-index) were included. The primary outcome measure was the PDC. RESULTS: The CMM group had consistently higher and statistically significant PDC levels across all the therapeutic classes in the measurement period (P < 0.05) when looking at the unadjusted comparison. In the multivariate models, CMM exposure was associated with higher PDC; the difference between groups was statistically significant in all therapeutic classes except for oral diabetes medications (oral diabetes medications: 0.0403, 95% confidence limits [CL] = -0.0050, 0.0850; statins: 0.0769, 95% CL = 0.0480, 0.1050; ACEIs/ARBs: 0.1083; 95% CL = 0.0710, 0.1450; and beta-blockers: 0.0484; 95% CL = 0.0060, 0.0910). Logistic regression showed that the CMM group had an increased probability of meeting the 80% PDC cut-point for statins (3.36, 95% CL = 0.048, 0.105); ACEIs/ARBs (3.57, 95% CL = 2.35, 5.42); and beta-blockers (2.56, 95% CL = 1.57, 4.18). CONCLUSIONS: Exposure to face-to-face CMM services resulted in improvement of medication adherence. CMM is a powerful practice model that should be encouraged by insurers and health plan administrators to increase rates of medication adherence.

Validating pharmaceutical product claims: questions a formulary committee should ask.

Claims, justifying the acceptance and placement of new products on health system formularies, are all too often presented in terms that are either unverifiable or only verifiable in a timeframe that is of no practical benefit to formulary committees. One solution is for formulary committees to request that (i) all predictive claims made should be capable of empirical testing and (ii) manufacturers in making submissions should be asked to submit a protocol that details how their claims are to be assessed. Evaluation of claims can provide not only a significant input to ongoing disease area and therapeutic reviews, but can also provide a needed link to comparative effectiveness research and value-based healthcare. This paper presents a set of protocol standards (PROST) together will questions that should be addressed in a protocol review.

Patient characteristics predicting the frequency of medication therapy management visits for patients with diabetes.

BACKGROUND: Patient characteristics associated with a higher exposure to medication therapy management (MTM) and the relationship between frequency of MTM visits and meeting clinically defined goals of therapy have not been documented. OBJECTIVE: The goal of this study was to evaluate factors predicting frequency of MTM visits for patients with diabetes and the impact of these visits on diabetes clinical outcomes. METHODS: All patients with diabetes participating in a 2007 MTM demonstration project (N = 121) were included in the analysis. A negative binomial regression controlling for age, sex, presence of diabetes complications, taking insulin, Charlson score Index, and hypertension and cholesterol medication regimen composition was used to assess predictors of the number of MTM visits. Optimal diabetes management differences between the 2 groups defined according to median number of MTM visits (low frequency, ≤4; high frequency, >4) was compared by using Wilcoxon Mann-Whitney and χ(2) tests. RESULTS: Having diabetes complications (relative risk = 2.83 [95% CI, 1.3-6.17]; P = 0.0088) and taking insulin (relative risk = 1.43 [95% CI, 1.12-1.83]; P = 0.0038) were associated with a higher number of MTM visits. At baseline, the high-frequency group had a significantly higher proportion of patients with insulin therapy (P < 0.01), higher proportion with diabetes complications (P = 0.07), and higher mean Charlson score (P = 0.08). The rate of optimal diabetes care was significantly lower in the high-frequency group before MTM (P = 0.02) but not statistically different from the low-frequency group during and 1 year after the demonstration project. CONCLUSIONS: Patients with diabetes complications and using regimens that include insulin received more frequent MTM visits. MTM services delivered to a diabetes population with more complex disease or taking insulin have a positive impact on optimal diabetes care.

Optimal diabetes care outcomes following face-to-face medication therapy management services.

Pharmacists play an integral role in influencing resolution of drug-related problems. This study examines the relationship between a pharmacist-led and delivered medication therapy management (MTM) program and achievement of Optimal Diabetes Care benchmarks. Data within Fairview Pharmacy Services were used to identify a group of patients with diabetes who received MTM services during a 2007 demonstration project (n=121) and a control group who were invited to receive MTM services but opted out (n=103). Rates of achieving optimal diabetes clinical management for both groups were compared using the D5 diabetes measure for years 2006, 2007, and 2008. The D5 components are: glycosolated hemoglobin (HbA1c<7%); low-density lipoprotein (<100 mg/dl); blood pressure (<130/80 mmHg); tobacco free; and daily aspirin use. Multivariate difference-in-differences (DID) estimation was used to determine the impact of 1 year of MTM services on each care component. Patients who opted in for MTM had higher Charlson scores, more complex medication regimens, and a higher percentage of diabetes with complications (P<0.05). In 2007, the percentage of diabetes patients optimally managed was significantly higher for MTM patients compared to 2006 values (21.49% vs. 45.45%, P<0.01). Nonlinear DID models showed that MTM patients were more likely to meet the HbA1c criterion in 2007 (odds ratio: 2.48, 95% confidence interval [CI]: 1.04-5.85, P=0.038). Linear DID models for HbA1c showed a mean reduction of 0.54% (95% CI: 0.091%-0.98%, P=0.018) for MTM patients. An MTM program contributed to improved optimal diabetes management in a population of patients with complex diabetes clinical profiles.

Communication Strategies Must Be Tailored to a Medication's Targeted Population: Lessons from the Case of BiDil.

BACKGROUND: The American population's diversity continues to grow, and its racial and ethnic mixes are changing. The US healthcare system must confront this changing reality. The introduction of isosorbide dinitrate/hydralazine hydrochloride (BiDil) to the US marketplace was a move toward recognizing these changing consumer needs. BiDil was approved specifically as a secondary treatment for heart failure in African-American patients. It remains the first and only drug approved by the US Food and Drug Administration for a race-based indication. To ensure commercial success, a drug must be made "visible" to healthcare providers and to consumers. OBJECTIVES: To describe and analyze the case of BiDil and its potential implications for drugs developed for targeted populations to help them avoid a similar fate of market withdrawal because of commercial considerations. METHOD: This analysis is based on 12 comprehensive interviews with 5 clinical investigators, 1 minority healthcare provider, and 5 pharmaceutical representatives, as well as a review of the literature. Overall, 12 one-hour semistructured interviews were conducted. Of the 11 interviewees, 10 were interviewed once and 1 was interviewed once early in the process and then had a second interview by the end of the study. When the 12 scheduled interviews were completed, the recordings were transcribed and subjected to analysis through the use of a readily available computer software package, using concepts and themes collected from the literature and the interviewees' responses. RESULTS: The interviewees lacked consensus regarding the unique nature of BiDil. The clinical researchers considered it innovative in identifying that taking the 2 drugs together produced the greatest clinical effect in African-American patients with heart failure. For them, BiDil represented an innovation in the emerging field of personalized medicine. However, they were dismayed to see that these beliefs were challenged by the medical community and their physician colleagues. They reported that practicing, mainly primary care physicians considered the development of a branded medication that combined 2 older drugs to be superfluous, because the same effect could be achieved by administering each agent individually at the same time. Obtaining a patent for BiDil, therefore, was seen simply as a desire for commercial gain. During the approval hearings, representatives of the sponsored company attributed these concerns to "misinformed physicians" and "uninformed patients." CONCLUSION: The case of BiDil demonstrates that a marketing strategy for a population with unique health issues requires an understanding of underlying cultural, social, and economic underpinnings. Ignorance of these dynamics within the African-American community was blatantly reflected at the launch of the drug. Although BiDil remains a treatment option, there is no marketing effort to promote its use. The failure to capture the targeted market for the drug has important implications for the future of commercial considerations in the development of race-based medications.

Addressing health care disparities using public reporting.

The literature highlights that disparities in health care performance exist. Publicly reporting data about disparities at an actionable level is needed. The Minnesota Health Care Disparities Report is designed to publicly report medical group health care performance rates for patients enrolled in state/federally funded programs. In addition, differences between patients enrolled in state-funded public programs and those in private or Medicare programs at statewide and medical group levels are presented. The endeavor is a cooperative one between Minnesota Community Measurement, an independent nonprofit community organization, and the Minnesota Department of Human Services, the state Medicaid agency. Public reporting makes transparent the gaps in the delivery of health care between patients enrolled in these programs at a medical group level and can facilitate quality improvement locally, where accountability lies and actions to address disparities can occur.

Athletes and asthma.

Many Minnesotans with asthma participate in recreational and competitive sports. If asthma is undiagnosed or if it is poorly controlled, its symptoms can compromise health, impair athletic performance, and limit sports participation. It can even lead to death. Asthma-related deaths during sports participation, while not common, have occurred in Minnesota. Having asthma should not limit an athlete's ability to compete and win at the highest levels of competition. This article briefly reviews asthma and exercise-induced bronchoconstriction, discusses the impact of asthma on sports participation and outlines asthma management strategies for team physicians, coaches, and athletic trainers.

Evidence development and publication planning: strategic process.

A number of decisions in the health care field rely heavily on published clinical evidence. A systematic approach to evidence development and publication planning is required to develop a portfolio of evidence that includes at minimum information on efficacy, safety, durability of effect, quality of life, and economic outcomes. The approach requires a critical assessment of available literature, identification of gaps in the literature, and a strategic plan to fill the gaps to ensure the availability of evidence demanded for clinical decisions, coverage/payment decisions and health technology assessments. The purpose of this manuscript is to offer a six-step strategic process leading to a portfolio of evidence that meets the informational needs of providers, payers, and governmental agencies concerning patient access to a therapy.

Relationship of the magnitude of member cost-share and medication persistence with newly initiated renin angiotensin system blockers.

BACKGROUND: Effective treatment for chronic diseases often requires medication refill persistence. Health plans have frequently increased the amount of member cost-sharing by implementing tier-copayment pharmacy benefit designs and raising copayments. However, increased member costshare may present a barrier to the management of chronic conditions. Little is known about the relationship between the magnitude of member cost-sharing and antihypertensive persistence among members newly initiating therapy. OBJECTIVE: To investigate and quantify the relationship between amount of prescription cost-sharing and medication refill persistence among members newly initiating therapy with a single-agent angiotensin system blocker--either an angiotensin-converting enzyme inhibitor (ACEI) or angiotensin II receptor blocker (ARB). METHODS: This was an observational cohort study of pharmacy and medical claims data for 29 employers with approximately 310,000 beneficiaries that did not have a change in pharmacy benefits including the amount of member cost-share in 2004. The claims data were supplemented with census data for household income and race at the Zip Code level. Selected patients were new users of single-agent ACEIs or ARBs (i.e., excluding ACEI or ARB in combination with hydrochlorothiazide or amlopdipine) between January 1 and June 30, 2004, without a pharmacy claim for an ACEI or an ARB in the 6 months prior to the index claim for either drug type. Medication refill persistence was measured in 3 ways: (1) total number of days without ACEIs or ARBs during 6 months follow-up, (2) proportion of days covered (PDC) with less than 80% defined as nonpersistent during 6 months follow-up, and (3) number of days to the first gap of more than 30 days in medication coverage from the index date to end of 2004 (mean [SD] follow-up=9.2 [1.8] months). Three statistical models were fit: Tobit model, examining the association between cost-sharing and total number of medication gap days; logistic regression, testing the association between cost-sharing and odds of being nonpersistent; and Cox proportional hazards model, assessing the association between cost-sharing and time to a 30-day gap. RESULTS: Among the eligible population, a study cohort of 1,351 members newly initiating a single-agent ACEI or ARB was identified. These members were 41.8% female and had a mean age of 55.9 (SD=13.1) years. On average, their member cost-share was $12.42 (SD=$8.50) per 30-day supply. Each $1 increment in per 30-day cost-share was associated with a 1.9% increase in total gap (beta=0.019, 95% confidence interval [CI], 0.007-0.030, P=0.001), a 2.8% increase in the odds of being nonpersistent (odds ratio [OR]=1.028, 95% CI,1.011-1.045, P=0.001), and a 1.0% increase in the risk of having a gap of more than 30 days (hazard ratio [HR]=1.010, 95% CI, 1.001-1.019, P=0.034). Following transformation of the cost-sharing coefficient in each model, a $10 increment in cost-share had a consistent negative influence; 18.9% greater total gap days (beta=0.189, 95% CI, 0.073-0.304), 31.9% greater odds of being nonpersistent (OR=1.319, 95% CI, 1.120-1.553), and 10.2% larger hazard of having a gap of more than 30 days (HR=1.102, 95% CI, 1.007-1.205). CONCLUSION: For members newly initiating single-agent angiotensin system blocking medication, the amount of prescription cost-sharing was associated with a negative impact on refill persistence.

Clinical profile, health-related quality of life, and asthma control in children attending US asthma camps.

BACKGROUND: Approximately 120 asthma camps presently serve nearly 10,000 children nationwide. A clinical profile of the children who attend asthma camps has not been published. OBJECTIVES: To create a standardized universal health history camp application that includes an assessment of health-related quality of life using the Child Asthma Short Form; to test a newly validated tool, the Childhood Asthma Control Test (C-ACT), to assess asthma control in children; to provide a clinical snapshot of the overall status of children with asthma in the United States; and to determine the benefit of children's asthma camps. METHODS: Participating camps distributed the universal health history and the Child Asthma Short Form as part of their application. The C-ACT was distributed separately. RESULTS: A total of 1,783 campers from 24 camps in 17 states provided the requested information. Camp attendees generally had moderately severe asthma, as indicated by a mean +/- SD parent-reported severity rating of 4.86 +/- 2.10 on a 10-point scale. Average daytime and nighttime symptom scores and functional limitation scores indicated children moderately burdened by their asthma symptoms. Using the C-ACT, 37% of children were found to have inadequately controlled asthma. Children who had attended asthma camp the previous year reported better use of asthma management tools, were more likely to be using controller therapy, and had more responsibility for taking their medication (P < .05). CONCLUSION: The burden of asthma experienced by children attending asthma camps is substantial, suggesting that there is an opportunity to improve the lives of children attending asthma camps.

Measurement of persistence and adherence to regimens of IOP-lowering glaucoma medications using pharmacy claims data.

PURPOSE: Determine persistence and adherence of glaucoma patients to therapeutic regimens of prostaglandin/prostamide-class IOP-lowering medications. DESIGN: Retrospective, population-based study. METHODS: Glaucoma patients in the IMS Health LifeLink database with a pharmacy claim for latanoprost (n = 1567), travoprost (n = 381), or bimatoprost (n = 476) between September, 2001 and March, 2002 who had no claims for IOP-lowering medication in the previous 180 days, and who were persistent during the first 90 days of therapy. Values reported in the quantity dispensed and days supply fields of the database were used in an algorithm that corrected anomalous data and adjusted days supply to calculate the main outcome measures, persistence, and adherence to therapy. RESULTS: The percentage of patients persistent for the 12-month observation period was 69.4% (1087/1567) for those prescribed latanoprost, 70.6% (269/381) for those prescribed travoprost, and 68.1% (324/467) for those prescribed bimatoprost. Mean adherence for patients prescribed latanoprost was 75.4% of the year, for those prescribed travoprost, 77.1% of the year, and for those prescribed bimatoprost, 78.2% of the year. The mean number of days adherent for bimatoprost-treated patients (291.2 days) was significantly greater than for latanoprost-treated patients (281.0 days), and not remarkably different from travoprost-treated patients (287.0 days). CONCLUSIONS: Overall, patients in this study who were taking IOP-lowering prostaglandin/prostamide medications had a mean adherence rate of 76% on average, suggesting that opportunities remain for improvement of adherence to therapeutic regimens for glaucoma treatment with prostamides and prostaglandins.