Effect of Medication Copayment on Adherence and Discontinuation in Medicare Beneficiaries with Type 2 Diabetes: A Retrospective Administrative Claims Database Analysis.

INTRODUCTION: Nonadherence to antihyperglycemic agents (AHAs) increases the incidence of morbidity and mortality, as well as healthcare-related costs, in patients with type 2 diabetes (T2D). This study examined the association between medication copayment and adherence and discontinuation among elderly patients with T2D who use generic versus branded AHAs. METHODS: A retrospective, observational cohort study used Medicare administrative claims data (index period: 1 June 2012 to 31 December 2013). Drug copayments were measured as the copayment of the index medication for a 30-day supply after patients met their plan deductible. Patients were stratified into a branded or generic cohort based on the index medication. Adherence was measured by the proportion of days covered (≥ 80%) and discontinuation by a treatment gap of > 60 days in 10 months during the follow-up period. Poisson regressions were conducted for medication adherence and discontinuation, while controlling for demographic, clinical, and comorbid conditions. RESULTS: Overall, 160,250 patients on AHA monotherapy were included in the analysis; 131,594 (82%) were prescribed a generic and 28,656 (18%) a branded AHA with a mean copay of $6 and $41, respectively. Increases in copayment increased nonadherence and discontinuation for branded medications but not for generic AHA medications. In both cohorts, elderly patients (≥ 75 years of age) had a lower risk of nonadherence and discontinuation. Black patients had a higher risk of nonadherence or discontinuing medication. Patients having more frequent inpatient, emergency room, and/or physician visits were at higher risk of nonadherence or discontinuing therapy in the branded and generic cohorts (P < 0.001). CONCLUSION: The impact of drug copayment on adherence and discontinuation varied considerably between branded and generic AHAs. Medicare patients taking branded AHAs had a higher risk of nonadherence with increasing copayment and were more likely to discontinue medication, whereas this association was not observed in patients taking generic medications. FUNDING: Merck & Co, Inc., Kenilworth, NJ, USA. Plain language summary available for this article.

Over-the-counter medication purchase and use by blind consumers.

Little is known regarding consumption of over-the-counter (OTC) medications by the blind. They may face difficulty while accessing information from OTC medication labels. This exploratory, cross-sectional study was designed to determine blind consumers' attitude and purchase behavior towards OTC medications and use of low-vision tools while using these medications.

Hypoglycemia in patients with type 2 diabetes using concomitant exenatide BID and long-acting insulin therapy.

OBJECTIVE: The objective of this study was to examine the frequency of hypoglycemia among patients with type 2 diabetes who had concomitantly used exenatide BID (exenatide) and long-acting insulin and continued this combination vs those who continued long-acting insulin alone. METHODS: Retrospective analyses, using a large managed care database, were used to estimate the frequency of hypoglycemia (episodes/patient/6 months) for patients who concomitantly used exenatide and long-acting insulin during a 6-month follow-up period. RESULTS: From among 2082 patients on concomitant exenatide and long-acting insulin, those who continued this combination (n=472) had a lower frequency of hypoglycemia compared to those who remained on long-acting insulin alone (n=312) (0.03 ± 1.9 vs 0.10 ± 1.01 [episodes/patient/6 months]; p<0.0001). LIMITATIONS: Only hypoglycemia that required medical intervention (coded for hypoglycemia) was captured. The study could not evaluate any association between insulin dose titration and hypoglycemia or examine other outcomes such as HbA1c, weight, and body mass index, due to lack of data availability. CONCLUSIONS: Patients who concomitantly used exenatide BID and long-acting insulin experienced a lower rate of hypoglycemia.

Comparison of utilization, cost, adherence, and hypoglycemia in patients with type 2 diabetes initiating rapid-acting insulin analog with prefilled pen versus vial/syringe.

BACKGROUND: Studies examining outcomes of different insulin delivery systems are limited. The objective of this study was to compare healthcare utilization, costs, adherence, and hypoglycemia rates in patients with type 2 diabetes mellitus (T2DM) initiating rapid-acting insulin analog (RAIA) using prefilled pen versus vial/syringe. METHODS: A retrospective analysis was conducted using a US claims database (1/1/2007 to 12/31/2008). Inclusion criteria were: ≥18 years old, with T2DM, ≥12 months of continuous eligibility, and new to RAIA. Difference-in-difference analyses after propensity score matching were conducted to compare changes in outcomes from 6 months prior to and 6 months after initiating RAIA with a prefilled pen versus vial/syringe (Wilcoxon rank-sum test for costs and t-test for other outcomes). Categories of utilization and costs (2009 USD) included total and diabetes-related inpatient, outpatient, and emergency room. Adherence was measured by proportion of days covered (PDC). Hypoglycemia was identified using ICD-9-CM codes. RESULTS: Baseline characteristics were similar between the prefilled pen (n = 239) and vial/syringe (n = 590) cohorts after matching. Adherence to RAIA was greater in the prefilled pen cohort than the vial/syringe cohort (PDC: 54.6 vs. 45.2%, p < 0.001). While the increase in diabetes-related pharmacy costs from before to after initiating RAIA was greater in the prefilled pen cohort than the vial/syringe cohort (+$900 vs. +$607, p < 0.001), the prefilled pen cohort was associated with greater reductions in the total diabetes-related costs (-$235 vs. +$61, p = 0.006) and the utilization of oral anti-hyperglycemic agents (-1.3 vs. -0.7, p = 0.016). There were no significant differences in other outcomes. LIMITATIONS: Claims databases do not provide optimal measures for adherence or T2DM severity, and only capture hypoglycemia events requiring clinical intervention. CONCLUSION: Initiating RAIA with a prefilled pen was associated with better adherence and greater reduction in total diabetes-related costs than a vial/syringe. There was no significant difference in total healthcare costs.

An economic evaluation of therapeutic alteration in the management of insomnia.

OBJECTIVES: The economic impact of switching patterns from older drug treatment for the management of insomnia has not been thoroughly investigated. The objective of this study was to examine the economic burden of therapeutic alterations for the treatment of insomnia. METHODS: Treated insomnia patients were identified from the Medstat Marketscan claims database who had at least one prescription for insomnia agents during the study period (05/01/01 to 11/30/03). A change in therapy was defined as having a recorded prescription for an insomnia treatment other than the index study medication during the post-index period, which included overlapping augmentation or complete therapy switch. Economic costs included direct medical and pharmacy expenditures. One-year follow-up costs were compared using Wilcoxon tests for bivariate analyses and generalized linear models with gamma functions for multivariate comparisons. RESULTS: Approximately 88% of the sample had no change in insomnia treatment. Patients on monotherapy (n = 24540) differed from patients altering therapy (n = 3267) with respect to age, gender and baseline Deyo-Charlson score. Patients altering therapy had a higher frequency of insomnia diagnoses (22 vs. 11%; p < 0.001) and comorbid depression or anxiety (21-45 vs. 12-25%; p < 0.001) than patients who did not alter therapy. Patients who changed therapy had approximately 67% higher (p < 0.001) direct medical costs compared to those who did not. Limitations of the study include observational study design, and lack of complete availability of all possible risk adjusters for clinical severity. CONCLUSION: Total direct medical costs were significantly higher in patients who altered therapy in a year compared to maintainers after controlling for baseline differences.

Diabetes Medication Satisfaction Tool: a focus on treatment regimens.

OBJECTIVE: To develop and test a patient questionnaire on treatment satisfaction with diabetes regimens. RESEARCH DESIGN AND METHODS: Survey items were developed from community clinic focus groups, pretested in patients with diabetes, and examined in two samples of treated patients. RESULTS: Sixteen items performed well in assessing treatment experiences: ease and convenience, lifestyle burdens, well-being, and medical control. Construct validity was supported by associations (P < 0.05) with treatment complexity, self-rated glucose control, health worries, and A1C. Internal consistency ranged from 0.89 to 0.95. CONCLUSIONS: The Diabetes Medication Satisfaction Tool offers a comprehensive assessment of patient acceptability, with diabetes therapy useful for individualizing therapeutic decision making.

The influence of co-morbidities on prescribing pharmacotherapy for insomnia: evidence from US national outpatient data 1995-2004.

OBJECTIVE: Patients with insomnia are likely to have other co-morbidities that could affect pharmacotherapeutic choices. This study examined the prevalence and impact of co-morbidities on the pharmacological treatment of insomnia. STUDY DESIGN: A retrospective data analysis of the National Ambulatory Medical Care Survey from 1995 to 2004, comprising patients with a diagnosis of insomnia, was conducted. Multivariate logistic regression models were used to predict the impact of co-morbidities on pharmacotherapy for insomnia. RESULTS: A total of 5,487 unweighted patient visits with insomnia were identified, representing 161.4 million patients in the US. Approximately 38% of these patients had at least one co-morbid condition. Patients with mental co-morbidities, especially anxiety, had decreased likelihood of receiving pharmacotherapy for insomnia. CONCLUSIONS: Mental co-morbidities such as episodic mood disorder, anxiety and depression are prevalent in patients with insomnia. However, many co-morbid patients do not receive pharmacological therapy specific for insomnia.

Health care costs and medication adherence associated with initiation of insulin pen therapy in medicaid-enrolled patients with type 2 diabetes: a retrospective database analysis.

BACKGROUND: Clinical, health, and economic outcomes in patients with type 2 diabetes may be influenced by self-management behaviors and type of pharmacotherapy. OBJECTIVE: This study examined differences in medication adherence and total health care costs among patients with type 2 diabetes who initiated or converted to insulin administration with a pen device in comparison with a vial/syringe as add-on therapy to oral antidiabetic drugs. METHODS: This study evaluated patients with type 2 diabetes who were enrolled in the North Carolina Medicaid program from September 24, 2001, to July 18, 2006. Patients receiving insulin with a vial/syringe who converted to pen therapy were compared with those who remained on vial/syringe in both unmatched comparisons (n = 560 and n = 9988, respectively) and after pair-matching (both cohorts, n = 560) with the use of propensity scores. In a second analysis, patients who initiated insulin with vial/syringe (n = 1162) were compared with a cohort that initiated insulin pen therapy (n = 168) after controlling for covariates in a multivariate regression model. All included patients had complete enrollment for at least 24 months of followup. Multiple linear regression models were used to predict the comparative impact on total health care costs and medication adherence for each cohort. Adjusted means were calculated to determine the group differences for each outcome. RESULTS: Diabetes-related and overall medication adherence was comparable for patients initiating insulin with a pen versus a syringe (53% vs 50% and 94% vs 94%, respectively). However, total annualized health care costs were significantly lower for patients using pen therapy than for those using a syringe ($14,857.42 vs $31,764.78, respectively; P < 0.05). Cost reductions with pen therapy were reflected in hospital costs ($1195.93 vs $4965.31, respectively; P < 0.05), diabetes-related costs ($7324.37 vs $13,762.21, respectively; P < 0.05), and outpatient costs ($7795.98 vs $13,103.51, respectively; P < 0.05). However, prescription costs of syringe were significantly lower ($535.70 vs $670.52; P < 0.05) and costs of pen were higher ($840.33 vs $0; P < 0.05) in patients who were switched from syringe to pen versus those who remained on syringe therapy. CONCLUSIONS: In a state Medicaid setting among patients with type 2 diabetes, initiating insulin therapy with a pen device was associated with comparable medication adherence and significant reductions in health care resource utilization and associated costs compared with vial/syringe insulin. Health care professionals and policy makers should consider the potential economic benefits of pen therapy when initiating insulin among Medicaid beneficiaries who fail to respond to oral antidiabetic drugs.

Health care costs and medication adherence associated with initiation of insulin pen therapy in Medicaid-enrolled patients with type 2 diabetes: a retrospective database analysis.

BACKGROUND: Clinical, health, and economic outcomes in patients with type 2 diabetes may be influenced by self-management behaviors and type of pharmacotherapy. OBJECTIVE: This study examined differences in medication adherence and total health care costs among patients with type 2 diabetes who initiated or converted to insulin administration with a pen device in comparison with a vial/syringe as add-on therapy to oral antidiabetic drugs. METHODS: This study evaluated patients with type 2 diabetes who were enrolled in the North Carolina Medicaid program from September 24, 2001, to July 18, 2006. Patients receiving insulin with a vial/syringe who converted to pen therapy were compared with those who remained on vial/syringe in both unmatched comparisons (n = 560 and n = 9988, respectively) and after pair-matching (both cohorts, n = 560) with the use of propensity scores. In a second analysis, patients who initiated insulin with vial/syringe (n = 1162) were compared with a cohort that initiated insulin pen therapy (n = 168) after controlling for covariates in a multivariate regression model. All included patients had complete enrollment for at least 24 months of follow-up. Multiple linear regression models were used to predict the comparative impact on total health care costs and medication adherence for each cohort. Adjusted means were calculated to determine the group differences for each outcome. RESULTS: Diabetes-related and overall medication adherence was comparable for patients initiating insulin with a pen versus a syringe (53% vs 50% and 94% vs 94%, respectively). However, total annualized health care costs were significantly lower for patients using pen therapy than for those using a syringe ($14,857.42 vs $31,764.78, respectively; P < 0.05). Cost reductions with pen therapy were reflected in hospital costs ($1195.93 vs $4965.31, respectively; P < 0.05), diabetes-related costs ($7324.37 vs $13,762.21, respectively; P < 0.05), and outpatient costs ($7795.98 vs $13,103.51, respectively; P < 0.05). However, prescription costs of syringe were significantly lower ($535.70 vs $670.52; P < 0.05) and costs of pen were higher ($840.33 vs $0; P < 0.05) in patients who were switched from syringe to pen versus those who remained on syringe therapy. CONCLUSIONS: In a state Medicaid setting among patients with type 2 diabetes, initiating insulin therapy with a pen device was associated with comparable medication adherence and significant reductions in health care resource utilization and associated costs compared with vial/syringe insulin. Health care professionals and policy makers should consider the potential economic benefits of pen therapy when initiating insulin among Medicaid beneficiaries who fail to respond to oral antidiabetic drugs.

Self-reported predictors of depressive symptomatology in an elderly population with type 2 diabetes mellitus: a prospective cohort study.

BACKGROUND: The prevalence of depression increases among the elderly with chronic medical conditions like diabetes. Hence, the purpose of this study was to determine predictors of depressive symptomatology in Medicare enrolled elderly population with type 2 diabetes mellitus. METHODS: A prospective cohort study was conducted by administrating health risk assessment questionnaire to elderly (> or =65 years) with type 2 diabetes. Responses were linked with administrative claim's data. Data were obtained from elderly with type 2 diabetes who were enrolled in Medicare Health Maintenance Organization (HMO) in southeastern United States. The instrument collected information related to demographics, health status, medication use, and healthcare service utilization prior to enrollment. Responses were combined with the administrative claims data of HMO to obtain information on actual utilization of healthcare resources. The Short Form Center for Epidemiologic Studies Depression scale was used to assess depressive symptoms. Multivariable logistic regression analyses were conducted to determine predictor variables. RESULTS: Of 792 respondents, about 17% had depressive symptoms. Almost 96% of patients were using 1 or more antidiabetic medications. Overall, increased risk of depression was associated with lower health related quality of life (HRQoL) (OR: 0.97; 95% CI: 0.96-0.98) and higher impairments in instrumental activities of daily living (IADLs) (OR: 1.31; 95% CI: 1.14-0.52) in elderly patients. Poor health related quality of life (OR: 0.97, 95%CI: 0.95-0.99) was associated with higher risk of depression in patients on insulin therapy. CONCLUSION: Impairments in daily activities and lower HRQoL were predictors of depressive symptomatology in elderly with diabetes. Determinants of depression varied according to pharmacotherapeutic class of antidiabetic medications.

Melasma and its impact on health-related quality of life in Hispanic women.

OBJECTIVES: Melasma poses a substantial emotional and psychosocial burden on patients. Even though melasma is prevalent in Hispanic women, its impact on health-related quality of life (HRQOL) has been under-reported. The purpose of this review is to evaluate the impact of melasma on the HRQOL of Hispanic women. METHODS: An extensive literature review of articles published in English and Spanish over the last 15 years (1991-2006) was conducted. The search terms used to obtain relevant information were 'melasma', 'women', 'health-related quality of life', HRQOL', 'treatment', 'Hispanic', and 'Latino'. Specific issues covered include HRQOL issues in melasma, instruments used and treatment modalities available for melasma. RESULTS: The literature search revealed that melasma has a deleterious impact on the HRQOL. It severely affects social life, emotional well-being, physical health and money matters in Hispanic women. CONCLUSION: Patient education, awareness and counseling are needed to improve HRQOL outcomes.

Switching from prescription to over-the counter medications: a consumer and managed care perspective.

An extensive literature review using databases, such as MEDLINE, Cochrane Collaboration, and ScienceDirect, provided information on the current trends, benefits, risks, and effects of switched medications on consumers MCOs. More than 80 ingredients or 700 medications have been changed from prescription (Rx) to over-the-counter (OTC) status. Although the Rx-to-OTC switch has resulted in significant cost savings for consumers (13 billion dollars) and MCOs (20 million dollars), the misuse of medications can cause side effects, hospitalizations, and even death. In conclusion, a balance must be struck between the increasing demand for these switched medications and their safety risks. In addition, the long-term benefits of many of these medications are still uncertain and need further exploration.

Obstruction of critical information on over-the-counter medication packages by external tags.

BACKGROUND: Over-the-counter (OTC) medication packages are important sources of information for consumers during product selection and use. Consumers may not be able to access information from OTC packages if external tags, namely price or anti-theft tags, are improperly placed. OBJECTIVE: To determine the amount and type of information concealed by anti-theft tags and price tags affixed on OTC drug packages. METHODS: A field study was performed by evaluating packages containing acetaminophen and combinations of acetaminophen in stores located in Houston. Five packages for 4 products selected from each store after an initial survey for presence of an external tag were examined. A data collection sheet was prepared that extracted the type and amount of information concealed by these tags. Data were analyzed by performing descriptive analyses to provide an understanding of the information obscured. RESULTS: A total of 24 stores were considered in the study, and 67 products and 285 packages were evaluated. External tags, both anti-theft and price tags, obscured significant amounts of information on the principal display panel (53.4%) and the Drug Facts panel (47.7%) of OTC packages. These tags concealed crucial information on various aspects of labels such as brand names (42.3%), product description (36.3%), warnings (51.5%), uses (10.4%), and purposes (7.2%). CONCLUSIONS: Results suggest that improper use of external tags clearly obscured important information on OTC medication packages necessary for consumers to make informed decisions regarding product selection and use. Tagging practices should be altered to allow consumers full access to drug information on the product.