Exploring access to care from the perspective of patients with breast cancer: A qualitative study.

OBJECTIVES: Patients face a myriad of personal and system-based challenges in accessing breast cancer care, but less is known about access as expressed and experienced by patients themselves. The objective of this qualitative study was to further explore the breadth of issues related to access from the perspective of patients with breast cancer across their care journey. METHODS: Twelve women participated in 1-h semi-structured interviews and 48 women participated in 2-h focus groups at six oncology practices in 2018. Grounded theory was used to analyze the data. RESULTS: Six primary themes emerged concerning access to care: information, psychosocial support, health insurance, financial resources, timeliness, and emotions. CONCLUSIONS: This study identified six core dimensions of access to care. Access encompassed not only gaining entrée to care services-in the traditional sense of access-but also the continuing support needed to effectively use those services throughout the cancer care journey. Future strategies aimed at improving access to breast cancer care should attend to these ongoing patient-centric and system-based issues which are mostly amenable to change.

Improving Asthma Management: Patient-Pharmacist Partnership Program in Enhancing Therapy Adherence.

Community pharmacist interventions can assist in improving adherence in patients with asthma. The objective of the study was to assess the feasibility of patient-centered counseling using the developed asthma-specific tools to identify barriers to adherence and identify their preliminary effect on adherence barrier score and asthma control. Adult patients with persistent asthma were invited to participate in a 3-month pre-post intervention study involving community pharmacist-provided patient-centered counseling. Bivariate analyses were conducted to determine whether there were changes in outcomes from the pre to post period. Of 36 recruited patients, 17 completed both pre and post surveys. At baseline, patients had a mean ACT score of 15.1 ± 3.5, with 94% having uncontrolled asthma, and an average of 4.2 ± 2.5 reported barriers. The following barriers were most common: not having an Asthma Action Plan (52.9%), use of inhaler more or less often than prescribed (47.1%) and forgetfulness (41.2%). The ACT score increased by 2.7 ± 5.4, which was not statistically significant; however, it might be clinically significant. Two barrier scores improved as a result of the intervention. Preliminary evidence on the feasibility of identifying and addressing patient-specific barriers to adherence delivered by pharmacists showed that it has the potential to resolve barriers and improve asthma outcomes.

Impact of a G-CSF Policy to Reduce Low-Value Care on Guideline Adherence and Mortality.

PURPOSE: Practice guidelines recommend the prophylactic use of granulocyte colony-stimulating factors (G-CSFs) in patients with high risk of febrile neutropenia, but evidence suggests that G-CSFs are frequently overused. The objectives of this study were (1) to determine the prevalence and prescribing patterns of G-CSF and (2) to evaluate the impact of a program initiative on G-CSF prescribing patterns, adherence to guidelines, and mortality. METHODS: In this retrospective cohort study, data were used from the electronic health records of patients with metastatic colorectal cancer who received care at a multicenter oncology practice network during two time periods: July 01, 2013, to December 31, 2014, and July 01, 2017, to December 31, 2017. Beginning 2016, a site-wide program initiative that involved educational materials, appropriate nonuse recommendations, and prior authorization was introduced in the oncology practice network with an aim of reducing G-CSF overutilization. Descriptive statistics, t tests, and chi-squared tests were employed to analyze program impact. RESULTS: There were 3,426 chemotherapy regimens corresponding to 2,968 patients. There were a total of 387 (11.3%) G-CSF-treated patients and 3,095 G-CSF administrations during the study period. G-CSF use was significantly lower in the postperiod, compared with the preperiod (P < .0001). Adherence to guidelines was significantly higher in the postperiod, compared with the preperiod (P < .0001). Mortality rates did not significantly differ between the two time periods. CONCLUSION: This study demonstrates that policy initiatives have the potential to positively affect G-CSF prescription patterns and promote guideline adherence. These findings could help prescribers adopt a cost-effective approach in patients with metastatic colorectal cancer, leading to enhanced clinical practice and value-based care.

Evaluation of access to care issues in patients with breast cancer.

AIMS: System-level efforts have been deployed to improve oncology care and access while reducing utilization and costs. Understanding the nature of access to care from the perspective of patients themselves is an unmet need. This study examined access to care in a population of women with breast cancer and its relationship to overall patient satisfaction. MATERIALS AND METHODS: Patients with breast cancer from six oncology clinics in five states completed a survey during routine office visits. Access to care (higher scores indicated increasing access barriers), overall patient satisfaction, and patient demographic/clinical characteristics were measured. The relationships between access (composite and factor scores) and satisfaction were assessed using multivariable analyses controlling for age (the only significant characteristic from bivariate analyses). RESULTS: A total of 180 patients completed the survey. Factor analysis of access to care items revealed an 8-factor measure - Insurance, Health System, Emotional, Holistic Treatment, Family Support, Knowledge/Understanding, Information Quality, and Financial Support - with high reliability (Composite: Cronbach alpha = 0.93; Factors: Cronbach alpha range = 0.85-0.91). Access composite score was moderately low (mean = 1.90), indicating an overall low level of access barriers, and overall patient satisfaction was high (mean = 4.59). The composite score (p < .001) and the Health System and Knowledge/Understanding factors (p < .01) were significant and negative predictors of overall satisfaction. LIMITATIONS: Study sites were high functioning clinics and all, but one, are Oncology Care Model practices. Thus, the scope of access to care issues for patients of under-resourced clinics might not be well addressed. CONCLUSIONS: Access to care overall and by factor was significantly predictive of patient satisfaction with care. In addition, access to care factors varied across several demographic and clinical characteristics. Future strategies that address access to care challenges should consider these modifiable, patient-centric, and system-based issues.

Examination of Barriers to Medication Adherence, Asthma Management, and Control Among Community Pharmacy Patients With Asthma.

OBJECTIVE: To describe the prevalence of common barriers to asthma medication adherence and examine associations between patient-reported asthma controller adherence and asthma control, therapy adherence barriers, and asthma management characteristics. METHODS: Previously developed asthma-specific tool was pilot tested on a convenience sample of adult patients with persistent asthma. The following data were collected via patient survey: demographic characteristics and comorbidities, adherence, asthma control, and asthma management characteristics. Descriptive and inferential statistics were used to address the study objective. RESULTS: The patients (N = 93) were 45.4 (17.2) years of age, and 66.7% were female. The majority had poor (68.8%) adherence, with 61.3% of patients having controlled asthma. There was no significant association between adherence and asthma control. The mean number of barriers for good and poor adherence groups differed significantly: 2.0 ± 1.1 and 5.4 ± 2.4, respectively (P < .0001). Having an asthma action plan (AAP) was the only asthma management characteristic significantly related to adherence. The majority of patients with poor adherence did not have an AAP (76.6%), whereas 81.5% of patients with good adherence did have an AAP (P < 0.0001). CONCLUSIONS: The use of this survey tool confirmed presence of asthma-specific barriers, thus using this specialized approach may lead to more effective, targeted counseling in community pharmacy settings.

Association between Vaso-occlusive Crises and Opioid Prescriptions among Patients with Sickle Cell Disease: A Retrospective Claims-based Study.

BACKGROUND/OBJECTIVES: Among sickle cell disease (SCD) patients, vaso-occlusive crises (VOCs) are recurrent and unpredictable attacks of acute pain. These pain crises are often treated with analgesics, including opioids, which have been associated with misuse and overdose. The aim of this study was to examine the association between VOC events and opioid use and assess the association between opioid prescriptions and health care resource utilization among SCD patients. METHODS: This was a retrospective cohort study using Texas Medicaid medical and prescription claims between September 2011 and August 2016. The index date was the first SCD diagnosis. Patients (2-63 years) with at least one inpatient or two outpatient SCD diagnoses, who were continuously enrolled during 12 months postindex, were included in the study. The primary outcome was number of opioid prescriptions, while the independent variable was number of VOC events. Covariates included age, gender, nonopioid medication use, nonstudy SCD-related medication (penicillin and folic acid) use, evidence of blood transfusions, number of SCD-related complications, number of SCD-related comorbid conditions, and Charlson Comorbidity Index score. Negative binomial regression analysis was used to address study objectives. RESULTS: Of 3368 included patients, 1978 (58.7%) had at least one opioid prescription with a mean of 4.2 (SD=7.2). Overall, 2071 (61.5%) had at least one VOC event with an average of 2.9 (SD=4.4). The results from the negative binomial regression showed that for every increase in VOC events, the number of opioid prescriptions increased by 9.5% (Incidence rate ratio=1.095, 95% CI: 1.078-1.111; P ≤ 0.0001). Other significant covariates associated with higher opioid use included age (13 and older compared to 2-12) and increase in the number of nonopioid pain medications, nonstudy SCD-related medications, and SCD-related complications. CONCLUSIONS: The majority of SCD patients had at least one VOC event and were prescribed opioids during the 12-month study period. We found that each VOC event was associated with a 9.5% increase in the use of opioids. SCD guidelines recommend opioids for the treatment of VOC-related pain. Payers and providers should be aware of opioid use in this population, consider appropriate VOC prevention measures, and provide SCD patients with access to appropriate pain management.

Association Between Vaso-Occlusive Crises and Opioid Prescriptions Among Patients with Sickle Cell Disease: A Retrospective Claims-Based Study.

Background/Objectives: Among sickle cell disease (SCD) patients, vaso-occlusive crises (VOCs) are recurrent and unpredictable attacks of acute pain. These pain crises are often treated with analgesics, including opioids, which have been associated with misuse and overdose. The aim of this study was to examine the association between VOC events and opioid use and assess the association between opioid prescriptions and health care resource utilization among SCD patients. Methods: This was a retrospective cohort study using Texas Medicaid medical and prescription claims between September 2011 and August 2016. The index date was the first SCD diagnosis. Patients (2-63 years) with at least one inpatient or two outpatient SCD diagnoses, who were continuously enrolled during 12 months postindex, were included in the study. The primary outcome was number of opioid prescriptions, while the independent variable was number of VOC events. Covariates included age, gender, nonopioid medication use, nonstudy SCD-related medication (penicillin and folic acid) use, evidence of blood transfusions, number of SCD-related complications, number of SCD-related comorbid conditions, and Charlson Comorbidity Index score. Negative binomial regression analysis was used to address study objectives. Results: Of 3368 included patients, 1978 (58.7%) had at least one opioid prescription with a mean of 4.2 (SD=7.2). Overall, 2071 (61.5%) had at least one VOC event with an average of 2.9 (SD=4.4). The results from the negative binomial regression showed that for every increase in VOC events, the number of opioid prescriptions increased by 9.5% (Incidence rate ratio=1.095, 95% CI: 1.078-1.111; P ≤ 0.0001). Other significant covariates associated with higher opioid use included age (13 and older compared to 2-12) and increase in the number of nonopioid pain medications, nonstudy SCD-related medications, and SCD-related complications. Conclusions: The majority of SCD patients had at least one VOC event and were prescribed opioids during the 12-month study period. We found that each VOC event was associated with a 9.5% increase in the use of opioids. SCD guidelines recommend opioids for the treatment of VOC-related pain. Payers and providers should be aware of opioid use in this population, consider appropriate VOC prevention measures, and provide SCD patients with access to appropriate pain management.

Comparison of Prostaglandin Analog Treatment Patterns in Glaucoma and Ocular Hypertension.

BACKGROUND: Prostaglandin analogs (PGAs) are considered an initial therapy to manage increased intraocular pressure (IOP) for patients with glaucoma. When the initial PGA treatment fails to lower IOP adequately, the patient may add or change medications or have surgery/laser treatment. OBJECTIVE: To compare medication adherence, duration of therapy, and treatment patterns among 3 PGAs-latanoprost, travoprost, and bimatoprost-as initial therapies for patients with glaucoma or ocular hypertension. METHODS: This was a retrospective cohort study using administrative claims data. The cohort consisted of patients newly diagnosed with glaucoma or ocular hypertension with at least 1 prescription claim for latanoprost, travoprost, or bimatoprost and enrolled in a Medicare Advantage plan between 2007 and 2012. The 24-month medication possession ratio (MPR) was used to measure medication adherence. Discontinuation of first-line PGA therapy was defined as nonpersistence (90-day gap allowance) of the index PGA or a change in therapy during the 24-month follow-up period. Types of second-line therapy (i.e., switch, addition, and surgery) were identified. The 1:1:1 propensity score matching was used. RESULTS: Patients who met the inclusion criteria were propensity score matched, resulting in 1,296 patients per PGA group. Latanoprost users showed higher adherence (50.1%) than travoprost (48.8%) and bimatoprost (43.0%) users. The latanoprost and travoprost groups had significantly higher MPRs than bimatoprost (P < 0.0001). The latanoprost group showed significantly longer duration of first-line therapy (372 days) than the bimatoprost group (343 days; P = 0.003) but not the travoprost group (361 days). After controlling for demographic and clinical characteristics, a Cox proportional hazards model showed that the travoprost and bimatoprost groups had a higher risk of discontinuation of first-line therapy than the latanoprost group (P < 0.0001). The percentage of patients continuing on the index PGA without treatment pattern change (i.e., switches, additions, and surgery) was higher for latanoprost users (52.9%) compared with travoprost (39.0%) or bimatoprost users (42.1%; P < 0.001). CONCLUSIONS: Patients who used latanoprost as their initial therapy were more likely to adhere and persist to the index PGA compared with bimatoprost users. The latanoprost group demonstrated a lower risk of discontinuing first-line therapy than the travoprost and bimatoprost groups. The results may assist ophthalmologists in determining the optimal management of this patient population with respect to treatment patterns. DISCLOSURES: No outside funding supported this study. All authors except Heo and Nair are employed by The University of Texas at Austin College of Pharmacy. Heo was with the Health Outcomes Division, The University of Texas at Austin College of Pharmacy during a portion of this study and is employed by Genesis Research. Nair is employed by Humana. The authors have no financial relationships relevant to this article to disclose. This study was presented as a poster at the 2016 International Society for Pharmacoeconomics and Outcomes Research Annual Meeting, May 2016, Washington, DC.

Examining the heterogeneity of treatment patterns in attention deficit hyperactivity disorder among children and adolescents in the Texas Medicaid population: modeling suboptimal treatment response.

Objectives: To examine suboptimal responses (SR) in attention deficit hyperactivity disorder (ADHD) among pediatric patients in the Texas Medicaid program receiving osmotic-release oral system methylphenidate (OROS-MPH) or lisdexamfetamine (LDX) and apply an SR prediction model to identify patients most likely to experience an SR to either OROS-MPH or LDX therapies. Methods: A retrospective cohort study was conducted using Texas Medicaid claims data of ADHD children and adolescents (6-17 years of age) initiating OROS-MPH or LDX. Primary SR endpoints were drug discontinuation, switching, and augmentation 12-months post-ADHD drug initiation. Logistic regression models were developed to predict SR to OROS-MPH and LDX in 1:1 matched groups of children and adolescent cohorts. Results: A total of 3,633 children and 1,611 adolescents were matched for each cohort. SR was observed among more children (76.4% vs 72.3%; p < 0.001) and adolescents (82.7% vs 78.2%; p = 0.002) initiating OROS-MPH compared to LDX. Patient sub-groups with the highest predicted risk of OROS-MPH SR experienced significantly lower observed SR rates (p < 0.05) when initiating LDX (children: 80.6% for OROS-MPH vs 75.8% for LDX; OR = 0.75, 95% CI = 0.60-0.94; adolescents: 87.2% for OROS-MPH vs 80.6% for LDX; OR = 0.61, 95% CI = 0.41-0.89). For patients with highest predicted SR rates to LDX, observed SR rates were not significantly different between patients initiating LDX or OROS-MPH. Conclusions: This study demonstrated how a personalized medicine approach using administrative claims data can be used to identify sub-groups of child and adolescent ADHD patients with different risks for suboptimal response with OROS-MPH or LDX in a Medicaid population.

Patterns of antiepileptic drug use in patients with potential refractory epilepsy in Texas Medicaid.

OBJECTIVES: Antiepileptic drug (AED) monotherapy is usually effective in 60% of the patients with epilepsy while the remaining patients have refractory epilepsy. This study compared treatment patterns (adherence, persistence, addition, and switching) associated with refractory and nonrefractory epilepsy. METHODS: Texas Medicaid claims from 09/01/07-12/31/13 were analyzed, and patients eligible for the study 1) were between 18 and 62 years of age, 2) had a prescription claim for an AED during the identification period (03/01/08-12/31/11) with no prior baseline AED use (6-month), and 3) had evidence of epilepsy diagnosis within 6 months of AED use. Based on AED use in the identification period, patients were categorized into "refractory" (≥3AEDs) and "nonrefractory" (<3AEDs) cohorts. The index date was the date of the first AED claim. Patients in both cohorts were matched 1:1 using propensity scoring and compared for adherence (proportion of days covered (PDC) ≥80% vs. <80%), persistence, addition (yes/no), and switching (yes/no) using multivariate conditional regression models. Conditional logistic regression and Cox proportional hazard models were used to address the study objectives. RESULTS: Of the 10,599 eligible patients, 2798 (26.5%) patients in the refractory cohort were matched to patients in the nonrefractory cohort. Patients in the refractory cohort had significantly higher (p < 0.005) mean (±Standard deviation (SD)) adherence (88.6% (±19.1%) vs. 77.0% ±â€¯(25.8%)) and persistence (328.0 (±87.3) days vs. 294.9 ±â€¯(113.4) days) as compared with patients in the nonrefractory cohort. Compared with patients with nonrefractory epilepsy, patients with refractory epilepsy were 3.6 times (odds ratio (OR) = 3.553; 95% confidence interval (CI) = 3.060-4.125; p < 0.0001) more likely to adhere to AEDs and had a 34.7% (hazard ratio (HR) = 0.653; 95% CI = 0.608-0.702; p < 0.0001) lower hazard rate of discontinuation of AEDs. Also, patients with refractory epilepsy were 3.7 times (OR = 3.723; 95% CI = 2.902-4.776; p < 0.0001) more likely to add an alternative AED and 3.6 times (OR = 3.591; 95% CI = 3.010-4.284; p < 0.0001) more likely to switch to an alternative AED. CONCLUSION: Patients with refractory epilepsy were significantly more likely to adhere and persist to AED regimen and were significantly more likely to add and switch to an alternative AED than patients with nonrefractory epilepsy.

Fetal fibronectin testing and pregnancy outcomes among Texas Medicaid patients at risk for preterm birth.

OBJECTIVES: Fetal fibronectin (fFN) testing between the 24th and 34th weeks of pregnancy in patients with symptomatic preterm labor (PTL) helps assess the risk of spontaneous preterm birth (sPTB), yet the extent of its use is unknown. We assessed use of fFN testing among Texas Medicaid enrollees with symptomatic PTL and evaluated time to infant delivery and healthcare utilization/costs. STUDY DESIGN: Retrospective cohort study using medical and pharmacy claims for Texas Medicaid enrollees. METHODS: We identified pregnant women triaged through the emergency department (ED) and hospital labor-and-delivery units with symptomatic PTL between January 1, 2012, and May 31, 2015. Patients with fFN testing prior to delivery were propensity score matched 1:1 to patients without fFN testing. Primary outcomes included time to delivery from initial PTL encounter and all-cause maternal healthcare utilization and costs. RESULTS: A total of 29,553 women met the criteria for analysis, of whom 14% had a record of receiving fFN testing. Each matched cohort included 4098 patients. Compared with those who did not, patients who underwent fFN testing had significantly more clinical risk factors (mean [SD]: 1.7 [1.1] vs 1.1 [1.0]; P <.0001) and were less likely to deliver during the initial hospital stay (odds ratio [OR], 0.539; 95% CI, 0.489-0.594), deliver ≤3 days following the hospital/ED encounter (OR, 0.499; 95% CI, 0.452-0.551); and receive their first PTL diagnosis during the initial hospital/ED encounter (OR, 0.598; 95% CI, 0.539-0.665). Patients who had an fFN test, compared with those who did not, had 17.5% higher total costs (P <.0001) during the 5 months prior to delivery, but had gestation lengths 9.4 days longer (24.6 vs 15.2 days) than those without testing. CONCLUSIONS: Frequency of fFN testing was low in Texas Medicaid enrollees with symptomatic PTL. Patients with fFN testing had longer gestation periods and were less likely to deliver within ≤3 days of a hospital/ED encounter for PTL. These results support the role of fFN in screening for risk for sPTB among women with symptomatic PTL.

Use of Statins and the Risk of Incident Diabetes: A Retrospective Cohort Study.

INTRODUCTION: Even though several landmark statin trials have demonstrated the beneficial effects of statin therapy in both primary and secondary prevention of cardiovascular disease, several studies have suggested that statins are associated with a moderate increase in risk of new-onset diabetes. These observations prompted the US FDA to revise statin labels to include a warning of an increased risk of incident diabetes mellitus as a result of increases in glycosylated hemoglobin (HbA1c) and fasting plasma glucose. However, few studies have used US-based data to investigate this statin-associated increased risk of diabetes. OBJECTIVE: The primary objective of our study was to examine whether the use of statins increases the risk of incident diabetes mellitus using data from the Thomson Reuters MarketScan (®) Commercial Claims and Encounters Database. METHOD: This study was a retrospective cohort analysis utilizing data for the period 2003-2004. The study population included new statin users aged 20-63 years at index who did not have a history of diabetes. RESULTS: The proportion (3.4 %) of statin users (N = 53,212) who had incident diabetes was higher than the proportion (1.2 %) of non-statin users (N = 53,212) who had incident diabetes. Compared with no statin use and controlling for demographic and clinical covariates, statin use was significantly associated with increased risk of incident diabetes (hazard ratio 2.01; 99 % confidence interval 1.74-2.33; p < 0.0001). In addition, risk of diabetes was highest among users of lovastatin, atorvastatin, simvastatin, and fluvastatin. Diabetes risk was lowest among pravastatin and rosuvastatin users. DISCUSSION: Because the potential for diabetogenicity differs among different statin types, healthcare professionals should individualize statin therapy by identifying patients who would benefit more from less diabetogenic statin types.

Medication Adherence and Persistence in Patients with Severe Major Depressive Disorder with Psychotic Features: Antidepressant and Second-Generation Antipsychotic Therapy Versus Antidepressant Monotherapy.

BACKGROUND: Major depressive disorder with psychotic features, or psychotic depression, is a severe mental health disorder often associated with a worse depression-related symptom profile when compared with major depressive disorder without psychotic features. While combination pharmacotherapy with an antidepressant and an antipsychotic is recommended as first-line therapy, antidepressant monotherapy has been found to be useful and efficacious in psychotic depression. OBJECTIVE: To assess the rates of antidepressant adherence and antidepressant persistence in Texas Medicaid patients with psychotic depression who used antidepressant plus second-generation antipsychotic (AD/SGA) therapy or antidepressant (AD) monotherapy. METHODS: Using Texas Medicaid prescription and medical claims data from September 2007 to December 2012, adult patients aged 18-63 years were included if they had no confounding psychiatric disorders, no antidepressant claims during a 6-month pre-index period, and at least 1 diagnosis for severe major depressive disorder with psychotic features (ICD-9-CM codes 296.24 and 296.34). The first claim date for an antidepressant served as the index date. All patients were required to have at least 2 antidepressant claims, and those in the AD/SGA cohort were required to have 2 or more claims for an SGA. Study covariates included age, gender, race/ethnicity, residence, Charlson Comorbidity Index (CCI) score, and tobacco use/dependence. Statistical analyses included descriptive statistics, univariate analyses, logistic regression, and Cox proportional hazards regression. RESULTS: A total of 926 patients met study criteria (AD cohort = 510; AD/SGA cohort = 416). The overall sample had a mean [±SD] age of 40.5 [±13.2] years and was primarily female (66.8%) and non-Caucasian (74.8%). When compared with the AD cohort, patients in the AD/SGA cohort had a 52.3% higher likelihood of being adherent to antidepressant therapy based on proportion of days covered (PDC; OR = 1.523; 95% CI = 1.129-2.053; P = 0.006). Similarly, antidepressant adherence was 42.0% higher for the AD/SGA cohort based on medication possession ratio (MPR; OR = 1.420; 95% CI = 1.062-1.898; P = 0.018). Younger patients, African Americans, and tobacco users/dependents had significantly worse likelihoods of antidepressant medication adherence based on PDC and MPR. The risk of antidepressant nonpersistence was 23.2% lower for patients in the AD/SGA cohort (HR = 0.768; 95% CI = 0.659-0.896; P = 0.001), compared with those in the AD cohort. Antidepressant nonpersistence was significantly higher in younger patients, African Americans, Hispanics, and tobacco users/dependents. CONCLUSIONS: Better antidepressant adherence and persistence outcomes were associated with combination pharmacotherapy with an AD and an SGA antipsychotic. This study provides real-world estimates that support the current first-line treatment recommendations for psychotic depression; however, it should be noted that the majority of study patients used AD therapy only. Future research in psychotic depression is needed. DISCLOSURES: Kim-Romo received funding to conduct this study from the PhRMA Foundation Pre-Doctoral Fellowship in Health Outcomes. Rascati, Richards, Ford, Wilson, and Beretvas declare no conflict of interest in relation to this manuscript. Kim-Romo and Rascati collaborated on the study design, data analysis, study interpretation, and writing of this manuscript. Richards, Ford, Wilson, and Beretvas provided critical evaluation of the study design, analysis, and interpretation, as well as edited this manuscript.

Asthma Controller Medication Adherence, Risk of Exacerbation, and Use of Rescue Agents Among Texas Medicaid Patients with Persistent Asthma.

BACKGROUND: Adherence to asthma long-term controller medications is one of the key drivers to improve asthma management among patients with persistent asthma. While suboptimal use of controller medications has been found to be associated with more frequent use of oral corticosteroids (OCS), few studies exist regarding the relationship between adherence to controller therapy and the use of short-acting beta2-agonists (SABAs). A better understanding of the association between adherence to asthma controller agents and use of reliever medications will help health care providers and decision makers enhance asthma management. OBJECTIVE: To determine if there is a relationship between asthma controller adherence, risk of exacerbation requiring OCS, and use of asthma rescue agents. METHODS: Texas Medicaid claims data from January 1, 2008, to August 31, 2011, were retrospectively analyzed. Continuously enrolled patients aged 5-63 years with a primary diagnosis of asthma (ICD-9-CM code 493) and with 4 or more prescription claims for any asthma medication in 1 year (persistent asthma) were included. The index date was the date of the first asthma controller prescription, and patients were followed for 1 year. The primary outcome variables were SABA (dichotomous: less than 6 vs. ≥ 6) and OCS (continuous) use. The primary independent variable was adherence (proportion of days covered [PDC]) to asthma long-term controller medications. Covariates included demographics and nonstudy medication utilization. Multivariate logistic and linear regression analyses were employed to address the study objective. RESULTS: The study sample (n = 32,172) was aged 15.0 ± 14.5 years, and adherence to controller therapy was 32.2% ± 19.7%. The mean number of SABA claims was 3.7 ± 3.1, with most patients having 1-5 claims (73.2%), whereas 19.4% had ≥ 6 SABA claims. The mean number of OCS claims was 1.0 ± 1.4. Adherent (PDC ≥ 50%) patients were 96.7% (OR = 1.967; 95% CI = 1.826-2.120) more likely to have ≥ 6 SABA claims when compared with nonadherent (PDC less than 50%) patients (P less than 0.001). As for OCS use, adherent patients had 0.11 fewer claims compared with nonadherent patients (P less than 0.001). Importantly, patients with ≥ 6 SABA claims had 0.7 more OCS claims compared with patients with less than 6 claims for SABA (P less than 0.001). The odds of having ≥ 6 SABA claims were higher for concurrent dual therapy users, older age, males, African Americans and higher number of nonstudy medications (P less than 0.001). Dual therapy users, younger age, Hispanic ethnicity, and higher number of nonstudy medications were associated with an increase in OCS use (P less than 0.005). CONCLUSIONS: Adherence to long-term controller medications was suboptimal among patients with asthma. Adherent patients had fewer OCS claims, indicating that adherence to controller therapy is critical in preventing asthma exacerbations requiring OCS use. Although there was a positive relationship between adherence to long-term controller medication and SABA use, increased SABA use served as a predictor of increased OCS use, which indicates poor asthma control. Health care providers should be aware of OCS and SABA use among patients who are both adherent and nonadherent to asthma controller medications.

Health Costs and Outcomes Associated with Medicare Part D Prescription Drug Cost-Sharing in Beneficiaries on Dialysis.

BACKGROUND: High out-of-pocket costs for prescription medications have been associated with poor patient outcomes. A previous study found that the Part D coverage gap was significantly associated with decreases in adherence and persistence for medications frequently used in patients undergoing dialysis. It is not known what effect the decreased use of prescription drugs associated with the coverage gap had on utilization and spending for other medical care.  OBJECTIVE: To determine the relationship between the Part D prescription drug cost-sharing structure and health and economic outcomes in Medicare beneficiaries on dialysis. METHODS: A retrospective analysis using data from the United States Renal Data System (2006-2008) was conducted for Medicare-eligible patients receiving dialysis. Patients were grouped in 1 of 4 cohorts based on low-income subsidy (LIS) receipt and benefit phase in 2007: Cohort 1 (non-LIS and did not reach the coverage gap); Cohort 2 (non-LIS and reached the coverage gap); Cohort 3 (non-LIS and reached catastrophic coverage after the gap); and Cohort 4 (received an LIS, and none of the LIS patients reached the coverage gap). Outcomes included medical care utilization, direct medical costs, and mortality.  RESULTS: A total of 11,732 subjects met the inclusion criteria. Patients in Cohorts 1, 2, and 3 had $3,222 lower, $2,457 lower, and $1,182 higher adjusted pharmacy costs (P less than 0.001), but their adjusted hospitalization costs were $1,499 (P = 0.09), $2,287 (P = 0.01), and $2,959 (P = 0.01) higher, respectively, compared with Cohort 4 (LIS). In the propensity score-matched cohorts, patients who reached the coverage gap (Cohort 2) had higher rates of hospitalization (relative risk [RR] = 1.02, 95% CI = 0.94-1.10), outpatient visits (RR = 1.16, 95% CI = 1.08-1.25), and other visits (RR = 1.17, 95% CI = 1.03-1.32) compared with those who had an LIS (Cohort 4). Patients in Cohort 3 had a higher rate of outpatient visits compared with those in Cohort 4 (RR = 1.14, 95% CI = 1.03-1.25). There were no differences in medical care utilization between patients in Cohort 1 and Cohort 4. Compared with patients in Cohort 4 (LIS), patients in Cohort 2 (those who reached the coverage gap) had 9% higher hospitalization costs (RR = 1.09, 95% CI = 1.01-1.18) and 6% higher outpatient costs (RR = 1.06, 95% CI = 0.97-1.17), respectively. During the 1-year follow-up period, patients in Cohort 2 had a 20% (HR = 1.20, 95% CI = 1.05-1.37) and a 22% (HR = 1.22, 95% CI = 1.01-1.47) increased risk of all-cause and cardiovascular-related mortality compared with those in Cohort 4, respectively.  CONCLUSIONS: Our findings suggest that reaching the Part D coverage gap was associated with unfavorable clinical and economic outcomes in patients undergoing dialysis.

Factors associated with seizure recurrence in epilepsy patients treated with antiepileptic monotherapy: A retrospective observational cohort study using US administrative insurance claims.

BACKGROUND: Few studies examine predictors of seizures in medically treated patients with epilepsy receiving antiepileptic monotherapy using a large patient population. OBJECTIVE: Our objective was to identify clinical, medication, and demographic factors associated with seizure recurrence in medically treated patients with epilepsy receiving one of four antiepileptic monotherapy regimens: lamotrigine, levetiracetam, oxcarbazepine, or topiramate. STUDY DESIGN: A retrospective cohort study was conducted using Innovus Invision™ Data Mart paid medical and prescription US commercial insurance claims data from January 2007 to September 2010. METHODS: Patients aged 18-64 years with a primary or secondary diagnosis of epilepsy and one or more prescription claim for an antiepileptic drug (AED) pre-index were included. The primary outcome was incidence of a seizure or seizure-related event, defined as an emergency room visit, ambulance service use, or inpatient hospitalization medical claim with a primary or secondary diagnosis of epilepsy during the 1-year follow-up. The factors included AED adherence, somatic comorbidity (measured via Charlson Comorbidity Index), mental health comorbidity, pre-index seizure, type of epilepsy diagnosis, presence of AED-interacting medications and any bioequivalent AED switch. The covariates included age, gender, and geographic region of residence. RESULTS: A total of 5.3 % (166/3,140) of patients on AED monotherapy had experienced a seizure or a seizure-related event requiring urgent care at 1-year follow-up. The multivariate analysis of the combined cohort showed that pre-index seizures/seizure-related events (odds ratio [OR] 4.23; 95 % confidence interval [CI] 2.77-6.46), any mental health comorbidity (OR 3.50; 95 % CI 2.14-5.70), and Charlson Comorbidity Index ≥1 (OR 2.91; 95 % CI 1.98-4.28) were significantly associated with post-index seizures/seizure-related events. Patients residing in Northeastern USA had a higher likelihood of a post-index seizure (OR 1.90; 95 % CI 1.17-3.08) than patients residing in the Southern region of the USA. Bioequivalent AED switch, type of epilepsy diagnosis, AED adherence, and presence of AED-interacting medications were not associated with seizure recurrence in the combined cohort analysis (p > 0.05). CONCLUSIONS: Epilepsy patients with comorbid conditions (both mental and somatic diseases) and prior seizures were more likely to experience seizures at 1-year follow-up. Non-adherent patients and patients with bioequivalent AED switches appeared to show no increased likelihood of seizure at follow-up. Clinicians may consider these findings before starting or transitioning to an AED monotherapy.

Adherence and persistence to prescribed medication therapy among Medicare part D beneficiaries on dialysis: comparisons of benefit type and benefit phase.

BACKGROUND: The implementation of Medicare Part D provided insurance coverage for outpatient medications, but when persons reach the "gap," they have very limited or no medication insurance coverage until they reach a second threshold for catastrophic coverage. In addition, some patients have a low-income subsidy (LIS), and their out-of-pocket costs do not reach the threshold for the gap. Little is known about how these Part D types (LIS versus non-LIS) and benefit phases (before the gap, during the gap, after the gap) affect medication adherence and persistence of dialysis patients.  OBJECTIVE: To examine medication use, adherence, and persistence for Medicare-eligible dialysis patients by Part D benefit type and benefit phase.  METHODS: A retrospective cohort study using data from the U.S. Renal Data System (USRDS) was conducted for Medicare-eligible dialysis patients. Outcomes included medication use, adherence, and persistence. Patients were categorized into 4 cohorts based on their Part D benefit phase that the beneficiaries reached at the end of the year and LIS receipt in 2007: Cohort 1 = non-LIS and did not reach the coverage gap; Cohort 2 = non-LIS and reached the coverage gap; Cohort 3 = non-LIS and reached catastrophic coverage after the gap; and Cohort 4 = received an LIS and none of the LIS patients reached the coverage gap. Outcomes were measured separately for 5 therapeutic classes of outpatient prescription drugs: antihyperglycemics, antihypertensives, antilipidemics, phosphate binders, and calcimimetics.  RESULTS: A total of 11,732 patients met the study inclusion criteria. Patients were distributed among the cohorts as follows: 3,678 (31.3%) patients in Cohort 1 who did not reach the coverage gap; 4,349 (37.1%) patients in Cohort 2 who reached the coverage gap but not catastrophic coverage; 1,310 (11.2%) patients in Cohort 3 who reached catastrophic coverage; and 2,395 (20.4%) patients in Cohort 4 who had an LIS (none of whom reached the gap). Overall, the percentage of patients who were adherent to their medications (≥ 80% medication possession ratio) was low: 39% for antihyperglycemics, 59% for antihypertensives, 54% for antilipidemics, 22% for phosphate binders, and 35% for cinacalcet. There were wide ranges in adherence rates depending on the cohort. For patients on antihyperglycemics, antihypertensives, antilipidemics, phosphate binders, and cinacalcet, the odds ratios for adherence to therapy were 0.76 (95% C I =0.63-0.92), 1.06 (0.94-1.19), 0.80 (0.67-0.95), 0.65 (0.55-0.76), and 0.39 (0.30-0.49), respectively; the hazard ratios for discontinuation of therapy were 1.18 (95% CI 1.06-1.31), 1.01 (0.93-1.10), 1.25 (1.12-1.40), 1.13 (1.05-1.21), and 1.61 (1.75-1.82), respectively, for Cohort 2 patients who reached the coverage gap compared with those in Cohort 4 who received an LIS. In addition, when comparing adherence before and after the benefit gap, patients in Cohort 2 were significantly more likely to be nonadherent to medications for diabetes (relative risk (RR) = 1.71, 95% CI = 1.48-1.99), hypertension (RR = 1.69, 95% CI = 1.54-1.85), hyperlipidemia (RR = 2.01, 95% CI = 1.76-2.29), hyperphosphatemia (RR = 1.74, 95% CI = 1.55-1.95), and hyperparathyroidism (RR = 2.08, 95% CI = 1.66-2.60) after reaching the coverage gap.  CONCLUSIONS: More than half of Medicare beneficiaries on dialysis reached the Part D coverage gap in 2007. Our findings suggest that the Part D coverage gap was significantly associated with decreases in adherence and persistence for medications frequently used in patients undergoing dialysis. Patients who reached the coverage gap (Cohort 2) often decreased use of or discontinued critical medications after reaching the coverage gap. Compared with patients who had an LIS (Cohort 4), patients in Cohort 2 had significantly lower medication adherence and persistence levels. The negative impact of the Part D coverage gap (high out-of-pocket cost sharing) on medication adherence and persistence for Medicare-eligible dialysis patients has implications for currently proposed Medicare end-stage renal disease bundled reimbursement payment and requires more research.

Medication effectiveness with the use of tumor necrosis factor inhibitors among Texas Medicaid patients diagnosed with rheumatoid arthritis.

BACKGROUND: Adalimumab (Humira [ADA]), etanercept (Enbrel [ETN]), and infliximab (Remicade [IFX]) are tumor necrosis factor (TNF) inhibitors indicated for the treatment of a variety of disorders. While their effectiveness has not been directly compared in a clinical trial, results from the majority of the indirect treatment comparisons suggest comparable efficacy and safety profiles. However, these TNF inhibitor agents differ in administration method and dosing flexibility, which may result in differences in medication use profiles (e.g., adherence, persistence, discontinuation, dose escalation, and switching to a new biologic rheumatoid arthritis drug) and effectiveness in clinical practice.  OBJECTIVE: To estimate the effectiveness of ADA, ETN, and IFX in patients with rheumatoid arthritis (RA) using a validated, claims-based algorithm designed for large retrospective databases. METHODS: Adult (aged 18-63 years) patients diagnosed with RA, and receiving ADA, ETN, or IFX, and insured by Texas Medicaid were included. The index date was the date of the first prescription claim for ADA or ETN or infusion record for IFX with no claim or infusion record of a biologic drug in the preceding 6 months (i.e., biologic naïve). The study time frame was from July 2003 to August 2011, and prescription and medical claims for each subject were analyzed over an 18-month period (6 months pre- and 12 months post-index). Based on a RA medication effectiveness algorithm (Curtis et al. 2011), a RA medication was classified as effective if each of the following 6 criteria were met: (1) high medication adherence (i.e., medication possession ratio [MPR] ≥ 80%, defined as the sum of days' supply for all fills or infusions divided by the number of days in the study period); (2) no switching to (or addition of) new biologic RA drugs; (3) no addition of new nonbiologic RA drugs; (4) no increase in dose or frequency of administration of the RA medication currently evaluated; (5) no more than 1 glucocorticoid (GC) joint injection; and (6) no increase in dose of a concurrent oral GC. Propensity score (PS) matching was employed, and paired tests (i.e., McNemar's) and multivariate conditional logistic regression analysis were used to compare groups. Demographic (i.e., age, gender, race) and clinical (i.e., use of nonbiologic disease-modifying antirheumatic drugs [DMARDs], pain medication use, GC medication use, RA-related and non-RA-related health care visits [i.e., ambulatory and inpatient visits], number of nonstudy RA medications, and comorbidity index) characteristics, including total health care utilization cost at baseline, served as study covariates. RESULTS: After PS matching, 822 patients (n = 274 per group) were included. The majority of the sample (69.2%) was between 45-63 years, female (88%), and Hispanic (53.7%). Results for each TNF inhibitor differed significantly for 2 of the 6 effectiveness criteria (i.e., medication adherence and dose escalation). A significantly higher proportion of patients on IFX were adherent compared with patients on ETN or ADA (38.3% vs. 16.4% and 21.2%, P less than 0.0001 for both). Adherence rates between ETN and ADA were not significantly different. A significantly higher (P less than 0.0001) proportion of patients on ETN had no dose escalation compared with patients on ADA or IFX (98.2% vs. 88.7% and 80.3%, P less than 0.0001). Dose escalation rate was also significantly lower (P = 0.0106) for ADA compared with IFX. The multivariate conditional logistic regression analysis indicated no significant difference in overall effectiveness using the claims-based algorithm among the 3 TNF inhibitors nor any significant relationship between effectiveness and the study covariates.  CONCLUSION: The study results suggest that when using a medication effectiveness algorithm, IFX, ETN, and ADA have comparable effectiveness in patients with RA. Patient adherence to therapy may be higher if given IFX, and patients who receive ETN are less likely to have a dose escalation.

Adherence to oral diabetes medications among users and nonusers of antipsychotic medication.

OBJECTIVE: This study compared adherence to oral diabetes medications among users and nonusers of oral antipsychotic medications. Adherence to oral antidiabetics and antipsychotics among antipsychotic users was also compared. METHODS: Texas Medicaid prescription claims data from July 1, 2008, to December 31, 2011, were used to examine adherence to oral antidiabetics among users and nonusers of antipsychotics for 12 months after the first prescription for oral diabetes medication. Users and nonusers of antipsychotics were matched on the basis of their chronic disease score (CDS). Medication adherence was measured by proportion of days covered (PDC), and patients with a PDC value ≥.80 were considered to be adherent. Bivariate and multivariate analyses were used to compare adherence between cohorts. RESULTS: A total of 1,821 patients from each group were matched. The mean PDC for oral antidiabetics was significantly higher among antipsychotic users (.63) than nonusers (.55) (p<.001). About 37% (N=678) of antipsychotic users and 24% (N=473) of nonusers were adherent to oral antidiabetics. After adjustment for age, gender, CDS, and number of prescriptions, antipsychotic users were 2.10 times more likely than nonusers to be adherent to oral antidiabetics (p<.001). Antipsychotic users had higher mean PDC values for antipsychotic medications than for oral antidiabetics (.78±.25 versus .63±.29, p<.001). CONCLUSIONS: Adherence to oral antidiabetics in the Texas Medicaid population was better among antipsychotic medication users than nonusers, but overall adherence was poor for both groups. Low adherence rates highlight the need for interventions to help improve medication management.

Progression to insulin for patients with diabetes mellitus using the Texas Medicaid database.

BACKGROUND: Patients newly diagnosed with type 2 diabetes mellitus generally initiate therapy with either metformin [Met] or a sulfonylurea [SU] drug, followed by the addition of a second agent (Met, an SU drug, or a thiazolidinedione [TZD] drug) if the diabetes is not well controlled. If necessary, the usual third line of treatment is the addition of insulin. OBJECTIVE: The purpose of our study was to compare the progression to insulin among 3 cohorts receiving the oral antidiabetic (OAD) drug combinations Met/SU, Met/TZD, or SU/TZD. METHODS: This study used data from the Texas Medicaid database. The date of addition of a second OAD was considered a patient's index date and patients were followed for up to 5 years. Cox proportional hazards regression compared the progression to first insulin use among cohorts, using the Met/SU cohort as the reference group, while adjusting for demographics, comorbidities, and propensity scores. RESULTS: A total of 4083 patients were included in the study (Met/SU = 2872, Met/TZD = 438, and SU/TZD = 773). Insulin was added to the medication regimen of patients by the end of follow-up in 19.7% of the Met/SU cohort, 17.6% of the Met/TZD cohort, and 26.3% of the SU/TZD cohort. The adjusted Cox proportional model estimated that patients in the SU/TZD cohort had a 40% higher probability of progression to insulin than patients in the Met/SU cohort (odds ratio [OR] = 1.40; 95% CI, 1.19-1.64), whereas there was no significant difference between the Met/TZD and Met/SU cohorts (OR = 0.85; 95% CI, 0.67-1.08). CONCLUSIONS: It appears that mechanism of action may play a role in progression to insulin for concomitant OAD agents. A slower progression to insulin was seen for patients receiving a paired sensitizer regimen (ie, Met/TZD) compared with those receiving a secretagogue sensitizer regimen (ie, SU/TZD).