Pharmacy Claims Database Research Articles

Hematopoietic Stem Cell Transplant Utilization in Relapsed/Refractory Hodgkin Lymphoma: A Population Level Analysis of Statewide Claims Data

Introduction: In the era of novel therapies, the first and subsequent lines of therapies are rapidly evolving in the treatment of patients with Hodgkin lymphoma (HL) in order to optimize disease control and reduce long term health risks. Hematopoietic stem cell transplant (HSCT) is often used following treatment failure. While utilization of HSCT can be ascertained from transplant-specific registries, the treatment path for patients with relapsed/refractory HL leading up to HSCT is largely unknown. We developed an algorithm to define a cohort of commercially insured patients with HL from 2009-2013 in the Massachusetts All Payer Claims Database (MA APCD) who received HSCT. Further, we describe treatment characteristics of this cohort.Methods: The Patient Protection and Affordable Care Act of 2010 established requirements for states to assess healthcare outcomes which resulted in at least 16 states establishing All Payer Claims Databases. The MA APCD provides detailed medical claims data, physician provider data, and pharmacy data for all commercially insured patients in the state, regardless of site of care. Moreover, each patient is assigned a unique identifier, which allows us to follow patients even if they change insurer (“insurance churning”). To our knowledge, no studies exist using APCD for HL from any state.We identified a cohort with HL who underwent HSCT during the study period from among 7,613 cases with ICD-9 diagnostic codes for HL and of those, 695 had ICD-9 codes for both HL and HSCT. To identify incident HSCT cases during our study period, we developed and iteratively refined an algorithm using ICD-9 diagnostic and procedure codes, dates of service, and length of stay which narrowed the cohort to 178 patients. After review of the medical and pharmacy claims databases by an oncologist (AW), 113 patients were identified as part of the final cohort who underwent autologous and/or allogeneic HSCT. Reasons for exclusion include not HL (34), not HSCT (8), and prevalent (i.e. “history of”) HSCT only (23). We then summarized initial treatment, salvage treatment, and HSCT where data were available.Results: Among this commercially insured cohort of 113 patients who received HSCT, the median age was 39.0 years and 51.3% were female. Initial therapy data were identified for 65 of the 113 patients (58%); 58 (89.2%) received doxorubicin, bleomycin, vinblastine, and dacarbazine (ABVD). Of the 60 people for whom salvage therapy data could be discerned, 32 (53.3%) received ifosfamide, carboplatin, etoposide (ICE), 11 (18.3%) received gemcitabine, vinorelbine, liposomal doxorubicin (GVD), 11 (18.3%) received other chemotherapy, and 6 (10%) received brentuximab vedotin. Notably, 92 (81.4%) of all transplants were autologous, 10 (8.9%) were allogeneic transplant, and 9 (8.0%) were autologous followed by allogeneic transplant. Of the 64 patients with initial therapy data, median time to HSCT after completion of initial treatment was 238.5 days (25th-75th percentile, 151.5-428.0). Additionally, 25 HSCT were performed during the year 2009 and 20 of these had unknown initial chemotherapy regimens. Our dataset was limited to the years 2009-2013 and this missing chemotherapy information is most likely due to initial treatment prior to 2009.Conclusion: We successfully developed and refined an algorithm to help identify HSCT among patients with HL within a large statewide claims database. We characterized a cohort of patients with relapsed/refractory HL, including patterns of initial and salvage treatments in a sizeable subset of patients. Median time to HSCT demonstrates that the majority of patients undergo transplant for relapsed/refractory disease within a year of completing initial treatment. Future directions include determining reasons for incomplete information on initial and salvage therapy, such as insurance product or type, different sites of care within community and academic practices, and potential referral patterns into the state for HSCT care. As less than 5% of cancer patients are enrolled onto clinical trials, partnerships between clinical experts and data science are a powerful way to use large claims databases to study more representative patient populations. DisclosuresRodday:Seattle Genetics: Research Funding. Kumar:Seattle Genetics: Research Funding. Parsons:Seattle Genetics: Research Funding.

Adherence to chronic medication in older populations: application of a common protocol among three European cohorts.

PurposeThe purpose of this study was to evaluate and compare medication adherence to chronic therapies in older populations across different regions in Europe.MethodsThis explorative study applied a harmonized method of data extraction and analysis from pharmacy claims databases of three European countries to compare medication adherence at a cross-country level. Data were obtained for the period between January 1, 2010, and December 31, 2011. Patients (aged ≥65 years) who newly initiated to oral antidiabetics, antihyperlipidemics, or antiosteoporotics were identified and followed for over a 12-month period. Main outcome measures were medication adherence (medication possession ratio, [MPR]; implementation) and persistence on index treatment. All country-specific data sets were prepared by employing a common data input model. Outcome measures were calculated for each country and pooled using random effect models.ResultsIn total, 39,186 new users were analyzed. In pooled data from the three countries, suboptimal implementation (MPR <80%) was 52.45% (95% CI: 33.43–70.79) for antihy-perlipidemics, 61.35% (95% CI: 52.83–69.22) for antiosteoporotics, and 30.33% (95% CI: 25.53–35.60) for oral antidiabetics. Similarly, rates of non-persistence (discontinuation) were 55.63% (95% CI: 35.24–74.29) for antihyperlipidemics, 60.24% (95% CI: 45.35–73.46) for antiosteoporotics, and 46.80% (95% CI: 36.40–57.4) for oral antidiabetics.ConclusionMedication adherence was suboptimal with >50% of older people non-adherent to antihyperlipidemics and antiosteoporotics in the three European cohorts. However, the degree of variability in adherence rates among the three countries was high. A harmonized method of data extraction and analysis across health-related database in Europe is useful to compare medication-taking behavior at a cross-country level.

PCV112 - PATTERN OF USE OF ANTIHYPERTENSIVE DRUGS IN TWO EUROPEAN COUNTRIES: COMPARISON OF THE INDEX THERAPIES AND PERSISTENCE

To compare the pattern of use and the persistence with antihypertensive (AHT) drugs in subjects initiating the therapy in the regions of Aragon (Spain) and Campania (Italy). Observational descriptive study based on data collected from two electronic pharmacy claims databases: the Information System for Medication Consumption in Aragon and the Campania Regional Database. The study population consisted of all inhabitants in both regions who initiated AHT treatment during 2015. Drugs were identified according to the Anatomical Therapeutic Chemical/ Defined Daily Dose classification. New AHT users were characterized and classified by type of initial therapy and pattern of use. Persistence rates were longitudinally estimated for one year using the Kaplan-Meier method. 25,582 and 99,897 new AHT users in Aragon and Campania, respectively, were included. Most of them received initially monotherapy (73.3% and 58.3% of the treated subjects, respectively), followed by fixed combinations (13.9% and 24.6%) and by separated drugs (9.2% and 10.0%). The Spanish region showed higher persistence rates among those with monotherapy (38.5% compared with 35.0% in Campania) and fixed combinations (43.3% compared with 37.6%), while in the case of separated drugs, the rate was of 32.3% in Aragon and 40.0% in Campania. Additionally, there were striking differences in the proportion of discontinuers who restarted the therapy and those who did not, as well as in the median time to discontinuation, according to the type of therapy and the population. There exist important differences in persistence with AHT in the two European populations depending on the type of therapy. Findings obtained by using electronic health care records allow a better understanding of the patient behavior and provide insight into the regimens that facilitate persistence. Therefore, they may be of interest in the design of interventions to improve the management of high blood pressure.

The PIPc Study—application of indicators of potentially inappropriate prescribing in children (PIPc) to a national prescribing database in Ireland: a cross-sectional prevalence study

ObjectivesEvidence is limited regarding the quality of prescribing to children. The objective of this study was to apply a set of explicit prescribing indicators to a national pharmacy claims database...

Opioid Analgesics in Georgia Medicaid: Trends in Potential Inappropriate Prescribing Practices by Demographic Characteristics, 2009-2014.

There has been a dramatic rise in the number of opioid prescriptions and opioid overdose deaths in the United States over the past 15 years. Misuse and abuse of opioids is also a growing public health concern in the United States. Medicaid enrollees are more likely to be prescribed opioids and are at higher risk of prescription drug overdose compared with non-Medicaid populations. Despite rising opioid drug overdose deaths in Georgia, prevalence of indicators for potential inappropriate prescribing practices has not been examined to date. To examine trends in the general use of opioids and the prevalence of indicators for potential inappropriate opioid prescribing among the Georgia Medicaid population across various demographic characteristics over time. This study used data from the Georgia individual Medicaid pharmacy claims database from 2009 to 2014. Data sample included 3,562,227 observations (patient prescriptions) representing 401,488 individuals. Outcome measures assessed the trends in the general use of opioids and the indicators of potential inappropriate prescribing practices by providers. These outcome measures were taken from previous expert panels and clinical guidelines (e.g., overlapping prescriptions of opioids, opioids and benzodiazepines, and opioids and buprenorphine/naloxone, as well as high daily doses of opioids). Analyses were stratified by gender, type of insurance (fee-for-service and managed care), age, and race/ethnicity. The average number of opioid prescriptions, average days supply of opioids per patient, and average daily dose of opioids per patient increased over time across all demographic categories with older, fee-for-service, male, and missing race groups experiencing higher use across all 6 years compared with their counterparts. A similar pattern was observed for average number of incidences of potential inappropriate prescribing of opioids in this population from 2009 to 2014. The percentage of Medicaid enrollees with at least 1 or more indicators of potential inappropriate prescriptions slightly increased from 17.17% to 18.21% during the study time frame. Moreover, the incidence rate of indicators for potential inappropriate prescribing of opioids also increased over time across all demographic groups, with the oldest age group (55-64 years) experiencing the largest increment. The incidence rate of potential inappropriate prescribing practices per patient increased more than 58% over the 6 years. The results of this study show that potentially inappropriate prescribing practices are common and are increasing over time in the Georgia Medicaid population across all demographic categories, with individuals who are listed in the missing race category, have fee-for-service plans, and are older experiencing the largest increments. These findings indicate that patients in certain demographic groups could be at higher risk for experiencing adverse health outcomes related to inappropriate prescribing of opioids. Further research is needed to explore which policy tools or interventions might be more effective in reducing inappropriate prescribing practices in this population. This research was supported by the National Institute on Drug Abuse of the National Institutes of Health under Award Number R01DA039930 and the Georgia Department of Community Health, contract number 2015012. The content is solely the responsibility of the authors and does not necessarily represent the official views of the National Institutes of Health or the Georgia Department of Community Health. The authors have nothing to disclose. A previous version of this paper was presented at the following conferences: International Health Economics Association 12th World Congress; July 8-11, 2017; Boston, MA, and Addiction Health Services Research Conference; October 18-20, 2017; Madison, WI.

Trends in opioid use in commercially insured and Medicare Advantage populations in 2007-16: retrospective cohort study

ObjectiveTo describe trends in the rate and daily dose of opioids used among commercial and Medicare Advantage beneficiaries from 2007 to 2016.DesignRetrospective cohort study of administrative claims data.SettingNational database of...

Anticholinergic burden in the Japanese elderly population: Use of antimuscarinic medications for overactive bladder patients.

To assess anticholinergic use, especially the use of antimuscarinics, in the elderly (aged ≥65years) Japanese overactive bladder and non-overactive bladder populations. Patient records were sourced from a large, nationwide Japanese pharmacy claims database. Anticholinergic use on a random day in 2016 (index date) was investigated through the Anticholinergic Cognitive Burden scale (primary scale), the Anticholinergic Drug Scale, the Anticholinergic Risk Scale and Beers criteria. The prevalence of anticholinergic use and anticholinergic scores at the index date were summarized descriptively. The overactive bladder population was defined as patients who had at least one prescription record for any antimuscarinic (fesoterodine, imidafenacin, oxybutynin, propiverine, solifenacin or tolterodine) or the β3-adrenoreceptor agonist, mirabegron, within the 1-year pre-index period. Among 1216126 outpatients, 35138 (2.9%) were included in the overactive bladder group. In total, 112 (68.7%) of the anticholinergics listed in the scales were identified. In those who received any Anticholinergic Cognitive Burden scale-listed anticholinergic, the mean scores were higher in overactive bladder patients versus non-overactive bladder patients (3.2±1.3 and 1.6±1.1, respectively). Similarly, overactive bladder patients who received antimuscarinics had higher Anticholinergic Cognitive Burden scores (3.3±1.2) than patients who received mirabegron only (1.7±1.1). In 58.8% of the overactive bladder patients, ≥80% of the total Anticholinergic Cognitive Burden score was exclusively attributable to antimuscarinics. Anticholinergic use was higher in overactive bladder patients versus non-overactive bladder patients. This increased use was largely attributable to antimuscarinics. The alternative use of mirabegron could therefore be considered to reduce the burden experienced by patients in Japan.

Developing a Model for a Data-Driven U.S. Referral Network for Heart Failure Clinical Trials

Introduction Recent studies show that less than half of all clinical trials achieve recruitment goals on time and within budget. Strategies to optimize recruitment in heart failure (HF) trials often include encouraging site investigators to reach out to referring physicians for potential study participants. However, these informal referral networks are often based on anecdotal experiences with local physicians rather than knowledge of which providers have the highest HF patient volumes and where they deliver care. To optimize recruitment in HF trials, we sought to develop a methodology for a data-driven U.S. HF referral network. Methods Using an integrated U.S. medical and pharmacy claims database of primarily commercial insurers, we reviewed 2016-17 claims data. We used ICD-10 codes to identify patients with HF with reduced ejection fraction (HFREF) and HF with preserved ejection fraction (HFPEF) and created maps of providers with ≥100 HFREF or HFPEF patients, and providers with Results We identified a cardiologist in private practice in Omaha, NE with ≥100 HFREF and HFPEF patients ( Figure ). There were 4 surrounding providers with practices that included 20-40 HFREF patients and 3 surrounding providers with practices that included 20-60 HFPEF patients. The surrounding providers included other cardiologists, internists, and family medicine physicians. The potential referral network included other private practices, community hospitals, and tertiary care hospitals. Conclusions In this analysis, we demonstrate a potential data-driven HFREF and HFPEF referral network for a cardiologist in Omaha, NE. The potential referral network included a diverse range of providers in different types of practice settings, with varying likelihood of being a source of referrals for clinical trials. Information about patient volumes, physician specialty, and practice environments can be used to guide targeted outreach and tailored recruitment strategies. Data-driven HF referral networks may allow for more focused, efficient outreach and more robust recruitment. Further research about the impact of data-driven HF referral networks on recruitment rates should be pursued.

Heart Failure Clinical Trials - Broadening the Definition of the Ideal Heart Failure Site Investigator

Introduction Despite a fiercely competitive clinical trial environment in heart failure (HF) and persistently low recruitment rates, industry and government sponsors continue to primarily engage cardiologists as U.S. site investigators for HF trials. We hypothesized that other types of U.S. providers may represent a rich pool of potential HF site investigators. Methods Using an integrated U.S. medical and pharmacy claims database of primarily commercial insurers, we reviewed 2016-17 claims data. We used ICD-10 codes to identify patients with HF with reduced ejection fraction (HFREF) and HF with preserved ejection fraction (HFPEF). We also identified HFREF and HFPEF providers and the rates of hospitalization of their HF patients. We analyzed provider use of ACE inhibitors, angiotensin receptor blockers (ARBs), and sacubitril/valsartan for HFREF and used this as a marker for quality of care. Results Based on medical and pharmacy claims, we identified 1,978,060 patients with HFREF and 1,508,726 patients with HFPEF in the U.S. Of HFREF patients, 0.5% received care from advanced HF/transplant cardiologists, 39% from cardiologists, and 25% from by internists ( Figure ). Of HFPEF patients, 0.2% received care from advanced HF/transplant cardiologists, 34% from cardiologists, and 30% from internists. Hospitalizations for HFREF by provider specialty were as follows: 1) advanced HF/transplant cardiologists (59%); 2) cardiologists (55%); and, 3) internists (64%). Use of ACE inhibitors, ARBs, or sacubitril/valsartan HFREF patients by provider specialty was as follows: 1) advanced HF/transplant cardiologists (49%); 2) cardiologists (47%); and, 3) internists (35%). Conclusions In this analysis, a quarter of HFREF patients and a third of HFPEF patients in the U.S. received care from internists. Less than half of HF patients cared for by providers of any specialty received guideline-based therapy with ACE inhibitors, ARBs, or sacubitril/valsartan. These results suggest that internists may represent a rich pool of potential site investigators for HF clinical trials. A combination of patient volume, use of guideline-based HF therapies, and other clinical trial metrics should be used to identify the most qualified HF site investigators, regardless of specialty.

Anticholinergic and sedative drug burden in community-dwelling older people: a national database study

ObjectivesThe Drug Burden Index (DBI) tool quantifies individual exposure to anticholinergic and sedative medications. The DBI has been internationally validated against adverse health outcomes in older people. DBI exposure has...

PSY110 - Real World Data Analysis of US Claims Database on Coagulation Factor IX Expenditures in Patients with Hemophilia B: Standard half-Life Vs. Extended Half-Life Products

Management of Hemophilia B requires intravenous factor IX (FIX) infusions to replenish missing coagulation factor. The introduction of extended half-life (EHL) replacement products in the US, with longer half-lives compared to standard half-life (SHL) product enabled comparison of expenditures and dispensation of clotting factor concentrates for the treatment of Hemophilia B with two EHL products versus an SHL product. De-identified claims from a large national specialty pharmacy claims database were used to identify male patients with severe or moderate hemophilia B who received FIX replacement from Apr 2015 (month first EHL FIX dispensed) to Sep 2017 and had data for at least 1 month of dispensation. SHL vs EHL groups were compared. Key outcome measures were direct expenditures and factor IUs dispensed. Expenditures and IUs dispensed were measured over monthly increments. Descriptive statistics were used to analyze results. Medians for expenditures and IUs were used to accommodate for the skewness of data distribution. 386 Hemophilia B patients met the inclusion criteria and were included in the analysis. The SHL group comprised of 293 nonacog alfa patients and the EHL group included 107 eftrenonacog alfa patients and 45 albutrepenonacog alfa patients. The albutrepenonacog group had a proportionately higher number of pediatric patients. The median FIX product dispensation per patient per calendar month was 16,134 IU (IQR, 26,903 IU) (nonacog) versus 16,380 IU (IQR, 17,287 IU) (eftrenonacog) and 10,039 IU (IQR, 10,620 IU) (albutrepenonacog). Median expenditures per patient per calendar month were higher for EHLs (eftrenonacog $48,336; IQR, $49,970; and albutrepenonacog $42,664; IQR, $45,135) than for SHL ($21,849; IQR, $36,102). This real-world data analysis, unadjusted for treatment regimen, showed higher expenditure among U.S. moderate/severe hemophilia B patients who used EHL, compared to SHL FIX. Further analyses, incorporating essential clinical characteristics and drug regimen, should be explored.

Mobile App Usage Patterns of Patients Prescribed a Smoking Cessation Medicine: Prospective Observational Study.

BackgroundCigarette smoking is the leading preventable cause of death and is responsible for more than 480,000 deaths per year in the United States. Smoking cessation is challenging for many patients. Regardless of available treatment options, most quit attempts are unaided, and it takes multiple attempts before a patient is successful. With the ever-increasing use of smartphones, mobile apps hold promise in supporting cessation efforts. This study evaluates the ease of use and user satisfaction with the Pfizer Meds app to support smoking cessation among patients prescribed varenicline (Chantix).ObjectiveStudy participants included varenicline users who downloaded and used the app on their personal smartphone. The main objectives were to report mobile app download frequency and usage details and to describe the participant-reported satisfaction with and usefulness of the app over the 14-week follow-up study period.MethodsAdults aged 18 years or older who had been prescribed varenicline were identified from the Express Scripts Incorporated pharmacy claims database. After meeting privacy restrictions, subjects were sent an invitation letter and second reminder letter with instructions on how to download the Pfizer Meds mobile app. Participants received a push notification to complete a smartphone-enabled survey regarding the utility of the app 12 weeks after downloading the app. Descriptive statistics summarized sociodemographics, use of varenicline, and details of use and satisfaction with the mobile app.ResultsOf the 38,129 varenicline users who were sent invitation letters, 1281 participants (3.35%) downloaded the Pfizer Meds app. Of the 1032 users with demographic and other data, 585 (56.68%) were females, and 446 (43.22%) were males; mean age was 46.4 years (SD 10.8). The mean number of app sessions per participant was 4.0 (SD 6.8). The end-of-study survey was completed by 131 survey respondents (10.23%, 131/1281); a large number of participants (117/131, 89.3%) reported being extremely, very, or moderately satisfied with the app. A total of 97 survey respondents (97/131, 74.0%) reported setting up a quit date in the app. Of those, 74 (74/97, 76%) reported quitting on their quit date.ConclusionsPositive patient engagement was observed in this study based on app download and usage. This study quantified how the Pfizer Meds app performed in an observational real-world data setting. The findings demonstrate the willingness of participants to set a quit date and use the app for support in medication adherence, refill reminders, and information regarding how to take the medication. This study provides real-world evidence of the contribution apps can make to the continued encouragement of smokers to improve their health by smoking cessation.

Benzodiazepine and Z-drug prescribing in Ireland: analysis of national prescribing trends from 2005 to 2015.

The aim of this study was to examine prescribing trends for benzodiazepines and Z-drugs to General Medical Services (GMS) patients in Ireland. A repeated cross-sectional analysis of the national pharmacy claims database was conducted for GMS patients aged ≥16 years from 2005 to 2015. Prescribing rates per 1000 eligible GMS population were calculated with 95% confidence intervals (CIs). Negative binomial regression was used to determine longitudinal trends and compare prescribing rates across years, gender and age groups. Duration of supply and rates of concomitant benzodiazepine and Z-drug prescribing were determined. Age (16-44, 45-64, ≥65 years) and gender trends were investigated. Benzodiazepine prescribing rates decreased significantly from 225.92/1000 population (95% CI 224.94-226.89) in 2005 to 166.07/1000 population (95% CI 165.38-166.75) in 2015 (P<0.0001). Z-drug prescribing rates increased significantly from 95.36/1000 population (95% CI 94.73-96.00) in 2005 to 109.11/1000 population (95% CI 108.56-109.67) in 2015 (P=0.048). Approximately one-third of individuals dispensed either benzodiazepines or Z-drugs were receiving long-term prescriptions (>90 days). The proportion of those receiving >1 benzodiazepine and/or Z-drug concomitantly increased from 11.9% in 2005 to 15.3% in 2015. Benzodiazepine and Z-drug prescribing rates were highest for older women (≥65 years) throughout the study period. Benzodiazepine prescribing to the GMS population in Ireland decreased significantly from 2005 to 2015, and was coupled with significant increases in Z-drug prescribing. The study shows that benzodiazepine and Z-drug prescribing is common in this population, with high proportions of individuals receiving long-term prescriptions. Targeted interventions are needed to reduce potentially inappropriate long-term prescribing and use of these medications in Ireland.

Adherence with Extended-Release Oxcarbazepine (Oxtellar XR®) vs. Immediate-Release Oxcarbazepine: Analysis of Pooled Data from Four National Pharmacy Claims Databases (P6.293)

Adherence with Extended-Release Oxcarbazepine (Oxtellar XR®) vs. Immediate-Release Oxcarbazepine: Analysis of Pooled Data from Four National Pharmacy Claims Databases (P6.293)

Abstract 9: Alirocumab Prior Authorization Approval and Prescription Fill Rates Among Medicare Advantage Patients in a Large US Managed Care Plan

Introduction: Alirocumab is a proprotein convertase subtilisin/ kexin type 9 (PCSK9) inhibitor approved as an adjunct to diet and maximally tolerated statin therapy for treatment of adults with heterozygous familial hypercholesterolemia (HeFH) or clinical atherosclerotic cardiovascular disease who require additional lowering of LDL-cholesterol. Barriers to possession, including therapy cost and cost-sharing implications, may contribute to low utilization of this therapy. Objective: To explore differences in demographic and clinical characteristics between patients with prior authorization (PA) approvals or denials for alirocumab as evidenced through filled alirocumab prescription claims. Methods: A retrospective claims-based database analysis of patients with a Medicare Advantage Prescription Drug (MAPD) plan was conducted to identify patients with evidence of a PA approval for alirocumab. Among the group of patients with a PA for alirocumab, the pharmacy claims database was searched for evidence of a corresponding prescription claim within 30 days following the first PA request (index date). The analysis was stratified by evidence of Federal low income subsidy (LIS) support, a program that provides extra assistance with prescription drug costs for eligible individuals whose income and resources are limited, and/ or dual eligibility (DE) status, eligible for Medicare and Medicaid, (LIS/DE) at index. Results: A total of 2,098 MAPD patients meeting study inclusion/exclusion criteria and with a PA for alirocumab were identified between March 1, 2016 and February 28, 2017. Non-LIS/DE patients comprised approximately 82% of the eligible population (n=1,730). There were several notable differences in baseline demographics between the non-LIS/DE vs. the LIS/DE cohorts with an approved PA claim, including Deyo-Charlson Comorbidity Index (2.2 vs. 3.0), prevalence of diabetes mellitus (39.2% vs. 54.7%), and prevalence of HeFH (11.8% vs. 15.6%). While the percentage of patients with an approved PA was similar between the LIS/DE and non-LIS/DE cohorts, 88.9% and 91.2%, respectively, substantially more patients in the LIS/DE cohort had evidence of alirocumab possession based on a paid claim (60.6%) vs. those in the non-LIS/DE cohort (17.3%). Conclusion: Although a high percentage of MAPD patients had evidence of an approved PA, there were notable differences in clinical and demographic characteristics between those with and without LIS/ DE status. Further, the proportion of patients with an approved PA and a paid prescription claim differed markedly amongst MAPD patients with and without LIS/DE status, suggesting further research is needed to understand potential barriers to obtaining PCSK9i therapy.

Abstract P274: Cross-sectional Analysis of Baseline Characteristics for New Users of Vorapaxar (PAR-1 Antagonist) and P2Y 12 Inhibitors

Introduction: Vorapaxar is indicated for the reduction of thrombotic events in patients with a prior myocardial infarction (MI) or peripheral arterial disease (PAD), and contraindicated in patients with a prior stroke, transient ischemic attack (TIA), or intracranial hemorrhage (ICH). This is the first descriptive study of vorapaxar in US clinical practice. Objectives: Main objective was to describe baseline characteristics of vorapaxar new users. For context, P2Y 12 new users were also examined, with indications summarized in Table 1. Methods: Cross-sectional analysis of vorapaxar new users ≥18 years with ≥1 prescription between June 2014 - June 2016 identified in Symphony Health’s outpatient pharmacy claims database linked to private practitioner claims and hospital data. Concomitant clopidogrel use was defined with overlapping days of supply. Medical history was defined using a 1-year baseline period. Results: The analysis included 1,362 vorapaxar (44% with clopidogrel), 975,023 clopidogrel, 133,724 ticagrelor, and 98,101 prasugrel new users (Table 1). Most ticagrelor (87%) and prasugrel (85%) users had evidence of coronary artery disease (CAD) compared with 52% of clopidogrel and 58% of vorapaxar users. In contrast, &lt;1% of ticagrelor and prasugrel users had PAD but no CAD vs. 6% of clopidogrel and 15% of vorapaxar users. The proportion of vorapaxar users (44%) with PAD, alone or with CAD, was 3-5 times larger than P2Y 12 users. PAD was more prevalent for vorapaxar with (50%) vs. without (39%) clopidogrel. Contraindications were infrequent for vorapaxar users - no ICH, &lt;4% with stroke or TIA. Median time from recent MI to therapy start was 6 months for vorapaxar vs. 3 days for ticagrelor and prasugrel and 7 days for clopidogrel. Vorapaxar users were mostly male and on average ~65 years old. Conclusions: The majority of vorapaxar new users had a history of CAD and/or PAD, with PAD prevalence more than twice that of P2Y 12 new users. Contraindications were infrequent.

Persistence and adherence to overactive bladder medications in Japan: A large nationwide real-world analysis.

To evaluate persistence and adherence to mirabegron and antimuscarinics in Japan using data from two administrative databases. The present retrospective study evaluated insurance claims for employees and dependents aged ≤75years, and pharmacy claims for outpatients. From October 2012 to September 2014, new users of mirabegron or five individual antimuscarinics indicated for overactive bladder in Japan (fesoterodine, imidafenacin, propiverine, solifenacin and tolterodine) were identified and followed for 1year. Persistence with mirabegron and antimuscarinics were evaluated using Kaplan-Meier methods. Any associations between baseline characteristics (age, sex and previous medication use) and persistence were explored. Adherence was assessed using the medication possession ratio. In total, 3970 and 16648 patients were included from the insurance and pharmacy claims databases, respectively. Mirabegron treatment was associated with longer median persistence compared with antimuscarinics (insurance claims: 44 [95% confidence intervals 37-56] vs 21[14-28] to 30[30-33] days, pharmacy claims: 105[96-113] vs 62[56-77] to 84[77-86] days). The results were consistent when patients were stratified by age, sex and previous medication. Persistence rate at 1year was higher for mirabegron (insurance claims: 14.0% [11.5-16.8%] vs 5.4% [4.1-7.0%] to 9.1% [5.3-14.2%], pharmacy claims: 25.9% [24.6-27.3%] vs 16.3% [14.0-18.6%] to 21.3% [20.2-22.4%]). Compared with each antimuscarinic, a higher proportion of mirabegron-treated patients had medication possession ratios ≥0.8. This large nationwide Japanese study shows that persistence and adherence are greater with mirabegron compared with five antimuscarinics.

Pharmacoepidemiology resources in Ireland\u2014an introduction to pharmacy claims data

IntroductionAdministrative health data, such as pharmacy claims data, present a valuable resource for conducting pharmacoepidemiological and health services research. Often, data are available for whole populations allowing population level analyses. Moreover, their routine collection ensures that the data reflect health care utilisation in the real-world setting compared to data collected in clinical trials.Setting and methodsThe Irish Health Service Executive-Primary Care Reimbursement Service (HSE-PCRS) community pharmacy claims database is described. The availability of demographic variables and drug-related information is discussed. The strengths and limitations associated using this database for conducting research are presented, in particular, internal and external validity. Examples of recently conducted research using the HSE-PCRS pharmacy claims database are used to illustrate the breadth of its use.Results and conclusionsThe HSE-PCRS national pharmacy claims database is a large, high-quality, valid and accurate data source for measuring drug exposure in specific populations in Ireland. The main limitation is the lack of generalisability for those aged <70 years and the lack of information on indication or outcome.

High-risk prescribing in an Irish primary care population: trends and variation.

The aims of the present study were to examine the prevalence of high-risk prescribing (HRP) in community-dwelling adults in Ireland from 2011-2015 using consensus-validated indicators, factors associated with HRP, and the variation in HRP between general practitioners (GPs) and in the dispensing of high-risk prescriptions between pharmacies. A repeated cross-sectional national pharmacy claims database study was conducted. Prescribing indicators were based on those developed in formal consensus studies and applicable to pharmacy claims data. Multilevel logistic regression was used to examine factors associated with HRP and dispensing. There were significant reductions in the rates of most indicators over time (P < 0.001). A total of 66 022 of 300 906 patients at risk in 2011 [21.9%, 95% confidence interval (CI) 21.8, 22.1%], and 42 109 of 278 469 in 2015 (15.1%, 95% CI 15.0, 15.3%), received ≥1 high-risk prescription (P < 0.001). In 2015, indicators with the highest rates of HRP were prescription of a nonsteroidal anti-inflammatory drug (NSAID) without gastroprotection in those ≥75years (37.2% of those on NSAIDs), coprescription of warfarin and an antiplatelet agent or high-risk antibiotic (19.5% and 16.2% of those on warfarin, respectively) and prescription of digoxin ≥250 μg day-1 in those ≥65years (14.0% of those on digoxin). Any HRP increased significantly with age and number of chronic medications (P < 0.001). a) After controlling for patient variables, the variation in the rate of HRP between GPs was significant (P < 0.05); and b) after controlling for patient variables and the prescribing GP, the variation in the rate of dispensing of high-risk prescriptions between pharmacies was significant (P < 0.05). HRP in Ireland has declined over time, although some indicators persist. The variation between GPs and pharmacies suggests the potential for improvement in safe medicines use in community care, particularly in vulnerable older populations.

Simulation of Lipid-Lowering Therapy Intensification in a Population With Atherosclerotic Cardiovascular Disease

In patients with atherosclerotic cardiovascular disease (ASCVD), guidelines recommend optimizing statin treatment, and consensus pathways suggest use of ezetimibe and proprotein convertase subtilisin/kexin type 9 (PCSK9) inhibitors in patients with persistently elevated low-density lipoprotein cholesterol (LDL-C) levels despite use of statins. Recent trials have provided evidence of benefit in reduction of cardiovascular events with these agents. To estimate the percentage of patients with ASCVD who would require a PCSK9 inhibitor when oral lipid-lowering therapy (LLT) is intensified first. This simulation model study used a large administrative database of US medical and pharmacy claims to identify a cohort of 105 269 patients with ASCVD enrolled from January 1, 2012, through December 31, 2013, who met the inclusion criteria (database cohort). Patients were sampled with replacement (bootstrapping) to match the US epidemiologic distribution and entered into a Monte Carlo simulation (simulation cohort) that applied stepwise treatment intensification algorithms in those with LDL-C levels of at least 70 mg/dL. All patients not initially receiving a statin were given atorvastatin, 20 mg, and the following LLT intensification steps were applied: uptitration to atorvastatin, 80 mg; add-on ezetimibe therapy; add-on alirocumab therapy, 75 mg (a PCSK9 inhibitor); and uptitration to alirocumab, 150 mg. Sensitivity analyses included evolocumab as a PCSK9 inhibitor. Efficacy was estimated from published studies and incorporated patient-level variation. Data were analyzed from December 2015 to May 2017. Treatment intensification strategies with LLT. Use of LLT among the population with ASCVD and distributions of LDL-C levels under various treatment intensification scenarios. Inclusion criteria were met by 105 269 individuals in the database cohort (57.2% male and 42.8% female; mean [SD] age, 65.1 [12.1] years). In the simulation cohort (1 million patients; 54.8% male and 45.2% female; mean [SD] age, 66.4 [12.2] years), before treatment intensification, 51.5% used statin monotherapy and 1.7% used statins plus ezetimibe. Only 25.2% achieved an LDL-C level of less than 70 mg/dL. After treatment intensification, 99.3% could achieve an LDL-C level of less than 70 mg/dL, including 67.3% with statin monotherapy, 18.7% with statins plus ezetimibe, and 14% with add-on PCSK9 inhibitor. Large gaps exist between recommendations and current practice regarding LLT in the population with ASCVD. In our model that assumes no LLT intolerance and full adherence, intensification of oral LLT could achieve an LDL-C level of less than 70 mg/dL in most patients, with only a modest percentage requiring a PCSK9 inhibitor.