Type 2 diabetes pharmacotherapy trends in high-risk subgroups.

Medication use trends among patients with type 2 diabetes from 2015 to 2019 were investigated in relation to the clinical group-specific recommendations from the 2018 American Diabetes Association (ADA)/European Association for the Study of Diabetes (EASD) consensus report. Data were drawn from a large health insurance claims database representing Commercial (total patient-year count: 2,379,704) and Medicare (total patient-year count: 845,823) insurance programmes (IBM® MarketScan®). The utilization of sodium-glucose co-transporter-2 inhibitors or glucagon-like peptide-1 receptor agonists increased over time but was lower in the Medicare cohort in every year evaluated. Patients diagnosed with obesity received recommended therapies at higher rates than those without obesity. Differences were more modest between those with versus without atherosclerotic cardiovascular disease (ASCVD) or chronic kidney disease, with greater treatment adoption in those without ASCVD in the Medicare cohort. Utilization of recommended treatments was paradoxically lower in those with versus without heart failure, and worse in the Medicare than in the Commercial cohort. Utilization of sulphonylureas was not different in those with versus without severe hypoglycaemia history. In conclusion, utilization of therapies recommended in the guidelines is increasing overall, which is not preferentially guided by ADA/EASD-defined clinical groups, and there exists a persistent gap in utilization between Commercial and Medicare populations.

Exploring performance predictors among employees in a pharmacist-led medication management center.

OBJECTIVE: Health care companies are increasingly interested in developing and maintaining employee motivation. However, this can be challenging with different professions working together in delivering telephonic medication therapy management services. The purpose of the study is to assess employees' perceptions of performance metrics, strategies to achieve those metrics, motivational work factors, and barriers to achievement at a medication management center (MMC). DESIGN: Focus group using purposive sampling. SETTING: Six in-person focus groups were conducted with the MMC employees. PARTICIPANTS: Separate focus groups were conducted for pharmacists, student pharmacist interns, and pharmacy technicians. Each group consisted of approximately 5 participants, lasted roughly 1 hour, and was facilitated by trained qualitative researchers. OUTCOME MEASURES: The semistructured sessions involved participants responding to open-ended, predetermined questions introduced by a facilitator. The sessions were audio-recorded and transcribed for analysis. Two independent reviewers analyzed the transcripts; a third independent reviewer facilitated a consensus to resolve discrepancies. RESULTS: Thirty MMC employees, with an average age of 32.1 ± 10.5 years, participated; most of them (73.3%) were women and had worked at the MMC for an average of 2.8 ± 2.2 years. Six themes were identified: (1) awareness and understanding of performance measures; (2) perceptions of performance measures; (3) suggested changes to make the performance measures more reflective of their roles; (4) motivating factors to improve performance; (5) performance barriers; and (6) strategies to achieve performance goals. The intrinsic motivational factors included providing patient care, helping change patients' lives, and meeting work goals. The extrinsic motivational factors included remuneration, management, teamwork, work environment, and feedback. The performance barriers were unrealistic goals, lack of feedback, ineffective communication, and inconsistent operational procedures. CONCLUSIONS: These study findings contribute to a growing body of research surrounding employee motivation within organizations with diverse workforces. Future work is warranted to investigate employee motivation in similar pharmacy-related settings.

Co-occurring Chronic Conditions and Economic Burden among Stroke Survivors in the United States: A Propensity Score-Matched Analysis.

OBJECTIVE: This study examined the impact of co-occurring chronic conditions on healthcare expenditures among noninstitutionalized older adults (age ≥50 years) with stroke in comparison to non-stroke-matched controls. METHODS: This study used a retrospective, cross-sectional, matched case-control design using pooled 2002-2012 Medical Expenditure Panel Survey (MEPS) data. Stroke survivors (N = 2913) were compared with matched controls (N = 8739) based on propensity scores. Healthcare expenditures for co-occurring chronic conditions were compared between stroke survivors and matched controls using ordinary least squares (OLS) regressions. All analyses were conducted in SAS 9.4 (SAS Institute Inc., Cary, NC, USA) using survey procedures adjusting for the complex survey design of the MEPS. RESULTS: The annual mean total healthcare expenditures (expressed in 2012 United States dollars) were significantly higher among stroke survivors compared with matched non-stroke controls ($18,796 versus $14,391, P < .001). OLS regressions revealed that co-occurring chronic conditions partially explained the excess healthcare expenditures among stroke survivors. The annual mean total healthcare expenditures among stroke survivors were significantly higher for most of the co-occurring chronic conditions compared with matched controls (e.g., in presence of hyperlipidemia, stroke survivor expenditures were $18,807 compared to $15,807 among matched controls). Stroke survivors with co-occurring arthritis, diabetes, or hypertension had significantly greater inpatient, emergency room, and prescription expenditures compared with matched controls. CONCLUSIONS: Stroke survivors experience a high economic burden. Interdisciplinary team-based treatment approaches to provide holistic care may help reduce the burden due to co-occurring chronic medical conditions among stroke survivors.

Understanding the impact of non-alcoholic steatohepatitis with metabolic comorbidities on adults: a real-world qualitative study.

OBJECTIVE: Limited real-world evidence exists to better understand the patient experience of living with symptoms and impacts of non-alcoholic steatohepatitis (NASH). This study aimed to (1) describe patient-reported perspectives of NASH symptoms and impacts on patients' daily lives and (2) develop a patient-centered conceptual NASH model. METHODS: A cross-sectional study using semi-structured qualitative interviews was conducted among adults (≥18 years) in the United States living with NASH. Eligible participants were diagnosed with NASH, had mild to advanced fibrosis (F1-F3), and no other causes of liver disease. The interview guide was informed by a targeted literature review (TLR) to identify clinical signs, symptoms, impacts, and unmet treatment needs of NASH. Participants described their experiences and perspectives around NASH and the symptoms, symptom severity/bother, and impact of NASH on their daily activities. Interviews were audio-recorded and transcribed verbatim for coding and thematic analysis. RESULTS: Twenty participants (age: 42.4 years; female: 50.0%) were interviewed. Participants discussed their experience with NASH symptoms (most frequent: fatigue [75.0%]; weakness/lethargy [70.0%]) and impacts (most frequent: physical and psychological/emotional [70.0% each]; dietary [68.4%]). Participants considered most symptoms to be moderately severe or severe and moderately or highly bothersome. Findings from the TLR and qualitative interviews were incorporated into a conceptual model that describes patient-reported symptoms and impacts of NASH, clinical signs, risk factors, and unmet treatment needs. CONCLUSION: Our study provides insights into patients' perspectives of NASH symptoms and their impact on their daily lives. These findings may guide patient-physician conversations, supporting patient-centered treatment decisions and disease management.

Study findings help to address the gap in current literature about patients' perspectives on NASH and its symptoms as well as its impact on daily life.The study proposes a holistic conceptual model that describes patients' perspectives of living with NASH, including symptoms and their impact, the clinical signs and risk factors of NASH, and the unmet treatment needs of the disease.Healthcare providers can use study findings to inform patient-focused decisions around treatment strategies for NASH.

Predictors of insulin pump initiation among people with type 2 diabetes from a US claims database using machine learning.

OBJECTIVE: Insulin pump use is increasing among people with type 2 diabetes (T2D), albeit at a slower rate compared to people with type 1 diabetes (T1D). Factors associated with insulin pump initiation among people with T2D in the real-world are understudied. METHODS: This retrospective, nested case-control study aimed to identify predictors of insulin pump initiation among people with T2D in the United States (US). Adults with T2D who were new to bolus insulin use were identified from the IBM MarketScan Commercial database (2015-2020). Candidate variables of pump initiation were entered into conditional logistic regression (CLR) and penalized CLR models. RESULTS: Of the 32,104 eligible adults with T2D, 726 insulin pump initiators were identified and matched to 2,904 non-pump initiators using incidence density sampling. Consistent predictors of insulin pump initiation across the base case, sensitivity, and post hoc analyses included continuous glucose monitor (CGM) use, visiting an endocrinologist, acute metabolic complications, higher count of HbA1c tests, lower age, and fewer diabetes-related medication classes. CONCLUSIONS: Many of these predictors could represent a clinical indication for treatment intensification, greater patient engagement in diabetes management, or proactive management by healthcare providers. Improved understanding of predictors for pump initiation may lead to more targeted efforts to improve access and acceptance of insulin pumps among persons with T2D.

Weight management treatment modalities in patients with overweight or obesity: A retrospective cohort study of administrative claims data.

Background: The purpose of this study was to describe demographic and clinical characteristics among patients who have medical encounters for weight management treatments and to investigate the association of those characteristics with treatment modality. Methods: This was a retrospective database study using medical claims, pharmacy claims, and enrollment information from commercial and Medicare Advantage with Part D members in the Optum Research Database from 01/01/2011-2/29/2020. Adult patients with a claim for a weight management treatment from 01/01/2012-2/28/2019 were categorized into cohorts according to the highest intensity intervention received. To examine the association between patient characteristics and treatment modality received, a multinomial logit model was performed. Results: Cohorts by increasing intensity included lifestyle intervention (LSI, n = 67,679), weight reduction pharmacotherapy (WRRx) with an anti-obesity medication (AOM, n = 6,905), weight reduction procedure (WRP, n = 1,172), and weight reduction surgery (WRS, n = 18,036). Approximately 32.1% and 16.6% of patients who received WRS or WRP had an LSI during the 12-month baseline, and only 0.6% and 0.4% had treatment with long-term AOMs. In a multinomial logit model, patients with type 2 diabetes (not including WRRx cohort), respiratory disorders, cardiovascular risk factors, pain disorders, and mental health conditions had increased odds of treatment with higher intensity intervention versus LSI. Patients who were male, received an intervention more recently (2016-2019), or had a Charlson comorbidity score of 1 (compared to 0) had decreased odds of treatment with higher intensity interventions. Conclusion: In this study, age, sex, body mass index, obesity-related complications, and Charlson comorbidity score appeared to influence the type of weight management treatment modality received. This study improves understanding of weight management treatment utilization and identifies gaps and opportunities to improve obesity care with the appropriate use of different treatment modalities.

An Early Assessment of the Real-World Treatment Patterns of Type 2 Diabetes: A Comparison to the 2018 ADA/EASD Consensus Report Recommendations.

INTRODUCTION: Using the American Diabetes Association (ADA) Hyperglycemic Pharmacotherapy Guidelines for type 2 diabetes, we evaluated the medication use patterns in real-world patients with type 2 diabetes in the USA. METHODS: Health care claims among patients with type 2 diabetes were analyzed (IBM® MarketScan® 2007 to 2019 Commercial and Medicare Databases). Diabetes treatment patterns were evaluated for the total patient sample of 580,741 during the year 2019. Prior years' claims data were used to construct patient history and determine clinical groups per the 2018 ADA/EASD consensus statement: atherosclerotic cardiovascular disease (ASCVD), chronic kidney disease (CKD), heart failure (HF), hypoglycemia (hypo), and obesity. The recommended therapy use rates (RTUR) were calculated for clinical groups. Univariate chi-square tests were performed to compare RTUR within and outside clinical groups. Multivariate logistic regression was used to identify variables associated with recommended therapy use. RESULTS: A large proportion of patients belonged to multiple clinical groups; this was more common in the Medicare cohort. Each clinical group in the Commercial cohort had a substantially higher RTUR than in the Medicare cohort. However, no clinical group achieved > 40% RTUR. The RTUR was the highest in the CKD and obesity groups in the Commercial cohort and in the hypo and obesity groups in the Medicare cohort, but lowest in hypo and HF groups in the Commercial and Medicare cohorts, respectively. CONCLUSION: Prevalence of guideline-aligned treatment use in 2019 was low, particularly since many patients fit into multiple risk groups with established treatment benefits.

Association of low-income subsidy, medicaid dual eligibility, and disability status with high-risk medication use among Medicare Part D beneficiaries.

BACKGROUND: Low-income subsidy/dual eligibility (LIS/DE) status and disability status may be associated with high-risk medication (HRM) use but are not usually accounted for in medication-use quality measures. OBJECTIVE: To examine the association of: 1) LIS/DE status and HRM use; and 2) disability status and HRM use, while controlling for both health plan level effects and patient characteristics for Medicare beneficiaries enrolled in Medicare Advantage Prescription Drug Plans (MA-PD) and stand-alone Prescription Drug Plans (PDP). METHODS: This retrospective cross-sectional study used 2013 Medicare data to determine if LIS/DE status and disability status were independently associated with HRM use (using the Pharmacy Quality Alliance HRM measure) in MA-PDs and PDPs. Multivariable generalized linear mixed models assessed the association of LIS/DE and HRM use, and disability and HRM use, after adjusting for health plan effect and patient-level confounders for MA-PD and PDP beneficiaries. RESULTS: Of 520,019 MA-PD beneficiaries, 88,693 (17.1%) were LIS/DE and 48,997 (9.4%) were disabled. Of 881,264 PDP beneficiaries, 213,096 (24.2%) were LIS/DE, and 83,593 (9.5%) were disabled. LIS/DE beneficiaries had a higher percent of HRM users compared to non-LIS/DE MA-PD (13.3% vs. 9.7%, p < 0.001) and PDP (17.1% vs. 13.2%, p < 0.001) beneficiaries. Disabled beneficiaries had a higher percent of HRM users compared to non-disabled MA-PD (17.0% vs. 9.6%, p < 0.001) and PDP (22.9% vs. 13.2%, p < 0.001) beneficiaries. Multivariable analyses showed LIS/DE (adjusted odds ratio [AOR] = 1.07; 95% CI = 1.04, 1.10) and disability (AOR = 1.38; 95% CI = 1.34, 1.42) were associated with HRM use among MA-PD and PDP beneficiaries (LIS/DE AOR = 1.14; 95% CI = 1.12, 1.16; disability AOR = 1.37; 95% CI = 1.34, 1.40). CONCLUSIONS: The association of LIS/DE and disability with higher HRM use in both MA-PD and PDP beneficiaries, when controlling for health plan effects and patient characteristics, suggests these factors should be considered when comparing health plan performance on HRM measures.

Evaluating the relationship between quality measure adherence definitions and economic outcomes in commercial health plans: a retrospective diabetes cohort study.

BACKGROUND: Diabetes is a prevalent chronic condition in the United States that results in considerable morbidity and mortality, frequent use of the health care system, and high health care expenditures. Adherence to antidiabetic medications can help improve health outcomes and lower health care utilization and expenditures. The Pharmacy Quality Alliance (PQA) Proportion of Days Covered (PDC): Diabetes All Class medication adherence measure was developed and endorsed to improve adherence to noninsulin antidiabetic medications; however, it has not been assessed in a commercial population of diabetes patients over a 1-year time frame. OBJECTIVE: To determine the association between adherence, as defined in the PQA medication adherence measures, and health care utilization and expenditure among commercially insured individuals using antidiabetic medications. METHODS: This 1-year retrospective study evaluated a cohort of individuals from IBM MarketScan Research Databases (2009-2015) with noninsulin antidiabetic medications. Eligible study subjects included adults (aged ≥ 18 years at index date) with continuous enrollment in their health plans for 6 months before (i.e., baseline period) and 12 months after (i.e., study period) the index date and ≥ 2 prescriptions dispensed for any medication included in the PQA PDC Diabetes All Class medication adherence measure, with at least 150 days between the first and last fill during the study period. The index date was defined as the first fill for a medication included in the PQA PDC Diabetes All Class adherence measure after a 180-day baseline period. Generalized linear models with log link and gamma distribution (expenditure) or negative binomial distribution (utilization) assessed relationships between adherence (≥ 80% PDC) and health care utilization and expenditure while adjusting for potential confounders. Cost ratios (CR) and rate ratios (RR) were computed using beta coefficients. Cohort characteristics were compared using t-tests, Wilcoxon rank sum tests, or chi-square tests with an alpha level of 0.001 set a priori. RESULTS: A total of 1,576,112 individuals were eligible; of these, 1,028,176 (65.2%) were adherent. Significant differences in demographic characteristics were observed between adherent and nonadherent groups (P < 0.001). Multivariable analyses demonstrated that adherence was associated with the following: (a) 16.6% fewer inpatient (RR = 0.834, 95% CI = 0.819-0.850) and 3.6% more outpatient service visits (RR = 1.036, 95% CI = 1.032-1.039) and (b) 16.8% lower inpatient expenditures (CR = 0.833, 95% CI = 0.829-0.836); 2.6% lower outpatient expenditures (CR = 0.974, 95% CI = 0.970-0.978); 16.4% higher prescription drug expenditures (CR = 1.164, 95% CI = 1.159-1.169); and 4.2% lower total (CR = 0.958, 95% CI = 0.954-0.962) expenditures. Adherent subjects were associated with lower incremental per member per month expenditures for inpatient (-$31.74), outpatient (-$10.09), and total (-$30.82) expenditures, yet higher prescription drug expenditures ($25.60) compared with nonadherent subjects. CONCLUSIONS: Adherence to noninsulin antidiabetic medications was associated with more outpatient and fewer inpatient visits, as well as lower total expenditures compared with nonadherence. DISCLOSURES: Funding was provided by grants from Pharmacy Quality Alliance, Merck & Co. (Kenilworth, NJ), and SinfoniaRx. In addition, Chinthammit reports personal fees from Eli Lilly and Company, outside the submitted work. Axon reports grants from the American Association of Colleges of Pharmacy and the Arizona Department of Health Services, outside the submitted work. Taylor reports grants from the Arizona Department of Health Services, outside the submitted work. Warholak reports grants from Novartis and the Arizona Department of Health Services, outside the submitted work. Chinthammit and Campbell disclose that this work was completed during their employment at the University of Arizona. This research was presented as a poster at the AMCP Annual Meeting 2019; March 25-28, 2019; San Diego, CA.

Hypertension, cholesterol and diabetes medication adherence, health care utilization and expenditure in a Medicare Supplemental sample.

ABSTRACT: Limited evidence exists regarding the relationships between adherence, as defined in Pharmacy Quality Alliance (PQA) medication adherence measures, health care utilization, and economic outcomes. PQA adherence measures for hypertension, cholesterol, and diabetes are of particular interest given their use in Medicare Star Ratings to evaluate health plan performance.The objective of this study was to assess the relationship between adherence and utilization and cost among Medicare Supplemental beneficiaries included in the aforementioned PQA measures over a 1-year period.Retrospective cohort study.Three cohorts (hypertension, cholesterol, and diabetes) of eligible individuals from the Truven Health MarketScan Commercial Claims and Encounters Research Databases (2009-2015) were used to assess associations between adherence and health care expenditure and utilization for Medicare Supplemental beneficiaries.Generalized linear models with log link and negative binomial (utilization) or gamma (expenditure) distributions assessed relationships between adherence (≥80% proportion of days covered) and health care utilization and expenditure (in 2015 US dollars) while adjusting for confounding variables. Beta coefficients were used to compute cost ratios and rate ratios.Adherence for all 3 disease cohorts was associated with lower outpatient and inpatient visits. During the 1-year study period, adherence was associated with lower outpatient, inpatient, and total expenditures across the cohorts, ranging from 9% lower outpatient costs (diabetes cohort) to 41.9% lower inpatient costs (hypertension cohort). Savings of up to $324.53 per member per month in total expenditure were observed for the hypertension cohort.Our findings indicate adherence is associated with lower health care utilization and expenditures within 1 year.

Health care resource utilization and cost of severe hypoglycemia treatment in insulin-treated patients with diabetes in the United States.

BACKGROUND: Hypoglycemia is a major limiting factor in achieving glycemic control in persons with diabetes. In some instances, recovery from a severe hypoglycemia event may require health care resource utilization (HCRU), including the use of emergency medical services (EMS), visits to the emergency department (ED), and inpatient hospitalization. OBJECTIVES: To (a) describe the profiles of patients who experience severe hypoglycemic events and (b) characterize HCRU and the associated cost related to severe hypoglycemia treatment. METHODS: This retrospective, observational cohort study used administrative claims data from IBM MarketScan Research Databases. The study examined a cohort of subjects who experienced severe hypoglycemic events that involved HCRU during the 1-year index period. Baseline patient demographic data were collected according to patient profiles, such as payer type, type of diabetes, age, and type of insulin. HCRU and the associated cost data categorized by the patient profiles and care progression scenarios were described. RESULTS: 9,563 patients from the IBM MarketScan Research Databases experienced a severe hypoglycemic event during the index period and were included in the study; approximately 75% of those patients did not experience a severe hypoglycemic event in the previous year. Of the 9,563 patients in the cohort, the largest patient profile (n = 1,767, 18.5%) consisted of those who were on Medicaid, had type 2 diabetes, and used basal/bolus or premixed-only insulins. Overall, more than 90% of the index severe hypoglycemic events involved visits to the ED. EMS claims in the 24 hours before the ED visit were found for half of the severe hypoglycemic events (51.5%). CONCLUSIONS: Differences in HCRU and the associated costs for the treatment of severe hypoglycemia were observed among patients based on insurance, diabetes, and insulin types. Clinicians need to be aware of these differences. Optimizing treatment of severe hypoglycemia, specifically EMS care, and examining patient profiles to develop targeted interventions could potentially provide benefits to patients and reduce cost and resource utilization. DISCLOSURES: This study was funded by Eli Lilly and Company. All authors are employees and shareholders of Eli Lilly and Company. The data presented here have been presented in poster form at AMCP Nexus 2020 Virtual, October 19-23, 2020; ADCES Virtual Conference 2020, August 13-16, 2020; and Virtual ISPOR 2020, May 18-20, 2020.

Associations of Renin-Angiotensin System Antagonist Medication Adherence and Economic Outcomes Among Commercially Insured US Adults: A Retrospective Cohort Study.

Background Medication non-adherence can result in considerable morbidity, mortality, and costs. The Pharmacy Quality Alliance hypertension medication adherence measure is used by US healthcare payers and providers to assess renin-angiotensin system antagonist medication adherence. However, associations between renin-angiotensin system antagonist adherence as calculated in quality measures, and healthcare service use and expenditure in commercial populations over a 1-year timeframe has not been assessed. Methods and Results This retrospective cohort study used eligible commercially insured individuals from the Truven Health MarketScan Commercial Claims and Encounters Research Databases (2009-2015). Generalized linear models with log link and gamma distribution (expenditure) or negative binomial distribution (usage) assessed relationships between hypertension adherence (≥80% proportion of days covered) and healthcare use and expenditures (in 2015 US dollars) while adjusting for covariates (age, sex, geographic region; health plan; Deyo-Charlson Comorbidity Index, number of chronic medications, and treatment naivety). Beta coefficients were used to compute cost ratios and rate ratios. A total of 4 842 058 subjects were eligible; of those, 3 310 360 (68%) were adherent (adherent mean age 53.3±8.0 years, 55.9% men; non-adherent mean age 50.3±9.1 years, 53.1% men). Adherence was associated with fewer inpatient (rate ratios, 0.612; 95% CI, 0.607-0.617) and outpatient visits (rate ratios, 0.995; 95% CI, 0.994-0.997); and lower total costs (cost ratios, 0.876; 95% CI, 0.874-0.878) compared with non-adherence. Adherence was associated with lower average per member per month total costs ($97.98) compared with non-adherence. Conclusions Adherence to renin-angiotensin system antagonists was associated with fewer outpatient and inpatient visits, and lower total costs compared with non-adherence in a 1-year time frame.

Current Procedural Terminology Codes for Medication Therapy Management in Administrative Data.

BACKGROUND: Three pharmacist-specific Current Procedural Terminology (CPT) codes exist to facilitate medication therapy management (MTM) reimbursement (codes 99605, 99606, and 99607). However, no studies have used CPT codes in administrative claims databases to identify subjects who have received MTM services. OBJECTIVE: To assess the prevalence of MTM services provided, using CPT codes identified in an administrative dataset. METHODS: A retrospective cohort study was conducted using a subset of Medicare Part D individuals from the IBM MarketScan Medicare Supplemental Research Databases (2009-2015). Researchers identified beneficiaries who received MTM services using CPT codes 99605, 99606, and 99607. RESULTS: Of the 16,483,709 individuals in the dataset, only 3,291 had CPT codes indicating that they received MTM services, representing an overall prevalence of 0.020%. CONCLUSIONS: The use of CPT codes as an indicator of MTM service provision resulted in far lower MTM utilization rates than in published literature. Reliance on CPT codes to identify MTM services in administrative claims is not recommended, given that it limited the researchers' ability to properly identify patient receipt of such services. More accurate methodologies are warranted for identifying MTM use and its effects on patient outcomes. DISCLOSURES: This work was supported by Pharmacy Quality Alliance; Merck Sharp & Dohme, a subsidiary of Merck & Co. (Kenilworth, NJ); and SinfoniaRx. The funding sources had no role in study design, collection, analysis, and interpretation of data, writing the report, or decision to submit the article for publication. Tate, Chinthammit, and Campbell completed this work during their employment at the University of Arizona. Pickering was an employee of Pharmacy Quality Alliance at the time of this study. Black is employed by Merck. Axon reports grants from the Arizona Department of Health Services and the American Association of Colleges of Pharmacy; Campbell reports a grant from the Community Pharmacy Foundation; Chinthammit reports fees from Eli Lilly; Black has received a grant from Merck; Warholak reports grants from the Arizona Department of Health Services and Novartis, all unrelated to this study. Taylor reports grants from Tabula Rasa Op-Co, during the conduct of the study, and from the Arizona Department of Health Services, outside the conduct of this study. This research was accepted as a poster presentation at the International Society for Pharmacoeconomics and Outcomes Research Annual Meeting, May 16-20, 2020, in Orlando, FL, but was not presented due to the COVID-19 pandemic. An abstract was published in Value in Health, 2020;23(Suppl 1):S305.

A retrospective cohort study evaluating the relationship between statin medication adherence and economic outcomes in commercial health plans.

BACKGROUND: Adherence to statin medications is suboptimal; however, the association of statin adherence, as defined in medication adherence quality measures, with healthcare service use and expenditure within one year has not been assessed in a commercially insured United States (US) population. OBJECTIVE: To investigate the relationship between statin adherence, as specified in the Pharmacy Quality Alliance (PQA) statin medication adherence quality measure, and healthcare resource utilization and expenditures within commercial health plans over a one-year period. METHODS: This one-year retrospective analysis involved a cohort of individuals from the Truven Health MarketScan Commercial Claims and Encounters Research Databases (2009-2015). Generalized linear models with log link and negative binomial distribution (use) or gamma distribution (expenditures) were used to assess relationships between medication adherence (≥80% proportion of days covered) and healthcare use and expenditures (adjusted to 2015 US dollars) while adjusting for covariates. Beta coefficients were used to compute cost ratios (CR) and rate ratios (RR). An alpha level of 0.001 was set a priori. RESULTS: Of 4,450,308 eligible individuals, 2,757,288 (61.9%) were classified as adherent. Multivariable analyses indicated adherent individuals had more outpatient (RR = 1.009, 95% CI = 1.007, 1.010) and fewer inpatient visits (RR = 0.756, 95% CI = 0.749, 0.762); and lower outpatient (CR = 0.965, 95% CI = 0.963, 0.967), inpatient (CR = 0.780, 95% CI = 0.779, 0.782), and total expenditures (CR = 0.975, 95% CI = 0.973, 0.977). Adherence was associated with lower per member per month total healthcare expenditures ($18.91) vs nonadherence. CONCLUSION: Within one year, statin adherence was associated with more outpatient and fewer inpatient visits, lower outpatient and inpatient expenditures, and lower total expenditures than nonadherence, within a commercially-insured population.

Geographic Variation in the Prevalence of High-Risk Medication Use Among Medicare Part D Beneficiaries by Hospital Referral Region.

BACKGROUND: Understanding geographic patterns of high-risk medication (HRM) prescribed and dispensed among older adults may help the Centers for Medicare & Medicaid Services and their partners develop and tailor prevention strategies. OBJECTIVE: To compare the geographic variation in the prevalence of HRM use among Medicare Part D beneficiaries from 2011 to 2013, for Medicare Advantage Prescription Drug (MA-PD) plans and stand-alone Prescription Drug Plans (PDPs). METHODS: This retrospective study used the data of a 5% national Medicare sample (2011-2013). Beneficiaries were included in the study if they were aged ≥ 65 years, continuously enrolled in MA-PDs or PDPs (~1.3 million each year), and had ≥ 2 prescriptions for the same HRM (e.g., amitriptyline) prescribed and dispensed during the year based on the Pharmacy Quality Alliance's (PQA) quality measures for HRM use. Multivariable logistic regression was used to estimate adjusted annual HRM use rates (i.e., adjusted predictions, average marginal predictions, or model-adjusted risk) across 306 Dartmouth Atlas of Health Care hospital referral regions (HRRs), controlling for sociodemographic, health-status, and access-to-care factors. RESULTS: Among eligible beneficiaries each year (1,161,076 in 2011, 1,237,653 in 2012, and 1,402,861 in 2013), nearly 40% were enrolled in MA-PD plans, whereas the remaining 60% were in PDP plans. The adjusted prevalence of HRM use significantly decreased among Medicare beneficiaries enrolled in MA-PD (13.1%-8.4%, P < 0.001) and PDP (16.2%-12.2%, P < 0.001) plans from 2011 to 2013. For MA-PD and PDP beneficiaries, HRM users were more likely to be (all P < 0.001) the following: female (MA-PD: 70.4% vs. 59.9%; PDP: 72.8% vs. 62.5%); White (MA-PD: 84.6% vs. 81.4%; PDP: 86.6% vs. 85.3%); with low-income subsidy or dual eligibility for Medicaid (MA-PD: 22.3% vs. 16.6%; PDP: 29.2% vs. 23.3%); and disabled (MA-PD: 15.6% vs. 8.7%; PDP: 15.4% vs. 8.5%) compared with non-HRM users in 2013. In 2013, significant geographic variation existed, with the ratios of 75th-25th percentiles of HRM use rates across HRRs as 1.42 for MA-PDs and 1.31 for PDPs. For MA-PDs, the top 5 HRRs with the highest HRM use rates in 2013 were Casper, WY (20.4%), Waco, TX (16.7%), Lubbock, TX (15.7%), Santa Barbara, CA (15.2%), and Temple, TX (15.1%); for PDPs, they were Lawton, OK (18.8%), Alexandria, LA (18.8%), Lake Charles, LA (18.6%), Oklahoma City, OK (18.0%), and Slidell, LA (18.0%). CONCLUSIONS: Substantial geographic variation exists in the prevalence of HRM use among older adults in Medicare, regardless of prescription drug plan. Areas with high prevalence of HRM use may benefit from targeted interventions (e.g., medication therapy management monitoring or alternative medication substitutions) to prevent potential adverse consequences. DISCLOSURES: No outside funding supported this study. The authors have nothing to disclose. This study was presented as a poster at the International Society of Pharmacoeconomics and Outcomes Research (ISPOR) Asia Pacific Meeting; September 8-11, 2018; Tokyo, Japan.

Assessing the association between medication adherence, as defined in quality measures, and disease-state control, health care utilization, and costs in a retrospective database analysis of Medicare supplemental beneficiaries using statin medications.

BACKGROUND: Adherence to medication, and related health and economic outcomes, is becoming increasingly important as populations age and as the number of Americans managing chronic conditions increases. The Pharmacy Quality Alliance (PQA) statin medication adherence measure is used in Medicare star ratings to evaluate health plan performance. Yet, limited evidence exists that investigates the association between statin medication adherence, as specified in the PQA adherence quality measure, and disease-state control, health care utilization, and costs. OBJECTIVE: To determine the association between adherence (≥80% proportion of days covered) and disease-state control, health care utilization, and health care costs for Medicare supplemental beneficiaries using statin medications eligible for inclusion in the PQA statin adherence quality measure. METHODS: This retrospective study used a cohort of eligible beneficiaries for inclusion in the PQA statin adherence measure with low-density lipoprotein (LDL) laboratory values from IBM MarketScan Medicare Supplemental Research Databases (2009-2015). A logistic regression model assessed the association between adherence and LDL control (controlled individuals had LDL levels ≤ 100 mg/dL). Health care utilization and costs during a 1-year period, from first statin medication claim, were compared between adherent and nonadherent groups using generalized linear models with log link and negative binomial distribution (utilization) or gamma distribution (costs), adjusting for covariates. Beta coefficients were used to compute cost ratios (CR) and rate ratios (RR). Cohort characteristics were assessed using t-tests, Wilcoxon rank sum tests, or chi-square tests. An a priori alpha level of 0.001 was used. RESULTS: The study cohort consisted of 77,174 beneficiaries, of whom 58,668 (76.0%) were classified as adherent to their statin medications. After controlling for other factors, odds of disease-state control were approximately 2 times higher among medication adherent beneficiaries compared with their nonadherent counterparts (OR = 2.192; 95% CI = 2.109-2.278). Multivariable analyses showed adherers experienced 4.7% fewer outpatient (RR = 0.953; 95% CI = 0.940-0.965) and 27.5% fewer inpatient (RR = 0.725; 95% CI = 0.687-0.766) visits; had 9.9% lower outpatient (CR = 0.901; 95% CI = 0.885-0.916) and 28.3% lower inpatient (CR = 0.717; 95% CI = 0.705-0.729) costs; 14.7% lower total costs (CR = 0.853; 95% CI =0.838-0.868); and 7.0% higher prescription drug costs (CR = 1.070; 95% CI = 1.052-1.089) than nonadherers. Adherence to statin medications was associated with a reduction in total costs of $157.32 per member per month. CONCLUSIONS: This retrospective database analysis demonstrated that statin adherence was associated with approximately twice the odds of having a controlled disease state compared with nonadherence in a large Medicare sample. Adherent beneficiaries had fewer outpatient and inpatient visits (lower utilization), lower outpatient and inpatient costs, and lower total costs, a calculated savings of $157.32 per member per month, despite having higher prescription drug costs. Finally, these results provide important new information by demonstrating that adherence (≥ 80%) is associated with lower health care costs in a short (1-year) time frame. DISCLOSURES: Funding for this study was provided by Pharmacy Quality Alliance; Merck & Co. (Kenilworth, NJ); and SinfoniaRx. All authors except Pickering and Black were employed by the University of Arizona College of Pharmacy or the Mel & Enid Zuckerman College of Public Health at the time of this study. Pickering is employed by the Pharmacy Quality Alliance, and Black is employed by Merck & Co. Chinthammit also reports employment with Eli Lilly and Company, and Campbell reports employment with the Pharmacy Quality Alliance. Axon reports grants from Arizona Department of Health Services, unrelated to this work. Warholak reports grants from Novartis and the Arizona Department of Health Services, unrelated to this work. This research was presented as a poster at the International Society for Pharmacoeconomics and Outcomes Research (ISPOR) Annual Meeting 2019, May 18-22, 2019, in New Orleans, LA.

Retrospective Review of Exceptions for Angiotensin-Converting Enzyme Inhibitor or Angiotensin II Receptor Blocker Recommendations for a Diabetic Medicare Population.

BACKGROUND: Renin-angiotensin system (RAS) antagonists are recommended for people with diabetes and hypertension or with elevated urinary albumin excretion. RAS antagonists are beneficial for some, yet clinically inappropriate for others. The percentage of patients for whom RASs are clinically inappropriate has not been compared across health plans. OBJECTIVES: To (a) identify reasons why RAS therapy was not recommended and (b) compare exception percentages between health plans. METHODS: This retrospective, cross-sectional analysis included Medicare Part D beneficiaries with diabetes, enrolled in health plans (n = 96) participating in a university-based medication therapy management (MTM) program between January 1 and December 31, 2013. The MTM program evaluated patient eligibility for RAS therapy via (1) a clinically derived software system assessing demographics and medication history, and (2) telepharmacist-delivered medication reviews. The MTM program database calculated the number of patients with diabetes and percentage of RAS therapy exceptions. RESULTS: An average of 55% of patients with diabetes qualified for MTM (range: 19%-88%). Of the 218,589 eligible, 94,359 had 1 or more reasons contraindicating RAS therapy (exception). For an average of 29% of patients, it was inappropriate to recommend the addition of an RAS antagonist; the overall exception rate ranged from 3% to 83%, suggesting a wide variation of exception rates for all health plans. CONCLUSIONS: A substantial difference existed across health plans where RAS therapy was considered clinically inappropriate to recommend for patients with diabetes. Future research must examine variations in therapy exceptions to understand the effect of encouraging broad-population RAS antagonist use. DISCLOSURES: SinfoníaRx provided funding for this project. Wild, Boesen, and Werner are employed by SinfoniaRx, which provided grant funding to the University of Arizona College of Pharmacy for the conduct of this study. This project was presented at the AMCP 27th Annual Meeting and Expo; April 8-10, 2015; San Diego, CA.

Psychometric Properties of the Patient-Reported Outcomes Measure of Pharmaceutical Therapy for Quality of Life (PROMPT-QOL).

OBJECTIVES: To assess the psychometric properties of a novel instrument for medication management, the Patient-Reported Outcomes Measure of Pharmaceutical Therapy for Quality of Life (PROMPT-QOL), using both conventional psychometrics and Rasch analysis in a large sample. METHODS: This study was conducted with 1156 adult outpatients continuously taking any medicines at least 3 months from three university hospitals in Bangkok, Thailand, between July 2014 and March 2015. The psychometric properties were assessed in five steps: 1) assessment of dimensional structure, 2) item selection, 3) assessment of practicality, 4) assessment of reliability, and 5) assessment of criterion and known-groups validity. RESULTS: The PROMPT-QOL contained 43 items including nine domains, and their five-point Likert scale functioning worked well. Most items fulfilled the item selection criteria. The PROMPT-QOL took an average administration time of 13.4 ± 5.8 minutes. Only two items had missing data of 0.1% to 0.2%. All domains provided good to excellent test-retest reliability with intraclass correlation coefficients between 0.67 and 0.83. All domains of the PROMPT-QOL yielded high Cronbach's α values between 0.77 and 0.89, greater than an acceptable level of 0.70, except for the Availability and Accessibility domain (0.58). A multiple regression showed that the Medication Effectiveness domain was the strongest predictor of the overall QOL of the PROMPT-QOL, followed by the Therapeutic Relationships, Psychological Impacts, Convenience, and Availability and Accessibility domains (adjusted R2 ~ 52%). As expected, patients with higher PROMPT-QOL domain scores were associated with being younger, more educated, having a lower number of medicines, patients' perceptions of better disease control, having no adverse drug reactions, and medicine preference. CONCLUSIONS: The PROMPT-QOL was practical, reliable, and valid for Thai patients.

Evaluation of a guided continuous quality improvement program in community pharmacies.

BACKGROUND: The importance of creating and sustaining a strong culture of patient safety has been recognized as a critical component of safe medication use. This study aims to assess changes in attitudes toward patient safety culture and frequency of quality-related event (QRE) reporting after guided implementation of a continuous quality improvement (CQI) program in a panel of community pharmacies in the United States (U.S.). METHODS: Twenty-one community pharmacies volunteered to participate in the project and were randomly assigned to intervention or control groups. Pharmacy staff in the intervention group received guided training to ensure full implementation of a CQI program while those in the control group partially implemented the program. Pharmacy staff in both groups completed retrospective pre-post safety culture questionnaires and reported medication errors and near misses that occurred in their practices. Rasch analysis was applied to assess questionnaire validity and reliability and to confirm if the ordinal level data approximated interval level measures. Paired t-tests and repeated measure analysis of covariance tests were subsequently used to compare observed changes in the attitudes of subjects and frequency of QREs reporting in intervention and control groups. RESULTS: Sixty-nine employees completed the questionnaire, a 43.9% response rate. Improvement in attitudes toward patient safety was statistically significant in the intervention group in six domains: staff, training, and skill (p = 0.017); patient counseling (p = 0.043); communication about mistakes (p < 0.001); response to mistakes (p < 0.001); organizational learning - continuous improvement (p < 0.001); and overall patient safety perceptions (p = 0.033). No significant differences were observed in QRE reporting rates between intervention and control groups. However, differences were observed in the types of QREs reported (e.g., incorrect safety cap) and the point in the prescription processing workflow where a QRE was detected (e.g., partner check station, and drug utilization review station) in the intervention group (p < 0.001). CONCLUSION: Guided CQI program implementation increased the self-reported patient safety culture attitudes among staff.

Cost-effectiveness of comprehensive medication reviews versus noncomprehensive medication review interventions and subsequent successful medication changes in a Medicare Part D population.

BACKGROUND: An estimated 1.5 million preventable medication-related adverse events occur annually, with some resulting in serious injury and even death. To help address this issue, the Centers for Medicare Medicaid Services (CMS) now require medication therapy management (MTM) programs to offer comprehensive medication reviews (CMRs) to all Medicare Part D beneficiaries at least once a year. During a CMR, patients receive an extensive amount of medication and educational information. In contrast, noncomprehensive medication reviews (non-CMRs) are more targeted and focus on resolving a particular medication-related problem (MRP) via short patient consultations, patient letters, and direct provider interventions.   OBJECTIVE: To conduct a cost-effectiveness analysis comparing CMRs with non-CMR interventions on successful medication regimen changes and reductions in adverse drug events (ADEs). METHODS: This decision analytic model compared the cost-effectiveness of CMRs with other intervention methods (non-CMRs) from a payer's perspective. For this model, a successful outcome was defined as a beneficiary case devoid of an ADE due to MRPs. The model was extensively tested and subjected to a thorough one-way sensitivity analysis and a second-order probabilistic sensitivity analysis with 10,000 iterations from the variable distributions.  RESULTS: Non-CMR interventions were less costly and more effective than CMRs. The point estimate for direct medical costs was $193 for CMRs and $157 for non-CMRs, and the estimated probability of avoiding an ADE was 0.93 and 0.94 for CMRs and non-CMRs, respectively. The 10,000 iteration-Monte Carlo simulation scatterplot and cost-effectiveness acceptability curve (CEAC) revealed a dominance by non-CMRs in preventing harmful ADEs from cost and effectiveness perspectives; however, there was an overlap in the 95% CIs for both cost and ADEs prevented. Despite this, a non-CMR intervention saved estimated $5,377.08 per ADE prevented. One-way sensitivity analysis indicated the results were sensitive to the cost of treating a preventable ADE. In 100% of cases, the CEAC demonstrated that non-CMRs were likely the most cost-effective intervention regardless of the health plan's willingness to pay.  CONCLUSIONS: The cost-effectiveness acceptability curve suggests that non-CMR interventions were less costly and more effective than CMRs; however, there was overlap in the 95% CIs for costs and ADEs prevented. In all cases, the CEAC demonstrated that non-CMRs were the most economical intervention with regard to time and cost. Non-CMRs show promise as a viable method to address MRPs, reduce ADEs, and improve patient-related health outcomes.