Comprehensive Medication Review Completion Rates and Disparities After Medicare Star Rating Measure.

Importance: Comprehensive medication reviews (CMRs) are offered to qualifying US Medicare beneficiaries annually to optimize medication regimens and therapeutic outcomes. In 2016, Medicare adopted CMR completion as a Star Rating quality measure to encourage the use of CMRs. Objective: To examine trends in CMR completion rates before and after 2016 and whether racial, ethnic, and socioeconomic disparities in CMR completion changed. Design, Setting, and Participants: This observational study using interrupted time-series analysis examined 2013 to 2020 annual cohorts of community-dwelling Medicare beneficiaries aged 66 years and older eligible for a CMR as determined by Part D plans and by objective minimum eligibility criteria. Data analysis was conducted from September 2022 to February 2024. Exposure: Adoption of CMR completion as a Star Rating quality measure in 2016. Main Outcome and Measures: CMR completion modeled via generalized estimating equations. Results: The study included a total of 561 950 eligible beneficiaries, with 253 561 in the 2013 to 2015 cohort (median [IQR] age, 75.8 [70.7-82.1] years; 90 778 male [35.8%]; 6795 Asian [2.7%]; 24 425 Black [9.6%]; 7674 Hispanic [3.0%]; 208 621 White [82.3%]) and 308 389 in the 2016 to 2020 cohort (median [IQR] age, 75.1 [70.4-80.9] years; 126 730 male [41.1%]; 8922 Asian [2.9%]; 27 915 Black [9.1%]; 7635 Hispanic [2.5%]; 252 781 White [82.0%]). The unadjusted CMR completion rate increased from 10.2% (7379 of 72 225 individuals) in 2013 to 15.6% (14 185 of 90 847 individuals) in 2015 and increased further to 35.8% (18 376 of 51 386 individuals) in 2020, in part because the population deemed by Part D plans to be MTM-eligible decreased by nearly half after 2015 (90 487 individuals in 2015 to 51 386 individuals in 2020). Among a simulated cohort based on Medicare minimum eligibility thresholds, the unadjusted CMR completion rate increased but to a lesser extent, from 4.4% in 2013 to 12.6% in 2020. Compared with White beneficiaries, Asian and Hispanic beneficiaries experienced greater increases in likelihood of CMR completion after 2016 but remained less likely to complete a CMR. Dual-Medicaid enrollees also experienced greater increases in likelihood of CMR completion as compared with those without either designation, but still remained less likely to complete CMR. Conclusion and Relevance: This study found that adoption of CMR completion as a Star Rating quality measure was associated with higher CMR completion rates. The increase in CMR completion rates was achieved partly because Part D plans used stricter eligibility criteria to define eligible patients. Reductions in disparities for eligible Asian, Hispanic, and dual-Medicaid enrollees were seen, but not eliminated. These findings suggest that quality measures can inform plan behavior and could be used to help address disparities.

Impact of initiating oral anticancer agents for leukemia on adherence to medications for multiple chronic conditions.

INTRODUCTION: Increased use of oral anticancer agents (OAAs) has empowered adults with chronic lymphocytic leukemia (CLL) and chronic myelogenous leukemia (CML) to manage their therapy, but this shift may complicate medication use, particularly among adults with multiple chronic conditions (MCC). METHODS: This retrospective cohort study used 2013-2018 commercial and Medicare claims data to assess medication use in adults with CML or CLL. To be included, patients must have been at least 18 years old, diagnosed with and had 2+ claims for an OAA indicated for either CML or CLL, continuously enrolled 12 months before and after OAA initiation, and treated for (2+ fills) at least two select chronic conditions. Proportion of days covered (PDC) determined medication adherence and was compared for 12 months before and after OAA initiation by Wilcoxon signed-rank tests, McNemar's tests, and difference-in-differences models. RESULTS: Among CLL patients, mean OAA adherence in the first year of therapy was 79.8% (SD: 21.1) and 74.7% (SD: 24.9) for commercial and Medicare patients, respectively; mean adherence for CML patients was 84.5% (SD: 15.8) and 80.1% (SD: 20.1) for commercial and Medicare patients, respectively. Adherence and the proportion adherent (PDC ≥ 80%) to comorbid therapies was generally unchanged following OAA initiation. Consistently unremarkable changes in MCC adherence were observed in 12-month difference-in-differences models, but significant decline was observed in MCC adherence after 6 months of OAA use. CONCLUSIONS: OAA initiation among adults with CML or CLL was not associated with significant, initial changes to adherence to medications for chronic diseases.

Patient-reported frailty phenotype (PRFP) vs. International Myeloma Working Group frailty index (IMWG FI) proxy: A comparison between two approaches to measuring frailty.

INTRODUCTION: Frailty assessments may help to identify patients at highest risk for treatment-related toxicity, early treatment discontinuation due to toxicity, and death in Multiple Myeloma. We aimed to compare the patient-reported frailty phenotype (PRFP) and a modified version of the International Myeloma Working Group frailty index (IMWG FI) in terms of their strengths, limitations, and classification of frailty in a cohort of patients with relapsed/refractory multiple myeloma (RRMM). MATERIALS AND METHODS: Data were pooled from six RRMM Phase 3 randomized clinical trials submitted to the Food and Drug Administration for regulatory review between 2010 and 2021. Patients were classified as fit, intermediate fit/pre-frail, or frail using both PRFP and the IMWG FI proxy. Agreement between the two approaches in classification of patient frailty was assessed using weighted Cohen's kappa. A contingency table and Venn diagram were generated to analyze overlap in categorization of patient frailty across the different severity groups. Descriptive statistics were used to summarize and compare the clinical and demographic characteristics of patients categorized as frail by PRFP vs. IMWG FI proxy. RESULTS: Of the 2,750 patients included in this analysis, IMWG FI proxy classified 16.4% (452) patients as frail, 28.1% (772) as intermediate fit/pre-frail, and 55.5% (1,526) as fit. Meanwhile, PRFP classified 21.7% (597) of patients as frail, 24.5% (675) as intermediate fit/pre-frail, and 53.8% (1478) as fit. Fair agreement was observed between PRFP and IMWG FI proxy (weighted Cohen's Kappa = 0.34 [0.31-0.37]). On average, patients who were categorized as frail by IMWG FI proxy were older and had higher Charlson Comorbidity Index scores than patients classified as frail by PRFP. In contrast, patients who were classified as frail by PRFP had worse EORTC QLQ-C30 Physical Functioning subscale summary scores as compared to patients in the IMWG FI proxy frail group (median score of 40 vs. 47 out of 100). DISCUSSION: Our analysis found fair concordance between IMWG FI proxy and PRFP. This demonstrates that while both frailty models measure the same underlying construct, the variables that constitute each approach may result in differing frailty categorizations for the same patient. Further prospective studies are needed to establish and compare the predictive and prognostic abilities of the different frailty indices in MM.

Evaluation of four machine learning models for signal detection.

Background: Logistic regression-based signal detection algorithms have benefits over disproportionality analysis due to their ability to handle potential confounders and masking factors. Feature exploration and developing alternative machine learning algorithms can further strengthen signal detection. Objectives: Our objective was to compare the signal detection performance of logistic regression, gradient-boosted trees, random forest and support vector machine models utilizing Food and Drug Administration adverse event reporting system data. Design: Cross-sectional study. Methods: The quarterly data extract files from 1 October 2017 through 31 December 2020 were downloaded. Due to an imbalanced outcome, two training sets were used: one stratified on the outcome variable and another using Synthetic Minority Oversampling Technique (SMOTE). A crude model and a model with tuned hyperparameters were developed for each algorithm. Model performance was compared against a reference set using accuracy, precision, F1 score, recall, the receiver operating characteristic area under the curve (ROCAUC), and the precision-recall curve area under the curve (PRCAUC). Results: Models trained on the balanced training set had higher accuracy, F1 score and recall compared to models trained on the SMOTE training set. When using the balanced training set, logistic regression, gradient-boosted trees, random forest and support vector machine models obtained similar performance evaluation metrics. The gradient-boosted trees hyperparameter tuned model had the highest ROCAUC (0.646) and the random forest crude model had the highest PRCAUC (0.839) when using the balanced training set. Conclusion: All models trained on the balanced training set performed similarly. Logistic regression models had higher accuracy, precision and recall. Logistic regression, random forest and gradient-boosted trees hyperparameter tuned models had a PRCAUC ⩾ 0.8. All models had an ROCAUC ⩾ 0.5. Including both disproportionality analysis results and additional case report information in models resulted in higher performance evaluation metrics than disproportionality analysis alone.

Utilization and impact of SLGT2 inhibitors among diabetes patients in a nationally representative survey: Findings from NHANES 2013-2020.

BACKGROUND AND AIMS: The purpose of this study is to examine patterns of utilization for antidiabetic medications among a nationally representative sample of the US population following the introduction of SGLT2 inhibitors in 2013. METHODS: The study utilized National Health and Nutrition Examination Survey (NHANES) data from 2013 to 2020 to identify adult patients with diabetes using antidiabetic medication. The proportion of patients with diabetes using different antidiabetic medications, including SGLT2 inhibitors, was plotted over time. To assess the statistical significance of the utilization trend of SGLT2 inhibitors and other oral antidiabetics, logistic regression models were employed. RESULTS: A weighted total of 26,421,357 individuals included in our study were diagnosed with diabetes. Among these, 18,751,659 diabetes patients were identified as medication users, with 1,058,686 (5.7 %) of them taking SGLT2 inhibitors. Over the 7-year study period, the percentage of patients taking SGLT2 inhibitors increased 21-fold, from 0.4 % in 2013-2014 to 9.4 % in 2017-2020. Despite this substantial increase, the utilization of other second-line antidiabetic agents, such as sulfonylureas, DPP-4 inhibitors, GLP-1 receptor agonists, and TZDs, remained relatively stable during the same period. CONCLUSIONS: SGLT2 inhibitor utilization has significantly increased among US diabetes patients; however, their rise has not substantially impacted the use of other second-line antidiabetic agents. Further research is needed to understand the social determinants and potential barriers affecting the broader adoption of these beneficial medications.

Prevalence and patterns of catastrophic spending for antidiabetic medication in 2020.

BACKGROUND: Medication costs for antidiabetic drugs have risen significantly in the United States, causing concerns about the affordability of these essential treatments. OBJECTIVE: To examine out-of-pocket spending for antidiabetic medication and evaluate what proportion of Americans reach catastrophic spending levels during the year. METHODS: This retrospective cohort analysis of nationally representative data from the 2020 Medical Expenditure Panel Survey (MEPS) was analyzed for respondents that reported a diabetes diagnosis. Prescription drug costs were identified from the MEPS Prescribed Medicines File, which included both total prescription payment and out-of-pocket payment for each medication fill. Catastrophic spending thresholds were evaluated based on the World Health Organization's definition, which is spending greater than 40% of a household's nonsubsistence income on health care payments. Statistical analysis was performed with Stata 17 and sample weights were applied adjusting for the MEPS complex survey design to produce national estimates. Descriptive statistics were reported as weighted counts and percentages for categorical variables and as medians with interquartile range for continuous variables. Comparisons of reaching catastrophic spending thresholds across study variables were evaluated with Pearson chi-square tests. A P value less than 0.05 was considered statistically significant in this study. RESULTS: The study included data from a weighted US population of 29.5 million Americans with diabetes. Among this group, 23.8 million (81%) reported use of a prescription medication to treat diabetes. Total reported out-of-pocket payments paid by the patient for antidiabetic medication surpassed $5.2 billion with the largest portion attributable to the insulin subclass, which accounted for 42% or $2.2 billion. The data suggest an estimated 3 million Americans (10.3%) experienced out-of-pocket spending for antidiabetic drugs that reached catastrophic spending thresholds in 2020. CONCLUSIONS: Affordability of prescribed medication in community-dwelling persons with diabetes remains a significant challenge for many Americans.

Prescription patterns of P2Y12 inhibitors following revascularization in the United States: 2013-2018.

P2Y12 inhibitors (i.e., clopidogrel, prasugrel, or ticagrelor) are effective at reducing adverse cardiovascular outcomes post-revascularization in coronary artery disease (CAD). However, the choice of a specific P2Y12 inhibitor may vary according to the patient's characteristics, and trends in the use of different P2Y12 inhibitors are not well studied in real-world settings. The objective of this study is to determine trends in the prescription patterns of P2Y12 inhibitors in patients with CAD. We studied 137,073 patients with CAD cross-sectionally using the IBM MarketScan database (2013-2018). Patients with CAD prescribed P2Y12 inhibitors within 14 days of index revascularization were included to compare the utilization of P2Y12 inhibitors based on age and clinical characteristics. There were differences in prescription patterns by age. Among patients aged less than or equal to 65 years (N = 92,734), a continuously increased utilization of ticagrelor was observed from 13.7% to 45.6% replacing clopidogrel as the most prescribed medication by 2018. Similarly, ticagrelor was the choice of drug among patients undergoing percutaneous coronary intervention. Among the patients at high bleeding risk, clopidogrel remained the most prescribed medication with use in 50.6% of patients in 2018 in patients aged less than or equal to 65 years. Contrarily, among the older adults with age 65 or above (N = 44,339), although ticagrelor use increased with time, clopidogrel remained the most utilized drug and was used by 66.2% of patients in 2018. Additionally, clopidogrel was the preferred medication among patients with stroke history. With the increasing use of ticagrelor in real-world practice, further research is needed to observe its impact on cardiovascular outcomes.

Measuring Frailty Using Patient-Reported Outcomes (PRO) Data: A Feasibility Study in Patients with Multiple Myeloma.

PURPOSE: The objective of this retrospective study was to determine the feasibility of measuring frailty using patient responses to relevant EORTC QLQ-C30 items as proxy criteria for the Fried Frailty Phenotype, in a cohort of patients with Relapsed/Refractory Multiple Myeloma (RRMM). METHODS: Data were pooled from nine Phase III randomized clinical trials submitted to the FDA for regulatory review between 2010 and 2021, for the treatment of RRMM. Baseline EORTC QLQ-C30 responses were used to derive a patient-reported frailty phenotype (PRFP), based on the Fried definition of frailty. PRFP was assessed for internal consistency reliability, structural validity, and known groups validity. RESULTS: This study demonstrated the feasibility of adapting patient responses to relevant EORTC QLQ-C30 items to serve as proxy Fried frailty criteria. Selected items were well correlated with one another and PRFP as a whole demonstrated adequate internal consistency reliability and structural validity. Known groups analysis demonstrated that PRFP could be used to detect distinct comorbidity levels and distinguish between different functional profiles, with frail patients reporting more difficulty in walking about, washing/dressing, and doing usual activities, as compared to their pre-frail and fit counterparts. Among the 4928 patients included in this study, PRFP classified 2729 (55.4%) patients as fit, 1209 (24.5%) as pre-frail, and 990 (20.1%) as frail. CONCLUSION: Constructing a frailty scale from existing PRO items commonly collected in cancer trials may be a patient-centric and practical approach to measuring frailty. Additional psychometric evaluation and research is warranted to further explore the utility of such an approach.

Performance of subgrouped proportional reporting ratios in the US Food and Drug Administration (FDA) adverse event reporting system.

BACKGROUND: Many signal detection algorithms give the same weight to information from all products and patients, which may result in signals being masked or false positives being flagged as potential signals. Subgrouped analysis can be used to help correct for this. RESEARCH DESIGN AND METHODS: The publicly available US Food and Drug Administration Adverse Event Reporting System quarterly data extract files from 1 January 2015 through 30 September 2017 were utilized. A proportional reporting ratio (PRR) analysis subgrouped by either age, sex, ADE report type, seriousness of ADE, or reporter was compared to the crude PRR analysis using sensitivity, specificity, precision, and c-statistic. RESULTS: Subgrouping by age (n = 78, 34.5% increase), sex (n = 67, 15.5% increase), and reporter (n = 64, 10.3% increase) identified more signals than the crude analysis. Subgrouping by either age or sex increased both the sensitivity and precision. Subgrouping by report type or seriousness resulted in fewer signals (n = 50, -13.8% for both). Subgrouped analyses had higher c-statistic values, with age having the highest (0.468). CONCLUSIONS: Subgrouping by either age or sex produced more signals with higher sensitivity and precision than the crude PRR analysis. Subgrouping by these variables can unmask potentially important associations.

Implementation outcomes associated with a value-based care model of comprehensive medication management in community pharmacies.

OBJECTIVE: Although the delivery of comprehensive medication management (CMM) in community pharmacies has been shown to improve health outcomes, inconsistent adoption hinders the benefit patients receive. Our objective was to examine the implementation of a novel value-based care model and the impact of educational and coaching support for pharmacists on patient access to CMM. The underlying care model provides a payment for CMM services combined with incentives to document and improve clinical outcomes and patient engagement. DESIGN: Cross-sectional study. SETTING AND PARTICIPANTS: In addition to fee-for-service payments, performance-based incentives were provided to 12 participating pharmacy organizations to promote pharmacist documentation of clinical values (blood pressure and tobacco status for patients with vascular disease and additionally hemoglobin A1c [HbA1C] for patients with diabetes). To promote patient engagement, pharmacies that engaged a higher proportion of attributed patients received additional incentives. OUTCOME MEASURES: Implementation outcomes included penetration (the proportion of eligible patients who received CMM), adoption (variation in penetration across organizations), and fidelity (documentation of all required clinical values). Comparisons were made using t-tests and chi-square testing. RESULTS: Among 1240 eligible patients, 478 (35.8%) had documentation of any service by a participating pharmacist during a one-year implementation period. Using diabetes as an example, documentation was consistently highest for tobacco status (38.1%), followed by blood pressure (29.7%), and HbA1C (38.1%). CMM recipients on average were older, used more medication, and were more likely to have at least one comorbid condition than non-recipients. 41.8% of patients with vascular disease had documentation of both blood pressure and tobacco status while 24.4% of patients with diabetes had blood pressure, tobacco, and HbA1C documentation. CONCLUSIONS: Improving pharmacist access to a patient's medical records could help improve access to CMM services for patients under value-based care models that rely on patient targeting and clinical measurements.

Comparative Risk of Hospitalized Bleeding of P2Y12 Inhibitors for Secondary Prophylaxis in Acute Coronary Syndrome After Percutaneous Coronary Intervention.

In closely monitored randomized controlled trials (RCTs), newer P2Y12 agents (ticagrelor and prasugrel) reduced cardiovascular outcomes compared with clopidogrel following percutaneous coronary intervention (PCI) in acute coronary syndrome. However, these RCTs indicated a higher bleeding risk with these newer agents. This study evaluated the comparative safety of each P2Y12 inhibitor on hospitalizations due to major bleeding in a real-world population. This retrospective, propensity score-matched (PSM) cohort study utilized the IBM MarketScan database over 6 years (2013-2018) to identify incident users of P2Y12 inhibitors with age ≥18 years. The primary safety outcome was hospitalization due to any major bleeding event including gastrointestinal, intracranial, and other serious forms of bleeding. In pairwise comparisons using Cox-proportional hazards models, ticagrelor, prasugrel, and clopidogrel users were compared for the primary safety outcome at 30, 90, and 180 days following the first prescription of P2Y12 inhibitor after PCI. There were 21,719 (ticagrelor vs. clopidogrel), 11,513 (prasugrel vs. clopidogrel), and 11,065 (prasugrel vs. ticagrelor) PSM pairs. Overall, the risk of major bleeding was similar for all P2Y12 inhibitors. Hospitalization for major bleeding was generally lower among ticagrelor users vs. clopidogrel and higher among prasugrel users compared with clopidogrel. Importantly, a 66% higher risk of major bleeding at 90 days is suggested with prasugrel compared with clopidogrel (hazard ratio 1.66; 95% confidence interval, 1.11-2.48). This study indicated a higher short-term bleeding risk with prasugrel compared with clopidogrel, which concurs with the results of RCTs.

Comparative Effectiveness of Ticagrelor, Prasugrel, and Clopidogrel for Secondary Prophylaxis in Acute Coronary Syndrome: A Propensity Score-Matched Cohort Study.

Comparative effectiveness evaluation of newer P2Y12 inhibitors (prasugrel and ticagrelor) compared with clopidogrel after acute coronary syndrome (ACS) is limited in real-world US populations. The objective of this study was to evaluate cardiovascular events based on ticagrelor, prasugrel, and clopidogrel use in a real-world patient setting. This retrospective cohort study used the IBM MarketScan database (January 1, 2013, to December 31, 2018) to create three propensity score-matched pairs: ticagrelor vs. clopidogrel (N = 21,719), prasugrel vs. clopidogrel (N = 11,513), and prasugrel vs. ticagrelor (N = 11,065). The primary outcome was a composite of myocardial ischemia, unstable angina, stroke, and heart failure hospitalization. These groups were compared in a time-to-event analysis for the primary outcome at 30, 90, and 180 days following P2Y12 inhibitors initiation after percutaneous coronary intervention. Compared with clopidogrel, ticagrelor use suggested a 10% reduction in the primary outcome at 90 days (hazard ratio (HR): 0.90, 95% confidence interval (CI): 0.82-0.99). There were no differences for all other matched pairs or follow-up combinations. In the subgroup analysis of females, the results suggested a risk reduction of 27% for prasugrel at 30 days (HR: 0.73, 95% CI: 0.53-1.00) and 17% for ticagrelor at 90 days (HR: 0.83, 95% CI: 0.70-0.98) when compared with clopidogrel. Among patients treated with bare-metal stents, the results suggested that prasugrel vs. ticagrelor was associated with a 55% and 33% reduced risk for the primary outcome at 30 days and 180 days, respectively. With limited evidence in the United States comparing these drugs, this study helps inform clinicians when choosing P2Y12 inhibitors after ACS.

Disparities in Medicare beneficiaries' receiving medication synchronization.

BACKGROUND: Medication synchronization (med-sync) aligns patients' monthly or quarterly chronic medications to a predetermined single pickup date at a community pharmacy. The study objective was to examine med-sync enrollment disparities based on Medicare beneficiaries' predisposing, enabling, and need characteristics. METHODS: This was a retrospective cohort study using a Medicare dataset of beneficiaries receiving medications from pharmacies that self-identified as providing med-sync. Medicare beneficiaries who were continuously enrolled in fee-for-service medical and pharmacy benefits during the study period (2014-2016) were included. Study cohorts (med-sync and non-med-sync patients) were defined, and bivariate and multivariable logistic regression analyses were performed. Andersen's Health Services Utilization Model guided our inclusion of predisposing, enabling, and need characteristics to examine for association with med-sync enrollment. RESULTS: A total of 170,180 beneficiaries were included, of which 13,193 comprised the med-sync cohort and 156,987 comprised the non-med-sync cohort. Bivariate logistic regression analysis revealed statistically significant differences (P < 0.05) in cohorts based on age, geographic region, type of residence, number of unique chronic medications, comorbidities, outpatient visits, and inpatient hospitalizations. Beneficiaries had higher odds of being enrolled in med-sync with increasing age (adjusted odds ratio [AOR] 1.003 [95% CI 1.001-1.005]) and if they resided in the Northeast (AOR 1.094 [95% CI 1.018-1.175]), South (AOR 1.109 [95% CI 1.035-1.188]), and West (AOR 1.113 [95% CI 1.020-1.215]) than those in the Midwest. Beneficiaries residing in nonmetro areas had lower odds of enrollment (AOR 0.914 [95% CI 0.863-0.969]) than those in metro areas. Beneficiaries with previous fewer inpatient hospitalizations (AOR 0.945 [95% CI 0.914-0.977]) were more likely to be enrolled, and those with more outpatient visits (AOR 1.003 [95% CI 1.001-1.004]) were more likely to be enrolled. Those taking a higher number of oral chronic medications (AOR 1.005 [95% CI 1.002-1.008]) had greater odds of enrollment in med-sync. CONCLUSIONS: Med-sync program expansion opportunities exist to address potential enrollment disparities based on age, geographic region, metropolitan area, and prior health utilization. Further studies are needed to develop and examine strategies among pharmacies to improve med-sync enrollment outreach to these subgroups of patients.

Direct-acting antiviral retreatment patterns for hepatitis C.

BACKGROUND: Despite the strong efficacy of direct-acting antivirals (DAAs) against the hepatitis C virus, many patients require a second regimen of DAA treatment. However, limited research exists to characterize rates of retreatment across different DAA agents or potential factors that may increase retreatment risk. OBJECTIVE: To characterize patterns and predictors of DAA retreatment among a large, generalizable, commercially insured US population of patients. METHODS: Using the IBM MarketScan Commercial Claims and Encounters data source, this retrospective cohort study examined retreatment patterns among patients receiving DAAs between 2013 and 2019. Descriptive statistics were used to compare patient characteristics predictive of retreatment risk and to examine rates of retreatment in patients initiating different DAA treatments. RESULTS: Among 31,553 DAA users, a total of 1,017 (3.2%) required DAA retreatment. Among the 1,017 patients re-treated, 44 (4.3%) received a third treatment regimen and 2 patients received a fourth treatment regimen. The average total cost for a retreatment regimen was $109,683, with patient out-of-pocket costs totaling $1,287 Patients requiring retreatment had higher rates of hypertension (32.0% vs 26.7%; P < 0.001), diabetes (16.9% vs 11.9%; P < 0.001), coagulopathy (9.9% vs 4.5%; P < 0.001), deficiency anemia (11.1% vs 7.4%; P < 0.001), alcohol abuse (3.3% vs 2.3%; P = 0.038), prior liver transplantation (3.4% vs 2.3%; P = 0.024), and hepatocellular carcinoma (6.1% vs 1.9%; P < 0.001) compared with patients not requiring retreatment. CONCLUSIONS: Although uncommon, some patients receiving DAAs require a second regimen of DAA treatment at substantial cost to both health plans and patients. These patients tend to have more comorbidities and markers of hepatic disease severity. Patients with high retreatment risk may benefit from careful monitoring for occurrences of retreatment.

Implementation of a model integrating primary and oncology pharmacists' care for patients taking oral anticancer agents (OAA).

Improvements in chronic myeloid leukemia (CML), chronic lymphocytic leukemia (CLL), and multiple myeloma (MM) treatment options have increased the 5-year survival rates for patients with these hematologic malignancies. In addition to cancer management, these patients may need help to manage multiple chronic conditions (MCC). The overall objective of this study is to examine the impact and implementation of a model that coordinates care between oncology and primary care pharmacists for people taking an oral anti-cancer agent (OAAs) and medications for comorbid chronic conditions. This is a multi-center, prospective, single-arm pilot study that will recruit up to 40 patients from Michigan Medicine and Vanderbilt University Medical Center (VUMC). Eligible participants will be 18 years of age or older, prescribed an OAA, have a diagnosis of either CML, CLL or MM, and be diagnosed with and taking medication for at least two specified chronic conditions. The Pharmacists Coordinated Care Oncology Model (PCOM) is a two-month intervention that builds upon current pharmacist clinical responsibilities. Generally, participants will complete a patient-reported outcome measure at 2 and 6 weeks post-OAA initiation that is sent to their oncology pharmacist, and they will also receive a comprehensive medication review at week 4 from a primary care pharmacist for their chronic medications. The pharmacists will communicate about the results via electronic medical record (EMR) and intervene if necessary. The primary endpoints are (1) dose-adjusted OAA proportion of days covered (PDC), and (2) PDC for chronic condition medications. PDCs will be determined via prescription records. The association of OAA and chronic medication PDCs will be quantified via correlation and chi-squared tests. The association between symptom experience and OAA adherence will be examined via correlation analyses. For implementation, characteristics of patient participants, feasibility, acceptability, adoption, fidelity, and trialability will be described. Data will be collected via EMR and pharmacist and patient interviews. Median/IQR for acceptability, adoption and fidelity will be reported, and patient interviews will be analyzed using a grounded theory approach and pharmacist interviews will be analyzed using thematic analyses.

Incidence and Risk Factors of Pulmonary Hypertension After Venous Thromboembolism: An Analysis of a Large Health Care Database.

Background Pulmonary hypertension (PH) is a devastating potential complication of pulmonary embolism, a manifestation of venous thromboembolism (VTE). The incidence of and risk factors for PH in those with prior VTE are poorly characterized. Methods and Results International Classification of Diseases (ICD) codes from inpatient and outpatient medical claims from MarketScan administrative databases for years 2011 to 2018 were used to identify cases of VTE, comorbidities before the VTE event, and PH occurring subsequent to the VTE event. Cumulative incidence and hazard ratios (HR), and their 95% CI, were calculated. The 170 021 VTE cases included in the analysis were on average (±SD) 57.5±15.8 years old and 50.5% were female. A total of 5943 PH cases accrued over an average follow-up of 1.94 years. Two years after incident VTE, the cumulative incidence (95% CI) of PH was 3.5% (3.4%-3.7%) overall. It was higher among older individuals, among women (3.9% [3.8%-4.1%]) than men (3.2% [3.0%-3.3%]), and among patients presenting with pulmonary embolism (6.2% [6.0%-6.5%]) than those presenting with deep vein thrombosis only (1.1% [1.0%-1.2%]). Adjusting for age and sex, risk of PH was higher among patients with VTE with underlying comorbidities. Using the Charlson comorbidity index, there was a dose-response relationship, whereby greater scores were associated with increased PH risk (score ≥5 versus 0: HR, (2.50 [2.30-2.71])). When evaluating individual comorbidities, the strongest associations were observed with concomitant heart failure (HR, 2.17 [2.04-2.31]), chronic pulmonary disease (2.01 [1.90-2.14]), and alcohol abuse (1.66 [1.29-2.13]). Conclusions In this large, real-world population of insured people with VTE, 3.5% developed PH in the 2 years following their initial VTE event. Risk was higher among women, with increasing age, and in those with additional comorbidities at the time of the VTE event. These data provide insights into the burden of PH and risk factors for PH among patients with VTE.

Medication Adherence Among Adults With Comorbid Chronic Conditions Initiating Oral Anticancer Agent Therapy for Multiple Myeloma.

PURPOSE: Increased use of oral anticancer agents (OAAs) has empowered adults with multiple myeloma (MM) to manage their oncolytic therapy, but such a shift may result in issues with medication use, particularly among patients being concurrently treated for pre-existing, multiple chronic conditions. METHODS: This retrospective cohort study used 2013-2018 commercial and Medicare claims data to assess medication use in adults with MM. To be included, adults (18 years and older) must have been diagnosed with and had 2+ claims for an OAA, had continuous enrollment for 12 months before and after OAA initiation, and have been previously diagnosed with and had prescription fills for 2+ select chronic conditions. The proportion of days covered metric assessed medication adherence and was compared for 12 months before and after the OAA initiation by Wilcoxon signed-rank tests, McNemar's tests, and difference-in-differences models. RESULTS: The mean OAA adherence in the first year of therapy was 58.3% (standard deviation: 24.5) and 65.1% (standard deviation: 27.01) for commercial and Medicare patients, respectively. Adherence and the proportion adherent (proportion of days covered ≥ 80%) to comorbid therapies generally declined in the first year after OAA initiation. Changes in medication use were particularly noticeable among those on antihypertensive therapy: adjusted analyses uncovered a 2.5% (Medicare) and 5.2% (commercial) difference in adherence to these medications between those initially adherent and nonadherent to OAA therapy (both P < .05). CONCLUSION: Initiating OAA therapy in adults with MM may complicate an already complex treatment regimen, resulting in poor overall medication adherence in patients with multiple comorbid conditions.

Opportunities for personalizing colorectal cancer care: an analysis of SEER-medicare data.

United States clinical practice guidelines for metastatic colorectal cancer recommend use of medications impacted by genetic variants but do not recommend testing. We analyzed real-world treatment using a cancer registry and claims dataset to explore pharmacogenomic (PGx) medication treatment patterns and characterize exposure. In a cohort of 6957 patients, most (86.9%) were exposed to at least one chemotherapy medication with PGx guidelines. In a cohort of 2223 patients with retail pharmacy claims available, most (79.2%) were treated with at least one non-chemotherapy (79.2%) medication with PGx guidelines. PGx-associated chemotherapy exposure was associated with age, race/ethnicity, educational attainment, and rurality. PGx-associated non-chemotherapy exposure was associated with medication use and comorbidities. The potential impact of PGx testing is large and policies aimed at increasing PGx testing at diagnosis may impact treatment decisions for patients with metastatic colorectal cancer as most patients are exposed to medications with pharmacogenomics implications during treatment.

Primary Care Physicians', Psychiatrists', and Oncologists' Coordination While Prescribing Medications for Patients With Multiple Chronic Conditions.

OBJECTIVES: Coordination of medication prescribing is important in the care of patients with multiple chronic conditions (MCC) given the involvement of multiple providers and multiple medications used to manage MCC. The objective of this study was to identify physician and practice factors associated with physicians' coordination of prescribing for complex patients with MCC. METHODS: Our cross-sectional study used a 33-item anonymous, online survey to assess physicians' coordination practices while prescribing for patients with MCC. We sampled primary care physicians (PCPs), psychiatrists, and oncologists across the United States. Coordination of medication prescribing was measured on a 7-point Likert-type scale. χ2, Fisher exact test, and binomial logistic regression, adjusted for factors and covariates, were used to determine differences in coordination of prescribing. Average marginal effects were calculated for factors. RESULTS: A total of 50 PCPs, 50 psychiatrists, and 50 oncologists participated. Most psychiatrists (56%) and oncologists (52%) reported frequently coordinating prescribing with other physicians, whereas less than half of the PCPs (42%) reported frequently coordinating prescribing. Female physicians were 25% points more likely to report coordinating prescribing than male physicians (P = 0.0186), and physicians not using electronic medical records were 30% points more likely to report coordinating prescribing than physicians using electronic medical records (P = 0.0230). Four additional factors were associated with lower likelihood of coordinating prescribing. CONCLUSIONS: Physician and practice factors may influence differences in coordination of medication prescribing, despite physician specialty. These factors can provide a foundation for developing interventions to improve coordination of prescribing practices for MCC.

Maternal ADHD and Perinatal Prescription Stimulant Use.

OBJECTIVE: To describe patterns and predictors of perinatal prescription stimulant use. METHODS: We used MarketScan® commercial claims data (2013-2018) and a repeated cross-sectional study design to assess perinatal use of prescription stimulants. Clinical/demographic characteristics were compared across cohorts of women who continued versus discontinued stimulant treatment at various stages of pregnancy. Associations were tested for significance using chi-square tests (categorical variables) and independent t-tests (continuous variables). RESULTS: Out of 612,001 pregnancies, 15,413 involved pre-pregnancy stimulant use. Of these, stimulant treatment was discontinued prior to conception in 6,416 (42%), discontinued during trimester 1 in 5,977 (39%), and continued into later trimesters in 3,020 (19%). Compared with pregnancies involving stimulant discontinuation prior to conception, those that continued into pregnancy occurred in women who were older (29.9 vs. 28.9 years) and had more severe ADHD (3.1 vs. 1.8 ADHD-related billing claims). CONCLUSIONS: There is considerable heterogeneity in the management of ADHD during pregnancy.