Real-World Incidence and Management of Immune-Related Adverse Events from Immune Checkpoint Inhibitors: Retrospective Claims-Based Analysis.

PURPOSE: We assessed real-world spectrum and patterns of irAEs for patients treated with anti-PD(L)1 ICIs. METHODS: irAEs were defined using medical and pharmacy claims for patients enrolled in a Medicare Advantage Prescription Drug plan who initiated treatment with anti-PD(L)-1 and received ≥ 1 dose of therapy between 1 September 2014 and 28 February 2018. RESULTS: Treatment was discontinued for 46.6% of patients, and withheld and subsequently restarted for 10.3%. While toxicity profiles did not differ by age, RiskRx-V co-morbidity index was higher in patients with irAEs. CONCLUSION: These data underscore the needs for tailored irAE diagnostic and management pathways.

The impact of real-world cardiovascular-related pharmacogenetic testing in an insured population.

BACKGROUND: Pharmacogenomics is intended to help clinicians provide the right drug to the right patient at an appropriate dose. However, limited evidence of clinical utility has slowed uptake of pharmacogenomic testing (PGT). OBJECTIVE: To evaluate the impact of real-world cardiovascular (CV)-related PGT on clinical outcomes, healthcare resource utilisation (HCRU) and cost in a large, heterogeneous population. METHODS: Individuals with Medicare Advantage Prescription Drug, Medicaid, or commercial coverage between 1/1/2011 and 9/30/2015 and ≥1 atherosclerotic CV-related diagnosis were identified. Those with ≥1 claim for CV-related PGT were included in the test group (index date = 1st PGT claim) and matched 1:2 to controls without PGT. Individuals aged <22 or ≥90 years old on the index date, with <12 months continuous enrollment before and after the index date, or without an ASCVD-related diagnosis in the 12-month pre-index period were excluded. The primary outcome was occurrence of a major CV event during the 12-month post-index period. RESULTS: After adjustment, the PGT group was significantly more likely to experience ischaemic stroke, pulmonary embolism, deep vein thrombosis or a composite event compared with controls. Adjusting for baseline characteristics, HCRU was significantly higher for the test group across all measured outcomes except all-cause and ASCVD-related inpatient admissions. Median all-cause and ASCVD-related healthcare costs were significantly higher for the test group. CONCLUSIONS: Real world PGT in a large population did not improve outcomes. Tailoring medication therapy to each patient holds great promise for providing quality care but a deeper understanding of how widespread utilisation of PGT might impact objective health outcomes is needed.

Incidence and characteristics of patients presenting with acute myocardial infarction and non-obstructive coronary artery disease.

OBJECTIVES: This study aimed to characterize the etiologies of patients presenting with myocardial infarction (MI) and found to have non-obstructive coronary artery disease (NOCAD) and compare risk factors and in-hospital mortality to those with obstructive coronary artery disease (CAD). BACKGROUND: Patients presenting with an MI are often found to have NOCAD defined as less than 50% luminal diameter reduction by visual estimation on coronary angiography. METHODS: This study is a retrospective analysis of a total of 2,038 patients that presented to NorthShore University HealthSystem with MI and underwent coronary angiography from 2010 to 2013. RESULTS: 1,822 patients (89%) had CAD and 216 (11%) had NOCAD. Of the NOCAD patients, the most common etiologies were Takotsubo cardiomyopathy (28%), no alternative explanation (26%), demand ischemia (21%), myopericarditis (7%), coronary artery vasospasm (5%), and coronary artery dissection (3%). NOCAD patients were more likely to be younger and female. There was no significant difference between NOCAD and CAD patients in terms of in-hospital mortality (3.7% vs. 4.0% respectively, OR = 1.1, 95% CI 0.5-2.3, P = 0.83 by univariate logistic regression, OR = 1.2, 95% CI 0.5-3.1, P = 0.74 by multivariable analysis). CONCLUSIONS: CAD patients were more likely to have traditional risk factors of diabetes, hypertension, hypercholesterolemia, previous MI, previous revascularization with percutaneous coronary intervention or coronary artery bypass graft surgery. Patients presenting with MI and NOCAD were found to have several different etiologies on coronary angiography with the most common being Takotsubo cardiomyopathy.

A comparison of clinical, utilization, and cost outcomes between oral treatments for multiple sclerosis.

BACKGROUND: Multiple sclerosis (MS) affects nearly 1 million people in the United States and causes significant disability and economic loss. Among the first available oral MS treatment options, clinical outcome comparisons and associated health care resource utilization are not clearly defined. OBJECTIVE: To compare MS outcomes, health care resource utilization, and relative costs across treatment with dimethyl fumarate (DMF), fingolimod (FG), or teriflunomide (TERI) among Medicare Advantage Prescription Drug (MAPD) plan and commercially insured beneficiaries. METHODS: This retrospective cohort study used the Humana Research Database. Eligible study patients had their first MS medication claim for oral DMG, FG, or TERI between January 1, 2013, and December 31, 2018. Patients were followed for a minimum of 12 months (mean follow-up = 3.8 years), until the earliest of the following occurred: health plan disenrollment, the end of the study period, or death. Study cohorts were balanced with inverse probability of treatment weighting. All-cause and MS-related health care resource utilization, time on therapy, and time after therapy were compared using inverse probability of treatment-adjusted multivariate generalized linear models across treatment groups. Relative costs were compared using a generalized linear model with a gamma distribution and log link. RESULTS: We identified 1,442 patients in 3 medication groups: DMF (n = 843), FG (n = 213), and TERI (n = 386). After weighting, there were no significant differences between the medication groups on demographic and clinical characteristics. Time on therapy (days) was significantly different across medication groups (P < 0.001). Time on therapy was longest for FG compared with the DM and TERI groups (644 vs 462 vs 521). The number discontinuing the index medication was significantly different for FG vs DMF vs TERI (74.7% vs 85.3% vs 80.7%; P < 0.001). FG had the lowest discontinuation rate. The mean (SD) annualized relapse rates (ARRs) were 0.47 (0.80), 0.42 (1.3), and 0.53 (1.3) (P = 0.037) for DMF, FG, and TERI, respectively. The percentage of those experiencing inpatient stays and the number of stays (mean [SD]) were significantly different among the FG group vs DMF vs TERI (29.9% vs 34.1% vs 40.9%; P < 0.001) and (0.57 [2.9] vs 0.74 [1.9] vs 0.91 [3.5]; P = 0.007), respectively. All-cause emergency department visits and the number of visits (mean [SD]) were significantly different for the FG cohort vs DMF vs TERI (46% vs 54.3% vs 61%; P < 0.001) and (1.84 [7.7] vs 2.38 [5.9] vs 2.87 [8.8]; P = 0.002), respectively. FG had the lowest impatient stays and emergency department visits of the 3 groups. CONCLUSIONS: Patients with MS initiated on FG used fewer health care resources and experienced lower ARR compared with patients on DMF and TERI.

Medication adherence star ratings measures, health care resource utilization, and cost.

OBJECTIVE: To examine the association between missed CMS Star Ratings quality measures for medication adherence over 3 years for diabetes, hypertension, and hyperlipidemia medications (9 measures) and health care utilization and relative costs. STUDY DESIGN: Retrospective cohort study. METHODS: The study examined eligible patients who qualified for the diabetes, statin, and renin-angiotensin system antagonist medication adherence measures in 2018, 2019, and 2020 and were continuously enrolled in a Medicare Advantage prescription drug plan from 2017 through 2021. A total of 103,900 patients were divided into 4 groups based on the number of adherence measures missed (3 medication classes over 3 years): (1) missed 0 measures, (2) missed 1 measure, (3) missed 2 or 3 measures, and (4) missed 4 or more measures. To achieve a quality measure, patients had to meet the Pharmacy Quality Alliance 80% threshold of proportion of days covered during the calendar year. RESULTS: The mean age of the cohort was 71.1 years, and 49.9% were female. Compared with patients who missed 0 of 9 adherence measures, those who missed 1 measure, 2 or 3 measures, and 4 or more measures experienced 12% to 26%, 22% to 42%, and 24% to 50% increased risks, respectively, of all-cause and diabetes-related inpatient stays and all-cause and diabetes-related emergency department visits (all  P  values < .01). Additionally, patients who missed 1, 2 or 3, and 4 or more adherence measures experienced 14%, 19%, and 20% higher monthly medical costs, respectively. CONCLUSIONS: Missing Star Ratings quality measures for medication adherence was associated with an increased likelihood of health care resource utilization and increased costs for patients taking medications to treat diabetes, hypertension, and hyperlipidemia.

Comparison of a second TNFi vs other biologic or targeted synthetic DMARD following an initial TNFi.

BACKGROUND: Patients with rheumatoid arthritis, psoriasis, psoriatic arthritis, ankylosing spondylitis, Crohn's disease, or ulcerative colitis may require treatment with a biologic or targeted synthetic disease-modifying antirheumatic drug (b/tsDMARD). Often, a tumor necrosis factor inhibitor (TNFi) is the initial b/tsDMARD. The TNFi may not be effective or may not be well tolerated, so patients will opt for a different TNFi or switch to a non-TNFi b/tsDMARD. No preference for a TNFi or non-TNFi has been established and guidelines are unclear. OBJECTIVE: To evaluate effectiveness by comparing patients using a second TNFi vs a non-TNFi after initial use of TNFi based on treatment patterns and health care utilization. METHODS: This retrospective analysis used Medicare Advantage prescription drug (MAPD) plan, Medicaid, and commercial plan claims data from Humana's Research Database (Louisville, KY). The first claim for TNFi or non-TNFi (July 1, 2016, to June 30, 2018) following earlier TNFi was the index date. Patients were required to have pre-index enrollment of 6 months and 12 months post-index along with diagnosis of rheumatoid arthritis, psoriatic arthritis, ankylosing spondylitis, Crohn's disease, ulcerative colitis, or psoriasis. During the 12-month follow-up, persistence to the index TNFi or non-TNFi was measured as continued therapy without a gap exceeding 45 days (81 days for intravenous infusions). Adherence was proportion of days covered at least 0.8. Addition of a nonbiologic DMARD or corticosteroid was also identified. Inpatient admissions and emergency department visits were observed. Inverse probability of treatment weights was used to balance cohorts. Logistic regression models were fit to TNFi vs non-TNFI on treatment and utilization measures. RESULTS: Of identified patients, 1,022 were indexed to a second TNFi and 1,024 were indexed to non-TNFi. Weighted cohorts were balanced, with mean age 56.5 vs 56.4 years, 70.5% vs 70.7% female sex, and 68.0% vs 67.9% MAPD plan. No differences were observed on persistence or adherence, with adjusted odds ratios (OR) of 1.05 (95% CI = 0.91-1.20) and 1.04 (0.91-1.20), respectively. No differences were observed for changes in therapy via switching to another TNFi/non-TNFi (OR = 0.93; 95% CI = 0.54-1.62), via nonbiologic DMARD addition (OR = 0.95; 95% CI = 0.83-1.11), or corticosteroid addition (OR = 1.09; 95% CI = 0.92-1.88). No differences were observed for hospitalization (OR = 1.16; 95% CI = 0.99-1.37) or emergency department visits (OR = 1.02; 95% CI = 0.89-1.18). CONCLUSIONS: No differences were found between a second TNFi vs a non-TNFi. As a result, choice of TNFi or non-TNFi following an initial TNFi may be driven by relevant patient-specific considerations. At the population level, policies that prefer either TNFi or non-TNFi appear reasonable. DISCLOSURES: The study was funded by Humana Inc. Mr Racsa is an employee of Humana Healthcare Research, Inc., a subsidiary of Humana Inc. Drs Asante and Bloomfield are employees of Humana Inc. Dr Schwab was an employee of Humana Healthcare Research, Inc., a subsidiary of Humana Inc., and is now an employee of RTI Health Solutions. Dr Cornett was an employee of Humana Inc. and is now an employee of ImmunoGen Inc.

Association of medication adherence quality measures for diabetes, hypertension, and hyperlipidemia with cognitive decline.

Background: While diabetes, hypertension, and hyperlipidemia each are associated with increased risk of cognitive decline, little is known regarding how nonadherence to medications for these conditions is associated with cognitive decline risk. Methods: We identified patients enrolled in a Medicare Advantage Prescription Drug plan who were eligible for inclusion in the CMS Star Medication Adherence quality measures for diabetes, hypertension, and hyperlipidemia in 2018, 2019, and 2020. To achieve an adherence quality measure, patients had to meet 80% of the proportion of days for the medication. We used propensity score with inverse probability of treatment weighting to balance outcomes for baseline characteristics and logistic regression models to compare odds of cognitive decline outcomes across patient groups. Results: The study population of 99,774 individuals had a mean age of 71.0 years and was 49.1% female, 73.9% White, and 17.8% Black, with 62.0% living in an urban setting. Compared with patients who missed zero adherence measures, those who missed one measure had 23%-33% increased odds of cognitive decline (any decline OR = 1.23; dementia OR = 1.33; Alzheimer's disease OR = 1.27; all P values <0.01). Patients who missed 2-3 measures had 37%-96% increased odds of cognitive decline (any decline OR = 1.37; dementia OR = 1.58; Alzheimer's disease OR = 1.96; all P values <0.01). Patients who missed ≥4 adherence measures had the greatest odds of cognitive decline (any decline OR = 1.64; dementia OR = 2.05; Alzheimer's disease OR = 2.48; all P values <0.01). Conclusion: Not achieving CMS Star Medication Adherence quality measures for diabetes, hypertension, and hyperlipidemia therapies was associated with increased risk of cognitive decline outcomes.

Value-based care through postacute home health under CMS PACT regulations.

OBJECTIVES: To assess in a Medicare Advantage population (1) whether discharge to home health, compared with discharge to home, following an inpatient stay subject to CMS postacute care transfer (PACT) regulations, is associated with better outcomes or lower expenditures and (2) whether the impact differs among subpopulations. STUDY DESIGN: Claims-based retrospective cohort study. METHODS: Instrumental variable (IV) analysis, with prior hospital-level probability of discharge to home health as the IV, to control for unobservable as well as observable confounders. RESULTS: Compared with 15,071 patients discharged to home, 4160 patients discharged to and receiving timely home health services were 60% less likely to be readmitted within 30 days and 37% less likely at 90 days. Total expenditures from time of admission to 90 days post discharge were 11% lower in the home health group. The association of discharge to home health with reduced readmission and reduced costs varied by subpopulations defined by surgical vs medical diagnosis-related group and receipt of intensive care management following discharge. CONCLUSIONS: The PACT policy may be promoting greater value by reducing readmissions while lowering total expenditures for patients who do not require intensive postacute care. Findings were in contrast to those of previous studies, in which discharge to home health has been associated with higher rates of readmission. Earlier studies did not control for unmeasurable confounders, involved narrowly defined populations, and used older data.

Comparison of Low-Value Services Among Medicare Advantage and Traditional Medicare Beneficiaries.

Importance: Low-value care in the Medicare program is prevalent, costly, potentially harmful, and persistent. Although Medicare Advantage (MA) plans can use managed care strategies not available in traditional Medicare (TM), it is not clear whether this flexibility is associated with lower rates of low-value care. Objectives: To compare rates of low-value services between MA and TM beneficiaries and explore how elements of insurance design present in MA are associated with the delivery of low-value care. Design, Setting, and Participants: This cross-sectional study analyzed beneficiaries enrolled in MA and TM using claims data from a large, national MA insurer and a random 5% sample of TM beneficiaries. The study period was January 1, 2017, through December 31, 2019. All analyses were conducted from July 2021 to March 2022. Exposures: Enrollment in MA vs TM. Main Outcomes and Measures: Low-value care was assessed using 26 claims-based measures. Regression models were used to estimate the association between MA enrollment and rates of low-value services while controlling for beneficiary characteristics. Stratified analyses explored whether network design, product design, value-based payment, or utilization management moderated differences in low-value care between MA and TM beneficiaries and among MA beneficiaries. Results: Among a study population of 2 470 199 Medicare beneficiaries (mean [SD] age, 75.6 [7.0] years; 1 346 777 [54.5%] female; 229 107 [9.3%] Black and 2 126 353 [86.1%] White individuals), 1 527 763 (61.8%) were enrolled in MA and 942 436 (38.2%) were enrolled in TM. Beneficiaries enrolled in MA received 9.2% (95% CI, 8.5%-9.8%) fewer low-value services in 2019 than TM beneficiaries (23.1 vs 25.4 total low-value services per 100 beneficiaries). Although MA beneficiaries enrolled in health management organization and preferred provider organization products received fewer low-value services than TM beneficiaries, the difference was largest for those enrolled in health management organization products (2.6 fewer [95% CI, 2.4-2.8] vs 2.1 fewer [95% CI, 1.9-2.3] services per 100 beneficiaries, respectively). Across primary care payment arrangements, MA beneficiaries received fewer low-value services than TM beneficiaries, with the largest difference observed for MA beneficiaries whose primary care physicians were reimbursed within 2-sided risk arrangements. Conclusions and Relevance: In this cross-sectional study of Medicare beneficiaries, those enrolled in MA had lower rates of low-value care than those enrolled in TM; elements of insurance design present in the MA program and absent in TM were associated with reduction in low-value care.

Removal of prior authorization for medication-assisted treatment: impact on opioid use and policy implications in a Medicare Advantage population.

BACKGROUND: More than 30% of Medicare beneficiaries and 40% of patients dually eligible for Medicare and Medicaid use opioids. With an estimated 8%-12% of patients developing an opioid use disorder (OUD) after initiating opioids, opioid misuse is a significant public health challenge, especially among high-risk Medicare populations. Medication-assisted treatment (MAT) is the use of medications for the treatment of OUD and to prevent relapse to opioid use. MAT is the most effective treatment for OUD. There are a variety of barriers to MAT therapy that may delay access to treatment. OBJECTIVE: To study the impact of the removal of prior authorization requirements for MAT medications on MAT utilization, opioid utilization, and clinical outcomes, including emergency department visits, inpatient admission, relapse rates, behavioral health services, and nonopioid pain medication utilization, among opioid-using individuals with Medicare Advantage Prescription Drug (MAPD) coverage. METHODS: This retrospective, cross-sectional study used administrative medical, pharmacy, and enrollment data to identify chronic opioid users and a subset cohort initiating MAT use in 2017, when prior authorization requirements were in effect, and 2018 after removal of prior authorization requirements. Opioid and MAT utilization and clinical outcomes from emergency department visits were also examined before and after prior authorization requirements. A logistic regression analysis was conducted to examine the impact of the policy change on relapse rates, comparing relapse rates in 2017 and 2018, after controlling for potentially confounding demographic and clinical factors. RESULTS: This policy change was followed by a decrease in opioid utilization, an increase in MAT initiation, and a 4% decline in relapse rates. Patients initiating MAT after removal of prior authorizations had a 19% decrease in likelihood of relapse, and those with an OUD diagnosis were 47% less likely to relapse. The majority of MAT recipients were aged younger than 65 years, had a mental or behavioral health disorder diagnosis, and initially used relatively low doses (< 90 MME) of prescription opioids. There were no statistically significant differences in the use of behavioral health services or the use of nonopioid medications from 2017 to 2018. CONCLUSIONS: Utilization management policies should ensure appropriate MAT use, while minimizing impediments to access. Providing patients with evidence-based therapy effective for the treatment of OUD is essential to patient recovery and combating the consequences of the opioid epidemic. Further strides are needed to eliminate additional obstacles to OUD care. DISCLOSURES: No outside funding supported this study. All authors are or were employees of Humana, Inc., at the time of the study and have no other potential conflicts of interest to disclose.

A Retrospective Database Study Comparing Diabetes-Related Medication Adherence and Health Outcomes for Mail-Order Versus Community Pharmacy.

BACKGROUND: Adherence to oral antihyperglycemic agents (AHAs) is important for managing blood glucose levels and avoiding hospitalizations or diabetes complications. Previous studies have found that use of mail-order pharmacy dispensing channels results in greater adherence than use of community pharmacies, but the link between use of mail-order pharmacies and improved clinical outcomes has not been established. OBJECTIVE: To compare the effect of mail-order and community pharmacy use on adherence to oral AHAs, hemoglobin A1c (A1c) level, and glycemic control, as well as emergency department (ED) and inpatient hospital use. METHODS: This retrospective cohort study of administrative claims data from January 1, 2008, to December 31, 2016, included patients with Medicare Advantage Prescription Drug plan coverage with ≥ 2 claims for the same oral AHA and a diagnosis of type 2 diabetes mellitus (T2DM). Patients were indexed to the start of the most advanced oral AHA identified to begin study observations at the start of a new treatment and assigned to mail-order or community pharmacy cohorts based on which channel dispensed ≥ 80% of their oral AHA claims; all others were excluded. Mail-order and community pharmacy patients were 1:1 propensity score matched. Matched cohorts were compared on proportion of days covered (PDC), adherence (PDC ≥ 0.8), A1c level, glycemic control, and ED and inpatient use for measurement periods of 12, 24, 36, and 48 months post-index. RESULTS: 19,307 mail-order and 19,307 community pharmacy users were matched. PDC was higher for mail-order pharmacy users at 12 months (0.93 vs. 0.82, P < 0.001) and sustainable through 48 months (0.87 vs. 0.77, P < 0.001). Adherence was also greater for mail-order pharmacy patients through 12 months (86% vs. 68%, P < 0.001) and sustainable through 48 months (78% vs. 62%, P < 0.001). Glycemic control as A1c < 7% was not significantly different, but control as A1c < 8% was greater for mail-order pharmacy users at 12 months (91% vs. 89%, P = 0.006) and was greater through 36 months (93% vs. 89%, P = 0.043). Effects on A1c level were not evident. Mail-order pharmacy users were less likely to have an ED visit within 12 months (26% vs. 28%, P < 0.0001), and the difference was observed through 36 months (50% vs. 54%, P < 0.0001). Similarly, fewer mail-order pharmacy users had an inpatient hospitalization within 12 months (17% vs. 19%, P < 0.0001), and the difference was observed through 48 months (43% vs. 47%, P = 0.009). CONCLUSIONS: The results of the study demonstrate a benefit to patients who use mail-order pharmacies for chronic medications to treat T2DM. The study identified greater glycemic control, lower ED use, and lower hospitalization among individuals using mail-order pharmacies. These positive outcomes were evident in the near term and sustained over time. DISCLOSURES: This study received no outside funding but was sponsored by Humana through regular employment activities by Schwab, Racsa, and Worley, who are employed by Humana Healthcare Research (formerly Comprehensive Health Insights). This study found benefits related to using mail-order versus community pharmacies for dispensing antihyperglycemic agents in the treatment of type 2 diabetes. Humana owns mail-order pharmacies under the Humana Pharmacy subsidiary. Mourer and Meah are paid employees of Humana Pharmacy Solutions. Rascati is employed by the University of Texas College of Pharmacy at Austin.

Long-term stability of CMV DNA in human breast milk.

BACKGROUND: Human cytomegalovirus (CMV) is the leading cause of intrauterine and perinatal viral infection. The most common route of CMV transmission in newborns is through breastmilk and this can lead to infant morbidity and mortality. Breast milk that has been frozen for an extended period may need to be tested for CMV DNA to determine the source of infection. It has been a challenge for clinical laboratories to ensure the stability of CMV DNA in frozen breast milk for accurate viral load measurement. OBJECTIVES: To evaluate the stability of CMV DNA in breast milk by testing quantitative viral loads over a 28-day period for breast milk stored at 4 °C and a 90-day period for breast milk stored at -20 °C. STUDY DESIGN: Baseline viral loads were determined on day 0 and the samples stored at 4 °C underwent extraction and amplification at four time points, up to 28 days. The samples stored at -20 °C underwent extraction and amplification at five time points up to 90 days. Log10 values were calculated and t-test, Pearson's coefficient, and concordance correlation coefficient were calculated. RESULTS: There was no statistically significant difference between the time points by t-test, and correlation coefficients showed greater than 90% concordance for days 0 and 28 as well as days 0 and 90 at both storage temperatures tested. CONCLUSIONS: The concentration of CMV DNA in breast milk was stable for 28 days at 4 °C and 90 days at -20 °C as the concentrations did not differ significantly from the baseline viral loads.

Comparative Effectiveness of Rapid-Acting Insulins in Adults with Diabetes.

BACKGROUND: Although there are a variety of insulin products and new delivery modalities available, the absence of direct clinical and economic comparisons can make treatment planning and formulary decision making difficult. Direct comparisons between insulin aspart and insulin lispro from a large heterogeneous population are not available. OBJECTIVE: To assess differences in clinical outcomes, medication adherence, utilization, and total health care costs between aspart and lispro and vial versus pen modalities for administering these short-acting insulin analogs. METHODS: This retrospective cohort study used administrative claims data from the Humana Research Database to identify people with type 1 or type 2 diabetes and Medicare or commercial insurance (with medical and pharmacy benefits) who newly initiated rapid-acting insulin between January 1, 2008, and December 31, 2013, and were continuously enrolled during the 12-month baseline and 12-month follow-up periods. Generalized linear models were used to assess differences in costs and utilization. Logistic regression models measured the likelihood of having a hypoglycemic event, worsening diabetes complications, or a change in glycated hemoglobin (A1c). RESULTS: 8,189 patients included in the study were grouped by rapid-acting insulin product (aspart, n = 5,364, and lispro, n = 2,566) and modality (vial, n = 6,135, and pen, n = 2,054). There were no significant differences in the percentage of patients with a hypoglycemic event, new or worsening diabetes complications, or change in A1c, and there were no significant differences in adjusted total health care, medical and pharmacy costs, or emergency department visits between any of the product or modality comparisons. There was a significant difference in mean annual inpatient stays between lispro and aspart (adjusted mean = 2.24, 95% CI = 0.73-6.69, and adjusted mean = 2.65, 95% CI = 0.86-7.86, respectively; P < 0.001) and pen and vial cohorts (adjusted mean = 1.74, 95% CI = 0.56-4.99, and adjusted mean = 3.05, 95% CI = 1.01-9.08, respectively; P < 0.001). Adherence was similar for the lispro and aspart cohorts. Adherence was higher in the pen cohort (as measured by medication possession ratio ≥80%) compared with the vial cohort (adjusted odds ratio = 1.29, 95% CI = 1.12-1.50). CONCLUSIONS: This study provides a comprehensive assessment of outcomes and costs between 2 commonly used rapid-acting insulin products. Overall, there was little differentiation between products, although adherence improved significantly with pen devices. These findings may simplify decisions related to formulary options and choice of therapy. DISCLOSURES: No outside funding supported this study. Racsa and Ellis are employees of Comprehensive Health Insights, a subsidiary of Humana, and Saverno was employed with Comprehensive Health Insights at the time of this study. Meah is an employee of, and owns stock in, Humana. The authors have no financial disclosures or potential conflicts of interest to report. All authors contributed equally to study concept and design, data interpretation, and manuscript preparation. Racsa collected the data.

Does Hepatitis C Treatment Adherence Affect Risk of Liver Transplantation? A Historical Cohort Study.

BACKGROUND: Chronic hepatitis C virus (HCV) is the primary cause of liver failure leading to transplantation, and medication adherence is essential to the therapeutic efficacy of HCV treatments. While there is evidence linking poor adherence with increased utilization and cost, published literature lacks examination of the association between medication adherence and risk of liver transplant. In addition, the impact of HCV treatment on total costs of liver transplantation is not well documented. OBJECTIVES: To compare (a) the relative risk of liver transplant by adherence in patients treated for HCV and (b) the total health care costs in treated and untreated patients who require liver transplant. METHODS: This observational, historical cohort study was conducted using administrative data from the Humana Research Database. To be included, patients were required to have a documented HCV diagnosis or treatment between January 1, 2008, and June 30, 2013. Patients were excluded if they had a hepatitis B diagnosis, were not fully insured by a commercial or Medicare Advantage Prescription Drug plan, or were outside the age range of 19-89 years. No minimum pre- or post-index enrollment period was required, and patients were followed for their entire post-index enrollment through December 31, 2013. The study population was divided into treated and untreated groups and then subdivided by presence or absence of a liver transplant. Date of liver transplant was defined as the index date for untreated liver transplant patients; otherwise, the index date was defined as either the date of first observed HCV treatment or diagnosis date (if no treatment or liver transplant). Cox proportional hazards models were used to estimate the relative risk of liver transplant by level of treatment adherence (> 80%, 50%-79%, and < 50%) based on proportion of days covered. General linearized models with log link and gamma distribution were used to compare median total health care costs from index date until end of study period (or death/disenrollment, whichever came first) between treated and untreated liver transplant patients. All costs were converted to 2013 U.S. dollars and reported as total costs per patient and per patient per month (PPPM) to account for varying follow-up periods. RESULTS: Of the 53,423 patients identified with HCV, 10,377 met exclusion criteria, leaving 43,046 patients (primarily Caucasian, males, mean age of 58 years) in the initial cohort. Only 6.29% (n = 2,708) of the total HCV cohort received HCV treatment, and less than 1% (n = 366, 0.8%) received a liver transplant. Although there were no significant differences in the risk of liver transplant by adherence level, there was an upwards trend in the rate of liver transplant as adherence worsened (> 80%: 1.25%; 50%-79%: 1.30%; and < 50%: 1.99%), and the average days to liver transplant was longer with higher adherence (> 80%: 683; 50%-79%: 623; < 50%: 454). Only 48 (13.11%) patients who received a liver transplant were treated for HCV. Adjusted median total and PPPM health care costs measured from index date until end of the study period were significantly higher for patients who received HCV treatment compared with those who did not (total=$231,139 vs. $86,167, adjusted P < 0.001; PPPM=$20,583 vs. $5,778, adjusted P = 0.008), driven by HCV-related medical costs and total pharmacy costs. CONCLUSIONS: Adherence with HCV regimens did not affect risk of liver transplant, underscoring the need for further evidence linking treatment adherence to future liver transplant risk. HCV-treated patients who required liver transplant incurred significantly higher health care costs than those without HCV treatment before liver transplant. Introduction of newer all-oral direct-acting antiviral regimens, with higher acquisition costs, will require further research to more accurately assess medication adherence and its relationship with transplantation, as well as with total health care costs. DISCLOSURES: No outside funding supported this research. Ems, Worley, Racsa, Gregory, Anderson, and Holt are employees of Humana. Brill has participated in a physician advisory board at Humana. The authors have no other financial disclosures to report. Study concept and design were contributed by Ems, Racsa, Worley, and Anderson, along with Gregory, Brill, and Holt. Racsa took the lead in data collection, along with Ems and Worley. All authors participated in data interpretation. Anderson, along with the other authors, wrote the manuscript, which was revised by Brill and Holt, with assistance from the other authors.

Comparing two tyrosine kinase inhibitors for treatment of advanced renal cell carcinoma in Medicare and commercially insured patients.

OBJECTIVE: The objective of this study was to compare treatment characteristics, survival and costs for sunitinib and pazopanib for advanced renal cell carcinoma (RCC) in a real-world setting. METHODS: Using claims data, this observational, retrospective cohort study selected individuals aged 19 to 89 years, with commercial or Medicare insurance, advanced RCC, and at least one pharmacy claim for sunitinib or pazopanib between 1 November 2009 and 31 December 2012. Treatment characteristics (treatment interruption, adherence, duration and discontinuation), survival, and costs were measured up to 12 months. Statistical models were adjusted for age, gender, geographic region, race, and RxRisk-V score. RESULTS: At baseline, pazopanib patients exhibited significantly worse health status indicators (RxRisk-V score, number of pharmacy claims, and pre-index total healthcare costs) than sunitinib patients. There were no differences in treatment characteristics or survival. Index medication costs (mean difference $5580, p = 0.03, adj p = 0.05) and total healthcare costs (mean difference $12,192, p = 0.09, adj p = 0.07) trended higher with sunitinib. Patients non-adherent with sunitinib incurred significantly higher total costs compared to patients non-adherent with pazopanib (mean difference $17,680, p = 0.04, adj p = 0.01). CONCLUSIONS: Mortality data and proxy variables for treatment effectiveness indicate comparable clinical value for both medications. Sunitinib treatment trended towards higher index medication and total healthcare costs despite higher pre-index total costs and worse health status indicators at baseline with pazopanib. Non-adherence with sunitinib was associated with significantly higher total healthcare costs, which may indicate differences in tolerability between the two agents and requires further investigation.

Alternative approaches to the calculation of nutrient density.

A renewed interest in promoting health and wellness has prompted both public- and private-sector organizations to adopt systems for rating the nutritional quality of individual food products. Compared here are three food quality scores for ranking foods. The absolute score varies by the food quality score algorithm used, but the relative ranking of foods within a food group is stable. Fruits and vegetables are substantially more nutrient-dense than items from other food groups. There is an imperative need for a simple, consistent method to guide consumers in making healthier food choices.