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Chi Nguyen,1 Luke Bamber,2 Vincent J Willey,1 Thomas Evers,2 Thomas P Power,3 Judith J Stephenson1 1HealthCore, Inc., Wilmington, DE, USA; 2Bayer AG, Wuppertal, 42096, Germany; 3AIM Specialty Health, Chicago, IL, USACorrespondence: Chi Nguyen, HealthCore, Inc., 123 Justison Street, Suite 200, Wilmington, DE, USA, Tel +1- 302-230-2000, Fax +1-302-230-2020, Email cnguyen@healthcore.comBackground: Patient-reported health related quality of life (HRQOL) is not routinely assessed in clinical practice. Little is known about health status outcomes reported by patients with heart failure with preserved ejection fraction (HFpEF) in non-clinical trial settings.Purpose: To better understand patient burden of HFpEF in terms of HF-specific functional and symptom status, HRQOL, healthcare resource utilization (HCRU) and costs in a US-based commercial and Medicare Advantage insured population.Patients and methods: We conducted a cross-sectional survey of patients with HFpEF and linked their survey and administrative claims data. Consenting, eligible patients completed a survey that included the 23-item Kansas City Cardiomyopathy Questionnaire (KCCQ-23) and the PROMIS Global Health-10 (GH-10) questionnaire, as well as clinical and demographic questions. HF medication use, HCRU and costs during the 12-month baseline period before the survey were determined from claims data. Generalized linear regression was used to assess the associations between baseline characteristics and the KCCQ-23 overall summary score.Results: Of 598 survey respondents with survey and claims data, 54.7% were female with mean age 74.0 years. The KCCQ-23 overall summary and clinical summary scores were 64.8 and 63.0, respectively, and the GH-10 physical and mental health summary scores were 39.9 and 45.5. Factors related to lower KCCQ-23 overall summary scores were HF treatment and symptom changes during the past 4-weeks before the survey, hospital admission during the past year, low household income, high comorbidity index, and morbid obesity (BMI> 40). Total all-cause healthcare costs were $38,243 during the year prior to the survey, of which 42% were HF-related.Conclusion: Patient-reported outcome measure scores indicated impairment due to HF symptoms and physical limitations in this real-world sample of patients with HFpEF, highlighting a need to assess patient-reported outcomes as well as the clinical and economic outcomes traditionally assessed by clinicians, health systems and payers.Keywords: heart failure with preserved ejection fraction, HFpEF, patient-reported health related quality of life, healthcare resource utilization, healthcare costs

Daina B Esposito,1 Vibha CA Desai,1 Judith J Stephenson,1 M Soledad Cepeda,2 Jennifer G Lyons,1 Crystal N Holick,1 Gregory P Wedin,3 Stephan Lanes1 On behalf of members of the REMS Program Companies Metrics Subteam1HealthCore, Inc., Wilmington, DE, USA; 2Janssen Research and Development, Titusville, NJ, USA; 3Upsher-Smith Laboratories, LLC, Maple Grove, MN, USACorrespondence: Judith J StephensonHealthCore Inc, 123 Justison Street, Suite 200, Wilmington, DE, 19801, USATel +1 302-547-5770Email jstephenson@healthcore.comBackground/Rationale: The US Food and Drug Administration (FDA) approved a Risk Evaluation and Mitigation Strategy (REMS) for extended release/long-acting (ER/LA) opioids in 2012. The purpose of this study was to assess patient knowledge of the safe use of these products following implementation of the REMS and to determine possible effects of the REMS, including impact on medication access.Objective: To assess patient knowledge of safe use of ER/LA opioids and use of REMS patient education tools such as the Medication Guide (MG) and Patient Counseling Document (PCD).Methods: This was a cross-sectional survey of commercially insured (Commercial) and Medicare Advantage-insured (Medicare) adults with ≥ 1 pharmacy claim for an ER/LA opioid (10/01/2015 – 02/28/2017) in the HealthCore Integrated Research Database and Medicaid-insured (Medicaid) adult members of a research panel, about their knowledge of safe use of ER/LA opioids and receipt/comprehension of the MG and PCD.Results: Survey respondents consisted of 382 Commercial, 43 Medicare and 40 Medicaid adults. While ≥ 95% of respondents received and read the MG, fewer were aware of the PCD (Commercial: 47%, Medicare: 65%, Medicaid: 53%). Almost 75% of the knowledge questions were answered correctly by ≥ 80% of all respondents; fewer respondents recognized that use of opioids as directed can lead to death (Commercial: 73%, Medicare: 56%, Medicaid: 63%), the MG should be read at each dispensing (Commercial: 78%, Medicare: 53%, Medicaid: 75%), opioids should not be stored in the medicine cabinet (Commercial: 77%, Medicare: 79%, Medicaid: 58%), missed doses should not be taken as soon as possible (Commercial: 56%, Medicare: 51%, Medicaid: 50%), and pills should not be crushed (Commercial: 85%, Medicare: 67%, Medicaid: 52%).Conclusion: Although most respondents reported reading and understanding the MG and exhibited knowledge of safe use of ER/LA opioids, providers’ use of the PCD and increased understanding of safe use core messages need reinforcement.Keywords: Risk Evaluation and Mitigation Strategy, opioids, patient knowledge

Immunization is an important component of preventive healthcare services. By recognizing and understanding factors associated with suboptimal vaccination compliance, healthcare providers can better approach at-risk populations and target efforts at reinforcing the vital importance of immunizations. The objective of this study was to understand the factors associated with adherence, beliefs and behaviors of influenza, pneumococcal, and herpes zoster vaccines receipt among commercially insured adults. A cross-sectional survey of patients with medical and pharmacy benefits for a 24-month period between August 1, 2014 and July 31, 2016 who were eligible to receive at least one of three adult vaccines (influenza, pneumococcal, and herpes zoster) was completed. Patients were identified as eligible to receive a vaccine based on current guidelines from the CDC ACIP. Health plan members were identified from administrative claims data in the HealthCore Integrated Research DatabaseSM (HIRD). Among the participants, 11% were eligible and up-to-date on all three vaccines; 52% on some and 37% were not up-to-date on any of the three vaccines. Participants with a healthcare provider were more likely to be up-to-date on eligible vaccines: 79.9% for none, 91.3% for some, and 97.8% for all eligible vaccines. The composite Vaccine Myth Belief score was significantly associated with being up to date on eligible vaccines: 45.0%/12.8% for none, 12/5%/30.8% for some, and 8.9%/33.3% for those up-to-date on all eligible vaccines. Despite numerous interventions designed to increase vaccination rates among adults, compliance remains suboptimal. It is evident that patient and provider education is necessary to fill knowledge gaps and misunderstandings; however knowledge by itself is not sufficient to improve immunization practices. Our results highlight a population that could benefit from a multidisciplinary approach, including interventions at the individual and health system levels.

Purpose To assess clinical characteristics and device satisfaction of patients with chronic obstructive pulmonary disease (COPD) treated with glycopyrrolate/eFlow® Closed System (CS) nebulizer (further referred to as eFlow) under real-world conditions. Participants and Methods Patients with COPD currently using eFlow were identified by the study sponsor. Consenting patients who met study inclusion criteria completed a cross-sectional survey that included a device satisfaction questionnaire. Means, medians, and standard deviations were calculated. Results Sixty-six patients met inclusion criteria and completed the survey. Participants' mean ± standard deviation age was 64.9 ± 11.9 years and the majority were white (86.4%) and female (59.1%). Almost two-thirds were former smokers. Thirty-nine (59.1%) reported their COPD to be severe/very severe and 38 (57.6%) reported a COPD exacerbation resulting in a hospitalization, ER visit, or medication modification over the past 12 months. Among 55 participants who had previously used another type of nebulizer, 44 (80%) were overall "much more"/"somewhat more" satisfied with the eFlow compared with their previous nebulizer(s). Regardless of prior nebulizer use, 60 (90.9%) participants were "satisfied"/"very satisfied" overall with the eFlow. Assembly and disassembly, operation, and cleaning were perceived as being "easy"/"very easy" by at least 65% of participants. Among all participants, 57 (86.4%) were "confident"/"very confident" of glycopyrrolate administration. On a Likert scale of 1 ("I don't like it") to 7 ("I like it a lot"), mean scores were at least 5.9 for portability, ease of cleaning, size, weight, short administration time, and relative silence of the device. Over 80% of participants said they "probably"/"definitely" would continue to use eFlow. Conclusion Based on this real-world study, the majority of patients were highly satisfied with, and confident in, using eFlow.

Objective A survey of US adults with type 2 diabetes mellitus was conducted to better understand patients' insulin initiation experiences and treatment persistence behaviors. Research design and methods Participants were recruited from consumer panels and grouped by basal insulin treatment pattern: continuers (no gap of ≥7 days within 6 months of initiation); interrupters (gap ≥7 days, resumed treatment); discontinuers (stopped for ≥7 days, not resumed). A quota of approximately 50 respondents per persistence category was set. Results A total of 154 respondents (52 continuers, 52 interrupters, 50 discontinuers) completed the survey. Mean age was 51.4 years; 51.9% male. Continuers were more likely to report their views being considered during initiation, and less likely to report a sense of failure. Concerns included insulin dependence (64.3% agree/strongly agree), frequent blood glucose monitoring (55.2%), costs/ability to pay (53.9%), fears of or mistakes during self-injection (52.6%), and weight gain (52.6%). Continuers were motivated by benefits of insulin therapy; experienced or potential side effects were notable factors for interruption/discontinuation. Healthcare provider instruction was indicated as a reason for continuing, stopping, and restarting therapy. Conclusion Benefits of basal insulin therapy motivated continuers while side effects impacted interruption/discontinuation. Persistence on basal insulin is often influenced by provider actions. Earlier provider intervention upon signs of treatment discontinuation may promote persistence.

Background/rationale Little is known about the reasons for visiting multiple doctors/pharmacies, known as doctor/pharmacy shopping, to obtain opioids. Objective To investigate patients' self-reported reasons for doctor/pharmacy shopping and assess whether doctor/pharmacy shopping behavior can be used as a surrogate measure of opioid abuse/misuse. Methods We conducted a cross-sectional web-based survey among adult patients with ≥2 pharmacy claims for immediate-release or extended-release/long-acting opioids between 7/1/2015 and 12/31/2016, identified from a large United States (US) commercial claims database. Patients were classified into no, mild, moderate, or severe shopping categories based on their claims. Reasons for doctor/pharmacy shopping and opioid abuse/misuse were determined from patient responses to the Prescription Opioid Misuse and Abuse Questionnaire. Results A random sample of 10,081 patients was invited to participate in the survey and 1085 (11%) completed surveys. The most frequently reported reasons for doctor/pharmacy shopping were convenience, availability, price, and multiple morbidities requiring pain management. Among patients in the no, minimal, moderate, and severe shopping categories, only 7.8%, 8.5%, 11.8% and 12.6% reported opioid abuse/misuse, respectively. Conclusion In this commercially-insured population, patient-reported reasons for doctor/pharmacy shopping do not suggest opioid abuse/misuse. Less than 15% of patients with shopping behavior in the past 3 months reported any reasons attributable to opioid abuse/misuse, indicating that shopping behavior in this population may not be a good surrogate for abuse/misuse.

Judith J Stephenson,1 Jonathon Colby Gable,2 Rebekah Zincavage,1 Gregory L Price,2 Collin Churchill,2 Emily Zhu,2 Keri Stenger,2 Mukul Singhal,1 Bal Nepal,1 Michael Grabner,1 Michael J Fisch,3 David Debono,4 Amy R Geschwender,5 Gebra Cuyun Carter2 1HealthCore, Inc., Wilmington, DE, USA; 2Eli Lilly and Company, Indianapolis, IN, USA; 3AIM Specialty Health, Chicago, IL, USA; 4Anthem, Inc., Indianapolis, IN, USA; 5SWOG Cancer Research Network, San Antonio, TX, USACorrespondence: Judith J Stephenson Tel +1 302-547-5770Email JStephenson@healthcore.comPurpose: To describe patients’ perspectives on the use of and potential challenges and barriers with adherence/persistence to cyclin-dependent kinase 4 and 6 inhibitors (CDK4& 6i’s) to treat metastatic breast cancer (MBC).Methods: This qualitative study consisted of 60-minute semi-structured telephone interviews with patients with MBC in the US who were either current or recent CDK4& 6i users, identified from administrative claims of survey-eligible commercial and Medicare Advantage patients in the HealthCore Integrated Research Database between November 1, 2018 and November 1, 2019. Patients were recruited by email and/or mailed letter. The 60-minute telephone interviews were conducted by a trained facilitator using a study-developed interview discussion guide that included topics impacting treatment choice and adherence/persistence. Interviews were audio-recorded, transcribed, and thematically analyzed.Results: All 462 eligible patients were sent a recruitment email and/or letter to which 36 patients responded, consented to participate, and met study inclusion criteria; 25 patients scheduled interviews, and 24 completed them. Study participants were predominately white, non-Hispanic (96%) with a mean age of 59.5 years. Participants reported a largely positive experience and mentioned very few adherence/persistence issues. They further reported appreciating the ease and convenience of oral oncolytics, coped with side effects, had strong medical and social support, and experienced few cost issues.Conclusion: The few adherence/persistence issues reported by participants contrasts with other findings of suboptimal oral oncolytic use. Interview themes indicated several factors that likely contributed to the lack of adherence/persistence issues: trusted relationship with oncologist, belief in importance of medication, positive medication views, strong medical and social support, and minimal personal drug cost. Future research should focus on whether and how much these factors impact adherence/persistence in more diverse populations. If adherence/persistence issues are identified in these populations, then it would be appropriate to study the development of interventions that target factors associated with better adherence/persistence.Keywords: oral oncolytics, patient perspective, semi-structured interviews, adherence, persistence, CDK4& 6i users

Introduction Complex or personalized insulin regimens challenge traditional adherence measures. Our objective was to develop an improved basal insulin (BI) adherence measure using both patient-reported and administrative claims data, resulting in a more complete measure. Methods Patients’ self-reported BI utilization over the previous 12 months was linked with their claims data for the same period. Hybrid medication possession ratio (MPR) was derived by calculating expected days of insulin supply [total dispensed insulin units from claims over 12 months divided by self-reported total daily dose (TDD)]. The hybrid MPR was compared against traditional claims-based MPR, adjusted claims-based MPR, and patient-reported MPR. For all MPR measures, the adherence threshold was ≥ 0.8. A logistic model was used to predict non-adherence per hybrid MPR. The predicted model-based MPR was compared with existing measures in a larger cohort. Results The study sample consisted of 296 patients. TDD derived from claims was higher than self-reported TDD [77.9 (71.8) vs. 57.7 (38.3)], implying average dispensed insulin would last longer than claims-based days supply. Correspondingly, hybrid and MPRs adjusted for package size (56% and 71%, respectively) were higher than claims-based MPR (50%). Age, total claims-based days supply, retinopathy, adjusted MPR-based adherence, and non-insulin injectable use were key predictors of hybrid MPR-based adherence. Applying the claims-based prediction model to a larger cohort to test validity showed high correlations with predicted and adjusted MPR-based adherence. Conclusions Traditional claims-based MPR underestimated adherence while adjusted MPR overestimated adherence when self-reported total daily dose was taken as benchmark insulin dose. The predicted model may help identify patients with poor basal insulin adherence. More research is needed to further confirm the findings. Funding Eli Lilly and Company, Indianapolis, IN, USA. Electronic supplementary material The online version of this article (10.1007/s12325-018-0828-4) contains supplementary material, which is available to authorized users.

The aim of this study was to assess insulin non-adherence among patients with type 2 diabetes (T2DM) to better understand relationships between adherence, basal insulin (BI) usage, and patient experiences. A cross-sectional survey of patients with T2DM using BI was conducted. Adherence was measured by the Morisky Medication Adherence Scale 8-Items (MMAS-8). Low adherence (LA) was defined as MMAS-8 score < 6, high adherence (HA) as MMAS-8 score = 8, and medium adherence as MMAS-8 score = 6 to < 8. Patients with MMAS-8 scores = 6 to < 8 were excluded from the analysis. Of 400 completed surveys, 395 patients (98.8%) completed all MMAS-8 items, 112 with LA, 134 with HA. Compared with HA patients, greater proportions of LA patients followed more complex BI dosing patterns (57.1% vs. 39.5%, P = 0.014), had some difficulty calculating their correct BI dose (40.2% vs. 6.8%, P < 0.001), reported having missed ≥1 dose per month (79.3% vs. 12.6%, P < 0.001), and temporarily stopped BI in the past year (23.2% vs. 0.7%, P < 0.001). In conclusion, understanding patients' experiences with BI therapy can help formulate strategies to improve adherence.

Omalizumab is indicated for the management of chronic idiopathic urticaria (CIU) in patients aged 12 years or older with persistent hives that are not adequately controlled by H1 antihistamines. While its safety and efficacy in CIU patients have been evaluated in multiple clinical trials, real-world use of omalizaumab in CIU has not been well characterized.To assess demographics, clinical characteristics, and treatment patterns of CIU patients who initiated omalizumab to better understand the usage of this agent in CIU management in the real world.This retrospective cohort study used medical and pharmacy claims data in the United States from the HealthCore Integrated Database to identify patients with CIU newly treated with omalizumab (≥ 4 omalizumab claims within 6 months of the initial claim) between March 21, 2014, and October 31, 2015 (study intake period). The index date was defined as the date of the first claim for omalizumab during the study intake period. Demographic and clinical characteristics were described for patients treated with omalizumab, as were treatment patterns associated with omalizumab and concomitant medications associated with CIU treatment. Descriptive and inferential statistics were reported. The Kaplan-Meier method was used to examine omalizumab treatment patterns.This study included 298 omalizumab-treated patients (mean [SD] age of 43.5 [13.64] years; 70.8% female); approximately 84% were seen by an allergist/immunologist. All patients had ≥ 12 months of continuous enrolment and a subset of 138 patients had ≥ 18 months of follow-up. For patients with ≥ 12 months of post-index follow-up, 12.1% (n = 36), 28.5% (n = 85), and 32.9% (n = 98) discontinued omalizumab within the 6-month, 12-month, and the entire post-index periods (mean 530 days), respectively; the mean number of days patients were continuously treated with omalizumab was 443.1 (95% CI = 425.0-461.3); the probabilities of continuous treatment (95% CI) were 0.879 (0.836-0.911), 0.711 (0.656-0.759), and 0.647 (0.585-0.703) for the 6-, 12-, and 18-month post-index periods, respectively. For the 98 patients who discontinued omalizumab during the entire post-index period, 28.6% restarted omalizumab after the first discontinuation within the post-index period (mean time from first discontinuation to first restart=329 days). Use of medications such as oral corticosteroids, montelukast, cyclosporine, and prescription H1 and H2 antihistamines decreased during the 1- to 6-month and 7- to 12-month post-index periods compared with those within the 6-month pre-index period.In this cohort of CIU patients who were newly prescribed omalizumab, the majority were treated by allergists/immunologists as expected, and approximately 60% of patients continued on therapy beyond 18 months. Concomitant medication use decreased after omalizumab initiation. These data on the real-world use of omalizumab for CIU may help to better inform decision-making processes for health care payers by quantifying omalizumab and concomitant medication treatment patterns over a longer time frame relative to previous studies. DISCLOSURES This study was sponsored by Novartis Pharmaceuticals, which provided funding support for the conduct of the study. Kavati, Ortiz, and Paknis are employees of Novartis Pharmaceuticals. Ke, Wertz, Huang, Wang, Willey, and Stephenson are employees of HealthCore, an independent research organization that received funding from Novartis Pharmaceuticals for the conduct of this study. Beck is an employee of the University of Rochester Medical Center, who was under contract with Novartis Pharmaceuticals to provide consulting services to this study, and reports grants from Genentech, outside the currently submitted work. Bernstein is affiliated with Bernstein Clinical Research Center, which was under contract with Novartis Pharmaceuticals to provide consulting services to this study, and reports receiving grants and personal fees from Novartis Pharmaceuticals, grants and personal fees from Genentech outside of the submitted work, and is an author on the Joint Task Force for Practice Parameters for Urticaria and the GALEN international guidelines for urticaria under preparation. Study concept and design were primarily contributed by Kavati, Ortiz, and Paknis, with assistance from the other authors. Huang, Wang, and Ke took the lead in data collection, with assistance from Wertz, Willey, and Stephenson. Data interpretation was performed by Ke, Wertz, and Willey, assisted by the other authors. The manuscript was written by Stephenson, Ke, and Wang, along with Willey, Wertz, and Huang, and revised by Bernstein and Beck, with assistance from the other authors. Selected study data were presented in a poster at the International Society for Pharmacoeconomics and Outcomes Research (ISPOR) 22nd Annual International Meeting on May 20-24, 2017, in Boston, Massachusetts. A poster based on this dataset was presented at the 2017 American College of Allergy, AsthmaImmunology (ACAAI) Annual Scientific Meeting on October 26-30, 2017, in Boston, Massachusetts.

Aims To describe primary care physicians’ (PCPs) perceptions of patient reactions and concerns about insulin initiation and identify opportunities for increased support. Methods Cross-sectional, online survey of PCPs prescribing basal insulin to adults with type 2 diabetes mellitus (T2DM). PCPs were identified from administrative claims of a large commercial health plan and descriptive results of PCP responses were reported. Results PCPs (N = 100) treated an average of 17 patients receiving insulin during a typical week. More than 85% of insulin initiation recommendations originated with PCPs. Most offered glucose monitoring instructions (96%) and advice on diet, exercise, and diabetes management (96%); 35% provided insulin titration algorithms; 93% reported that patients often or always took their insulin daily within 3 months of initiation; 31% of PCPs reported monthly office contacts with patients for the first 3 months; 16% reported no outreach efforts; fewer than 20% connected patients with support groups. When starting basal insulin, PCPs reported patients feeling personal failure regarding their diabetes treatment (33% often/always) and lacking confidence in their ability to manage insulin therapy (38% often/always). Conclusions Study results identify additional opportunities for assisting patients in making the transition to insulin, including more frequent direct outreach to monitor insulin usage.

To examine treatment patterns, treatment response, and demographic and clinical characteristics of patients with chronic idiopathic urticaria (CIU) newly initiated on omalizumab therapy in real-world practice in the US.This retrospective observational cohort study used US claims data from the HealthCore Integrated Research Database (HIRDThis study consisted of 88 patients with a mean (SD) age of 43.4 (± 13.46) years, 68.2% were female, and 36 patients had ≥18 months post-index eligibility. Among 69 patients with documented index dose, 75.4% received omalizumab 300 mg and 69.6% remained on index dose throughout follow-up. For 52 patients with documented index dosing frequency, 96.2% had every 4-week dosing frequency. Among 86 patients with omalizumab documentation, 83.7% reported CIU improvement after omalizumab initiation and 24.4% discontinued omalizumab. For all patients, the proportion using oral corticosteroids (OCS) decreased pre- to post-index (52.3% vs 39.8%). Similar results were observed for patients with ≥18 months post-index eligibility.In this real-world analysis, the majority of patients remained on omalizumab for ≥12 months, and had a positive response. OCS use decreased following omalizumab initiation.

Judith J Stephenson,1 Debra Wertz,1 Tao Gu,1 Jeetvan Patel,2 Anand A Dalal2 1HealthCore, Inc., Wilmington, DE, 2GlaxoSmithKline, Research Triangle Park, NC, USA Purpose: The degree to which symptoms such as dyspnea affect patients with COPD is individualized. To address the gap between clinical symptom measures and self-perceived disease burden, we investigated the symptom status of adult patients with COPD and followed with an administrative claims analysis of health care resource utilization and costs. Methods: This was a hybrid US observational study consisting of a cross-sectional patient survey followed by a retrospective analysis of administrative claims data. The primary COPD symptom measures were the modified Medical Research Council (mMRC) Dyspnea scale and the COPD Assessment Test (CAT). Results: A total of 673 patients completed the survey. Of these, 65% reported mMRC grades 0–1 (low symptomatology) and 35% reported mMRC grades 2–4 (high symptomatology); 25% reported CAT score

Objective A survey of US adults with type 2 diabetes mellitus was conducted to better understand patients’ insulin initiation experiences and treatment persistence behaviors. Research Design and Methods Participants were recruited from consumer panels and grouped by basal insulin treatment pattern: continuers (no gap of ≥7 days within 6 months of initiation); interrupters (gap ≥7 days, resumed treatment); discontinuers (stopped for ≥7 days, not resumed). A quota of approximately 50 respondents per persistence category was set. Results A total of 154 respondents (52 continuers, 52 interrupters, 50 discontinuers) completed the survey. Mean age was 51.4 years; 51.9% male. Continuers were more likely to report their views being considered during initiation, and less likely to report a sense of failure. Concerns included insulin dependence (64.3% agree/strongly agree), frequent blood glucose monitoring (55.2%), costs/ability to pay (53.9%), fears of or mistakes during self-injection (52.6%), and weight gain (52.6%). Continuers were motivated by benefits of insulin therapy; experienced or potential side effects were notable factors for interruption/discontinuation. Healthcare provider instruction was indicated as a reason for continuing, stopping, and restarting therapy. Conclusion Benefits of basal insulin therapy motivated continuers while side effects impacted interruption/discontinuation. Persistence on basal insulin is often influenced by provider actions. Earlier provider intervention upon signs of treatment discontinuation may promote persistence.

Background/Rationale Little is known about the reasons for visiting multiple doctors/pharmacies, known as doctor/pharmacy shopping, to obtain opioids. Objective To investigate patients’ self-reported reasons for doctor/pharmacy shopping and assess whether doctor/pharmacy shopping behavior can be used as a surrogate measure of opioid abuse/misuse. Methods We conducted a cross-sectional web-based survey among adult patients with ≥2 pharmacy claims for immediate-release or extended-release/long-acting opioids between 7/1/2015 and 12/31/2016, identified from a large United States (US) commercial claims database. Patients were classified into no, mild, moderate, or severe shopping categories based on their claims. Reasons for doctor/pharmacy shopping and opioid abuse/misuse were determined from patient responses to the Prescription Opioid Misuse and Abuse Questionnaire. Results A random sample of 10,081 patients was invited to participate in the survey and 1085 (11%) completed surveys. The most frequently reported reasons for doctor/pharmacy shopping were convenience, availability, price, and multiple morbidities requiring pain management. Among patients in the no, minimal, moderate, and severe shopping categories, only 7.8%, 8.5%, 11.8% and 12.6% reported opioid abuse/misuse, respectively. Conclusion In this commercially-insured population, patient-reported reasons for doctor/pharmacy shopping do not suggest opioid abuse/misuse. Less than 15% of patients with shopping behavior in the past 3 months reported any reasons attributable to opioid abuse/misuse, indicating that shopping behavior in this population may not be a good surrogate for abuse/misuse.

BACKGROUND: Hypoglycemia is a common side effect of glucose-lowering therapy, especially insulin and sulfonylureas, which can lead to serious complications including death. The prevalence of hypoglycemia reported in observational studies has been low, likely because only severe events are captured. As non-severe hypoglycemia events are frequently not reported by patients, there is a need to better understand how patients describe hypoglycemia, what they do when they experience it, and how it impacts their daily lives. METHODS: This was a qualitative study consisting of four focus groups conducted in May 2018 among T2D patients who experienced hypoglycemia in the past 6 months. Adult T2D patients treated with insulin and/or sulfonylureas who resided in NYC and Atlanta were identified and recruited from the HealthCore Integrated Research Database (HIRD®) as well as from patient research panels maintained by the focus group facilities. Focus groups were 90-minutes long and led by an experienced moderator who used a study-specific discussion guide. Patients’ insights regarding how they defined hypoglycemia, its impact on their daily lives, and opportunities for intervention were grouped into common themes. RESULTS: Of 27 participants (14 NYC/13 Atlanta), 52% were female, mean age 39 years, 48% African-American, and mean time from T2D diagnosis 11.3 years. Two-thirds of patients (67%) tested their blood glucose ≥5 times a week and 52% on a daily basis; 85% of patients reported their most recent fasting blood sugar to be

Xuehua Ke,1 Jessica Marvel,2 Tzy-Chyi Yu,2 Debra Wertz,1 Caroline Geremakis,1 Liya Wang,1 Judith J Stephenson,1 David M Mannino3 1HealthCore Inc., Wilmington, DE, 2Novartis Pharmaceuticals Corporation, East Hanover, NJ, 3University of Kentucky, Lexington, KY, USA Objective: To evaluate the impact of lung function, measured as forced expiratory volume in 1 second (FEV1) % predicted, on health care resource utilization and costs among patients with COPD in a real-world US managed-care population.Methods: This observational retrospective cohort study utilized administrative claim data augmented with medical record data. The study population consisted of patients with one or more medical claims for pre- and postbronchodilator spirometry during the intake period (July 1, 2012 to June 30, 2013). The index date was the date of the earliest medical claim for pre- and postbronchodilator spirometry. Spirometry results were abstracted from patients’ medical records. Patients were divided into two groups (low FEV1% predicted [

ObjectiveTo characterize healthcare costs, resource use, and treatment patterns of survey respondents with a history of depression who are high utilizers (HUds) of healthcare and to identify factors associated with high utilization.MethodsAdults with two or more depression diagnoses identified from the HealthCore Integrated Research Database were invited to participate in the CODE study, which links survey data with 12-month retrospective claims data. Patient surveys provided data on demographics, general health, and symptoms and/or comorbidities associated with depression. Similar clinical conditions also were identified from the medical claims. Factors associated with high utilization were identified using logistic regression models.ResultsOf 3132 survey respondents, 1921 were included, 193 of whom were HUds (defined as those who incurred the top 10% of total all-cause costs in the preceding 12months). Mean total annual healthcare costs were eightfold greater for HUds than for non-HUds ($US56,145 vs. $US6,954; p

Objective The study sought to assess awareness, perceptions, and value of telehealth in primary care from the perspective of patients. Materials and Methods We conducted a cross-sectional, Web-based survey of adults with access to telehealth services who visited healthcare providers for any of the 20 most-commonly seen diagnoses during telehealth visits. Three groups were studied: registered users (RUs) of telehealth had completed a LiveHealth Online (a health plan telehealth service provider) visit, registered nonusers (RNUs) registered for LiveHealth Online but had not conducted a visit, and nonregistered nonusers (NRNUs) completed neither step. Results Of 32 831 patients invited, 3219 (9.8%) responded and 766 met eligibility criteria and completed surveys: 390 (51%) RUs, 117 (15%) RNUs, and 259 (34%) NRNUs. RUs were least likely to have a primary care usual source of care (65.6% vs 78.6% for RNUs vs 80.0% for NRNUs; P Conclusions Telehealth users reported that they relied on live video for enhanced access and were less connected to primary care than nonusers were. Telehealth may expand service access but risks further fragmentation of care and undermining of the primary care function absent better coordination and information sharing with usual sources of patients’ care.

This two-phased study consists of a decision tree model built from real-world claims data to determine factors related to physician choice of 2nd line therapy for type 2 diabetes (T2D) patients after metformin, followed by a physician focus group study to validate results of the data-driven approach. We identified 58patients in the U.S. who initiated sulfonylurea (SU), DPP-4 inhibitor, GLP-1-RA, or insulin after metformin during 2012-2014 from the HealthCore Integrated Research Database. Claims-derived factors, such as demographics, clinical characteristics, and prior healthcare utilization and costs, were selected from a classification and regression tree (CART) model that minimized classification errors. Of factors most predictive of 2nd line drug assignment, patients’ cost sharing for antidiabetic drugs (Relative Importance, RI=1) was 3 times more important than HbA1c level (RI=0.3), and 10 times more important than age, comorbidity, and kidney status (GFR) (RI=0.1). SU was most likely to be assigned to patients with lowest drug spending, moderate HbA1c control, abnormal kidney function, or no comorbid conditions. Similar themes were identified from the four physician focus groups (consisting of 8 endocrinologists and 10 PCPs in NYC and LA) and supported the findings. This study identified a gap in diabetes care where patients often receive SU due to lack of access to other treatment options. Disclosure S. Wu: None. A.D. Raval: None. J.J. Stephenson: None. X. Peng: Employee; Self; Eli Lilly and Company. H. Weisman: Employee; Self; Anthem, Inc. D.E. Faries: Employee; Self; Eli Lilly and Company.

Judith J Stephenson,1 Mayura U Shinde,1 Winghan Jacqueline Kwong,2 An-Chen Fu,1 Hiangkiat Tan,1 William S Weintraub3 1HealthCore, Inc., Wilmington, DE, 2Daiichi Sankyo, Inc., Basking Ridge, NJ, 3Christiana Care Health System, Newark, DE, USA Objective: To compare oral anticoagulant (OAC) adherence among patients with nonvalvular atrial fibrillation (NVAF) using patient-reported and claims-based measures, and to evaluate the effect of OAC adherence on health care costs and patient satisfaction with OAC therapy.Methods: This was a hybrid US observational study consisting of a longitudinal cohort survey followed by linkage and analysis of respondents’ administrative claims data. Patients with NVAF receiving warfarin, dabigatran, rivaroxaban, or apixaban completed an initial survey and follow-up surveys at 4, 8, and 12 months. Patient-reported adherence was measured at each survey by Morisky Medication Adherence Scale (MMAS-8) and pharmacy claims-determined adherence by the proportion of days covered (PDC) for the 12-month period following the initial survey date; adherence was defined as MMAS-8 score =8 and PDC ≥80%. Patient satisfaction with OAC therapy was assessed by the Duke Anticoagulation Satisfaction Scale (DASS).Results: Overall, 675 patients completed at least the initial survey (warfarin, n=271; dabigatran, n=266; rivaroxaban, n=128; apixaban, n=10). Fewer than half (47.9%) were PDC adherent, 37.2% were MMAS-8 adherent, and 19.4% were adherent by both measures. Total medical costs of PDC-adherent patients were significantly lower vs PDC-nonadherent patients (US$640 vs $993 per-patient per-month, respectively, p

The objective of this study was to examine patient characteristics, treatment patterns, and exacerbations among patients with asthma newly treated with omalizumab.Data for this study were obtained from administrative claims and medical records. The index date was the date of the first claim for omalizumab. All patients had ≥12 months of continuous health plan eligibility before and after the index date. Demographic and clinical characteristics were obtained 12 months before the index date. Treatment patterns of asthma medications, including omalizumab, and asthma exacerbations were evaluated in the preindex and postindex periods.The study included 1564 patients. Asthma-related medication use decreased from the preindex to the postindex periods (oral corticosteroids, 83.3%-66.4%, P0.001; inhaled corticosteroids [ICSs], 33.1%-26.8%, P0.001; long-acting βIn this real-world analysis, patients newly initiating omalizumab therapy for allergic asthma used fewer concomitant asthma medications, while experiencing significant reductions in asthma exacerbations, especially hospitalization- and emergency department-specific exacerbations, from pre- to post-omalizumab treatment initiation periods.

John F Foley,1 Kavita V Nair,2 Timothy Vollmer,3 Judith J Stephenson,4 Timothy Niecko,5 Sonalee S Agarwal,6 Crystal Watson6 1Rocky Mountain Multiple Sclerosis Clinic, Salt Lake City, UT, USA; 2Skaggs School of Pharmacy and Pharmaceutical Sciences, University of Colorado Denver, Aurora, CO, USA; 3Department of Neurology, University of Colorado School of Medicine, Aurora, CO, USA; 4HealthCore, Inc., Wilmington, DE, USA; 5Niecko Health Economics, Tierra Verde, FL, USA; 6Biogen, Cambridge, MA, USA Background: Multiple sclerosis (MS) patients experience lower health-related quality of life (HRQoL) than the general population. In clinical trials, natalizumab significantly improved HRQoL and reduced relapse rates and disability progression in patients with relapsing MS. In a 1-year analysis of patients included in the current study, HRQoL improvement occurred within 3 months of natalizumab initiation and continued for 1 year thereafter. However, natalizumab’s long-term efficacy in improving HRQoL has not been studied.Methods: In this longitudinal, observational, single-arm US study, HRQoL and treatment satisfaction were evaluated in MS patients receiving intravenous natalizumab 300mg every 4 weeks in clinical settings. Patients completed surveys at baseline and every 6 months for 3 years and reported the following measures: Short Form-12 Version 2 (SF-12v2), Multiple Sclerosis Impact Scale (MSIS-29), and Treatment Satisfaction Questionnaire for Medication.Results: In this study, 120 patients completed ≥3 years of natalizumab treatment. Significant HRQoL improvements were evident from baseline to year 3 by increases in SF-12v2 Physical Component Summary (PCS) and Mental Component Summary scores (P

The prevalence of irritable bowel syndrome with constipation (IBS-C) is estimated to be between 4.3% and 5.2% among adults in the United States. Little is known about the health care resource utilization and costs associated with IBS-C.To (a) evaluate the annual total all-cause, gastrointestinal (GI)-related, and IBS-C-related health care costs among IBS-C patients seeking medical care in a commercially insured population and (b) estimate the incremental all-cause health care costs among IBS-C patients relative to matched controls.Patients aged ≥ 18 years with continuous medical and pharmacy benefit eligibility in 2010 were identified from the HealthCore Integrated Research Database, which consists of administrative claims from 14 geographically dispersed U.S. health plans representing 45 million lives. IBS-C patients were defined as those with ≥ 1 medical claim with an ICD-9-CM diagnosis code in any position for IBS (ICD-9-CM 564.1x) and either ≥ 2 medical claims for constipation (ICD-9-CM 564.0x) on different service dates or ≥ 1 medical claim for constipation plus ≥ 1 pharmacy claim for a constipation-related prescription on different dates of service during the study period. Controls were defined as patients without any medical claims for IBS, constipation, abdominal pain, or bloating or pharmacy claims for constipation-related prescriptions. Controls were randomly selected and matched with IBS-C patients in a 1:1 ratio based on age (± 4 years), gender, health plan region, and health plan type. Patients with diagnoses or prescriptions suggesting mixed IBS, IBS with diarrhea, chronic diarrhea, or drug-induced constipation were excluded. Total health care costs in 2010 U.S. dollars were defined as the sum of health plan and patient paid costs for prescriptions and medical services, including inpatient visits, emergency room (ER) visits, physician office visits, and other outpatient services. The total cost approach was used to assess total all-cause or disease-specific health care costs for patients with IBS-C, while the incremental cost approach was used to examine the excess all-cause costs of IBS-C by comparing IBS-C patients with matched controls. Generalized linear models with bootstrapping were used to assess the incremental all-cause costs attributable solely to IBS-C after adjusting for demographics, Elixhauser Comorbidity Index (ECI) score, and other general and GI-related comorbidities not included in the ECI score.A total of 7,652 patients (n = 3,826 each in the IBS-C and control cohorts) were included in the analysis. The mean (± SD) age was 48 (± 17) years, and 83.6% were female. The mean annual all-cause health care costs for IBS-C patients were $11,182, with over half (53.7%) of the costs attributable to outpatient services, including physician office visits and other outpatient services (13.1% and 40.6%, respectively). Remaining total all-cause costs were attributable to hospitalizations (21.8%), prescriptions (19.1%), and ER visits (5.4%). GI-related costs ($4,456) comprised 39.8% of total all-cause costs, while IBS-C-related costs ($1,335) accounted for 11.9% and were primarily driven by costs of other outpatient services (50.3%). After adjusting for demographics and comorbidities, the incremental annual all-cause health care costs associated with IBS-C were $3,856 ($8,621 for IBS-C patients vs. $4,765 for controls, P less than 0.01) per patient per year, of which 78.1% of the incremental costs were due to medical services, and 21.9% were due to prescription fills.IBS-C imposes a substantial economic burden in terms of direct health care costs in a commercially insured population. Compared with matched controls, IBS-C patients incurred significantly higher total annual all-cause health care costs even after controlling for general and GI-related comorbidities. Incremental all-cause costs associated with IBS-C were mainly driven by costs related to more frequent use of medical services as opposed to prescriptions.

For high-risk patients who do not achieve guideline-recommended LDL-C levels, more intensive treatment including statin-uptitration to higher doses or potency, as well as combination therapy may be considered. A better understanding of statin treatment patterns in real-world clinical practice may contribute to improved lipid-lowering management in these patients.We determined treatment pattern changes among patients with high risk of cardiovascular disease who were not at low-density lipoprotein cholesterol (LDL-C) goal on statin monotherapy.Treatment pattern changes were evaluated among patients newly initiated on statins between January 1, 2006, and August 31, 2009, in the HealthCore Integrated Research Database. Rates and mean time to first and second treatment changes were examined in patients with claims for coronary heart disease (CHD), atherosclerotic vascular disease (AVD), and diabetes mellitus during 12 months before index, who were not at LDL-C70 mg/dL at their first-eligible LDL-C test (≥ 4 weeks after index). Therapy change was assessed for 12 months after the LDL-C result.Of 11,473 eligible subjects, 61.3% had diabetes, 26.6% had CHD and AVD, and 12.1% had CHD and AVD and diabetes. At index, patients were prescribed medium-potency levels of statins, including simvastatin (44.7%), atorvastatin (31.5%), and other statins (23.8%). Mean ± SD LDL-C before statin initiation was 138 ± 34 mg/dL, and at the first-eligible LDL-C result after index, it was 101 ± 25 mg/dL. During follow-up, 7444 subjects (64.9%) experienced a first treatment change, with mean time to change of 93.8 ± 92 days, whereas 4029 (36.1%) had no treatment change. Discontinuation of index therapy occurred in 46.9% of subjects and medication switches or titration in 18.0% (index statin titration, switch to other statins, other lipid-lowering therapies [LLT], including ezetimibe). Of the discontinuers, 27.4% restarted LLT. Of subjects with a first treatment change who did not discontinue, 48.9% experienced a second therapy change. Results were similar between the 3 high-risk groups.In this managed-care setting, among patients with high risk of cardiovascular disease who were not at LDL-C goal, statins were usually started at medium-potency doses without being titrated up, whereas nearly one-half had a discontinuation of LLT within 12 months. These treatment patterns indicate the need for better patient and provider education as well as other system-wide modifications to improve medication adherence.

To characterize cancer-related breakthrough pain (BTcP) among community-dwelling patients with cancer.Data from the National Breakthrough Pain Study, a cross-sectional observational survey describing breakthrough pain (BTP) in the community, were analyzed for a subset of patients with BTcP. Eligible patients were community-dwelling adults with commercial insurance and insurance claims consistent with cancer and chronic pain who consented to a structured telephone interview. Assessments included the Brief Pain Inventory-Short Form (BPI), the Short Form 12 Health Survey, the Sheehan Disability Scale, the Work Performance Questionnaire, Generalized Anxiety Disorder-7 Screener, and Patient Health Questionnaire-2.In total, 112 patients with cancer pain also experienced BTcP; 83.3% were in remission. Most patients reported experiencing ≥2 BTcP episodes per day, a median time to BTcP peak of 15 minutes, and a median duration of BTcP of 30 minutes. Mild pain at onset that gradually worsened was reported by 54.5% of patients, and incidental pain triggered by physical activity was reported by 58.0%. Most patients who reported using a medication to manage BTcP received an oral immediate-release opioid, such as oxycodone or hydrocodone, and only 1 received a rapid-onset opioid; few (24.1%) reported that pharmacologic treatment for BTcP worked every time. Patients reported mean (standard deviation) BPI scores of 4.2 (1.75) and 5.7 (1.98) for average and worst pain intensity during the preceding 24 hours, respectively, and high interference with activity, mood, ability to walk and work, social relations, sleep, and enjoyment of life.Results indicate that BTcP among community-dwelling patients with cancer continues to be a health burden and reveals opportunities to improve its management.

Nella Bieszk,1 Michael Grabner,2 Wenhui Wei,1 Nicole G Bonine,2 Judith J Stephenson,2 1Sanofi US, Inc., Bridgewater, NJ, 2HealthCore, Inc., Wilmington, DE, USA Objective: To evaluate awareness of the 2012 American Diabetes Association (ADA) Position Statement among physicians and assess its effects on patient-centered glycated hemoglobin (A1C) goals in the management of type 2 diabetes (T2D). Research design and methods: The Summarizing Real-World Individualized TrEatmEnT GoalS and Potential SuppOrT Systems in Type 2 Diabetes (SWEET SPOTS) study used the HealthCore claims database to identify T2D patients, stratified by risk, and their treating physicians to assess primary care physician and endocrinologist awareness of the 2012 ADA Position Statement. Physicians completed online surveys on A1C targets before and after receiving an educational intervention to review the position statement. Results: Of 125 responding physicians (mean age 50.3years, 12.8% endocrinologists) who were linked to 125 patient profiles (mean age 56.9 years, 42% female, mean A1C 7.2%), 92% were at least somewhat aware of the position statement prior to the intervention and 59% believed that the statement would impact how they set A1C targets. The educational intervention resulted in mostly less stringent goal setting for both lower and higher risk patients, but changes were not significant. The proportion of physician-assigned A1C targets within ADA-recommended ranges increased from 56% to 66% post-intervention (P

Adherence to disease-modifying therapies (DMTs) is essential for the reduction of multiple sclerosis (MS) progression and relapse. However, only limited data currently exist on the impact of treatment adherence on MS-related clinical and economic outcomes in the real world setting.To assess the impact of treatment adherence on MS-related hospitalizations (inpatient [INP]), ER visits, MS relapses, and medical costs.Patients with ≥ 1 ICD-9-CM code for MS who received ≥ 1 DMT between July 1, 2004 and June 30, 2008 were identified using the administrative claims database. The first DMT received during the study period was defined as the index treatment and ≥ 6-month preindex and ≥ 12-month postindex continuous health-plan enrollment were required for inclusion. Adherence was assessed using the medication possession ratio (MPR); patients with MPR ≥ 80% were regarded as adherent. Multivariate analyses were used to evaluate the impact of adherence on MS-related outcomes after controlling for baseline demographic and clinical characteristics.In this cohort (n=2446), 59.6% of the patients were adherent to their DMT. Compared with the nonadherent group, adherent patients were significantly less likely to have MS-related INP (odds ratio [OR]: 0.63, 95% confidence interval [CI], 0.47-0.83) and MS relapses (OR: 0.71, 95% CI, 0.59-0.85). No significant difference was found in ER risk between adherent and nonadherent groups (8.4% vs. 10.5%, P=0.068, OR: 0.80, 95% CI: 0.60-1.07). On average, the adherent group incurred lower medical costs than the nonadherent group ($3380, 95% CI, $3046-$3750 vs. $4348, 95% CI, $3828-$4940, P=0.003).Treatment adherence is associated with better clinical and economic outcomes including lower risks for MS-related hospitalization, MS relapse, and less MS-related medical costs. Treatments that require infrequent administrations and have favorable adherence profiles may benefit patients who are unable to adhere to DMT therapies. Such treatments may be important in improving disease outcomes and may be suitable therapeutic candidates for the management of MS.

To compare asthma-related resource utilization, adherence and costs among adults prescribed asthma controller regimens.Medical and pharmacy claims from a US managed-care claims database were used to identify adults (18-56 years) initiating asthma controller therapy. Patients had 2 years continuous enrollment and ≥ 1 medical claims for asthma (ICD9: 493.xx) (January 2004 - March 2009). Asthma exacerbations, short-acting β-agonist (SABA) fills, adherence (MPR ≥ 0.80) and asthma-related costs were assessed for 1 year after the initial asthma controller medication claim. Separate logistic and negative binomial regression models for monotherapy and combination therapy were developed to examine the impact of controller therapy on outcomes.A total of 28 074 patients [inhaled corticosteroids (ICS) (26.3%), leukotriene modifiers (LM) (23.2%), ICS + long acting β-agonist (LABA) (48.5%), ICS + LM (2%)] were included. LM patients had lower odds of ≥ 6 SABA fills (OR(adj) = 0.83, 95% CI: 0.73-0.96) and lower rates of asthma exacerbations (RR(adj) = 0.82, 0.75-0.89) vs. ICS patients. Odds of ≥ 6 SABA fills were similar for ICS + LM vs. ICS + LABA (OR(adj) = 1.3, 0.96-1.76); the rate of asthma exacerbations was greater for ICS + LM compared with ICS + LABA (OR(adj) = 1.4, 1.2-1.6). The proportion adherent was greatest for LM (14.9%) and ICS + LABA (4.1%). LM patients had higher unadjusted pharmacy costs, but lower medical costs compared to ICS patients. For combination therapy, ICS + LM had higher unadjusted mean medical and pharmacy costs vs. ICS + LABA. Higher adjusted mean total costs in the post-index period were observed for LM vs. ICS patients ($837 vs. 684) and for ICS + LM vs. ICS + LABA patients ($1223 vs. 873).LM monotherapy was associated with lower medical costs but higher total costs resulting from greater treatment adherence. Conversely, higher costs for ICS + LM resulted from greater exacerbations compared to ICS + LABA despite similar adherence. Higher total costs with LM were due to drug costs. Precise utilization of the medications filled by patients could not be determined.

Objective: To determine the impact of treatment with oral naltrexone on healthcare costs in patients with alcohol-related disorders. Methods: Using data from the MarketScan Commercial Claims and Encounters Database for 2000–2004, we identified a naltrexone group (with an alcohol-related diagnosis and at least one pharmacy claim for oral naltrexone) and two control groups. Alcohol controls had an alcoholrelated diagnosis and were not prescribed an alcoholism treatment medication. Nonalcohol controls had no alcohol-related diagnosis and no prescription for an alcoholism treatment medication. The control groups were matched three to one to the naltrexone group on demographic and other relevant measures. Healthcare expenditures were calculated for the 6-month periods before and after the index naltrexone drug claim (or matched date for controls). Univariate and multivariate analyses were used to compare the groups on key characteristics and on healthcare costs. Results: Naltrexone patients (n = 1,138; 62% men; mean age 45 ± 11 years) had significantly higher total healthcare expenditures in the pre-index period than either of the control groups. In the postindex period, naltrexone patients had a significantly smaller increase than alcohol controls in total alcohol-related expenditures. Total nonalcohol-related expenditures also increased significantly less for the naltrexone group than for the alcohol control group. Multivariate analyses showed that naltrexone treatment significantly reduced alcohol-related, nonalcohol-related, and total healthcare costs relative to alcohol controls. Conclusions: Although prior to treatment patients with alcohol-related disorders had higher healthcare costs, treatment with oral naltrexone was associated with reductions both in alcoholrelated and nonalcohol-related healthcare costs.

Phase 3 clinical trials performed primarily outside the US demonstrate that intravesical instillation of chemotherapy immediately after transurethral resection of the bladder (TURB) decreases cancer recurrence rates. The authors sought to determine whether US urologists have adopted this practice, and its potential effect on costs of bladder cancer (BC) care.By using 1997-2004 MEDSTAT claims data, the authors identified patients with newly diagnosed BC who underwent cystoscopic biopsy or TURB, and those who received intravesical chemotherapy within 1 day after TURB. Economic consequences of this treatment compared with TURB alone were modeled using published efficacy estimates and Medicare reimbursements. The authors used a time horizon of 3 years and assumed that this treatment was given for all newly diagnosed low-risk BC patients.Between 1997 and 2004, the authors identified 16,748 patients with newly diagnosed BC, of whom 14,677 underwent cystoscopic biopsy or TURB. Of these, only 49 (0.33%) received same-day intravesical instillation of chemotherapy. From 1997 through 2004, there has been little change in the use of this treatment. The authors estimated a 3-year savings of $538 to $690 (10% to 12%) per patient treated with TURB and immediate intravesical chemotherapy compared with TURB alone, reflecting a yearly national savings of $19.8 to $24.8 million.Instillation of intravesical chemotherapy immediately after TURB has not been embraced in the US. Adopting this policy would significantly lower the cost of BC care.

Objective: To assess multiple sclerosis (MS) patients' experience with natalizumab (TYSABRI, Biogen Idec, Inc. and Elan Pharmaceuticals, Inc.) in a clinical practice setting. Abstract: Methods: MS patients who were enrolled in the TOUCH (TYSABRI Outreach Unified Commitment to Health) prescribing program and who had received their third natalizumab infusion participated in this study. Patient-reported measures included an overall quality-of-life (QOL) assessment, an adapted version of the Multiple Sclerosis Impact Scale-29 (MSIS-29), and pre-/post-disease level and functional status scores. MSIS-29 responses were modified to measure patient-perceived change since initiating natalizumab. Paired t-tests assessed pre-/post- changes in disease level and functional status, where negative change indicated improvement. Abstract: Results: Results from 451 patients in this study indicated that 73% were female and, on average, were diagnosed with MS >11 years previously. Almost all (96%) patients had used one or more MS drugs prior to natalizumab initiation. After receiving natalizumab, 97% of all patients reported an improvement or remained stable in their overall QOL. Despite the short treatment duration, there were significant improvements (mean ± SD change) in disease level (-0.26 ± 0.99, paired t-test - 5.47; p < 0.001) and functional status (-0.33 ± 0.73, paired t-test - 9.40; p < 0.001) scores. More than 80% of patients reported an improvement in one or more MSIS-29 physical items. The physical item on the adapted MSIS-29 with the highest reported improvement (58%) was 'the ability to do physically demanding tasks'. The physical item with the lowest reported improvement (32%) was 'problems using transport'. Abstract: Conclusion: Overall, the experiences of MS patients with natalizumab were positive in a clinical practice setting. Patients reported improvements in overall QOL, ambulation and functional status as early as after three natalizumab infusions. While preliminary, these early results are suggestive of a beneficial effect of natalizumab in patients with MS and warrant further long-term investigation of the impact of this treatment on patient outcomes.

Objective Health-care expenditures are strongly influenced by overall illness burden. Appropriate risk adjustment is required for correct policy analysis. We compared three risk adjustment methods: the Charlson comorbidity index (CCI), the chronic disease score (CDS), and the Agency for Healthcare Research and Quality's comorbidity index (AHRQCI) in terms of their estimation power in analyzing health-care expenditures. Method Data from the Thomson MarketScan® Research Databases (Thomson Healthcare, Ann Arbor, MI) were used to estimate total health-care expenditures of migraine patients treated by a triptan. Seven distinct multivariate models were evaluated for model fit (CCI only, CDS only, AHRQCI only, CCI + CDS, CCI + AHRQCI, CDS + AHRQCI, and CCI + CDS + AHRQCI). The estimation power of these indices (alone and in combination) was evaluated using Bayesian and Akaike information criteria, log-likelihood scores, and pseudo R 2 values. Results Confirming results from previous studies, when comorbidity indices were considered individually the results were inconclusive. Statistically the best performance was observed in the model that included all three of the comorbidity measures (CCI + CDS + AHRQCI); however, the practical differences in the estimated values were small. Conclusion Low correlation between these comorbidity indices shows that it is possible to have potential risk factors that are not captured in the single comorbidity index. Each comorbidity measure considers different risks, and the collinearity of the three measures is not strong enough to preclude using them simultaneously in the same model.

Background: Treatment complexity is an important risk factor for medication non-adherence. Previous studies have shown higher rates of non-adherence among patients taking medications requiring more frequent dosing than those requiring less frequent dosing. However, few studies have investigated the relationship between dosing frequency and adherence to oral anticoagulants (OACs). This study evaluated the impact of dosing frequency of OAC on adherence among patients with non-valvular atrial fibrillation (NVAF). Methods: Survey-eligible NVAF patients on commercial or Medicare Advantage health plans, receiving warfarin (W), dabigatran (D), rivaroxaban (R) or apixaban (A) from October 2011 to June 2014, were identified using administrative claims data from the HealthCore Integrated Research Database. Consenting patients completed an initial patient survey and three follow-up surveys at 4, 8 and 12 months either over the telephone or via the internet. Study surveys included questions on the dosing schedule of their OAC medications, medication side effects, the Morisky Medication Adherence Scale 8-item (MMAS-8) and other topics. An overall MMAS-8 score that ranged from 0 to 8 was calculated, with higher scores indicating greater adherence. Patients with MMAS-8 scores Results: Of the 798 patients who completed the initial study survey (323 W, 320 D, 141 R and 14 A users), 398 (50%) completed the 4-month, 327 (41%) the 8-month and 256 (32%) the 12-month surveys, respectively. The proportion of patients who reported taking their OAC once daily (QD) was stable over the 12-month study period. At baseline, 60% of patients reported OAC QD use (317 W, 23 D, 141 R, 1 A users), and 67% patients reported OAC QD use (107 W, 6 D, 45 R, 1 A) at 12 months. The proportion of non-adherent patients taking OAC twice daily (BID) was consistently higher than those taking OAC QD (BID vs. QD: 13% vs.7% [initial survey]; 16% vs.9% [4-month]; 21% vs.10% [8-month]; 23% vs.15% [12-month]). After controlling for potential confounders, BID users were 92% more likely to be non-adherent compared to QD users (odds ratio [95% CI] =1.92 [1.29 to 2.87], p=0.001). Younger patients were more likely to be non-adherent compared to patients ≥65 years old (p≤0.01). Conclusions: This study showed that younger age and a more frequent dosing schedule was associated with an increased level of self-reported non-adherence with OAC therapy. Future studies are needed to explore how this association may impact economic and clinical outcomes.

To determine the economic impact of sustained non-remission of depression on the total annual all-cause healthcare costs of patients with a history of depression.Adults with ≥2 claims with depression diagnosis codes from the HealthCore Integrated Research Database were invited to participate in this retrospective/prospective fixed-cohort repeated-measures study. Patients with scores5 at initial survey and 6 month assessment on the Quick Inventory of Depressive Symptomatology (QIDS-SR) were considered to be in 'sustained non-remission', while those with scores ≤5 at both assessments were considered to be in 'sustained remission'. Patients also completed self-report instruments to assess pain, fatigue, anxiety, sleep difficulty, and other health and wellness domains. Survey data were linked to patient claims (12 month pre- and post-initial-survey periods). After adjusting for demographic and clinical characteristics using propensity scores, post-survey costs and resource utilization were compared between remission and non-remission groups using non-parametric bootstrapping methods.Of the 640 patients who met inclusion criteria, 140 (21.9%) were in sustained remission and 348 (54.5%) never achieved remission. Using propensity-score adjusted costs, sustained non-remission of depression was associated with higher annual healthcare expenditures of$2300 per patient ($14,627 vs. $12,313, p = 0.0010) compared to remitted patients. Higher costs were associated with greater resource utilization and increased medication use. Non-remitters were prescribed more medications than remitters, including antidepressants and second-generation antipsychotics. Although length of antidepressant exposure over 12 months was similar, remitters were more likely to be adherent to antidepressants. Non-remission was associated with anxiety, pain, fatigue, sleep disruption, diabetes, anemia, obesity, and heavy drinking.Failing to achieve remission of depression was associated with increased costs and greater resource utilization. Clinicians should strive to achieve sustained remission in patients with depression. Study limitations included reliance on claims data for initial identification of cohort and high rate of attrition in the analytic sample.

SummaryConflicting evidence exists regarding predictors of and antithrombotic benefit on mortality in hospitalised acutely-ill medical patients. We compared mortality risk within 90 days post-discharge among medically ill patients who did and did not receive antithrombotics. This retrospective claims analysis included patients40 years with nonsurgical hospitalisation2 days between 2005 and 2009 using the HealthCore Integrated Research Database. Antithrombotic use (i.e. anticoagulants and antiplatelets) post-discharge was captured from pharmacy claims. All-cause mortality was determined from Social Security Death Index; cause of death was identified from National Death Index database. Kaplan-Meier survival curves were generated and hazard ratios (HR) for mortality risk were estimated using Cox proportional hazards models. Patients prescribed anticoagulants or antiplatelets post-discharge had lower risk of short-term mortality. For the anticoagulant model, the most significant predictors of mortality were malignant/benign neoplasms (hazard ratio [HR] 1.6, 95 % confidence interval [CI] 1.5–1.7), liver disease (HR 1.6, 95 % CI 1.5–1.7), anticoagulant omission (HR 1.6, 95 % CI 1.4–1.8), gastrointestinal or respiratory tract intubations (HR 1.5, 95 % CI 1.3–1.7), and blood dyscrasias (HR 1.4, 95 % CI 1.4–1.5). For the antiplatelet model, the most significant predictors of mortality were antiplatelet omission (HR 3.7, 95 % CI 3.3–4.1), liver disease (HR 1.6, 95 % CI 1.4–1.7), malignant/benign neoplasms (HR 1.6, 95 % CI 1.5–1.6), gastrointestinal or respiratory tract intubations (HR 1.5, 95 % CI 1.3–1.7), and blood dyscrasias (HR 1.4, 95 % CI 1.4–1.5). These mortality risk factors may guide future studies assessing potential benefits of antithrombotics in specific subsets of patients.