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Michael Grabner,1 Julja Burchard,2 Chi Nguyen,3 Haechung Chung,4 Nilesh Gangan,3 J Jay Boniface,2 John AF Zupancic,5 Eric Stanek1 1Scientific Affairs, HealthCore, Inc., Wilmington, DE, USA; 2Research and Development, Sera Prognostics, Salt Lake City, UT, USA; 3Health Economics and Outcomes Research, HealthCore, Inc., Wilmington, DE, USA; 4Research Operations, HealthCore, Inc., Wilmington, DE, USA; 5Department of Neonatology, Beth Israel Deaconess Medical Center, Harvard Medical School, Boston, MA, USACorrespondence: Michael GrabnerScientific Affairs, HealthCore, Inc., 123 Justison St, Suite 200, Wilmington, DE, 19801, USATel +1 302-230-2000Email mgrabner@healthcore.comBackground: Preterm birth (PTB) carries increased risk of short- and long-term health problems as well as higher healthcare costs. Current strategies using clinically accepted maternal risk factors (prior PTB, short cervix) can only identify a minority of singleton PTBs.Objective: We modeled the cost-effectiveness of a risk-screening-and-treat strategy versus usual care for commercially insured pregnant US women without clinically accepted PTB risk factors. The risk-screening-and-treat strategy included use of a novel PTB prognostic blood test (PreTRM®) in the 19th– 20th week of pregnancy, followed by treatment with a combined regimen of multi-component high-intensity-case-management and pharmacologic interventions for the remainder of the pregnancy for women assessed as higher-risk by the test, and usual care in women without higher risk.Methods: We built a cost-effectiveness model using a combined decision-tree/Markov approach and a US payer perspective. We modeled 1-week cycles of pregnancy from week 19 to birth (preterm or term) and assessed costs throughout the pregnancy, and further to 12-months post-delivery in mothers and 30-months in infants. PTB rates and costs were based on > 40,000 mothers and infants from the HealthCore Integrated Research Database® with birth events in 2016. Estimates of test performance, treatment effectiveness, and other model inputs were derived from published literature.Results: In the base case, the risk-screening-and-treat strategy dominated usual care with an estimated 870 fewer PTBs (20% reduction) and $54 million less in total cost ($863 net savings per pregnant woman). Reductions were projected for neonatal intensive care admissions (10%), overall length-of-stay (7%), and births < 32 weeks (33%). Treatment effectiveness had the strongest influence on cost-effectiveness estimates. The risk-screening-and-treat strategy remained dominant in the majority of probabilistic sensitivity analysis simulations and model scenarios.Conclusion: Use of a novel prognostic test during pregnancy to identify women at risk of PTB combined with evidence-based treatment is estimated to reduce total costs while preventing PTBs and their consequences.Keywords: preterm birth, cost effectiveness, progesterone, prognostic test

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.

Chronic disease is associated with increased health care resource utilization and costs. Effective development and implementation of health care management and clinical intervention programs require an understanding of health plan member enrollment and disenrollment behavior.To examine the health plan enrollment and disenrollment behavior of commercially insured and Medicare Advantage members with established chronic disease compared with matched members without the disease of interest, using data from a large national health insurer in the United States.This retrospective matched cohort study used administrative claims data from the HealthCore Integrated Research Database from January 1, 2006, to November 30, 2015, to identify adults with chronic disease (type 2 diabetes mellitus [T2DM], cardiovascular disease [CVD], chronic obstructive pulmonary disease [COPD], rheumatoid arthritis [RA], and breast cancer [BC]). Members with no established chronic disease (controls) were directly matched to members with established chronic disease (cases) on demographic characteristics. The earliest date on which members met the criteria for a given disease was defined as the index date. Controls had the same index date as the matched cases. All members had ≥ 12 months of continuous health plan enrollment before the index date. Outcomes included health plan member disenrollment and enrollment duration. Incidence rates per 1,000 member-years for member disenrollment were evaluated along with incidence rate ratios (relative risk) using a Poisson model. Time to disenrollment was analyzed by Cox proportional hazard models and Kaplan-Meier survival curves. Sensitivity analyses were conducted where death was included as a disenrollment event.70,907 health plan members with BC (99.7% female, mean age 60.5 years); 28,883 members with COPD (52.3% female, mean age 66.7); 835,358 members with CVD (50.5% female, mean age 62.7 years); 210,936 members with T2DM (45.2% female, mean age 53.6 years); and 31,954 members with RA (72.0% female, mean age 55.5 years) were matched to controls and met the study criteria. The incidence rates of health plan disenrollment ranged from 155 to 192 members per 1,000 members per year. Compared with controls, members with chronic disease were 30%-40% less likely to disenroll from a health plan (This real-world study demonstrated that members with chronic disease had a significantly lower rate of disenrollment and a longer duration of enrollment compared with matched controls and were continuously enrolled for almost a year longer than members without a diagnosed chronic disease. Understanding health plan enrollment and disenrollment behavior may provide a valuable context for determining the time frame for the effect of health care programs and initiatives.Funding for this study was provided by HealthCore, a wholly owned subsidiary of Anthem. Chung, Deshpande, Zolotarjova, Quimbo, and Willey are employees of HealthCore. Kern and Cochetti are former employees of HealthCore. Quimbo, Cochetti, and Willey are shareholders of Anthem. HealthCore receives funding from multiple pharmaceutical companies to perform various research studies outside of the submitted work. The preliminary results of this study were presented at AMCP Nexus 2015; March 26-29, 2015; Orlando, FL, and the International Society for Pharmacoeconomics and Outcomes Research (ISPOR) 2017 Conference; May 20-24, 2017; Boston, MA.

This study aimed to determine which characteristics of youths with posttraumatic stress disorder (PTSD) were associated with receiving prescriptions for antidepressants, antipsychotics, or benzodiazepines.A 2011-2012 retrospective cohort of children and adolescents with a new episode of PTSD was extracted from medical and pharmacy claims from a nationally representative sample of privately insured persons. Multivariate logistic regression assessed attributes (demographic characteristics, mental and general medical comorbidities, insurance arrangements, specialty type, and geographic location) associated with utilization of antidepressants, antipsychotics, and benzodiazepines.Among 7,726 youths with a new episode of PTSD in 2012, just less than 60% received psychotherapy alone, about 6% received pharmacotherapy, and about 35% received neither psychotherapy nor pharmacotherapy. Among utilizers of medications, 71.3% used antidepressants and 21.6% used antipsychotics. Youths prescribed medication tended to be older and have more general medical and mental comorbidities. Provider specialty, capitated insurance arrangements, and more comorbidities predicted being prescribed antidepressants. History of hospitalization, noncapitated insurance arrangements, nonuse of psychotherapy, and more comorbidities predicted being prescribed antipsychotics. Antidepressants and antipsychotics were more likely to be used in the South.Only three-fifths of youths with PTSD received first-line treatment (psychotherapy). More than one in 20 received pharmacotherapy, which appeared to be associated with the most severe and complex presentations. More than one-third of youths with PTSD received neither therapy nor medication, signaling compromised quality of care. Future research should confirm the factors associated with pharmacotherapy prescription and explore ways to increase the use of psychotherapy in primary care.

Background/aims Health plan administrative claims data present a cost-effective complement to traditional trial-specific ascertainment of clinical events typically conducted through patient report or a single health system electronic health record. We aim to demonstrate the value of health plan claims data in improving the capture of endpoints in longitudinal pragmatic clinical trials. Methods This retrospective cohort study paralleled the design of the ADAPTABLE (Aspirin Dosing: A Patient-centric Trial Assessing Benefits and Long-Term Effectiveness) trial designed to compare the effectiveness of two doses of aspirin. We applied the ADAPTABLE identification query in claims data from Anthem, an American health insurance company, and identified health plan members who met the ADAPTABLE trial criteria. Among the ADAPTABLE eligible members, we selected overlapping members with PCORnet Clinical Data Research Networks in the 2 years prior to the index date (1 April 2014). PCORnet Clinical Data Research Networks consist of network partners (or healthcare systems) that store their electronic health record data in the same format to support multi-institutional research. ADAPTABLE outcome events—cardiovascular hospitalizations including admissions for myocardial infarction, stroke, or cardiac procedures; hospitalizations for major bleeding; and in-hospital deaths—were evaluated for a 2-year follow-up period. Events were classified as within or outside PCORnet Clinical Data Research Networks using facility identifiers affiliated with each hospital stay. Patient characteristics were examined with descriptive statistics, and incidence rates were reported for available Clinical Data Research Networks and claims data. Results Among 884,311 ADAPTABLE eligible health plan members, 11,101 patients overlapped with PCORnet Clinical Data Research Networks. Average age was 70 years, 71% were male, and average follow-up was 20.7 months. Patients had 1521 cardiovascular hospitalizations (571 (37.5%) occurred outside PCORnet Clinical Data Research Networks), 710 for major bleeding (296 (41.7%) outside PCORnet Clinical Data Research Networks), and 196 in-hospital deaths (67 (34.2%) outside PCORnet Clinical Data Research Networks). Incidence rates (events per1000 patient-months) differed between available network partners and claims data: cardiovascular hospitalizations, 4.1 (95% confidence interval: 3.9, 4.4) versus 6.6 (95% confidence interval: 6.3, 7.0), major bleeding, 1.8 (95% confidence interval: 1.6, 2.0) versus 3.1 (95% confidence interval: 2.9, 3.3), and in-hospital death, 0.56 (95% confidence interval: 0.47, 0.67) versus 0.85 (95% confidence interval: 0.74, 0.98), respectively. Conclusion This study demonstrated the value of supplementing longitudinal site-based clinical studies with administrative claims data. Our results suggest that claims data together with network partner electronic health record data constitute an effective vehicle to capture patient outcomes since >30% of patients have non-fatal and fatal events outside of enrolling sites.

Supplemental material, 846853_Appendix_Table_1 for Administrative claims data to support pragmatic clinical trial outcome ascertainment on cardiovascular health by Qinli Ma, Haechung Chung, Sonali Shambhu, Matthew Roe, Mark Cziraky, W Schuyler Jones and Kevin Haynes in Clinical Trials