The Annual Economic Burden of Respiratory Syncytial Virus in Adults in the United States.

BACKGROUND: Current estimates of the economic burden of respiratory syncytial virus (RSV) are needed for policymakers to evaluate adult RSV vaccination strategies. METHODS: A cost-of-illness model was developed to estimate the annual societal burden of RSV in US adults aged ≥60 years. Additional analyses were conducted to estimate the burden of hospitalized RSV in all adults aged 50-59 years and in adults aged 18-49 years with potential RSV risk factors. RESULTS: Among US adults aged ≥60 years, the model estimated 4.0 million annual RSV cases (95% UI, 2.7-5.6 million) and an annual economic burden of $6.6 billion (95% UI, $3.1-$12.9 billion; direct medical costs, $2.9 billion; indirect costs, $3.7 billion). The 4% of RSV cases that were hospitalized contributed to 94% of direct medical costs. Additional analyses estimated $422 million in annual hospitalization costs among all adults aged 50-59 years. Among adults aged 18-49 years with RSV risk factors, annual per capita burden was highest among people with congestive heart failure at $51,100 per 1000 people. DISCUSSION: The economic burden of RSV is substantial among adults aged ≥50 years, and among adults aged 18-49 years with RSV risk factors, underscoring the need for preventive interventions for these populations.

Who gets treated for influenza: A surveillance study from the US Food and Drug Administration's Sentinel System.

OBJECTIVE: We describe the baseline characteristics and complications of individuals with influenza in the US FDA's Sentinel System by antiviral treatment timing. DESIGN: Retrospective cohort design. PATIENTS: Individuals aged ≥6 months with outpatient diagnoses of influenza in June 2014-July 2017, 3 influenza seasons. METHODS: We identified the comorbidities, vaccination history, influenza testing, and outpatient antiviral dispensings of individuals with influenza using administrative claims data from 13 data partners including the Centers for Medicare and Medicaid Services, integrated delivery systems, and commercial health plans. We assessed complications within 30 days: hospitalization, oxygen use, mechanical ventilation, critical care, ECMO, and death. RESULTS: There were 1,090,333 influenza diagnoses in 2014-2015; 1,005,240 in 2016-2017; and 578,548 in 2017-2018. Between 49% and 55% of patients were dispensed outpatient treatment within 5 days. In all periods >80% of treated individuals received treatment on the day of diagnosis. Those treated on days 1-5 after diagnosis had higher prevalences of diabetes, chronic obstructive pulmonary disease, asthma, and obesity compared to those treated on the day of diagnosis or not treated at all. They also had higher rates of hospitalization, oxygen use, and critical care. In 2014-2015, among those aged ≥65 years, the rates of hospitalization were 45 per 1,000 diagnoses among those treated on day 0; 74 per 1,000 among those treated on days 1-5; and 50 per 1,000 among those who were untreated. CONCLUSIONS: In a large, national analysis, approximately half of people diagnosed with influenza in the outpatient setting were treated with antiviral medications. Delays in outpatient dispensed treatment were associated with higher prevalence of comorbidities and higher rates of complication.

Harnessing the Biologics and Biosimilars Collective Intelligence Consortium to Evaluate Patterns of Care.

INTRODUCTION: As clinical trials test efficacy rather than effectiveness of medications, real-world effectiveness data often vary from clinical trial data. Given the recent market entry of multiple biologics and biosimilars, a dedicated assessment of these diverse agents is needed to build the evidence base regarding efficacy and safety of innovator biologics and biosimilars. PROGRAM DESCRIPTION: The Academy of Managed Care Pharmacy's Biologics and Biosimilars Collective Intelligence Consortium (BBCIC) was convened to address the lack of real-world, postmarket outcome evidence generation for innovator biologics and corresponding biosimilars. The BBCIC is a multistakeholder scientific research consortium whose participants prioritize topics and collaboratively conduct research studies. The BBCIC conducts a wide range of analyses, including population characterization, epidemiologic studies, and active observational studies, and develops best practices for conducting large-scale studies to provide real-world evidence. OBSERVATIONS: Over the past 3 years, we undertook multiple descriptive analyses with the goal of characterizing data availability and demonstrating the feasibility and efficacy of using the BBCIC distributed research network (DRN), which includes commercial claims data from 2008-2018 covering approximately 100 million lives, with approximately 20 million active members in 2017 from 2 major U.S. health plans and 3 regional integrated delivery networks. We analyzed 4 medication classes of particular interest to biologics and biosimilars development: insulins, granulocyte colony-stimulating factors, erythropoietic-stimulating agents, and anti-inflammatories. We were able to identify exposures and user characteristics in all 4 categories. Herein we describe the successes and challenges of conducting some of our analyses, specifically among insulin users with type 1 diabetes mellitus. IMPLICATIONS: Our results demonstrate the BBCIC DRN's ability to identify and characterize exposures, cohorts, and outcomes that can contribute to more sophisticated comparative surveillance of biosimilars and innovator biologics in the future. Additional linkages to laboratory data and a wider range of insurance carriers will further strengthen the BBCIC DRN. DISCLOSURES: This study was coordinated and funded by the Biologics and Biosimilars Collective Intelligence Consortium (BBCIC) and represents the independent findings of the BBCIC Insulins Principal Investigator and the BBCIC Insulins Research Team. Lockhart is employed by the BBCIC; Eichelberger was employed by the BBCIC at the time of this study. McMahill-Walraven is employed by Aetna, a CVS Health business. Panozzo, Marshall, and Brown are employed by Harvard Pilgrim Healthcare Institute. Aetna receives external funding through research grants and subcontracts with Harvard Pilgrim Healthcare Institute, which are funded by the FDA, NIH, PCORI, BBCIC, Pfizer, and GSK; the Reagan-Udall Foundation for IMEDS; and PCORI for the ADAPTABLE Study. Aetna was reimbursed for data and analytic support from Harvard Pilgrim Healthcare Institute and the Reagan Udall Foundation for the U.S. Food and Drug Administration. This work was presented as a poster at AMCP Nexus 2018; October 22-25, 2018; in Orlando, FL.

Variation in rotavirus vaccination coding in state US Medicaid data.

Differences in state Medicaid policies and practices may result in variation in the recording of individual-level vaccination claims, which may present challenges for vaccination research using state Medicaid data. We describe differences in procedure coding for rotavirus vaccination in four states' Medicaid programs by identifying rotavirus vaccine-specific codes and oral vaccine administration codes. The proportion of vaccinated children with vaccine-specific and oral vaccine administration codes differed substantially across states: two states used vaccine-specific codes almost exclusively (95.9% and 99.0%); one had exclusively oral vaccine administration codes (>99.9%); another had a mixture (32.1% vaccine-specific codes, 40.0% oral vaccine administration codes, and 27.9% both). Depending on the research question, studies using Medicaid data in states without (or with incomplete) vaccine-specific coding may be infeasible. Prior to initiating research, investigators should carefully evaluate state Medicaid policies and patterns of vaccination uptake, as vaccine reimbursement policies and availability of vaccine claims may vary.

Associations between parents' satisfaction with provider communication and HPV vaccination behaviors.

BACKGROUND: Despite increasing awareness of the importance of a provider recommendation for HPV vaccine, the U.S. has yet to achieve the Healthy people 2020 goal of 80% series completion among adolescents. This failure indicates a need for further examination of the modifiable influences on parents' decision-making. Healthcare providers can influence parents' HPV vaccination decision-making, but little is known about parents' perspectives on the counseling they receive. We sought to assess U.S. parents' satisfaction with provider communication about HPV vaccine and associations with vaccination behaviors. METHODS: Parents of 11-to-17-year-old adolescents who discussed HPV vaccination with a healthcare provider at least once (n = 795) completed our online survey in Fall 2016. We assessed their satisfaction with the discussion using the HPV Vaccine Communication Satisfaction Scale (α = 0.94). We examined associations between satisfaction (categorized as low, moderate, or high), and three vaccination behaviors: refusal/delay, series initiation (≥1 dose), and continuation (≥2 doses among initiators) using multivariable logistic regression. RESULTS: Most parents reported high (36%) or moderate (38%) satisfaction with provider communication about HPV vaccination; fewer reported low (26%) satisfaction. Moderately satisfied parents (vs. low) had lower odds of refusal/delay (aOR = 0.59, 95% CI: 0.38-0.89), and higher odds of initiation (aOR = 1.71, 95% CI:1.15-2.55) and continuation (aOR = 2.05, 95% CI: 1.24-3.40). The associations were stronger for highly satisfied parents (refusal/delay aOR = 0.45, 95% CI: 0.29-0.70, initiation aOR = 3.59, 95% CI: 2.23-5.78, and continuation aOR = 4.08, 95% CI: 2.38-7.01). CONCLUSIONS: Our study suggests that parent satisfaction with provider communication may play an important role in HPV vaccination decision-making. Yet, communication satisfaction has been largely unexamined in the HPV-vaccine literature to date. We introduce a brief, 7-item HPV Vaccine Communication Scale that can be used to assess parents' level of satisfaction with their provider's communication specific to HPV vaccine. We identify communication areas for providers to prioritize when discussing HPV vaccine with parents.

Direct, indirect, total, and overall effectiveness of the rotavirus vaccines for the prevention of gastroenteritis hospitalizations in privately insured US children, 2007-2010.

We demonstrate how direct, indirect, total, and overall effectiveness estimates and absolute benefits of rotavirus vaccines vary through the years following vaccine introduction. Privately insured US children in a large claims database were followed from age 8 months until they 1) experienced a hospitalization for rotavirus or acute gastroenteritis; 2) lost continuous health plan enrollment; 3) turned 20 months of age; or 4) reached the end of the study period. Vaccine effectiveness estimates in preventing rotavirus and acute gastroenteritis hospitalizations were estimated using Cox proportional hazards regression, stratified by calendar year and adjusted for birth month. Incidence rate differences were estimated to determine the absolute number of gastroenteritis hospitalizations prevented in the cohort. Among 905,718 children, 51%, 66%, 80%, and 86% received 1 or more doses of rotavirus vaccine in each year from 2007 to 2010. The direct vaccine effectiveness of 1 or more doses of rotavirus vaccine in preventing rotavirus gastroenteritis hospitalizations ranged from 87% to 92% each year. Accounting for indirect protection increased estimates of vaccine effectiveness by an additional 3%-8% among those vaccinated. Failing to account for population-level vaccine benefits in 2010, when circulation of rotavirus was low, could underestimate the sustained impact of the vaccine program.