Real-World Data to Treat Health Conditions

Cincinnati—A drawback of traditional outcomes research studies is the lack of availability of clinical data within administrative claims databases. Whereas these studies can identify healthcare utilization patterns and, in some cases, proxies for disease control, without access to specific prescribing information and clinical elements, these types of studies often have limited utility in medical decision-making.

Beginning in 2011, AstraZeneca and HealthCore, Inc. set out to generate real-world data on the most effective and economic ways to treat health conditions. This collaboration included working with healthcare providers to integrate administrative claims data with electronic health records (EHRs) to enhance existing research that health plans and providers can use to make more informed decisions.

Attendees at the AMCP meeting had an opportunity learn more about this partnership and its progress during a Pharmacy Partnership Briefing session titled Improving Traditional Outcomes Research by Enhancing the Research Data Environment. The information was presented by Brian Sweet, MBA, executive director, healthcare alliances, AstraZeneca, and Marcus Wilson, PharmD, president, HealthCore, Inc.

The speakers began the session highlighting the gap in care in key areas of chronic disease. The burden of chronic disease is intensifying with 5% of the population making up half of US healthcare costs. By 2030, chronic diseases will affect 50% of all Americans. The economic burden of treating chronic disease is significant with 75% of total healthcare going toward treatment.

The prevalence of innovative payment models is increasing. Emerging US payment models are seeking to align provider and payer interests. Models with a degree of shared risk continue to evolve across the care continuum. The models include pay-for-performance, hospital-physician bundling, episodic bundling, and shared-saving models (accountable care organization and patient-centered medical home). To be successful, healthcare entities will need new systems and capabilities, the presenters explained.

Success within the evolving healthcare system requires shifting focus from activities to outcomes. Understanding outcomes requires insight at the patient level and of total cost. This insight will allow for a better understanding of gaps and best practices in quality, care, and cost.

Through innovative and advanced analytical deliverables developed using claims and EHR data, real-world evidence would help support:

     Patients: Identifying unmet medical needs, improving quality, outcomes, and coordination of patient-centered care.

     Integrated delivery networks/hospitals: Improving quality of care and outcomes while providing insights into cost containment.

     Payers: Analysis of new payment models, risk, and outcomes-based contracts.

     Pharmacy/biotech: Market analysis to support product innovation for development of reimbursable products and to demonstrate the value of medicines in improving health outcomes and total cost of care.

The presentation continued with an update on the collaboration’s progress. AstraZeneca and HealthCore, Inc.’s vision is 2-fold. The partnership set out to expand the collaboration into a broader healthcare consortium with other public and private organizations to integrate healthcare data and improve community health. The speakers noted that Delaware Medicaid joined the collaboration in February 2012; additional collaborators will be announced soon.

The partnership also wanted to conduct real-world studies designed to determine how to most effectively and economically treat disease. The speakers reported that 22 research projects have been completed, more than 40 feasibility counts and study concepts completed, 5 posters completed and 4 in development, and 1 manuscript published and 2 in development.

The presenters also reviewed the 6 key learning points thus far: (1) stakeholder alignment is key; (2) many are not ready from a technological perspective; (3) trust between parties has to be established; (4) understanding of data complexity and ability to integrate data is essential; (5) development and implementation costs can be high; and (6) results can be transformational for health and healthcare.

The second half of the presentation focused on examples of how integration of clinical data elements with administrative claims can enhance traditional outcomes research studies and decision support among providers and health plans. Inclusion of clinical data from conditions such as hypertension, glaucoma, or cardiovascular disease may better identify severity of disease and risk factors for future events. Integration of electronic health data is key because each data source contributes unique information. Data sources include health plan claims and outpatient and inpatient chart information.

Integration of key clinical data in the EHR is also crucial. The chart-based elements include patient vital signs, physical findings, immunizations, family history, prescription and over-the-counter medications, and test results. Health information technology (HIT) improvements also play a role in research and decision support. “HIT will facilitate real-world research to some extent. More importantly, it will make putting research into action quickly a reality. Without effective and trusted tools for decision support, the knowledge gap at the point of care will only widen,” according to the speakers.

The information gathered from the integration of data sources can be used by the pharmaceutical industry, health plans, and healthcare providers in improving comparative effectiveness research, formulary decision-making, and other critical healthcare decisions.