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BioPharma: Real World Evidence

HIT Perspectives Biopharma Insights – September 2014

Real-World Evidence Comes to Mainstream Health Care

By Craig Richardson, Senior Consultant

Taking a cue from the pharmaceutical industry, real-world evidence (RWE) is a concept that is migrating quickly to mainstream health care.  In addition to knowledge gained from the narrow confines and small populations of the gold standard of randomized, controlled clinical trials, drug manufacturers are now using large data sets and sophisticated analytics to understand how their existing drugs actually perform in the real world. RWE is what happens to the large sets of anonymized, patient-level real-world data (RWD). Using a variety of data sources (such as those as shown in Figure 1, below),  pharmaceutical companies, payers, and regulators can assess the real-world effectiveness, risks, safety and cost benefits of a drug, procedure or device by analyzing data from thousands of patients. As a result, RWE provides an unprecedented window into how a product is used: by whom, under what circumstances and for what outcomes.

Figure 1.  Examples of Data Sources for RWE
Examples of Data Sources for RWE
Source: Point-of-Care Partners

It’s easy to see how RWE will become increasingly important to payers, providers and regulators. Using RWE, they have an accurate and advance assessment of the risks and benefits of treatments and actual health outcomes in large patient populations. RWE can be further translated into safety and other messaging for patients and prescribers. RWE adds value to a range of health care stakeholders in specific ways. For example:

Payers and regulators are starting to demand RWE before they embrace any treatments.Expensive specialty medications are a case in point. RWE will create value for payers by helping to identify – as never before – patient cohorts likely to benefit from a particular therapy, based on health assessments, biomarkers, clinical status, risk adjusters, social media and other factors. This, in turn, will feed directly into coverage and payment decisions that help ensure beneficiaries receive the most cost-efficient yet effective, high-quality therapies.

RWE can be an effective tool for such regulators as the Food and Drug Administration (FDA) and Centers for Medicare and Medicaid Services (CMS). RWE does not eliminate the need for randomized clinical trials. However, RWE results in analyses – built off scientifically credible, anonymized patient-level data – of the effectiveness of medicines, which regulators are beginning to require for decisions related to safety, utilization and access. Once drugs come on the market, RWE also can help identify the scope and nature of dangerous side effects and adverse events more quickly.

RWE can be a boon to researchers. It can help them optimize trial designs as well as identify target patient populations, clinical trial sites and investigators. RWE also can inform comparative effectiveness research.

RWE creates opportunities for health information technology (health IT) infrastructure vendors to provide the RWD needed for analyses. Vendors can create value for payers and regulators by aggregating clinical data from electronic health records as well as linking claims and registry data.

Pharmaceutical manufacturers already are using RWD and RWE to assist with branding. For example, these tools can help brand teams assess how physicians and patients are using specific products, such as identifying which patient groups respond most positively to a product and tracking physician message effectiveness through prescribing behavior.  Pharma companies also must provide RWD and RWE in a standardized format (aka dossier) to the Academy of Managed Care Pharmacy’s eDossier system. This is a centralized, evidenced-based product evaluation portal that payers and providers (such as hospital systems) consult as they determine whether medications are suitable to be added on formulary.

Looking ahead, developing the capability for a systematic approach to delivering high-quality RWD studies will be a requirement. Understanding and developing the right data and analytics approach will become important. Forward planning will be essential to assess when evidence will be required, the feasibility of study options and creation of appropriate partnerships for data availability and analysis. Point-of-Care Partners is one of the few health IT consulting firms with RWE expertise. Let us bring you up to speed on this coming trend in health care and develop real-world strategies for putting data and analytics into practice in your organization.