Abstract
Shivang Doshi, Director, Boston Healthcare Associates
Patient access to transformative healthcare technologies or services that have the potential to significantly improve health outcomes is mounting amidst the adoption of Real-World Evidence (RWE) by a range of stakeholders, leading to greater uptake by payers.
The appeal of RWE can be attributed to an increasingly complex and dynamic healthcare landscape that demands new approaches for evidence generation to leverage broad coverage and adoption of the myriad of innovative healthcare products and services available on the market.
RWE draws upon a variety of sources including electronic health records, consumer data, payer claims databases, patient registries, and others, enabling innovators to describe how a product will perform in a broader, more representative population over a period of time. This approach to evidence generation is of significant interest to payers, as they are increasingly reliant on RWE to make coverage and reimbursement decisions.
Compared to traditional clinical trials, RWE provides information comparators and outcomes that may not be part of clinical trial protocols. This approach is also less costly, offers greater flexibility over data analysis, and reflects the heterogeneous nature of ‘real-world’ experiences and practices, and whether or not a product or service adds ‘value’ to the healthcare system. For innovators, it also helps identify pain-points along the care paradigm and quantify the clinical and economic burden of disease.
RWE is also having a significant impact on the development and uptake of advanced molecular-based diagnostics, which are more expensive and complex compared to traditional single-marker assays and have prompted payers to manage utilization closely. The recent proposed national coverage determination for next-generation sequencing assays in oncology, which allows FDA-cleared assays that are included in a prospective registry to be covered, further underscores the expanding role of RWE in coverage decisions.
With this in mind, it is imperative that diagnostic innovators effectively demonstrate the value proposition of a test, particularly because it is the lack of clinical utility evidence that is most cited by payers as the reason for negative coverage for a diagnostic. RWE taps into routine collection of electronic data in hospital billing, medical records, and other clinical and administrative data, which can be leveraged at different stages of a product life-cycle to inform product strategy. As a result, innovators need to explore technology-driven solutions that integrate these multiple data sources, and reliably standardize data using technological advances, such as natural language processing to harness the true potential of RWE.
The continued growth in data volume, variety, and velocity—as well as the need to quickly deliver insights derived from that data—makes efficient connectivity and data sharing between systems an essential element of RWE collection. Currently, the interoperability of multiple systems, incomplete longitudinal data on patients, and data privacy issues are impeding a comprehensive view of RWE. Stakeholders will need to increase their uptake, and coordination of, information technology systems that address these system design needs and enable organic data collection supporting the clinical utility of advanced diagnostics.
Providing more individualized therapy to patients through the use of advanced diagnostics holds great promise for the future of medicine. The evolving environment for advanced diagnostics should ultimately facilitate greater innovation. Providing reimbursement that appropriately reflects value, rewarding innovation, and creating RWE standards are all part of the solution. Industry and policymakers will need to continue to work together to strike the right balance and ensure that the transformative potential of advanced diagnostics are fully realized.