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Matthew Sussman explores strategies for facilitating access to the timely patient data and analysis needed for successful value-based agreements between manufacturers, payer and provider organizations in 2020 and beyond.
Exploring strategies for facilitating access to the timely patient data and analysis needed for successful value-based agreements between pharma manufacturers, payer and provider organizations in 2020 and beyond.
For nearly a decade, US healthcare policymakers have been discussing the industry shift from a fee-for-service model toward one based on value. This model prioritizes patient outcomes over volume of services delivered and, in 2019, an estimated 25 percent1 of care-delivery in physician and hospital reimbursement models was value-based. However, drug companies have historically struggled to structure and execute these types of contacts – as of February 2020, to our knowledge there have only been 23 publicly-disclosed2 value-based contracts involving drugs and biologics. For drug manufacturers, the transition to value-based contracting requires a shift in thinking and a willingness to work with their customers (both payers and providers) to gain increased access and timely analysis of patient data.
As payers and providers can attest, data is the cornerstone of value-based care (VBC) models. However, payers and providers have struggled to put the mechanisms in place to successfully access and report on this data, and the challenge is far greater for manufacturers, whose role in the supply chain limits contact with patients outside of clinical trials. Overcoming this absence of data, whether it be due to challenges of regulation, access, interoperability or technological infrastructure is a key component in establishing value-based care models between pharmaceutical manufacturers and their customers.
How, then, can pharma, payers and providers come together to advance value-based care in their respective segments of the care continuum? This will require a closer look at the necessary VBC infrastructure as well as data and analytic requirements, including determining the answers to difficult questions such as: Which activities are required to conduct a successful VBC model, and who are the responsible parties? Who should manage the data? Who is responsible for data analysis? And ultimately, who owns the results?
How can pharmaceutical companies and their customers advance value-based care in their segment of the continuum? Prior to a VBC launch, both parties must form a collaborative infrastructure with shared interests and program goals in mind. Having the necessary infrastructure in place before pursuing a value-based contract is crucial in successful execution. This includes having an outlined protocol design, competent IT infrastructure, and a mutually agreeable understanding of entity responsibilities.
Additionally, enlisting the assistance of a third-party analytics coordinating center will aid in the design of VBC protocols, certify management and timely processing of customer data, and ensure the transparency of VBC findings. The following process flow diagram highlights the design, data management, and implementation phases of a collaborative VBC framework:
The first question we must ask when approaching the use of patient data for value-based contracting is which entity should manage the customer’s data. Third-party analytics coordinating centers that have policies, procedures, and HIPAA-compliant systems in place for securely transferring and storing customer data should hold the responsibility for managing this critical phase of the process. In fact, by holding third-party vendors accountable for data management activities, manufacturers can limit any potential liability in this regard.
A clear and often-practiced activity for accessing patient data is through the execution of Business Associate’s Agreements (BAAs) between payers or providers and recipients of the data. BAAs, which allow for the receipt of protected health information (PHI) by third parties, define covered entities as “organizations that provide treatment, payment and operations in healthcare” (i.e., payers, providers) and business associates as organizations that receive and protect PHI (e.g., third-party vendors).
Next is the analysis of the data. Prior to conducting the analysis, however, it is imperative to ensure a proper study design with details provided via an industry-standard study protocol (i.e., the recipe for conducting the analysis). The protocol should provide transparency concerning the patient selection process, time periods for evaluation, and definitions for study measures and data analysis. Based on the protocol, the analysis should be reasonably reproducible by an external party. The protocol should be developed, and owned, by the pharma manufacturer, pharma customer and a third-party data analytics vendor.
To ensure a trustful VBC arrangement, the analysis should be conducted, and owned, by the third-party data analytics center. For example, Express Scripts saved $4.3 billion on medication costs in 2019 via VBC programs with pharma. With so much money at stake on both sides of the VBC arrangement, it is essential to enlist a neutral third party to process the protocol.
The results are owned by the pharma manufacturer, pharma customer and a third-party data analytics vendor. On the pharma side, the manufacturer is responsible for the results of their intervention and how it performs in the real-world outside of controlled clinical trial settings. Both the pharma manufacturer and customer are responsible for the implications and outcomes of a VBC, and terms must be set at the start of the relationship to ensure that both parties are meeting their side of the agreement. Lastly, the third-party vendor is responsible for verifying and validating the analytic findings that serve as the foundation for the VBC agreement.
In addition to establishing a collaborative framework as described above, other activities should be considered to ensure the successful launch of a VBC program:
In conclusion, data driven VBC agreements between pharmaceutical manufacturers and payers or providers are more attainable than the industry has shown thus far. Once the who and how is understood more widely, it all comes down to proper execution. The data needed to establish better value-based drug pricing is readily available to us, all that’s left is gaining access to that data and investing in the analytics power needed to uncover the insights to inform better decision-making. What does this mean? The future of value-based drug pricing is much closer than it appears.
Matthew Sussman is VP of Modeling & Strategy Services, BHE.