Hospital systems, including those reeling financially from COVID-19, can partner with myriad stakeholders to capitalize on the momentum around real-world evidence to inform the development of evidence-based care pathways, design population healthcare programs and develop a new revenue stream as a means to enhance clinical care.
Collaborations with pharmaceutical companies and diagnostics manufacturers, and other third-party health technology / finance technology companies as well as payers have been enabled by the 21st Century Cures Act, the anticipated implementation of interoperability rules, and movement toward value-based care models. At the same time, cloud computing is becoming ubiquitous and costs for the technology are decreasing, pushing real-world evidence to a tipping point.
Taken together, these factors could enable hospital systems to design programs, products and services to glean insights from longitudinally collected data on patient treatment selection and outcomes as providers move toward value-driven care and away from fee-for-service.
HRI spoke with PwC principals Ash Malik and Will Suvari about how hospital systems and clinics could maximize the value of their data assets to improve patient outcomes and physician workflows through collaborations and co-development of products, services and tools needed to enable that process.
We’ve been hearing about real-world evidence (RWE) for many years. Why is the time ripe now for providers and health systems to capitalize on RWE?
When it comes to therapeutics and drugs, we are starting to witness products and therapeutics that are coming to market sooner rather than later through several accelerator programs enabled by the regulators to address high unmet needs. The market launch of these products, however, is supported by comparatively slimmer books of clinical evidence, and they therefore need to be able to tell their efficacy, safety and value story based on studies designed to review more effectively and closely the real-world patient population being treated with these drugs.
An obvious partner for developing these programs and executing on the study protocols designed to study real-world patient treatment and outcomes data is hospital systems and their network of regional clinics. Manufacturers can gain further evidence on the safety and efficacy of their product in a more real-world setting and extend their programs to monitor a more diverse set of patient populations, and hospitals can start to use that evidence to design quality programs for these new agents that are getting into the market sooner rather than later.
We’re seeing the increased role for real-world evidence growing across the health industries. The COVID-19 pandemic has implications for payers who are already starting to see a change in their portfolio mix, which could affect profitability. As a result, which drugs get to stay on the formulary could increase the burden on pharmaceutical companies to generate evidence and make the case that they provide a greater benefit. Pharmaceutical companies could work with payers or hospital systems to generate that evidence.
HRI: What are some of the use cases of RWE for health systems?
Ash Malik: A very direct use and impact case would be the development of evidence-based care pathways to inform diagnosis / drug selection and standardization of care protocols for adverse event management. As an example, consider non-small cell lung cancer, where we have approximately seven biomarkers approved and recommended in clinical guidelines to be tested for to inform the use of targeted therapeutics. In a particular published study, when you start looking across a set of physicians participating in a broad network of clinics, not all are testing for each of the seven biomarkers. Some are testing for four, others for three or fewer and making a potentially suboptimal treatment decision before waiting for the test results to be in, since these can take up to 21 days, thus driving patient and caregiver anxiety through the roof and compelling the doctors to make a safer but not fully informed prescription decision.
When they finally get all of the biomarker data or the results from a next-generation sequencing panel, doctors if prompted by the results and evidence-based care pathways will most likely realize the patient should be on a more targeted therapy versus the checkpoint inhibitor that was chosen in the first place.
Will Suvari: There are similar examples in heart failure. Some systems are building programs around better population health for patients through medication and discharge consults. Others are looking at risk stratification as a driver of real-world value.
For example, if you can identify which patients need intensive follow-up and which don’t, you can demonstrate better outcomes at a net lower cost for payers. Systems that use this evidence to inform their care pathways could see differences that go straight to their bottom lines.
HRI: What should health systems be thinking about as they consider collaborations, and do they have to be with pharmaceutical and life sciences companies?
Ash Malik: Health systems need to understand and align internally on the scope of the programs they will pursue. While enhancing patient outcomes and improving physician workflows can be the first gate to pass, programs around building a value dossier for payers, informing drug pricing and contracting strategies, and driving physician and patient engagement, can be additional considerations.
They might have several partners that are not just pharma but also life science companies and other commercial entities that run high-end analytics and provide data aggregation and contract research organization services. It’s about building an internal dataset and IT infrastructure to enable population health management with a good understanding of patient mix and the requirements to build commercialization capabilities.
With care pathway development, you’re looking for improved outcomes and better-designed physician workflows that allow certain aspects of care management to be administered through specialty nurses and physician assistants, thus effectively driving down cost of care. In that process, you look for the right partner to help you do that. If it’s around a drug you are actively using, maybe pharma is the partner.
Will Suvari: Who they partner with will depend on the goal you’re trying to achieve. If the goal is saving money and achieving better outcomes, payers might be a better partner.
If, alternatively, your goal is creating better clinical pathways, a provider is the logical choice.
HRI: What are the processes, procedures and technologies that health systems need to put in place to enable this capability?
Ash Malik: There are a number of requirements to stand this up. Have you designed the data models that inform the different use cases you plan to pursue? How far back do you go on a patient’s history? Do you have an active program for digitizing their past care records? Do you have record ingestion and curation capabilities?
Then there are technology requirements with data warehousing in the forefront and how you develop the appropriate interactive tools for the consumption of analytics by the physicians and the staff serving the patients.
There are also interoperability requirements and the need for payers to collaborate on these requirements that hospitals are starting to implement. Hospitals also need to consider: Do we have the right dataset in structured fields that we are collecting longitudinally? Do we have the right data governance and IT infrastructure in place? Do we have a sponsor for the in-house program to drive population health programs and design metrics that track patient performance and benchmark physicians? There are also significant regulatory and compliance requirements that need to be met around patient privacy protection and bioethics consideration for the organization.
Will Suvari: Hospitals also have to think about how they market this or engage with whoever they decide their customer base is going to be. There is no business-to-business marketing department at most hospitals, and sometimes the concept doesn’t really go anywhere. If you've got the capabilities in-house to create an insight-driven platform to guide care, address population health or make other worthwhile insights to the healthcare community, you have to invest in the ability to sell it, whether that’s through a third party or building that capability.