Buzzwords in the life sciences industry – there are many: Artificial Intelligence (AI), Gen AI, Machine Learning (ML), digital health, and real-world data (RWD)/real world evidence (RWE). All are vast, complex areas with notable potential to impact our clients and the industry overall – across the continuum of the product lifecycle, spanning clinical and commercial aspects at the product, corporate and industry level.
Here, we’ll focus on RWD. In this blog, I’ll take a brief look at three topics:
- What is real-world data?
- Why – and how – is it valuable to our clients?
- What are some the key business uses cases?
Firstly, what is RWD?
Real-world data in medicine is data derived from a number of sources that are associated with outcomes in a diverse patient population in real-world settings, including but not limited to health insurance claims, lab data, electronic health records, and patient surveys. This data can include, among other information, patient demographics, diagnoses, procedures, treatments, lab results, and patient outcomes. At Norstella, we have a remarkable volume of claims data and lab results data, along with electronic health record (EHR) data across about 19 counties.
Before we move to our second point above, let’s differentiate between RWD and RWE; they are not synonymous:
- Real-World Data (RWD) is data obtained from many independent sources that follow healthcare outcomes in a diverse population. The FDA defines it as data relating to patient health status and/or the delivery of health care, routinely collected from various sources. RWD is mainly observational and pertinent to actual clinical practice, in contrast to strictly controlled experimental data acquired in randomised clinical trials. It is primarily sourced from real-world medical environments and reflects realistic healthcare scenarios. RWD examples include data derived from electronic health records (EHRs), pharmacy registries, patient surveys, medical claims, billing data, product and disease registries, e-health devices, clinical trials, and observational studies.
- Real-World Evidence (RWE) is the clinical evidence about the proper usage, benefits, and harms of a therapeutic or medical device obtained from RWD. It is extracted from RWD to form an analysis for the potential clinical study, base rationale, and engineer proper trial infrastructure.
Now, let’s explore why RWD is valuable to our clients. How can it be leveraged to support their overall corporate strategy?
Well, the real-world experiences of patients as they journey through their healthcare experience – interacting with healthcare professionals, visiting medical and treatment centres and dealing with insurance companies is not necessarily smooth and seamless. For drug manufacturers, it is vitally important that they deepen their understanding and continue to monitor the landscape and evolving market across the product lifecycle in an effort to ensure they are bringing treatments to market for patients in need. This includes leveraging data assets to address myriad business-related questions and demands, across development, through commercialisation and into post-launch support, including:
- What are the top indications to target?
- What is the unmet need in the market?
- What are the benefits of this product over other available treatments, and what is the value proposition for key stakeholders? Patients? Physicians? Payers?
- What is the target product profile and the benefits of the treatment that will help guide physicians to modify their treatment paradigm and more easily decide which therapies to prescribe? And in what order or combination?
- How does payer behaviour differ from their own guidelines?
- Post launch, what is the uptake versus forecast? What is market share across line of therapy? What does switching behaviour look like, including length of time between switching?
Access to timely real-world data that helps to uncover these insights is a significant advantage to companies looking to ensure they are optimally positioned in the market. The specific indications or therapeutic areas will dictate the types of data most relevant and valuable to address any given business need. For example, rare and ultra rare business needs could benefit greatly from Norstella’s genetic mutation data, while some oncology-focused business needs could be addressed more thoroughly with oncology biomarker data linked with the open claims data.
The ability to tap into unstructured data is another trend that is gaining increasing interest, especially physician notes, which can provide even deeper insights into the patient journey and associated diagnosis and treatment paradigms. We will cover that further in a future blog.
To be impactful, real-world data must be cleansed and organised, as well as being comprehensive and timely. In addition, it becomes more valuable when it is integrated or linked with other data assets to extend visibility into the patient journey and deeper insights across other business needs. Like any other form of big data (another buzzword of the recent past!) there is little-to-no value without utility resulting in insights and actionable next steps.
Lastly, what are some of the commercial use cases for real-world data?
There are three I’ll summarise now, and we’ll dig into them in more detail in future blog posts.
1) Corporate Strategy: Real-world data can inform decisions on indication prioritisation and portfolio optimisation, line of therapy strategy, commercial opportunity assessment, BD&L strategy, regional prioritisation. Insights derived from RWD sources such as claims data allow companies to define and demonstrate the value they bring to patients, providers, and payers, while helping to establish and maintain a leading position in the marketplace.
2) R&D planning: Assessing the indications to identify the greatest potential involves looking at myriad factors, many supported by RWD, including diagnosis and treatment rates, gaps in standard of care, current patient journey. Assessing the competitive landscape also is an important factor here, understanding the competitive intensity and evolving landscape to help our clients leverage deeper insights to converge their efforts with the evolution of the market to be at the right place at the right time.
3) Commercial Strategy: This can be quite involved and encompasses both looking back and looking to the future. By leveraging RWD, Norstella can help clients analyse market size, treatment patterns, standard of care and unmet need, and healthcare utilisation, as well as the role of lab results and genetic biomarkers – providing valuable insights into the effectiveness, benefits and incremental value of their therapies versus competitors’ treatment regimens. This also can support development of a target product profile, which can be used for a variety of audiences: providers, payers and investors. There also are numerous use cases for leveraging RWD post launch, which we will explore in a future blog. i.e. uptake curves/adoption rates, line of therapy, and switching behaviour.
As you can see, RWD is a very broad topic and there is much more we can cover. I’m looking forward to sharing additional insights and information in future posts, as well as highlighting some impactful RWD Use Cases.
