Identifying and measuring value is a particularly interesting quandary for life sciences companies, as inevitably each of these viewpoints will interact with the industry in some way, shape or form.
Traditionally, it was relatively straightforward for companies to define the value of an intervention through the efficacy and safety results of treatments tested within the confines of a clinical trial. Payors and other decision-makers have created specific measures within different disease categories to define ‘what good looks like,’ when it comes to demonstrating value.
However, amid an ongoing global pandemic and surging demand for greater diversity, equity, and inclusion in healthcare, our understanding of value is changing, and life science companies are increasingly looking beyond the confines of clinical trial results for more inclusive and diverse ways to measure value.
With the availability of a plethora of healthcare data points and analytics, information can now be gathered from a variety of sources outside of the traditional trial setting, a development that has greatly increased the number of invested stakeholders across all levels of the product development lifecycle.
This complexity presents a significant challenge and opportunity for companies, as stakeholders are likely to have varying priorities and perceptions when it comes to defining and demonstrating a product’s value.
Each key type of healthcare stakeholder perceives value through a slightly different lens. For example, for a patient, value may be gained through having extra time to spend with their loved ones, or the ability to maintain their independence. Their perspective is inevitably more humanistic, more holistic. For a physician, value is likely to be strongly linked to clinical outcomes; how will a treatment impact how long a patient lives or how well their condition is managed. For payors, value is closely tied to costs, on a population basis, and whether the resources could be better used elsewhere. Their perspective considers the whole healthcare system rather than the individual patient. It is important to take these general perceptions from theoretical discussions in the boardroom into the real world to understand the impact they may have on healthcare decision making.
First, digital health and telemedicine are playing an increasingly important role for many patients. In some ways, this pivot supported greater inclusivity as people did not necessarily need to take time off work to get to physicians’ waiting rooms. At the same time, it has been well-evidenced that postponed routine disease monitoring and surgeries have had – and will continue to have – a negative ripple effect on timely diagnoses. Countless patients have missed out on diagnoses due to not having access to digital health interventions or not seeing healthcare providers in a timely way.
As such, the value of a new intervention needs to be assessed in the context of a mindset shift that includes the possibility of remote diagnoses, treatment, and monitoring, while at the same time, being inclusive by ensuring traditional ways of engaging with patients.
Additionally, costs relating to the pandemic have forced a reassessment of spending overall. The relative value of all interventions – COVID- and non-COVID-related – has been recalibrated to allow the system to cope with the current pressures.
While each of these contributing factors is helping to shape our changing perception of value, perhaps the most influential output of the pandemic is the emerging role of real-world evidence.
When clinical trials were delayed due to the pandemic or other pressures, real-world research has provided much-needed insights to guide regulatory approvals, access, and reimbursement discussions. The ability of real-world research to capture the value of an intervention, in a very broad sense, is one of the key reasons why it is becoming so important in healthcare decision making. We have seen an increase in regulatory submissions using real-world evidence over recent years, and this increase only accelerated because of the pandemic.
Collating data from various points of care can help to identify and understand the true patient experience, including the impact of a treatment on symptom burden, patient quality of life, treatment satisfaction, and healthcare resource use. For patients, this is an important development that means their input and experience is at the heart of determining the value of an intervention. Gaining real-world insights from clinicians is also key as the day-to-day treatment of patients can vary widely from the clinical trial setting.
Evaluating data sources is key here, as the variety and quality of data captured on the potential value of an intervention can quickly become challenging. It is becoming increasingly important to spend time upfront thinking strategically about what real-world insights are needed to demonstrate value, and what the best research approaches are to meet these needs.
As people from heterogenous backgrounds are likely to have varying priorities that impact how they define or perceive value in healthcare, this presents companies with an opportunity to develop value stories that demonstrate how new interventions address these individual needs and values.
The apparent disparities in both access to care, and patient outcomes from that care, should be a call to action to ensure that, when we are defining the value of a new intervention, we are inclusive, embracing diversity and acknowledging the value of the opinions and perspectives of all stakeholders. This starts with increased diversity in clinical trial recruitment, supplemented with real-world research conducted in diverse patient populations, so we can better understand the value that patients will derive from a new intervention.
This is reinforced by accessible and appropriate health information at all stages of the patient journey, inside and outside of clinical trials. It’s about understanding what means the most to a representative group of patients, and how an intervention works in the context of their health beliefs and behaviours.
For example, imagine that you are trying to sell someone a car. If you don’t understand what the customer values in a car, whether they are looking for something with a punchy acceleration or that helps minimise their carbon footprint, how do you know what features you’re going to highlight or even what car you should be showing them?
It is important to involve patients across the stages of clinical development to truly understand their needs, especially when it comes to demonstrating value. Payors and healthcare providers should be listening to the real unmet needs that patients face with their diseases and conditions, as they are best able to vocalise what they would value the most in a new treatment approach.
Understanding patient beliefs and behaviours is a critical step towards understanding how they will perceive the value of a new intervention and in crafting a value narrative grounded in robust research that will resonate with patients and the people who care for them. We recommend not only consulting with patients prior to developing value narratives, but also involving them in testing and validating the developed value story prior to roll-out.
Through real-world data, companies can generate a broader evidence base to support the value of their interventions, as well as assess the beliefs and behaviours of key stakeholders. These insights can then be used to define, capture, and demonstrate value in a way that influences decision-making across all stages of the patient journey.
Expanding our understanding of value using inclusive and diverse real-world data will be increasingly important as we advance in the era of personalised medicine. Offering patients an individualised approach when decision-making is based on a population basis raises challenges. It’s these very complex decisions around the relative value of a mixture of different healthcare measures in a population that will present the greatest challenge for the future, and the conversation will continue to shift towards establishing whether a new intervention is ‘worth’ the demonstrated value, not just its value per se.
Shanida Nataraja leads AXON’s Real-World practice and oversees a global team of consultants servicing real-world mandates for a wide range of Pharma companies. Before entering the healthcare communication industry, Shanida completed a BSc and PhD in neuroscience at University College London, and two years of postdoctoral research into learning and memory at Johns Hopkins University.
During her 21 years in the healthcare communication industry, Shanida has gained experience in a wide range of health economic and outcomes research (HEOR) and market access activities, including communication support and analytical/publication planning for non-interventional research, value proposition/value story development, and evidence synthesis & literature reviews. In addition Shanida brings expertise in broader communication activities, including communication strategy and positioning workshops, market and competitor analyses, scientific story flow and key message development, advisory boards, scientific symposia, train-the-trainer and other educational programmes, and disease awareness campaigns.
AXON is a global healthcare communications agency that ignites change in healthcare. Through the power of life-changing communications, we contribute to medical advances that improve lives. At the core of every scientific innovation and advancement, there is a simple and compelling story to be told. We know how to tell that story, how to use the right tools to reach the right audiences at the right time, to provoke meaningful change.
We specialise in advising clients on medical affairs, clinical studies, real-world evidence, marketing, advocacy, and communications, all underpinned by insights and creative strategy. AXON has an international reach, with offices in Copenhagen, London, New York, and Toronto, and a worldwide affiliate network. Established in 2002, we have a deep heritage and expertise in healthcare strategy and communication, and we continue to learn and grow in the fast-changing healthcare sphere. AXON is proudly an AVENIR GLOBAL company.