Words by Saskia Pronk
A revolutionary impetus is permeating the healthcare industry, also known as ‘the third wave of medicine’, digital therapeutics are now being developed by as many as 150 firms worldwide. Like pharmacologic interventions, digital solutions receive regulatory approval but with an important distinction: rather than swallowing a pill or receiving an injection, the therapeutic is delivered through software on your handheld device. Moving through this evolving space, pharmaceutical companies are searching to define the business value of digital solutions while finding their place within a new class of collaboration.
Much like the smartphone in everyone’s pocket, real-world data collected from digital therapies allow ongoing software updates and improvements; this is a significant advantage over the traditional pharmaceutical ‘one-and-done’ process. “The real-world data that we collect with prescription digital therapeutics is a significant benefit over traditional therapeutics, as it allows us to continually refine and enhance the product based on how clinicians and patients are accessing and using the therapeutic”, explains Dr Corey McCann, CEO, Pear Therapeutics.
Digital therapeutics are now being developed by as many as 150 firms worldwide
Digital therapeutics are set to equip pharma with multiple other sources of value and medical affairs departments will find themselves uniquely positioned to nurture and convey it. According to Alex Butler, Co-Founder, Foundry3, these range from innovating the clinical trial programme by enabling more specific measurement of disease progression, to working synergistically with existing therapies through providing support to those on a prescribed product. Also, supporting those patients who aren’t on the company’s medicines, which will ultimately help a company demonstrate commitment to the broader community – especially in the case of rarer conditions.
Aligning with tech companies to achieve this has previously proved a hard pill to swallow. “In some senses the greatest challenge [for pharma] is the acceptance that in order to build successful interventions in digital health, they need to be built in collaboration”, clarifies Butler. Due to the industry’s traditional business model, a process of co-creation is essential in this space: “Pharma have generally struggled with developing truly user-centered solutions that add value separate from medicine and beyond the organisationally defined objectives”, points out Butler.
Such early collaborations in the field are often simplified to pharma taking on sales and marketing for the prescription-only digital therapeutic, while the tech side manage the digital end of the software-based products, tweaking them based on real-world evidence from clinicians and patients.
However, for pharma to make their mark on the digital solutions sphere, they need to be seen as more than just ‘distributors’. They have significant offerings to bring to the development of digital therapeutics, specifically, MA and their many decades of experience with demonstrating evidence. Just like traditional therapies, digital ones require the same level of rigor to validate them through demonstrable improved patient outcomes in the real-world. “This requires custodians from the medical and scientific teams to drive implementation and focus on the evidential improvement in patients”, Butler explains.
Nevertheless, in order to maximise their potential, MA departments will have to adapt in the digital realm suggests Butler. “The focus should no longer be on compliance with MA holding the gatekeeper role, MA need to force through innovation and take risks on behalf of all of us in healthcare who are trying to help.”
The industry is still navigating a path to correctly evaluate, regulate, and ultimately pay for these therapeutics
With the use of these therapeutics set to significantly augment a medicine’s value proposition in a real-world setting, it will not be long before an innovative support programme is an expected component of a drug launch, perhaps forming part of the medicines license or risk management plan set out by MA executives. Because of this, Butler believes: “Pharma need to start with taking more risks with investment, more importantly bringing these investments into the mainstream of the organisation rather than keeping them at arm’s length through seed funds or acceleration programmes.”
As this new exciting sector in the healthcare space develops, “The industry is still navigating a path to correctly evaluate, regulate, and ultimately pay for these therapeutics”, explains McCann. However, what is clear is that within these new pharma–tech collaborations, MA will ultimately find themselves in a unique position to step-up and be advocates of digital therapies, communicating their medical value to support or act in isolation to traditional pharmacologic therapies.