Thinking Ahead: Development Considerations for Value Centric Digital Healthcare Innovations
Chief Medical Affairs Officer, WPP Health Practice
The area of healthcare data-driven innovations, apps and clinical-decision support tools is rapidly expanding, with new entrants focusing on the use of intelligent algorithms and relying on significant evidence- based data-sets. Happening concurrently is the forging ahead of the use of the newer technologies, with artificial intelligence (AI) techniques enhancing the potential effectiveness and cost effectiveness of new innovations. Much of the latter focus has been on utilizing data to maximize insights value, which in turn, looks to compliment tools development for providing better and safer care for patients and the healthcare system.
Clearly these developments provide great opportunities for healthcare systems, innovator technology organizations, and ultimately, patients. Indeed, the Federal Drug Agency (FDA) has been clear about its approach to considering such technologies, with the broad scope of digital health technologies to include categories such as mobile health (mHealth), health information technology (HIT), wearable devices, telehealth and telemedicine, and personalized medicine. The development of such innovations will, to a greater or lesser extent, be developed with a clear ‘value proposition’ in mind to support commercial success. These will include helping healthcare providers and other stakeholders using digital healthcare innovations to:
- Reduce inefficiencies
- Improve access
- Reduce costs
- Increase quality
- Personalize medications
No doubt, patients, consumers and healthcare providers can use digital health to better manage and track their health and wellness-related activities. Tracking through the use of smart phones, social networks, and internet applications is not only changing the way we as a society communicate, but also provides innovative ways for us to assess and monitor our health (and sickness status), general well-being and giving us greater access to information. These enhancements also enable a convergence of people, information, technology and high level of connectivity to improve healthcare and health outcomes.
In what was an FDA first, the Boston- and San Francisco-based innovator, Pear Therapeutics, was granted a de novo clearance for its reSET system for the treatment of substance abuse. To date, it’s the first FDA-cleared software-only digital therapy with claims to improve clinical outcomes in a disease.
As the first FDA-cleared Prescription Digital Therapeutic (PDT) for disease treatment, reSET was able to demonstrate improved abstinence and treatment retention in a randomized controlled clinical study. The reSET innovation is a 12-week program designed to treat addiction and dependency on stimulants, cannabis, cocaine, and alcohol. Thinking about the potential value a digital therapy innovation like this can offer, begs the question of funding such innovations in both the private and public healthcare systems. Both healthcare systems have begun to adopt more rigorous, evidence-based, Value Frameworks (VFs) to assess (through Health Technology Assessment (HTA) approaches) and appraise (make decisions) on the willingness to fund new innovations.
Although there remain many questions yet unanswered, what is clear is that with the increasing pace and focus on the development of potential PDTs, innovators will be truly:
- Aware and knowledgeable about the various HTA systems that exist in different countries, navigating which are critical
- Able to consider the needs of HTA within the planning for PDT development to support future commercial success
- Experienced enough to engage effectively with HTA agencies through the assessment and appraisal process
The standards of evidence required to demonstrate PDT effectiveness and economic impact are being developed. Understandably, and as a guiding principle, the standard of evidence expected of digital tools will be proportionate to the function of the tool being assessed. Likewise, different functions will require different types and levels of evidence.
When developing a PDT, it will be critical to understand what functions the product delivers, how it adds ‘value’ relative to current approaches and this will ultimately guide what sort of clinical evidence generation plan should be put in place. By investing in these insights to drive optimised clinical development of PDTs, it will also support the creators to become intimate with the intended evaluation body’s package of evidence needed to and crucially outline any gaps in evidence. The latter is of particularly important so that innovating companies do not lose time and/or commercial revenues undertaking superfluous evidence required to meet the needs of the disjointed HTA agencies and wider healthcare system stakeholders.
Within the Chief Medical Office at WPP’s Health Practice we have approached this opportunity to partner with innovators in PDTs through our E3 HTA Programme:
- Educate – focus on educating the companies on what is HTA, implications and why critical to get finding – linking Technological Science to Value
- Empower – focus on supporting the company plan activities and build strategic plans for data generation with a focus on Patient Access to their technologies
- Engage – with Patients, KOLs, Payers and HTA agencies in the most impactful way possible to support patient outcomes and commercial success
The maximising of ‘Patient Access’ to new and innovative technologies, for example; biopharmaceutical gene therapies, cutting edge diagnostics or indeed PDTs, will only be a reality through innovator companies establishing a clear value canvass for their innovations with a central clinical development plan to meet the needs of country HTA agencies and the wider healthcare stakeholder community.