ARTICLE SUMMARY:
There has been an increased focus on use of digital health technologies in recent years, now accelerated by the COVID-19 pandemic, but several barriers remain to market access, mainly regarding reimbursement. The Life Sciences Practice team at CRA explores these challenges and how companies might overcome them to encourage faster access and reimbursement of DHT. By Eva Marchese, Lev Gerlovin, Lorenzo D’Angelo, and Anthony Barron, CRA.
Digital health is a rapidly emerging field showing significant potential to improve the quality and efficiency of healthcare systems around the world, and more industry stakeholders are recognizing the important role of digital health especially due to the COVID-19 pandemic. The FDA defines the digital health field broadly, from Software as a Medical Device (SaMD) adding functions to a hardware medical device, to artificial intelligence and cloud-based services, and even to novel digital devices with new technology. The rise of digital health technologies (DHTs) has largely been driven by an increased incidence of non-communicable diseases and a desire by patients to take a more active role in their disease management. Patient access to technology and interest in their own medical data has resulted in the development and advancement of many new devices and apps to track progress and symptoms of different diseases and conditions, communicate directly with healthcare providers, educate patients and support clinicians.There is also growing interest from healthcare purchasers (payors and hospital administrators) in buying value-based healthcare solutions based on reliable data metrics around treatment efficacy and continuous monitoring in real-world settings. DHTs have the potential to allow payors and manufacturers to track patient outcomes and treatment adherence better, faster and more accurately, and thus support wider adoption of value-based healthcare models.
Despite progress being made in digital health there are several barriers hindering innovation and adoption of DHTs. One of the key issues is funding because in many cases there are no dedicated access pathways or value assessment processes for DHTs, and funding flows are driven in silos. DHT suppliers must therefore often face a fragmented marketplace with no clear route to market, potentially hindering adoption.
