Utilization management practices play an important role in optimizing and driving utilization patterns toward clinically- and cost-effective products, but the application of inappropriate exclusions can negatively affect the overall health care spend. Digital therapeutics is a nascent field, and many questions exist on what part they play in overall treatment. During a presentation at AMCP eLearning Days, Jeenal Patel, PharmD, BCGP, formulary manager, and Patty Taddei-Allen, PharmD, MBA, BCACP, BCGP, senior director of clinical analytics, both of WellDyne,discussed how utilization management can be applied to digital therapeutics and health technology.
U.S. drug costs continue to rise due to increased utilization and unit costs, and the manufacturing pipeline remains packed with specialty medications. Exclusionary practices are a strict management strategy to mitigate overall drug costs, and risk of exclusion may encourage manufacturers to discount drug costs for a better position on the formulary. The number of exclusions is anticipated to rapidly increase in the near future.
Exclusions often consist of high-cost brands with lower-cost generic equivalents, combination drugs, and prescription drugs when over-the-counter alternatives are available. Exclusions allow pharmacy benefit managers to focus on cost containment and create a competitive pricing landscape.
There are, however, challenges and unintended consequences associated with this practice, including patient dissatisfaction with change in therapy, clinical disruption, impacts on adherence, and an increase in the volume of prior authorization appeals.
Digital therapeutics—including mobile health, wearable devices, telehealth, and more—provide evidence-based software and/or hardware that measures and/or intervenes in the service of human health, such as by measuring diagnostics, biomarkers, and more.
There are three main categories of digital therapeutics: improve a health function, manage a disease, and treat a disease. The claims of the products range from low to medium risk (improving a health function) to medium to high risk (managing or treating a disease). All require clinicals trials and ongoing evidence generation. The FDA Center for Devices and Radiological Health regulates some forms of digital therapeutics, but software that meets the definition of a medical device but has low risk may not require regulatory enforcement by the FDA.
Digital therapeutics present a challenge, as the framework for formulary evaluation has yet to be defined. There are also gaps in infrastructure to support these therapies and confusion over whether to classify them under medical or pharmacy benefits. There also remains a lack of understanding among providers, patients, and plan sponsors with regard to these treatments.
The path forward to better integrating digital therapeutics into utilization management practices includes a careful evaluation of restriction policies before implementation and continued reevaluation while accounting for various disease states and types. Digital therapeutics should be added to formulary frameworks in a similar cadence as medications, and a similar scientific review of peer-reviewed literature should be applied when including digital therapeutics to formulary, as is the case for prescription drug reviews.
Presentation: Evaluating Digital Therapeutics, Drugs, and Health Technology for Optimizing Clinical and Financial Outcomes. AMCP eLearning Days, April 20-24.