The intersection of prescription drugs and medical devices: the evaluation and funding challenges of two categories of emerging health technologies

Health technology assessments (HTAs) are policy analysis frameworks contributing to the approval, reimbursement, and rollout of biotechnology and pharmaceuticals. New innovations in health technologies expose gaps in reimbursement and implementation guidelines. We defined two types of emerging health technologies: (1) therapeutic innovations, such as drug-device combination products or nondrug alternatives to prescription drugs and (2) disruptive health innovations such as novel surgeries and gene replacement therapies. We aimed to determine delineated definitions for these categories through a comprehensive review of HTA guidelines across 20 nations. Utilizing databases such as International Network of Agencies for HTA, International Society for Pharmacoeconomics and Outcomes Research, and European Medical Agency, we identified products falling within these categories. Real-world case studies highlighted the inadequacies stemming from the absence of clear definitions and proposed solutions to enhance current HTA guidelines. These shortcomings apply at the state or provincial level in addition to national jurisdictions as existing funding structures and silos fail to accommodate the unique attributes of these technologies.