RESUMO
Digital therapeutics (DTx) are a rapidly growing therapeutic category with more than 150 clinical trials evaluating US Food and Drug Administration-regulated DTx to develop additional evidence by the end of 2022. Investments in DTx development have doubled since 2019, reaching $14.7 billion in 2021. Prescription DTx are regulated by the US Food and Drug Administration and require demonstration of efficacy and safety prior to commercialization and reimbursement by payers. Drawing insights from the Massachusetts Medicaid program's early experience with prescription DTx, we provide an overview of this new category of therapeutics and suggest a roadmap for payers and policymakers to evaluate the value of prescription DTx for their member population. Finally, we propose solutions to potential challenges that may be encountered in the DTx coverage and reimbursement management.
Assuntos
Medicaid , Prescrições , Estados Unidos , Humanos , MassachusettsRESUMO
The Clinical Classifications Software (CCS), by grouping International Classification of Diseases (ICD), provides the capacity to better account for clinical conditions for payers, policy makers, and researchers to analyze outcomes, costs, and utilization. There is a critical need for additional research on application of CCS categories to validate the clinical condition representation and to prevent gaps in research. This study compared the event frequency and ICD codes of CCS categories with significant changes from the first three quarters of 2015 to 2016 using National Inpatient Sample data. A total of 63 of the 285 diagnostics CCS were identified with greater than 20% change, of which 32 had increased and 31 decreased over time. Due to the complexity associated with the transition from ICD-9 to ICD-10, more studies are needed to identify the reason for the changes to improve CCS use for ICD-10 and its comparability with ICD-9 based data.
