What role should digital therapeutics (DTx) play in our therapeutic area? What regulatory and access processes need to be established to ensure that these treatments are safe, effective and of high value? What evidence is needed to support the safety, efficacy and value claims?
These questions and more have been addressed as part of DTx’s AMCP Partnership Forum. The proceedings of this meeting identified some areas where DTx oversight and guidance could be improved, including:
…standardize product definitions and classifications across the DTx industry; emphasize the value of regulatory approval in establishing DTx evidence standards; establish an evidence framework to guide DTx coverage and reimbursement decisions; consider unique DTx product aspects such as data security, privacy, and product Update; increase awareness and expertise of DTx among all healthcare stakeholders; and promote DTx adoption and equitable access.
This Abraham et al. (2022) The publication also has a good table discussing some of the key considerations that regulators and payers will face when determining whether to cover digital therapeutics.
More discussions are available at full text.
