Understanding Economic Decision-Making in Digital Therapeutics Development: Qualitative Approach

Area of Science:

• Health Informatics
• Health Economics
• Digital Health

Background:

• Digital therapeutics (DTx) offer software-driven interventions but face low adoption due to insufficient economic evidence.
• Knowledge gaps exist regarding economic decision-making in DTx development, especially among researchers.

Purpose of the Study:

• Investigate researchers' decision-making on economic impact factors during DTx development and clinical validation.
• Examine mechanisms and contextual conditions influencing these economic decisions.

Main Methods:

• Conducted 17 semistructured interviews with diverse DTx researchers.
• Employed critical realism, deductive/inductive coding, and abductive/retroductive inference.
• Utilized qualitative system dynamics modeling to visualize causal loops.

Main Results:

• Identified three mechanisms: professional norms prioritizing clinical validation, researcher inexperience with economic factors, and DTx adoption uncertainties.
• These mechanisms lead to economic considerations being marginalized in DTx development.
• Despite recognizing economic evidence importance, it remains peripheral in researchers' frameworks.

Conclusions:

• Complex interactions between institutional structures, intrapersonal factors, and implementation uncertainties deprioritize economic considerations in DTx development.
• Identified mechanisms offer intervention points to integrate economic value assessment throughout the DTx lifecycle.
• Strengthening economic evaluation can enhance DTx adoption in healthcare systems.