Digital Therapeutics 101: Navigating DiGA and Reimbursement

Why is reimbursement the biggest challenge for digital therapeutics?

Digital therapeutics (DTx) have matured significantly: stronger clinical evidence, better user engagement, and growing recognition from clinicians. Yet one barrier remains defining — reimbursement. A DTx product may deliver measurable clinical value, but without a clear funding model, adoption stalls.

Germany’s DiGA framework changed the global conversation by offering a formal reimbursement pathway for digital therapeutics. It created a blueprint for how digital interventions can be prescribed like medicines. Understanding DiGA — and similar pathways — helps DTx companies build sustainable business models.

What makes DiGA so influential?

Germany’s DiGA approval pathway is the first national framework that lets physicians prescribe digital therapeutics and have them reimbursed like drugs. It set a precedent:

• Evidence matters
• Quality matters
• Usability matters
• Data protection matters
• Real clinical outcomes matter

DiGA also allows provisional listing while evidence is being gathered, giving startups space to scale and learn.

What do DTx companies need to demonstrate?

To succeed in reimbursement pathways, DTx products must show:

• Clinically validated outcomes
• High usability and adherence rates
• Clear definitions of intended use
• Strong data protection and security practices
• Patient benefit in real-world scenarios
• Accessibility for diverse populations

Regulators want more than functionality — they want proof that the product meaningfully improves health.

How should DTx companies approach evidence generation?

Evidence should follow the same rigour as pharmaceutical or device studies:

1. Define measurable endpoints

What changes should your product achieve — symptom reduction, adherence, quality of life improvements?

2. Run feasibility studies

These uncover usability barriers and refine assumptions before larger trials.

3. Conduct robust clinical evaluations

Randomised or controlled trials strengthen credibility and support reimbursement submissions.

4. Capture real-world data

Post-market evidence helps secure and maintain reimbursement.

Why is usability such a critical factor for reimbursement?

Payers care about engagement because digital therapeutics only work if people use them consistently. High-quality UX design:

• Improves adherence
• Reduces drop-offs
• Increases therapeutic impact
• Demonstrates product maturity
• Strengthens regulatory submissions

Usability is not aesthetic — it’s clinical.

What reimbursement paths exist beyond DiGA?

While DiGA is the most structured model today, similar paths exist or are emerging:

• Coverage through employer or insurer partnerships
• Value-based reimbursement tied to outcomes
• Integration into chronic care management programs
• Pharma partnerships combining DTx with therapeutics
• Pilot-to-procurement models with health systems

The global trend is clear: reimbursement models for DTx are expanding, but evidence remains the currency.

How can startups position themselves for long-term success?

Winning companies:

• Invest early in clinical evidence
• Prioritise UX excellence
• Build trust with clinicians
• Demonstrate audit-ready quality processes
• Align product strategies with reimbursement pathways
• Understand local regulatory nuances

Digital therapeutics don’t succeed by being “apps.” They succeed by being clinically credible, compliant, and reimbursable.

‍