Pharma and DTx for better patient care

By April Lara

August 29, 2024

Digital Therapeutics

The digital therapeutics (DTx) industry has experienced a resurgence in recent years, driven by regulatory shifts, providing a fertile ground for pharmaceutical companies to innovate. These offer clear guidelines, streamlined processes, and supportive policies, creating a conducive environment for DTx development and adoption.

This, in turn, presents opportunities for pharma companies to strategically partner with DTx developers, enhance patient management through DTx-powered solutions, and introduce innovative products that leverage DTx technology.

Regulatory clarity, provided by initiatives such as the FDA's Digital Health Advisory Committee (DHAC) and the DTA's accreditation program, has reduced uncertainty and de-risked the development process, encouraging more companies to enter the DTx space. Changes in reimbursement policies, including the Access to Prescription Digital Therapeutics Act in the US, have produced advantageous incentives for DTx adoption by payers and healthcare providers.

Europe has also been a leader in regulating digital therapeutics (DTx). The Medical Device Regulation (MDR) provides a framework for the development, manufacturing, and commercialisation of DTx, while the Health Technology Assessment Regulation establishes a framework for assessing their clinical effectiveness, safety, and cost-effectiveness.

Several EU member states have implemented specific initiatives to support DTx adoption. For example, Germany's Digital Healthcare Act and France's national health insurance system facilitate reimbursement.

Opportunities ahead

These regulations have opened up new opportunities for pharmaceutical companies. By understanding the key areas of focus, pharma companies can position themselves to benefit from this growing industry.

Partnerships with DTx developers can bring shared risk, increased value within product development, and widened market access. It can also be used to personalise treatments, improve patient outcomes, and reduce healthcare costs.

Here, working with payers on coverage and reimbursement for DTx is relevant for wide adoption. Pharmaceutical companies can also advocate for reimbursement policies and provide evidence of clinical effectiveness added to economic value.