Digital Therapeutics (DTx) are evidence-based digital health treatments, also known as Software as a Medical Device (SaMD). Unlike generic health apps freely available for download, digital therapeutics are products that undergo rigorous clinical and regulatory review, ensuring the highest standards of efficacy and safety.
Digital therapeutics can be prescribed by physicians as stand-alone treatments or alongside existing therapies. Their digital nature enables them to target and treat unmet needs at home and around the clock, empowering patients by lowering thresholds to high-quality care.
Digital Therapeutics are medical treatments that can make medical claims, receive regulatory authorization and reimbursement. DTx products are to health apps what prescription drugs are to vitamin supplements bought at a grocery store.
DTx products are designed and developed to treat specific medical disorders and diseases, defined by ICD-10 diagnose codes.
DTx products undergo clinical studies demonstrating effectiveness, similar to traditional pharmaceutical treatments.
DTx products can be prescribed by healthcare providers either as stand-alone treatments or alongside existing drugs or therapies. Their costs can similarly also be reimbursed by public and private health coverage plans.
DTx products are developed according to rigorous regulatory and data security processes, and are subject to safety and efficacy review and approval from regulatory bodies such as the FDA. DTx products receive a medical device class classification when on the market.
Since 2020, Germany’s Digital Healthcare Act (DVG) has meant that any doctor or health-care provider has been able to prescribe Digital Health Applications (DiGA’s) to any of the 72 million citizens insured through the state healthcare system.
A DiGA is a digital medical product Class I or IIa that provides treatment, detection, monitoring or other medical function of a medical disease or injury.
The German Federal Institute for Drugs and Medical Devices (BfArM) has created a “Fast Track” that enables DiGA’s that have established risk and data protection compliance to launch prior to having established positive care effects through clinical studies..
The “Fast Track” procedure allows DiGA’s to conduct clinical trials during their first 12 months of listing. During this period DiGA’s can nonetheless be prescribed and reimbursed.
The DVG mandates that any DiGA approved by the BfArM either temporarily or permanently must be reimbursed by the federal statutory health system, which covers 72 million German citizens and constitutes the world’s fourth largest healthcare market.
Collaborative identification of real-world pain points and unmet patient needs. Development of novel DTx Product built upon the Alex Therapeutics Platform.
Regulatory review and approval of DTx documentation by Notified Body (EU), FDA (US) or other regulatory agency.
Clinical validation of DTx products is a significantly faster and easier process than traditional medicines due to their digital nature and rapid periods of effect.
DTx products allow for innovative marketing & sales processes to be more easily utilized, as well as more rapid and cost-effective distrubution strategies.