[How About This Book] The Near Future... The 'Third Generation Drug' Digital Therapeutics

[Asia Economy Reporter Chunhee Lee] Digital therapeutics (DTx) is still an uncharted territory in South Korea, with no products yet approved by the Ministry of Food and Drug Safety. However, this also means many possibilities are opening up. Fifteen products in South Korea alone have entered clinical trials for commercialization, and overseas, companies like Pear Therapeutics and Akili Interactive have received approval from the U.S. Food and Drug Administration (FDA), gradually opening the market.

'The Digital Therapeutics Revolution' is a compass-like book exploring the still unknown world of DTx. The authors, who handle big health checkup data central to DTx development or are directly involved in DTx creation, define DTx as the 'third new drug.' This means it is the next generation of medicine beyond first-generation small molecules and second-generation biopharmaceuticals. As digital transformation, including the metaverse, emerges as a key theme of the era, DTx is expected to be the core of this transformation within the healthcare system.

The authors view DTx not simply as a therapeutic agent but as a 'platform.' This is because patients, healthcare providers, pharmaceutical companies, payers such as insurers, governments, and policymakers can all use DTx to fill the long-unmet needs. This advice aligns with recent attention in the bio industry on platforms enabling the development of various drugs like antibody-drug conjugates (ADC) and messenger RNA (mRNA), suggesting that DTx should also be developed to continuously provide additional development momentum for various indications.

So, what practical benefits can DTx bring? The authors present a blueprint where 'precision medicine' and 'personalized medicine' become possible through DTx. The greatest characteristic enabling this is biomarkers. Currently, measuring diseases requires visiting a hospital to draw blood or take images. In contrast, DTx utilizes digital biomarkers that can be easily collected via smartphones or wearable devices. Because it allows real-time observation of various data that were previously unused, it enables a better understanding of the patient's condition and thus personalized treatment.

However, these benefits of DTx have not yet been realized. Commercialization of DTx is an urgent priority. The authors identify 'real-world data (RWD)' and 'real-world evidence (RWE)' as critical conditions determining the success of DTx commercialization. Unlike conventional drugs, DTx allows detailed monitoring of actual patient usage, which should be leveraged to ensure safety and focus on performance improvement. They also emphasize that proving actual benefits and reducing resource consumption to lessen patients' economic burden is essential to gain access to reimbursement markets.

It is anticipated that the Ministry of Food and Drug Safety may approve the first DTx product in South Korea as early as this year. However, even after approval, various procedures such as new medical technology assessment and the Health Insurance Policy Deliberation Committee must be completed for actual reimbursement. Concerns remain that it may take 2 to 3 years for the market to settle through actual commercialization. Nevertheless, the realization of patient-tailored medicine through DTx, as depicted in this book, is believed to be a future that will eventually come.

The Digital Therapeutics Revolution | Written by Seongwook Ha & Yuyoung Kim | Cloud Nine | 352 pages | 23,000 KRW