Tens of billions of serious illness digital therapy market, NMPA first certificate released!

Regarding the recent "digital therapy" that capital and the industry are chasing, the Eggshell Research Institute has conducted a comprehensive survey of the development of the domestic industry in the "China Digital Therapy White Paper 2.0: When the Wind Borrows Lightly, Enter the Sky in One Fell Swoop".

As of September 2021, a total of 73 Chinese companies are involved in digital therapy, with psychiatric disorders, behavioral and cognitive impairments being the most competitive tracks, followed by endocrine, nutritional and metabolic disorders including diabetes, and the least popular in the field of oncology.

Digital Therapy Industry Pictures (Icon Source: Eggshell Research Institute)

Digital therapy for oncology diseases, which few people have set foot in, actually has a huge clinical unmet need. The number of patients with more than 4 million cases of malignant tumors every year, complex treatment plans, constantly updated clinical knowledge, lack of oncology science and education resources, weak out-of-hospital infrastructure... Each factor is driving the digital transformation of the oncology process.

Zhongxi Medical Technology (formerly "Digital Healing Medical Technology"), a subsidiary of Zero Kr Technology, confirms the significance and importance of digital medicine in the field of oncology.

Founded in 2020, Zhongxi is headquartered in Wuxi iCampus Park, relying on government industrial policies and medical technology ecosystem, with patient benefits as the center and evidence-based medicine as the support, and is committed to creating a full life cycle management solution for tumor patients through digital therapy. Recently, the company's first digital therapy product, TH-002, was approved by NMPA, becoming the first specific digital therapy product for patients with early-stage lung cancer in the mainland and even in the world.

After receiving this news, Arterial Network interviewed Chen Kaishen, founder and CEO of Zhongxi Medical Technology, for the first time, to try to solve the following problems:

1. What new solutions does digital therapy bring to tumor management?

2. What business model should digital therapy use?

3. Where is the trend of digital therapy?

Two challenges faced by traditional follow-up

The accelerated postoperative rehabilitation management of tumor patients is empowered by digital therapy, which solves the two core problems of out-of-hospital management of tumor patients after discharge.

The first is the standardization of the follow-up system. In the domestic medical system, there is a contradiction between the excessive number of patients with chronic diseases and the relatively small number of professional medical resources, so hospitals often outsource about 2/3 of the follow-up work to third-party enterprises that can carry follow-up visits, covering all patients' out-of-hospital follow-up as much as possible. Due to the uneven capacity and level of third-party institutions, there are often differences in the mode and target identification of different entities, and it is difficult to ensure the consistency and integrity of the follow-up results.

Second, there is a visiting vacuum between the follow-up procedure and the patient's need for out-of-hospital intervention. Follow-up visits conducted by graduate students and attending physicians in the department are often for scientific research purposes, there is a fixed frequency of visits, and the form of follow-up is often based on scales; follow-up by the hospital's own follow-up center as the main body mainly undertakes follow-up reminder work, or simple disease inquiry.

However, from the patient's point of view, whether it is early postoperative complications or adverse reactions caused by medication, abnormal events will not follow the arrival of the follow-up time point. On the contrary, patients always want to get high-quality feedback and suggestions at the first time they find problems, and always want to get feedback on the effectiveness of "sense of gain" in daily treatment. Under the current mechanism, both of these needs are difficult to meet, which leads to a gradual decrease in patient compliance over time, and is likely to have a direct negative impact on the quality of life and even the life cycle of patients.

The emergence of the Internet has been regarded by pioneers of chronic disease management as a breakthrough solution to the dilemma of chronic disease management. Theoretically, the number of chronic diseases is large, the duration of the disease is long, the causes are complex, the cumulative cost of treatment is high, and frequent doctor-patient exchanges are required. Conventional offline systems are difficult to carry massive management needs, and the Internet is indeed one of the reasonable means to solve the management of chronic diseases, but this is not all.

In the white-hot period of the "100 Sugar Wars" in 2015, more than 700 apps focused on diabetes management, but few finally ran out. In the end, this innovation in communication methods still does not solve the problem of adherence to diabetes management, and does not fundamentally help patients benefit. After all, patients don't pay for the process, they're only willing to pay for the outcome.

How can I improve compliance and how can I really benefit my patients? The increased sense of patient participation in management and self-management under digital therapy may be the key.

What kind of digital solutions does Zhongxi bring?

The essence of Zhongxi digital therapy is a set of integrated treatment programs based on artificial intelligence, big data, Internet of Things and other technologies, and its carrier is out-of-hospital patient management software, which can provide tumor patients with integrated out-of-hospital treatment and rehabilitation management under the category of "big medicine" such as symptom monitoring and intervention, medication management, rehabilitation training, and psychological and nutritional support. On the one hand, it improves the awareness and compliance of tumor patients with standard treatment in the context of precision treatment, and on the other hand, it improves the efficiency of patients' out-of-hospital intervention and management (compared with traditional Internet medical treatment. Arterial Network has mentioned that the essence of Internet medical treatment is connectivity, but the essence of digital therapy is treatment), which ultimately improves the treatment benefits of patients.

Chen Kaishen gave such an example in an interview: "Patients often have chest tightness, shortness of breath and other symptoms due to the reduction of respiratory units after undergoing lung tumor surgery, which in turn affects their daily functions and lives. Patients are individually instructed to carry out lung function-related training according to their specific situation to help them better achieve rapid recovery of lung function. Under normal circumstances, patients will follow the doctor's instructions for a certain degree of training, but only if there is no accurate guidance feedback for training, patients will not be able to adjust the exercise mode, and as the enthusiasm for exercise slowly disappears, it is difficult to achieve their recovery and prognosis. ”

"There is an adaptive module in Zhongxi's digital therapy product TH-002, behind which is an artificial intelligence model trained using massive data to assess the physical state in daily units according to the patient's basic situation, symptom feedback, and degree of achievement, and generate the next day's task based on this information and assessment conclusions." The advantage of this approach is to establish a precise and rapid feedback mechanism, and patients can see that their efforts have reaped the results and that their bodies are getting better day by day under their own efforts. In other words, the patient's transition from passive participants to active managers is the key to really running through chronic disease management. ”

As a medical device, digital therapy must also meet the needs of efficacy, so as to truly solve the problem of the clinical side. "Through the patient's personalized task setting and the patient's high degree of cooperation, when the patient returns to the hospital for review, the indicator of 1 month after surgery can often reach the level that it takes 6-12 months to achieve without software intervention." The achievement has also been recognized by the state. Last year, we and Peking University Cancer Hospital jointly applied for the MINISTRY of Industry and Information Technology's AI+5G patients' full-course lung cancer patient management project, which became a pilot project of the Ministry of Industry and Information Technology in this field. In the future, we will continue to make efforts to manage patients' problems hierarchically and hierarchically through the real-world application of products, thereby greatly improving the management efficiency of clinical teams. This performance is particularly valuable in today's world of scarce professional medical resources. ”

What business model should digital therapy use?

As the source of digital therapy, the United States is pushing its commercialization faster than at home. Specifically, many digital therapy companies have partnered with commercial insurance companies to encourage doctors to prescribe digital therapy to patients during follow-up. If the patient does not follow the prescribed steps for exercise or medication, the commercial insurance agency may refuse to pay on this basis.

Looking at the rationality of the plan alone, the way of cooperation with insurance companies can not only ensure that patients are forced to participate in the management process of chronic diseases, but also give patients incentives to implement digital therapy with the help of clauses, but at present, it is difficult to reproduce this model in China.

At present, the development of domestic commercial insurance is still one of the key factors. To form such a model, insurance companies must cooperate with hospitals, digital therapy companies, and require patients to participate in the digital therapy prescription issued by the hospital, which is a difficult thing to do today when the concept of digital therapy has not yet been popularized, and it requires insurance companies to spend a lot of money to promote cooperation and promote products.

The lack of product access is the second key factor. Due to the innovation of digital therapy itself, after completing market access, enterprises also need to declare price access in various provinces and cities, and they do not have the ability to "prescribe" until they enter the hospital directory. It takes longer to enter the medical insurance directory and achieve the most ideal price for volume.

For Zhongxi, the NMPA-certified digital therapy for lung cancer can go very quickly in commercialization. Zero Kr Technology is engaged in linkCare services for cancer management, lung cancer digital therapy can be directly added to the LinkCare system, to complete the zero krypton digital life cycle care platform, the formation of a service that covers patients from the discovery of lesions, to the diagnosis/consultation/consultation and treatment in the hospital, to the consultation/consultation, drug purchase/renewal, drug infusion/distribution, patient management/education, follow-up and even medical insurance/commercial insurance payment, etc., covering the full cycle of disease diagnosis and treatment; it can also cooperate with pharmaceutical companies. For example, a strategic cooperation framework agreement was signed with AstraZeneca to jointly explore the application of digital therapy in multiple scenarios such as disease treatment and out-of-hospital management, and find a new entry point for digital therapy.

But in any case, the most core scenario of digital therapy should still be the hospital.

In Chen Kaishen's view, the commercial insurance restrictions and incentive mechanisms in the United States are tools, and the key to digital therapy to be recognized by doctors and patients should still fall on its clinical value. Only when digital therapy itself has value can the commercialization of products run through the hospital.

In May 2021, zhongxi digital therapy model completed the world's largest multi-center real-world study (11958 cases of postoperative patients with stage I.-III.A non-small cell lung cancer) so far, validating the value of digital therapy in clinical evidence-based research, and improving patient survival rate by means of patient management and follow-up. The results were also presented at the World Lung Cancer Congress 2021.

At the commercial level, the commercialization of Zhongxi's lung cancer digital therapy products may only be a matter of time. According to Chen Kaishen, Zhongxi's digital therapy products have now opened the price access application process in many provinces and cities.

Where is the digital therapy trending?

The out-of-hospital portion has always been a blank space in the care chain, and even in the NCCN (National Comprehensive Cancer Network) guidelines, only a small part of the content is about the description of patient care or follow-up.

The advent of digital therapies now fills this area well, and with the help of this digital tool, the once-non-mandatory mandate of doctors has been transformed into an active connection between doctors and patients, and the two sides will jointly take a key step from hospital treatment to continuous treatment and management.

It took Nearly two years to develop TH-002, a digital therapy product that addresses the comprehensive treatment problems behind lung cancer. Now sitting on the zero krypton tumor big data platform and TH-002 clinical and approval experience, the process of switching from lung cancer to other cancers will be faster and more effective; according to Chen Kaishen, in the future, Zhongxi will fill in the treatment blank area of more cancer species in digital therapy to benefit more tumor patients.

At the same time, the success of TH-002 in the field of serious medical care has also made a good start for digital therapy. With the promotion of policies such as performance appraisal of tertiary public hospitals and the Thousand Counties Plan, the mainland medical system will have the ability to provide more adequate surgical supply. At that time, whether it is the first and second level surgery brought by the day surgery center or the three or four level surgery of the tertiary hospital, in order to ensure the efficient operation of the entire system, it is necessary to strengthen the postoperative follow-up of patients and avoid repeated admissions of patients as much as possible.

Under this trend, whether it is Zhongxi Medical Technology for oncology diseases, or other companies, there are opportunities to write a new chapter in postoperative follow-up and out-of-hospital patient management with digital therapy.

*Cover image source: 123rf