Opinion The Value of Digital Therapeutics (DTx)

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Junya Tsujii, Senior Researcher, National Institute of Biomedical Innovation Policy

1. Introduction

Digital Therapeutics ("DTx") is described as "digital products that provide evidence-based therapeutic interventions to treat, manage, and prevent diseases and other conditions. "1) It is expected to bring about significant changes in the current state of medicine and healthcare. For example, one of the features of DTx is the "acquisition of continuous daily data," which facilitates the management of patients' health status outside of hospital visits and enables filling in gaps in treatment without active intervention by healthcare professionals. In addition, "treatment intervention using digital technology" can provide new treatment options for patients who have had difficulty accessing timely and appropriate treatment due to external factors (e.g., place of residence, lack of specialist physicians) or patient characteristics (e.g., pregnant women, children). In addition, the "promotion of disease understanding through education" is expected to change patient attitudes toward treatment and lead to more active participation in treatment.

Currently, DTx are being developed in countries around the world, and three DTx have received manufacturing and marketing approval in Japan, starting with CureApp's "Nicotine Dependence Treatment Application and CO Checker". While several other DTxs are under development with the aim of obtaining the next manufacturing and marketing approval, discussions on a new pharmaceutical affairs and insurance reimbursement system that takes into account the characteristics of programmed medical devices ("SaMD"), including DTxs, are being carried out in parallel. In particular, the development of an insurance reimbursement system is an important issue that has a significant bearing on the business predictability of DTx development, and stakeholders from industry, government, and academia are discussing what the system should aim for.

The concept of evaluation of DTx in terms of medical reimbursement was summarized in the 2022 reform of the reimbursement system for insured medical materials, which states that "DTx shall be evaluated as a technical fee or a specified insured medical material in accordance with product characteristics" and "DTx shall be evaluated based on product characteristics, including reflection in facility standards, while keeping in mind the viewpoint of reforming the way physicians work. 2) "The evaluation shall be made based on the characteristics of the product, including reflection in facility standards, etc., while keeping in mind the perspective of reforming the way doctors work. However, it was pointed out at the general meeting of the Central Social Insurance Medical Council held on January 18, 2023, that "the evaluation system for programmed medical devices (SaMD) should be reviewed and the future of SaMD should be discussed" in preparation for the revision of medical fees in fiscal 2024 .3) Further review of the system is an urgent task. In response to the above, the Ministry of Health, Labour and Welfare (MHLW) has been working on the revision of the system of reimbursement for insured medical materials. 3) In response to the above, the SaMD working group was established under the organization specializing in insured medical materials, and has already begun to discuss how the system should be evaluated in terms of insurance reimbursement. In the second and third meetings of the working group, interviews were held with six industry organizations (AI Medical Device Council, Japan Digital Health Alliance, Japan Medical Venture Association, Japan Medical Device Industry Association, European Business Association, and American Medical Device and IVD Manufacturers Association). The discussions included clarification of evaluation criteria and evaluation axes for medical fees that take into account the unique value and characteristics of SaMD4, 5).

Thus, discussions are underway to appropriately evaluate the value of SaMD, including DTx, in the reimbursement system, but these discussions have only just begun. The author believes that in order for various values to be evaluated in the reimbursement system, both developers and recipients of DTx (patients, healthcare professionals, insurers, etc.) must (1) recognize values (presentation of specific values and common understanding of the importance of the values), (2) agree on values (agreement on the validity of the values that can be evaluated), and (3) evaluate the values (establishment of a specific value evaluation system). It is essential to be involved in the process of (1) recognizing value (presentation of concrete value and common understanding of the importance of value), (2) agreeing on value (agreement on the validity of possible values), and (3) evaluating value (establishment of a concrete value evaluation mechanism). However, at present, the "various values of DTx" are not necessarily well organized, and there is a lack of public awareness6).

This paper discusses the various values of DTx with reference to the cases of Germany, where many DTx are being developed in anticipation of the various values of DTx in the reimbursement system, and the United Kingdom, where the voices of a wide range of patient groups and medical experts are taken into account in the evaluation of medical technology.

2. current status of DTx in Germany and the UK

2-1. Germany

In Germany, with the enactment of the Digital Supply Act in December 2019, DTx approved as DiGA (German for digital health app) is now available to patients through public health insurance. In addition to compliance with the requirements for safety, fitness for use, data protection, information security, and quality (e.g., interoperability), proof of clinical efficacy ("positive care efficacy") is required to obtain approval. However, proof of positive care effect is not required at the time of initial application. If the evaluation in the literature and the study plan for positive care effect are approved, reimbursement will be made in the form of provisional registration for a fixed term (usually 12 months, but maximum 24 months). During this period, developers are required to demonstrate positive care effects using clinical trials and real-world data.

Positive care effects, which can be described as the value component of DTx in Germany, can be divided into two main categories: "medical benefits" and "improvements in patient-related structures and processes" (Table 1). According to the DiGA guidelines of the Federal Institute for Drugs and Medical Devices (BfArM), "medical benefits" are treatment benefits that can be demonstrated in clinical trials, etc., while "improvements in patient-related structures and processes" are defined as benefits that support patient health behaviors in the detection and treatment of diseases and disorders, as well as benefits related to the integration of processes between patients and healthcare professionals. 7). In addition, as will be discussed in more detail in section 3, the guidelines provide examples of 4 and 9 specific value elements for "medical effectiveness" and "improvement of patient-related structures and processes," respectively (Table 1). These value elements are based on the assumption that the value is directly enjoyed by the patient (i.e., directly perceived by the patient) and must be demonstrated by appropriate endpoints.

In order to be approved as a DiGA, at least one of the value elements included in either "medical effectiveness" or "improvement of structures and processes relevant to patients" must be demonstrated. In other words, proof of "medical effectiveness" is not required; as an example, ProHerz, which aims to assist heart failure patients in self-management and early detection of deteriorating health status, only included one element of "improvement of patient-related structures and processes" - "alignment with guidelines and recognized treatment standards" was the only one that was subject to validation. However, proving multiple value elements from both positive care effects has been shown to have a potentially positive impact on reimbursement prices.

Table 1 Germany: Summary of positive care effects required for DiGA approval

Reference: Status of DTx development in Germany

In order to investigate the value factors of DTx in Germany, we would like to provide a bird's eye view of the DTx (DiGA) development status in Germany as background information: according to information from the DiGA Directory, there were a total of 47 DiGA products approved as of May 24, 2023, with positive care efficacy proven at this time There were 18 products (including 7 products that were transferred from provisional registration to full registration) and 29 products on provisional registration (Figure 1) 8). Looking at each year, more than 10 products were approved each year. In addition, approximately three years after the start of the application process in May 2020, seven products had moved from provisional registration to full registration, while six products had been removed from registration (four products were unable to prove positive care efficacy and two products were removed due to manufacturer intent). In addition, many of the targeted disease areas (classified according to ICD-109) ) were mental and behavioral disorders (e.g., depression, plasmaphobia) and musculoskeletal and connective tissue (e.g., arthropathy, back pain), and similar characteristics were observed from year to year.

Figure 1 Germany: DiGA development status

2-2. the United Kingdom

In the United Kingdom, the "Evidence standards framework for digital health technologies" published by NICE (National Institute for Health and Care Excellence) defines the evidence standards that DTx must meet10) . DTx falls into Tier C (used for disease treatment, management, diagnosis, etc. with direct impact on health), which is considered to have the highest potential risk to users and systems, and includes design elements (e.g., compliance with appropriate technical standards for safety and reliability), value statements (e.g., value of DTx compared to standard care systems), and performance measures (e.g., performance of DTx compared to standard care systems). DTx must meet 21 criteria in five categories: design elements (e.g., compliance with appropriate technical standards of safety and reliability), description of value (e.g., value of DTx compared to standard systems of care), demonstration of performance (e.g., evidence of effectiveness through clinical trials), value delivery (e.g., cost effectiveness), and implementation considerations (e.g., strategies for realizing the benefits of DTx). 11). The criteria also include factors other than effectiveness and safety; for example, "Description of Value" includes system efficiency and outcomes of care, structural and procedural effects, and cost/resource impacts (quantified where possible) 12). Structural and procedural effects may include access to care, health literacy, adherence to care plans, or coordination of care, and similar values to "patient-related structural and process improvements" in Germany may be considered in the UK.

It should be noted, however, that meeting the above evidence criteria does not directly lead to adoption within the UK insurance system. NICE is also involved in the preparation of "Medtech innovation briefings (MIBs)," which provide information on new medical technologies, including DTx, to assist the National Health Service (NHS) and medical institutions in making decisions on the adoption of such technologies, and "medical technologies guidance (MTG)," which provides the basis for recommendations on the adoption of medical technologies in the NHS. The MIB and MTG are important for the use of DTx in the NHS. For example, Sleepio, a DTx for the treatment of insomnia, became the first DTx to be recommended by NICE as an effective alternative to sleeping pills, based on the results of its evaluation in the MTG (released on May 20, 2022 )13). In addition, in terms of promoting access to promising DTx, in priority areas of health and social security and in areas appropriate for national evaluation, NICE evaluates medical technologies that address unmet needs of the population and gives recommendations to support early patient access, called Early Value Assessment ( EVA)" has been launched14). This system is similar to Germany's Fast Track in that it does not require complete evidence for evaluation (evidence is generated from real-world data after clinical use, etc.). When a drug is "recommended for use," it is allowed to be used in clinical practice for a limited period (e.g., three years), and as of the end of May 2023, more than 10 DTx products in three therapeutic areas had been recommended for use.

In evaluating MIB, MTG, and EVA, in addition to medical effectiveness and economic cost, the evaluation is characterized by taking into account the real voices of non-patients such as patient groups (including family members) and medical professionals (physicians, etc.) As described in section 2-1, the evaluation of DTx in Germany is based on the value "directly" enjoyed by the patient. In order to properly understand the various values that DTx brings, it is essential to consider not only the values directly enjoyed by patients, but also the values that spill over to society at large from multiple perspectives. It can be said that the UK is making progress in considering the value of DTx.

3. what is the value of DTx?

In order to share a common understanding with readers, I would like to first present an overall picture of the "value that DTx brings" as I see it (Figure 2). The author classifies the value of DTx from the viewpoint of its beneficiaries into two broad categories: "value directly felt by the patient" and "value that spreads to the patient's surroundings," organizing the former as "medical value" and the latter as "social value. Furthermore, "medical value" was classified into "therapeutic value" based on efficacy and safety, and "supportive value" that optimizes the treatment process structurally and processually, and contributes to improving treatment effectiveness or expanding treatment opportunities and self-management capacity.

From here, we will discuss each of these values in detail with reference to the cases in Germany and the U.K.

Fig. 2 Overall picture of the

3-1. Medical Value

3-1-1. Therapeutic Value

DTx is "a digital product that provides evidence-based therapeutic interventions to treat, manage, or prevent diseases," and one of its main purposes is "disease treatment. Efficacy and safety, which are related to the essence of treatment, are core elements of the value that DTx brings, and in this paper, the value based on efficacy and safety is described as "therapeutic value.

As an element of value related to the efficacy of DTx, we believe that "medical effectiveness" in Germany is applicable. The four outcomes considered as "medical effectiveness" are (1) improvement of health status, (2) reduction of morbidity, (3) prolongation of survival, and (4) improvement of quality of life (Table 1).

3-1-1-1. Examples Related to Therapeutic Value

Efficacy: Improvement of health status

A survey of the 47 products currently approved (full or provisional registration) in Germany to determine which medical effects were subject to verification showed that 43 products (91%) verified improvement in health status. Specific items verified included reduction of disease-related symptoms such as anxiety, depression, and pain, as well as improvement in smoking status, weight, HbA1c, and other disease-related indicators (Table 2).

Efficacy: Improvement of quality of life

Nine of the 47 products (19%) demonstrated improvement in quality of life, and an additional six demonstrated improvement in health status. The remaining three products (indications: breast cancer, multiple sclerosis, and endometriosis) were only considered to improve quality of life, and the improvement in quality of life associated with management or improvement of disease-specific dysfunctions (pain, sleep disturbance, etc.) and psychological disorders (anxiety, helplessness, etc.) were verified.

Table 2 Germany: Verification of Medical Effectiveness

Reference: Efficacy: prolongation of survival

One of the medical benefits that was not observed as a demonstrated case in the DiGA was "prolonged survival". As a point of reference, several cases exist in DTx in oncology, which are not registered as DiGAs. For example, Moovcare, the first application reimbursed in France, analyzes the risk of cancer recurrence and complications based on symptoms entered weekly by lung cancer patients, and prompts doctors to consider consultations and tests when specific changes are deemed to indicate high risk. Moovcare has been proven to improve the 1-year survival rate by approximately 30%15) and prolong overall survival by 7.6 months16). Similarly, Kaiku Health, an application that shares cancer patients' symptom records with physicians and others for appropriate treatment management, has an algorithm designed based on research showing that the use of electronic patient-reported outcomes increases median overall survival by 5.2 months17). On the other hand, while not specific to oncology, a meta-analysis of several clinical trials found that digital health interventions significantly reduced all-cause (10.2% to 8.5%) and cardiovascular (9.6% to 7.3%) mortality rates18).

Safety

Safety includes not only the safety of the DTx itself (its eligibility as a medical device), but also the invasiveness of the DTx to the human body, which is generally considered to be low because the DTx is a device certified as a medical device and is not expected to act directly on the body due to intervention via an app, etc. The physical invasiveness of the device is low. It should be noted, however, that safety concerns remain, as inappropriate information or interventions (effective for one patient but not for another) provided to an individual may have adverse physical and mental effects.

3-1-2 Supportive Value

As mentioned in the introduction, DTx has the characteristics of "routine continuous data acquisition," "treatment intervention using digital technology," and "promotion of disease understanding through the provision of education. By taking advantage of these characteristics, DTx will not only contribute to the provision of treatment effects, but will also bring value through "optimization of a series of treatment-centered processes," such as disease management through data, provision of new treatment options using digital technology, and promotion of active participation in treatment by changing patient awareness toward treatment. The author believes that there is value to be gained through the "optimization of a series of treatment-centered processes. In this paper, "supportive value" is defined as the value that optimizes the treatment process in terms of structure and process, and contributes to "improving treatment effectiveness" or "expanding treatment opportunities and self-management capabilities.

As an element of supportive value, we would like to consider the "improvement of patient-related structures and processes" in Germany as a basis. Improvement of patient-related structures and processes" includes (1) coordination of treatment procedures, (2) consistency with guidelines and recognized treatment standards, (3) adherence, (4) promotion of access to treatment, (5) patient safety, (6) health literacy, (7) patient independence, (8) coping with disease-related difficulties in daily life, and (9) reduction of treatment-related labor and burden for patients and their relatives. (A summary of each value element is provided in Table 1). Based on these value elements, the author believes that two perspectives are important when considering supportive value: "contribution to improved treatment effectiveness" or "contribution to expanded treatment opportunities and self-management capacity (e.g., prompt treatment access, favorable treatment course). From these perspectives, Table 3 classifies the nine value elements involved in "improving patient-related structures and processes" in Germany. From here, based on the classification in Table 3, the author will consider the value that DTx brings to "improving treatment effectiveness" or "expanding treatment opportunities and self-management capacity.

Value contributing to "improved treatment efficacy

As shown in Table 3, of the nine value factors in Germany, we consider that all of the eight value factors except "promotion of access to treatment" are value factors that contribute to the improvement of treatment effectiveness.

For example, value factors such as "coordination of treatment procedures" and "alignment with guidelines and recognized treatment standards" are expected to improve communication with healthcare professionals through data obtained on a daily basis, as well as to provide appropriate intervention, including during gaps in treatment, to provide personalized treatment and prevent serious illness through early intervention. The data is also expected to provide personalized treatment and prevent serious illnesses due to early intervention. In addition, "patient safety" will enable early detection of severe events and rapid identification of undesirable events by the patients themselves (or their families) through real-time disease management via data.

In addition, the ability for patients to enjoy treatment consistent with guidelines and recognized standards of care (equivalent treatment) anywhere in the country through the use of routine continuous data and therapeutic intervention using digital technology is expected to lead to the equalization of the quality of care (assurance of quality of care).

In addition, "adherence," "health literacy," and "patient independence" will promote disease understanding through the provision of appropriate education to patients, which will lead to their active participation in treatment and ensure a successful outcome. Similarly, "coping with disease-related difficulties in daily life" and "reducing treatment-related labor and burden on patients and relatives" can be said to enhance treatment effectiveness by improving resilience to disease-related difficulties and burdens in daily life through education on appropriate coping methods and disease understanding.

Value contributing to "expansion of treatment opportunities and self-management capacity

In this paper, the value that contributes to "expansion of treatment opportunities and self-management capacity" refers to the value of ensuring access to appropriate treatment in accordance with the patient's wishes, reducing treatment-related burdens, and bringing about a favorable course of treatment (maintenance of health in the prognosis). As shown in Table 3, among the nine value elements in Germany, "promotion of access to treatment," "health literacy," "patient independence," and "reduction of treatment-related effort and burden on patients and relatives" are considered as elements contributing to this value.

For example, "promotion of access to treatment" will enable the provision of new treatment options to patients who have had difficulty accessing appropriate treatment due to their place of residence or patient characteristics (e.g., pregnancy, resistance to treatment, etc.). In addition, "Reducing treatment-related labor and burden on patients and relatives" is expected to provide prompt access to treatment via digital technology such as apps for patients with mental illnesses who have been forced to wait a long time before starting treatment due to a lack of specialist doctors, etc.

In addition, "health literacy" and "patient independence" will bring patients to change their awareness of diseases and practice healthy behaviors through the provision of appropriate education. In other words, DTx may be expected not only to restore patients' physical and mental conditions that have declined due to the disease to their pre-disease state, but also to strengthen them and prevent the recurrence and severity of the disease through the improvement of their health literacy and independence (sense of self-efficacy). In practice, it will be necessary to verify the relationship between the improvement of health literacy and patient independence and the maintenance of health (prevention of recurrence, etc.) in the prognosis, but it can be said that these are valuable factors that lead to good treatment outcomes.

The "improvement in patient productivity," which was observed in the case of "coping with disease-related difficulties in daily life" described below, is a value directly perceived by patients as a result of treatment, and can be considered one of the "medical values (supportive values). However, labor, housework, childcare, etc., which are the subject of productivity, affect the patient's surroundings to varying degrees. Therefore, the improvement of patient productivity can be said to be a value that has a ripple effect on society, and in this paper, it is organized as one of the "social values.

Table 3: Contribution of each factor to the supportive value considered by the author

3-1-2-1. Examples Related to Supportive Value 3-1-2-2.

From here, specific verification cases related to supportive value will be reviewed, including outcomes for each value element.

In the 47 products currently approved in Germany, the validation cases related to supportive value (cases related to "improvement of patient-related structures and processes") are: alignment with guidelines and recognized treatment standards: 1 product, health literacy: 2 products, patient independence: 3 products, coping with disease-related difficulties in daily life: 2 products, and related difficulties in daily life: 2 products, and reduction of treatment-related effort and burden on patients and relatives: 1 product (Table 4, when multiple value factors were applicable to the same product, they were counted separately).

Table 4 Germany: Validation cases related to supportive value

Alignment with guidelines and recognized treatment standards

Alignment with Guidelines and Recognized Standards of Care is a value factor that ensures that treatment is consistent with guidelines and recognized standards, even when the patient is not face-to-face with the physician.

ProHerz, which aims to implement guideline-based treatment and prevent/early detection of serious illness, etc., supports heart failure patients' self-management through the recording of daily vital data and, via digital technology, provides personalized health coaching and other services for the prevention of serious illness. In the validation of ProHerz, the outcome is the degree of self-care behaviors (behaviors to maintain life, healthy functioning, and well-being) of heart failure patients. Although not subject to verification of positive care effects, the study also states that the provision of treatment consistent with guidelines and recognized standards of care contributes to improved health and quality of life for patients.

Health literacy

Health literacy is a value component that promotes understanding and implementation of information and ensures successful treatment by providing customized medical and other information commensurate with the target population.

edupression.com is a DTx designed to improve knowledge about depression and reduce symptoms by providing online-based psychoeducation for depressed patients. For the health literacy validation, the outcome is "the ability to recognize depression and make informed decisions about treatment," which is expected to contribute to the reduction of depressive symptoms. In addition, it has been suggested that increasing patient knowledge of depression may positively impact the course of the illness, reducing the probability of recurrence by up to 50%19).

Cara Care for irritable bowel syndrome also states that one of the benefits of Cara Care for irritable bowel syndrome is to improve patients' health literacy, which is necessary for successful treatment through the provision of individualized psychoeducation. The study's outcome is "the ability to access, understand, evaluate, and apply information in health care, disease prevention, and health promotion." The study found that improved health literacy contributes to the alleviation of irritable bowel syndrome and comorbid symptoms (anxiety, depression) and to improved quality of life.

Patient independence

Patient independence is a value component that effectively helps patients engage in their own health-related decision-making process by practicing and enhancing independent health behaviors.

Mindable helps patients manage their illness by sharing self-recorded symptoms, events, and behaviors with their physicians and others, and improves their self-efficacy and anxiety-related control skills by providing appropriate psychological education. With "perception of control related to depressive and anxiety symptoms" as the outcome, it has been validated that patient independence contributes to symptom reduction in square phobia and panic disorder.

Based on cognitive behavioral therapy, VORVIDA helps patients develop skills to manage their own drinking behavior and reduce their alcohol consumption. Through this process, one of the goals is to increase self-efficacy and prevent relapse. In this validation, the outcome is "an individual's confidence in his/her ability to avoid drinking (against temptation) under certain circumstances," which contributes to a reduction in alcohol consumption.

Kranus Edera, which is used to treat impotence due to organic causes, also supports active participation in treatment by patients through physical training, psychological support, and education about the disease. The study will test the effectiveness of Kranus Edera by using "knowledge, skills, and confidence in managing one's own health and wellness" as an outcome, and the study will demonstrate that patient independence contributes to improved erectile dysfunction and quality of life.

Coping with disease-related difficulties in daily life

Coping with Disease-Related Difficulties in Daily Life" is a value component that helps patients reduce and overcome daily difficulties related to their disease.

The My Tinnitus App has been validated using "changes in mood and behavior (relaxation/tension, mood, self-esteem, social interaction, meaning, and ability to act) associated with treatment" as the outcome, and provides tinnitus-specific psycho-education and self-management instructions to patients to reduce tinnitus symptoms, distress and stress. The study states that it will result in a reduction in tinnitus symptoms, distress, and stress.

Cara Care for irritable bowel syndrome, on the other hand, uses "work productivity and impairment to daily life" as an outcome and states that it will have a positive effect on the productivity of work and daily life activities that have been reduced due to the disease (irritable bowel syndrome). Note that, as mentioned above, this paper organizes the improvement of patients' productivity as one of the "social values.

Reduction of treatment-related effort and burden on patients and relatives

The "reduction of treatment-related effort and burden for patients and relatives" is the value component of saving time and effort and reducing avoidable physical or emotional burden for patients and their families.

VELIBRA aims to help patients reduce anxiety symptoms and other symptoms by providing information on cognitive-behavioral therapy-based coping strategies and relaxation exercises for square phobia and other disorders. In clinical trials, the study is validating "the level of psychological distress in people with psychological problems in general" as an outcome, and it is assumed that reduction of disease- and treatment-related psychological stress leads to improved health status (reduction of anxiety and depressive symptoms).

Promoting access to treatment and reducing treatment-related effort and burden on patients and relatives

The two value elements listed here contribute to the prompt provision of appropriate treatment for each patient by improving accessibility of treatment and reducing the waiting time for patients to receive treatment. Although we could not find a case study in Germany that verified these factors, we would like to refer to a related evaluation case study in the United Kingdom.

Sleepio, which is used for insomnia, has the advantage of providing pregnant women with insomnia with an alternative option that does not involve the use of drugs20). Daylight, which is used to treat generalized anxiety disorder, is expected to provide treatment opportunities for those who do not wish to speak with a medical professional, and to reduce waiting time for treatment by supporting the implementation of cognitive behavioral therapy, which used to require intervention by a specialist21).

3-1-2-2. Organizing Supportive Value 3-2-2.

Based on the above, the supportive value that the author believes can be brought by DTx is summarized in Figure 3. Nine value elements related to "improvement of patient-related structures and processes" in Germany were defined as elements of supportive value, and the supportive value of DTx was established from the outcomes brought about by each element. Of these, the values circled by solid lines are those that contribute to "improved treatment efficacy" and those circled by dashed lines are those that contribute to "expanded treatment opportunities and self-management capacity.

Figure 3: Supportive value of DTx in the author's opinion

Social Value

The author believes that, as well as medical values, values that spill over into society through the use of DTx (social values) should also be recognized as values brought about by DTx. Referring to a case study of the evaluation of medical technology in the United Kingdom, the author would like to summarize the social value from the viewpoints of family members (family caregivers), medical professionals, and insurers.

Value from the family (family caregiver) perspective

As a value from the family (family caregiver) perspective, "reduction of caregiving burden" is mentioned in the case of pharmaceuticals .22) Similarly, DTx is expected to reduce the burden of family caregiving through early health recovery associated with treatment, etc. On the other hand, DTx has features not found in pharmaceuticals, such as symptom management through continuous monitoring and remote treatment intervention. On the other hand, DTx has features not found in pharmaceuticals, such as symptom management through continuous monitoring and remote therapeutic intervention. For example, in Dexcom G6, a real-time blood glucose monitoring system, patient groups have shown the possibility of reducing the burden on parents and caregivers of children with diabetes by reducing the need for nighttime (midnight) blood glucose testing through the alert function for hypoglycemia23). In addition, it has been noted to reduce the anxiety that parents and caregivers may experience when they are away from their diabetic child, and these are values that may reduce the psychological burden on the family. In addition, the EVA for "Guided Self-Digital Cognitive Behavioral Therapy for Children and Adolescents with Mild to Moderate Symptoms of Anxiety or Depressed Mood" recommends the use of four types of DTx and notes that telemedicine with these DTx will increase treatment access for patients in rural areas where public transportation is poor and parents cannot drive to and from 24). While the main perspective is to provide a new treatment option for previously untreated patients, it may also be said to reduce the burden on family caregivers who have to accompany patients on long trips for face-to-face treatment.

Value from the perspective of healthcare professionals

One possible value from the healthcare provider's perspective is the "efficiency of healthcare resources. As a specific example, Space from Depression, which is used to treat depression, has been shown to reduce the therapist's response time required for a series of treatments by approximately 137 minutes25). In addition, d-Nav, an application that optimizes insulin dosage based on past and current blood glucose levels for type 2 diabetes, is mentioned as reducing the intervention of healthcare professionals in managing patients' blood glucose levels, allowing them to focus more time on areas other than diabetes management26). In addition, health care professionals have pointed out that Smart Peak Flow, which manages asthma patients' symptoms by monitoring maximum expiratory flow (peak flow), allows health care professionals to easily monitor patients' conditions and quickly respond to changes in treatment according to their conditions through the sharing of asthma data with health care providers27, 28). (27, 28).

Value from the insurer's perspective

One possible value from the insurer's perspective is "optimization of medical costs" through reduction of medication use and prevention of serious illnesses through the use of DTx. For example, Sleepio, which is used for insomnia, estimates that the reduction in office visits and medications can reduce costs by 4.52 pounds per person per year, or an estimated 90.08 pounds over three years, compared to usual care20, 29). In addition, the aforementioned diabetes management systems, Dexcom G6 and d-Nav, are expected to reduce healthcare costs by reducing the incidence of severe hypoglycemia and complications23, 26). In addition, the Lenus COPD Support Service, which remotely manages chronic obstructive pulmonary disease (COPD), is expected to reduce events of symptom exacerbations requiring hospitalization by sharing patient-reported outcomes, wearable devices, and other data with healthcare professionals30).

In considering social value, it is important to quantitatively demonstrate outcomes related to care burden and productivity, as well as reduced response time and costs compared to standard treatment, to gain the understanding of stakeholders. However, as in the U.K., it is also essential to consider the real voices of patient groups (including family caregivers) and medical professionals, who are the parties that enjoy the value, and to focus on the values that cannot necessarily be quantified.

3-3. organization of the value that DTx brings

Figure 4 summarizes the various values that DTx can bring. These two values are directly perceived by patients and are collectively referred to as medical value in this paper. Supportive value is defined as the value brought about by the elements involved in "improving patient-related structures and processes" in Germany, and is organized as 10 values that optimize the treatment process structurally and process-wise, and contribute to improving treatment effectiveness or expanding treatment opportunities and self-management capacity. The supportive values are based on outcomes brought about by the characteristics of DTx (e.g., routine continuous data acquisition, treatment intervention using digital technology, and promotion of disease understanding through the provision of education) and may be considered "DTx-specific values.

In addition to medical values, values that spill over to society through the use of DTx (improvement of social productivity, efficiency of medical resources, and optimization of medical costs) were also organized as values that should be recognized in the same way (social values). Some of these social values are also mentioned as values that should be evaluated in the same way for pharmaceuticals, and we believe that it will be important to take initiatives with reference to discussions on various value evaluations for pharmaceuticals.

Figure 4: The author's view of the value of DTx

4. Conclusion

In this paper, we have systematically organized the values brought by DTx into two broad categories, "medical value" and "social value," from the perspective of value recipients, with reference to the cases in Germany and the U.K. The values associated with each category are described below. As mentioned above, among medical values, "supportive values" related to optimizing the treatment process, improving treatment efficacy or expanding treatment opportunities and self-management capabilities are considered "DTx-specific values" brought about by the characteristics of DTx. In order to appropriately evaluate innovation and build an environment where innovative DTx can be continuously produced, it will be necessary to establish a system that takes into account not only therapeutic values such as efficacy and safety, but also "supportive value" and "social value," as described in this paper.

On the other hand, it is essential for the industry side to not only demand the evaluation of the various values of DTx in the reimbursement system, but also to create evidence to objectively evaluate the value of DTx and to properly communicate the value of DTx to the recipients. The first thing that industry should do is to present the various values of DTx in concrete terms and discuss the various values of DTx with stakeholders in industry, government, academia, and the private sector.

In the future, the values and their elements should be reviewed according to the new DTx that will be created as digital technology advances, and we hope that this report will help promote discussion of the various values of DTx.

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