Discussion on the Deployments of Digital Therapy — Four Major Aspects
According to the IQVIA 2021 Digital Health Trend Report, its trend analysis looks at four major aspects, Innovation, Evidence, Regulation, and Adoption
In this article, the discussions are based on these four aspects. Market adoption is the most critical challenge. Author considers that the prevalence of digital therapy is the trend, but IDS (Integrated Delivery Service) or IDN(Integrated Delivery Network) will be the most suitable environment to adopt such technology in the near future.
(1) Accelerating innovation of digital health tools
According to the IQVIA report, more than 350,000 health-related apps will be launched before 2021, and more than 90,000 health-related apps will be launched in 2020 alone.
Wearable products are also a driving force to accelerate the introduction of such apps.
But in author’s opinion, because of validating and evidence-based requirements, there is still a long way to go for wearable products to enter the field of DTx or DC (Digital Care).
On the contrary, he combination of some existing medical devices with the corresponding App, will enter the field of DTx and DC earlier than the wearable.
The reason lies in the regulatory and application threshold.
Regulatory Threshold
Since the medical device is related to safety of human life, the introduction of new technologies is relatively conservative. It has to go through various safety and performance verifications before it has the opportunity to go on the market.
Listing by competent authoring is actually just the minimum standard in terms of safety and performance. But the extent of performance is unknown.
In addition, because many health agencies adopt the principle of trusting the manufacturer, as long as the manufacturer’s experimental procedures are correct and the data looks reasonable, they seldom raise the issue.
However, the health authorities in some countries are not fools. They know that there will be false claim, so they will regularly invite third-party verification units to purchase products on the market, conduct sampling tests, and make public from time to time. These test reports will be a favorable evidence for some passing manufacturers.
In addition, some competitors in the same industry will purchase products from other competitors and send them to third-party verification units for testing. The most famous example is a company of the world’s largest brand of blood glucose machines, which regularly collects blood glucose machines sold in Europe.
Therefore, listing is actually just a low standard in terms of safety and performance. At least after various third-party verifications, with some feasible third-party verifications, it only means that the product is genuine.
Application Threshold
If you also need to prove that it is helpful in caring for/treating diseases, you also need Application Study. It is necessary to integrate medical materials and designated indications for clinical trials to prove that the use of this product can effectively improve related indications.
If it is to be adopted by insurance companies or even the government, the number and quality of experiments are also key factors.
(2) Advancing regulatory approval and commercialization
Recently NICE in the UK to introduce an insomnia treatment app, and Japan approved a digital therapy app for high blood pressure. In addition, the US FDA promoted the Pre-cert program to cope with changing digital medical products and AI/ML Framework approval regulations.
Fig 1 is from IQVIA. The report points out the regional distribution of digital therapy (DTx) that has passed regulatory approval, of which CE in the European Union accounts for 76.9%, followed by FDA in the United States at 34.6%. At the same time, about 15.3% of CE and FDA approved,
It is worth mentioning that these applications are mainly neuromedicine and physical and mental medicine, of which about 2/3 are in digital therapy DTx, and about 40% in digital care DC, some of which are endocrine, cancer, cardiovascular diseases, etc. Caregivers will also use cognitive behavioral therapy (CBT) as part of their treatment. [1]
In fact, the biggest obstacle to the inability of early-stage advanced medical materials to be marketed is the lack of supporting regulations by competent authorities. After 10 years of interaction between manufacturers and regulatory agencies, significant progress has been made.
(3) Growing maturity of clinical evidence
There are several levels of clinical evidence generation, observational study (Observational study), randomized controlled trial (randomized controlled trial, RCT), systematic literature review (Systematic Review), and meta-analysis (Meta-analysis):
Observational study : Used to measure the efficacy of an intervention in a non-experimental “real situation”. Observational studies cannot be used as a reliable source of “safety, efficacy, or effectiveness” (safety, efficacy, or effectiveness) of medical practices, but they can still provide some relevant information:
These studies can:
1) provide information about the actual use and practice of medical practices
2) examine the benefits and risks of using specific medical practices in the general population
3) help to establish hypotheses that can be confirmed in subsequent experiments
4) provide Community-level data can be used to design more informative practical clinical trials
5) to provide relevant information for clinical practice.[2]
Randomized controlled trial (RCT): It is currently the gold standard for testing new drugs or therapies, and tests the efficacy and safety of new products before they go on the market.
“Randomized” means that the researcher randomly assigns subjects to the experimental group (receiving the treatment to be tested) or the control group (not receiving the treatment to be tested); Another group of people received a placebo or sham treatment as a reference.
Through the existence of “random allocation” and “control group”, the experimental bias can be reduced, and the reliability and validity of the test results can be ensured. [3]
Systematic Review: It is an evaluation of the existing literature in the problem, using rigorous, highly reproducible, and least error-causing methods to systematically search, identify, select, evaluate, and synthesize research topics relevant information. Systematic literature review is considered to be the best source of research literature, and it is a key existence for evidence-based medicine. This method is also recommended in other fields. [4]
Meta-analysis: A review procedure that uses statistical techniques to synthesize the results of previously independently performed studies. Integral analysis In order to unify the findings, first collect a large number of individual research results, and then perform statistical analysis to seek general conclusions; discuss the causal relationship and narrative of the research, and propose alternative treatments, so as to expand the scope of the research literature significance. [5]
In terms of evidence strength, meta-analysis>systematic literature review>randomized controlled trials>observational trials.
Randomized controlled trials and observational trials are single trials, which can be regarded as point descriptions, while meta-analysis and systematic literature review are to explore the phenomenon of the entire group, because the more evidence, the higher the reliability.
Therefore, in Fig. 2, the number of digital health efficacy studies published from 2007 to 2020 is discussed, and the indicator of maturity is the proportion of all studies using combined analysis and systematic literature review.
Looking at the chart, the maturity level is growing gradually every year, reaching 14% by 2020.
Fig. 3 makes a more microscopic analysis of the overall maturity. The abscissa is the maturity of the evidence, and the ordinate is the positive degree of the result. This figure shows the degree of evidence for various indications.
(4) Overcoming barriers to adoption
With regulatory approval and sufficient clinical evidence, the next biggest challenge is market adoption.
From the perspective of Fig 4, there are four main types of business models for this type of product
(1) Directly to consumers (Direct-to-Consumer): Like a general app, it directly faces customers after it is put on the shelf, and the user pays directly, or the health care provider provides relevant information, such as QR code, and recommends patients to pay at their own expense use.
(2) Insurance benefits in the form of medical materials (“Device-Like” Reimbursement, (Medical Benefit)): As in some countries, certain medical materials are covered by health insurance, and the relevant policies of the country are followed.
(3) “Drug-Like” Reimbursement, (Pharmacy Benefit)): This part is mainly related to the environment in the United States. If it is positioned as a drug, it may be related to PBM (pharmacy benefit manager). According to According to the American Pharmacists Association, “PBM is mainly responsible for the development and maintenance of the formulary, contracting with pharmacies, negotiating discounts and rebates with pharmaceutical companies, and processing and paying for prescription drug claims.” [6]
That is to say, the payment conditions will be related to PBM.
(4) Value-Based Contracting: Here is the most suitable example. In the United States, there is a composite organization of insurance companies and medical care, called IDS (Integrated Delivery Service) or IDN(Integrated Delivery Network) [7]. Kaiser Permanente is one of the representative model.
Because insurance and medical care are in the same system, from an insurance point of view, we will always pursue the best medical effect without wasting insurance expenditures. This kind of unit attaches great importance to Fee for Performance (payment based on results). The general medical unit is Fee for Service (billed by service).
The biggest difference is that billing for services often indiscriminately prescribes surgeries to increase income. This is also the reason why medical insurance in many countries is about to go bankrupt. The outcome-based billing is based on the patient’s health status. This is also a solution in view of the abuse of medical resources. But it can only be implemented in institutions similar to this IDS/IDN.
Take a certain IDN as an example. Because this IDN adopts Fee for Performance in the cardiovascular department, patients receive effective care and the need for surgery is reduced. Therefore, the income of the unit for surgery has been greatly reduced, but from the insurance department of the institution, it was found that the money saved by this unit from the insurance expenditure was greater than the previous operation income, so the expenditure for the entire institution was saved, so the doctors in this department still received bonuses as rewards.
Therefore, this kind of approach has the means of proving the curative effect and can save unnecessary medicine expenses. For IDS/IDN institutions, it is very profitable.
It is worth mentioning here that products such as DC have a low probability of falling into medical device or drug payments, so IDS/IDN is the most suitable application field.
Observations
In the past ten years of development, many DTx and DC products have obtained sufficient clinical evidence, but market adoption is the most difficult challenge.
Based on author’s observation, this type of product is most likely to start from the fourth business model, because this type of product meets the requirements of Fee for Performance (paid by result) such as IDS/IDN. In addition, the public medical system is also very suitable for the development of such products.
Fig. 5 is the digital formulary currently used by US insurance companies and IDNs.
However, because IDS/IDN is not yet the mainstream of the medical industry, there is still a long way to go before it becomes a type of payment for medical materials or medicines.
But the author believes that this will inevitably happen in the future.
1：https://www.iqvia.com/insights/the-iqvia-institute/reports/digital-health-trends-2021
2: https://zh.m.wikipedia.org/zh-hant/%E8%A7%82%E5%AF%9F%E6%80%A7%E7%A0%94%E7%A9%B6
3：http://www.angle.com.tw/ahlr/discovery/post.aspx?ipost=3402
4：https://www.editage.com.tw/resources/tutorial/a-young-researchers-guide-to-a-systematic-review.html
5: https://terms.naer.edu.tw/detail/1314566/
6: https://zh.wikipedia.org/wiki/%E8%97%A5%E7%89%A9%E7%A6%8F%E5%88%A9%E7%AE%A1%E7%90% 86
7: https://en.wikipedia.org/wiki/Integrated_delivery_system
