With four more Digital Therapeutics (DTx) added in January, Germany is a leader in reimbursing of prescribed digital health applications. The DiGA directory lists now 42 digital therapeutics available to be prescribed and reimbursed for German patients.
BfArM has so far received 165 applications. By the 22nd of February 2023, there were 43 positive decisions. Sixteen DTx are DiGA-approved permanently, 27 are approved provisionally (gathering additional RWE), and five were removed from the directory (two of them on developer request).
How to get a digital health application (DiGA) in Germany?
Arrange a doctor’s appointment
It is best to let your doctor advise you on your desired DiGA DTx.
Get a prescription
You get a red prescription. If you do not receive one, the health insurance company can also pay for the DiGA without a prescription.
Submit the prescription to your health insurance company (Krankenkasse). This can be done online. If in doubt, contact customer service.
Your cash register will send you an activation code for three months (90 days) of DiGA usage. After that, you will need to submit a prescription again.
Download the app
Download the app to your mobile phone. Every DiGA is available in the google play store or app store. Some can also be used via browser.
Where exactly you have to enter the code in the app depends on the DiGA. However, the application should query for the code itself.
NOCD is the world’s leading provider of treatment for obsessive-compulsive disorder (OCD) and Community-Driven Therapy. Founded in 2018, the company aims to help get proper diagnosis and treatment to 180 million people suffering from OCD.
According to NOCD, it takes an average of 17 years for people with OCD to get proper treatment due to high costs and a shortage of specialists. NOCD offers Exposure and Response Prevention (ERP) therapy, the most proven OCD treatment, and partners with insurance plans to make it affordable. Inside the NOCD platform, patients can do live video sessions with a licensed ERP therapist, and get support between sessions from self-help tools and peer communities.
Stephen Smith – NOCD Founder and CEO
NOCD founder, Stephen Smith is himself an OCD patient. It is his own experience in the search for a diagnosis and effective treatment, that has driven him to start NOCD. Listen to the interview with Stephen Smith by Alex Wess from The Pulse by Wharton Digital Health below:
NOCD – Results so far
According to the research data, the Virtual ERP at NOCD Therapy has demonstrated clinically significant outcomes, including a 35% reduction in OCD symptom severity and an over 40% reduction in anxiety, stress, and depression symptoms.
NOCD has been successful in its coverage expansion, it is now available in all 50 States of USA and in the United Kingdom. In the US it is working with main insurance plans. The company assesses, that 2 of 3 US patients would have the service covered.
NOCD has over 300 ERP therapists and is providing more than 20,000 virtual therapy sessions per month. It also offers access to the largest online OCD community with over 100,000 community member engagements per month.
Most media outlets focus on Mr. Tazbaz’s recent career as a cloud infrastructure at Oracle and earlier at social software Ning. For us, however, the most important is his voluntary and very personal engagement in patient care, especially in Hematology and Oncology.
Since 2010 Troy Tazbaz has been involved in campaigning for The Leukemia & Lymphoma Society, a Patient Advocacy Group, and the largest nonprofit dedicated to fighting blood cancer. Since 1949, the LLS has donated over $1.6 billion to support research on leukemia, lymphoma, Hodgkin’s disease, and myeloma.
Mr. Tazbaz has very personal experience in oncology treatment and care. He was supporting his wife, Brynn Fowler in her patient journey as documented on her blog, The Millenial with Cancer. Mrs. Fowler was diagnosed with Stage IV Colon Cancer at the age 37. Now, after Mrs. Fowler has passed away, the website is still maintained by Mr. Tazbaz as The Continuum Diaries.
Do you know that FDA already approved 521 Artificial Intelligence and Machine Learning (AI/ML)-Enabled Medical Devices?
PAPNET. The failure of the pioneering AI/ML-enabled test.
Five hundred apps may not surprise you in January 2023, given the noise around Open AI and its GPTChat. However, the first such device, PAPNET Testing System, was approved over 28 years ago. In 1995, the year of Johnny Mnemonic and Ghost in the Shell movies!
Fig.1 Neural net-based (PAPNET, Neuromedical Systems, Suffern, NY) display of squamous cells (Papanicolaou stain) from a balloon smear showing effects of radiotherapy. Marked cell enlargement and vacuolization of cytoplasm are easily recognized.
PAPNET was using a neural network to analyze and interpret cytology from Pap smears. While this early system generated a lot of interest and Google Scholar lists 217 peer-reviewed articles on PAPNET results, the business side of it was not that great. The cost-effectiveness of the system in comparison to manual screening by cytotechnician was not there. Neuromedical Systems Inc, the company behind PAPNET went bust in 1999, and now its intellectual property is a part of Becton, Dickinson and Company portfolio.
List of FDA-approved Artificial Intelligence and Machine Learning (AI/ML)-Enabled Medical Devices
If you look at the list of approved AI/ML-enabled medical devices, you will notice that the vast majority (392 medical devices, 75% of the whole) are for Radiology. Cardiovascular (57,11%), Hematology (15, 3%), and Neurology (14, 3%) are the remaining three significant categories.
Fig. 2: Split of approved AI/ML-enabled medical devices by Specialty Panel.
There are only 15 companies that have more than five AI/ML-enabled medical devices approved. Five of those companies are actually subsidiaries of GE, which in total owns 42 AI/ML-enabled medical devices. Then there is Siemens with 27 devices, Canon with 15, Aidoc Medical with 13, and Zebra Medical Vision with 9 devices. Philips, which also submitted its devices via different subsidiaries has in total 10 approved AI-enabled devices
Table 1. Companies with over 5 approved AI/ML-enabled medical devices
The market for Artificial Intelligence / Machine Learning – enabled Medical Devices seems to be poised for growth. At a recent HLTH 2022 conference in Las Vegas, Michelle Wu, CEO of NyquistData, a company offering an AI-supported intelligence platform dedicated to MedTech companies discusses the advantages of using AI to unlock the potential of unstructured data from medical devices.
Cleerly. An example of an AI-enabled medical device for a heart-attack-free future.
A good example of upcoming Artificial Intelligence / Machine Learning – enabled Medical Device may be Cleerly. The startup has raised $279 million from investors including Fidelity, T. Rowe Price, Novartis and Peter Thiel.
Founded by cardiologist James Min, former professor at Weill Cornell Medical College and director of the Dalio Institute of Cardiovascular Imaging at New York-Presbyterian, Cleerly uses AI to improve diagnostics cutting down on the time it takes to flag patients at risk.
Its proprietary AI algorithms analyze CCTA images to generate a 3D model of patients’ coronary arteries, identify their lumen (the cavity or channel within a tube or tubular organ such as a blood vessel) and vessel walls, locate and quantify stenoses, as well as identify, quantify and categorize plaque.
In 2020 Covid-19 pandemic focused humanity’s attention on healthcare and HealthTech. According to CB Report, 2020 was the year when a record number of seven digital health companies have achieved the status of unicorns.
The truth is not that exciting, as CB Report included two companies that are not digital health. Those are Gan & Lee (insulin manufacturer from China, recently wandering into oncology with a new CDK 4/6 inhibitor) and German CureVac, known for its breakthrough achievements in RNA vaccine technology.
While both are interesting for other reasons, we shall focus on the five digital health companies valued above one billion dollars. Who are those unicorns of 2020?
GoodRx, headquartered in Santa Monica, CA collects drug prices from pharmacies across the U.S. and helps users find the cheapest option for the medication they’re seeking. Its founders are Doug Hirsch (one of the first Yahoo! employees, later VP of Product at Facebook). Scott Marlette (who developed Facebook Photos) and Trevor Bezdek (founder of Tryrarc, an IT services and consultancy provider working with Anthem/BlueCross). It has been Doug’s personal experience of searching after the most affordable medicine, that has inspired GoodRx.
GoodRx had a very successful IPO and is profitable. However, it is facing competition from Amazon’s PrimeRx. When in November 2020 Amazon announced its offering, shares of GoodRx felt 23%. Another shock came in March 2021, when GoodRx presented its 2020 results with $551M revenue (42% growth YoY), but also an unexpected $230M net loss (in comparison to $63M net income in 2019).
I remain optimistic about GoodRx future, as it has maintained the growth of its user base and the service it is offering is helping US-based patients to save money while adhering to prescribed treatment.
Grail, based in Menlo Park, CA, is a company specialized in blood tests. Its main product, called the Galleri test, is able to detect more than 50 types of cancer from one blood sample. It allows for early detection of the disease, which highly improves chances for successful treatment. The idea behind the test is a combination of Machine Learning and insights gathered from the Human Genome Project. The commercialization of the Galleri test is expected this year.
Grail has started in 2016 as a spin-off from Illumina, supposed to focus on liquid biopsy. It has raised above $2bn from investors including Jeff Bezos and Bill Gates. Illumina has kept a stake in the company, and in September 2021 re-acquired Grail for $8bn.
One Medical is a membership-based digital platform for primary care service. The focus is on a seamless patient experience. One Medical offers telemedicine, online appointments for same-day or next-day, on-site labs. One Medical work in 12 U.S. markets, is available in DTC model and as an employee health benefit.
Founded by Tom X. Lee (who founded also a mobile clinical reference app Epocrates), the company went public in January 2020, raising $245M with a valuation of $1.7bn. One Medical is not profitable yet, reporting a $14M loss for 2020, however, its revenues and user-base are rising.
Hims & Hers is a wellness brand operating digital pharmacy and telehealth platform. It has been started by Andrew Dudum and Jack Abraham via their VC Atomic. The initial offering o the company was around men’s health, in particular hair loss and erectile dysfunction, and it has been a tremendous success with $1M sales in the first week.
The company quickly grew with “hers” offering for women, and expansion into other therapeutic areas (primary care, mental health, dermatology). Hims & Hers includes its own EHR, and is targeting uninsured Millenials and Gen-Z patients with subscription plan priced at 20$ monthly.
The company went public in Jan 2021 raising $280M at the valuation of $1.6bn. While Hims & Hers is not profitable (estimated adj. EBITDA -$20M), its revenues are growing fast.
Butterfly Network is working on a portable ultrasound medical imaging device. If successful it will decrease the cost and enable 3D imaging in remote areas, at home, or in an emergency setting with a Butterfly device and a smartphone.
The company is founded by Dr. Jonathan M. Rothberg, inventor of over 100 patents, mostly known for his work on next-gen DNA sequencing. As the company was heading towards IPO, it has also appointed a new CEO, Todd Fruchterman, former president of medical solutions at 3M.
Butterfly network went public via a merger with SPAC, at the valuation of $1.5bn. It has so far netted a $540M investment and it estimates to bring revenue of $78m in 2021.
Deprexis – Digital therapeutics (DTx) for depression has received DiGA fast-track approval for DTx prescription and reimbursement in Germany.
The innovative DiGA process allows for fast-track approval of digital therapeutics and is the first such program in the world. It was created by the 2019 Digital Healthcare Act and allows apps to be prescribed by doctors while costs will be reimbursed through German statutory health insurance.
The federal regulator, BfArM, manages DiGA. To get through DiGA, there are certain conditions:
Safety and Suitability for Use confirmed by CE certification as a medical product in the lowest-risk classes
Data Protection Conformity to data protection legislation (EU-wide GDPR and German Federal Data Protection Act (BDSG))
Information security Assessment is based on the recommendations of the German Federal Office for Information Security (BSI)and specific parts of IT-Grundschutz (ITbasic data protection) catalogs designated for healthcare apps.
At the time of writing this, there were 59 applications for DiGA listing, 40 for provisional listing, and 19 for the final listing. So far BfArM has approved 11 applications and rejected one. 25 applications have been withdrawn. In theory, the full approval process should take three months.
Deprexis, the 11th DiGA-approved application is interesting on its own. The manufacturer of the app is GAIA Group, an offspring of Airbus which builds its products on a proprietary AI platform called brocaⓇ.
The focus here is clearly not on UX, but on medical benefits. Deprexis may not have the nicest UX, but is a proper DTx providing a three-month-long highly individualized Cognitive Behavioral Therapy support program for patients with depression. Application is able to perform a dialogue with the patient, learning from the input on the way. It contains 10 content modules and is available online via desktop and mobile app interface.
Deprexis is backed by clinical data from at least nine studies, one of which had a sample of 3,800 patients, which does not sound much in pharmaceuticals, but it is a lot in DTx. While in Germany it just received reimbursement, in the US the price for treatment is $400 one-time payment, or $540 in three monthly installments of $135 each.
Coronavirus COVID-19 (NCov-2019) has tested some of the digital health capabilities such as AI-based predicitive models and real-time big data visualization. As a positive side effect, it has also allowed public to learn about epidemiology via video games.
AI-based predictive models caught COVID-19 faster than us
According to the news reports, two AI-based and one human volunteer-based warning systems were first to alert humanity about the threat coming from Wuhan.
The first to react was the automated HealthMap system at Boston Children’s Hospital, which scans online news and social media reports for signals of spreading disease. Its warning was very quick and accurate (pneumonia cases in Wuhan) – raised at 11:12PM local time on December 30, but it did not assign significance high enough to the message.
The third and most publicized report came from another AI-based model called BlueDot. BlueDot first became aware of the pneumonia cases in Wuhan on December 31st, and in addition to notifying their clients and government stakeholders directly, they publicly released their findings in the Journal of Travel Medicine on January 14th. While it was not truly the fastest, it is worth hearing how Kamran Khan, a Canadian MD, and founder of BlueDot explains the process behind.
Big Data Visualization to track Coronavirus COVID-19 (NCov-2019)
Dashboards showing the number of infected people, geographical spread and trends of the disease are useful to HCPs but also journalists and the public. This use case, although unfortunate, shows how important it is to be able to see and not only read data.
The first and most known dashboard came from the team at Johns Hopkins University. The dashboard, first shared publicly on Jan 22, illustrates the location and number of confirmed COVID-19 cases, deaths, and recoveries for all affected countries. It has been accompanied by an article in The Lancet.
Currently, there are multiple dashboards showing diverse aspects of the epidemic of COVID-19. The list of dashboards with working links can be found at ESRI website.
Coronavirus virally spreads a game for people want to know
Due to the virus business slows down. Except for Ndemic Creations, a studio that in 2012 developed Plague Inc. A game that simulates a viral epidemic.
Plague Inc. is a game, but it is based on science and realistically shows the spread of viral infections amongst the human population. In the game, the player is supposed to infect all humans before the cure is available. It is so successful in teaching about epidemiology, that it has been endorsed by the CDC. During the COVID-19 outbreak, it has reached the top of charts on the Apple Store. According to its developers, similar peaks in popularity have accompanied the Ebola outbreak in Africa in 2014-2016.
MoovCare claims to be the first application of its kind. It allows controlling lung cancer treatment based on reports on outcomes submitted by patients via web or mobile-connected devices. It enables the early identification of relapse or complications requiring rapid and specific care. According to the clinical data from the III phase randomized study on 300 patients as presented at ASCO, this mHealth application provides direct benefit in terms of prolonged survival.
The main advantage of using the app in lung cancer therapy is early detection of relapse, which is symptomatic and typical for lung cancer. This allows optimal treatment and in turn increases of survival rate among patients.
An additional effect of the app is improved treatment compliance (observance of scheduled visits, lower number of inopportune phone calls, lower number of imaging). All this at a comparatively very low cost of less than 10 000 USD versus 265 000 USD per one CT-scan for Lung Cancer.
How does MoovCare work?
MoovCare is being “prescribed” to ambulatory patients. Patients are asked to fill in the web-based form each week, self-assessing 12 clinical parameters and having a free text field to enter any information they consider of importance. Data are securely passed and processed within the application. An algorithm behind MoovCare analyses the data provided and in case of any anomaly detected reports it to the oncologist and hospital dashboard. Based on the alert from Moovcare healthcare providers can contact patients and take any necessary action. Company and research behind MoovCare.
MoovCare is a product of Sivan Innovation. Founded in 2014 in Jerusalem by Daniel Israel, Sivan Innovation is an Israeli E-health start-up and R&D company. The research presented at ASCO has been conducted by Dr. Fabrice Denis at the Cancer Institute of Western France
MoovCare is a perfect example of how digital innovation, mHealth, and IoT trends are positively impacting healthcare and patient outcomes. We look forward to seeing more of such innovations coming not only from startups such as Sivan innovation but also from Big Pharma companies with their vast R&D resources.
Internet of Things (IoT), sometimes called also Internet of Everything, is a concept of enabling Internet-based connection between computing devices embedded into everyday objects. Internet of Things is already technically feasible and applied in multiple scenarios. With wider adoption, Internet of Things brings revolutionary changes to existing processes in most, if not all industries..
Internet of Things applications are impacting all three stages of health care: prevention, diagnosis and treatment. Wearable sensors and quantified self software embedded in smart-watches are good example of using Internet of Things in Healthcare for disease prevention and healthy lifestyle promotion. Going forward, wearable or digestible connected sensors are part of diagnosis useful especially in remote areas and in chronic conditions.
As for the treatment itself, connected packages and medication dispensers such as CleverCap, MedMinder or Philips Lifeline are used to improve patients adherence to the treatment. A step forward from adding connectivity to packages is putting it directly on medication. Proteus Digital Health, a company backed by Novartis and Oracle has already received FDA market clearance in the United States and a CE mark in Europe for its wearable and Ingestible Sensor devices.
Video: Proteus Digital Health – Your Health, Powered By You
Internet of Things in Clinical Environment: MBANs
MBAN stands for Medical Body Area Network and is a concept of low power network of body sensors worn directly or in close proximity to the patient. MBAN is connecting to the hub via LAN of health care facility (ie. hospital). MBAN allows constant monitoring of patient’s health parameters while in the facility, even while moving. Outside of the facility, MBAN may also serve patient – for example by connecting blood sugar level sensor with insulin injection pump.
Video: Medical Body Area Networks (MBANS) should expand patient monitoring
Internet of Things and Big Data
With wider adoption of connected wearable sensors and MBANs the amount of available relevant real world evidence becomes so huge, that medical research may, at least partially, shift its paradigm from experimental to statistical approach. Instead of setting up costly trials and recruiting patients with specific conditions, investigators will be able to perform analysis of existing data gathered from already diagnosed and treated population.
Video: Data analytics: Changing the practice of medicine
According to the research quoted by NHS over a fifth of patients with diabetes will have experienced a largely avoidable hypoglycemic episode whilst in hospital. Wearable technology may help doctors to detect deterioration early and act without delay. NHS England hopes, that connected sensors will be used to monitor health of people with long term conditions such as diabetes, heart failure, liver disease or asthma. The information gathered by wearable technology will be uploaded directly into patients’ records through the digital health services platform.
Nowadays, NHS maintains highly successful application (50 million hits per month) NHS Choices, that allows UK citizens to search and register for GP visit, book prescription and register for other services. NHS Choices provides also preliminary symptom checker, medical knowledge database and health related news promoting healthier lifestyle.
From the pharmaceutical marketing perspective embracing wearables in healthcare clear opportunity. Wearable (but also ingestible and implantable) devices and sensors will provide us with valuable real world evidence.With the mass adoption of such sensors assessment of treatment efficiency and drug safety will improve on unimaginable scale. Use of wearables in healthcare may also greatly impact treatment adherence (making patient to take medication as and when prescribed). In general, it moves medicine from population-based to individual data based, truly personalized healthcare.
Technology providers seeing vast business opportunity are joining those efforts. Then, they go back seeing how hard it is to operate in strictly regulated market.We all may remember how Google’s Larry Page and Sergey Brin were discussing their work on sensor contact lenses for diabetes (with Novartis/Alcon) and longevity medicine project of Calico. Their learning was in Sergey Brin’s words:
“Generally, health is just so heavily regulated. It’s just a painful business to be in. It’s just not necessarily how I want to spend my time. Even though we do have some health projects, and we’ll be doing that to a certain extent. But I think the regulatory burden in the U.S. is so high that think it would dissuade a lot of entrepreneurs.”
For pharmaceutical companies and healthcare providers this regulatory burden is given for their core business. For them, raise of wearable devices and mobile health applications raises some issues. Our smartphones, fitbits, jawbones and misfit shine wearables are not meant to be medical devices. Data acquired by wearables may not be accurate as they do not hae to be. They are not designed to the clinical and healthcare standard – there are no backup systems if the battery goes down, if user switches the phone in silent mode etc. Today wearable technology for pharma is still not good enough to bet patients safety on it. FDA’s guidance allows wearables in healthcare only as general wellness, low risk devices.
The solution may come from the alliance of pharma and technology. Novartis with Google and Qualcomm, UCB with MC10, GSK with Medidata have chosen this direction. Another may be innovative startups companies willing to align with regulatory and compliance burden for a benefit of entering profitable niche leftover by more established players.
K-message believes that finally wearables and more generally, the internet of things will change and shape the future of healthcare and pharmaceutical industry. If you know or, even better, make a product or service intended to be a part of this future we will be happy to cover your story.
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