As more and more Digital Therapeutics (DTx) are developed, we are often asked: what are the most scalable and sustainable routes to market? The right commercialization model is a key component of success in this rapidly growing space. However, whether you choose a pharma partnership or another popular distribution channel, success is likely to depend on physician awareness of your DTx and their willingness to prescribe it. A direct-to-consumer approach is one way around this, but it too has its own advantages and disadvantages.
Germany’s DiGA, also known as Digital Health Applications or Digitale Gesundheitsanwendungen in German, and similar DTx review platforms (like the mhealth pyramid in Belgium) have the potential to play a key role in not only providing a path to reimbursement for DTx, but also for increasing provider awareness and trust in digital therapies. Apps that are approved for the DiGA database become reimbursable under the German statutory health insurance, making them prescribable to approximately 72.8 million people, 87.7% of the German population.
Facts and Figures: Approvals, pricing, and more
Since the launch of the DiGA in 2019 as part of Germany’s initiative to increase the digitization of healthcare, the German Federal Institute for Drugs and Medical Devices (BfArM) has received a total of 72 DiGA submissions (updated: May 12th, 2021). So far 15 of these submissions have been approved and added to the DiGA Directory, 3 were denied, 30 were withdrawn, and 24 are still under review. The DiGA’s fast-tracked review process is designed to provide a rapid review of applications guaranteeing a positive or negative designation within three months or less.
CE-marked medical devices are eligible to apply for the DiGA database so long as
1) They are a medical device of risk class I or IIA;
2) Their main function is based on digital technologies;
3) The medical purpose is achieved through the apps main digital functions;
4) The DiGA detects, monitors, treats or alleviates a disease or compensation of injuries or disabilities;
5) And finally, the DiGA must be used only by the patient or by the patient and physician in combination.
Application process and review
Once the application is submitted, DiGA applicants are assessed based on criteria such as data security, user friendliness, and interoperability. All DiGA must also be able to demonstrate a “positive healthcare effect” during the application process or following a 1-2 year trial phase in order to receive final admission into the database.
A Positive Healthcare Effect
With only 15 approved applications to date, most new submissions will have to demonstrate the benefits of their app as compared to the “standard of care.” However, as the database becomes more crowded and DiGA approved applications become part of the new standard of care, applicants may be required to demonstrate how their app holds up to the competition. In these cases it will become increasingly important for apps to clearly define how their USP differs from that of an already approved DiGA with a similar value proposition. Price becomes a determining factor in a situation where two or more DiGA approved apps are determined to be no different from one another. In this case the physician may be required to prescribe the more cost-efficient option.
Kalmeda is currently the least expensive app on the database at 116,97 Euros and Elevida is the most expensive at 743,75 Euros. The prescription length for these apps and most others is 90 days. With only a few apps on the database so far, it will be interesting to see how prices change as the marketplace becomes more crowded. Brian Dolan at Exits & Outcomes is tracking the latest additions to the DiGA as well as temporarily added products that may later be removed by the BfArM if they don’t receive final approval.
Current DiGA Apps
Approved applications cover a variety of conditions such as cancer, multiple sclerosis, and after care for stroke victims. However, many of the 15 approved apps address mental health and behavioral change. Julia Hagen, Director Regulatory & Politics at the Health Innovation Hub (hih) in Berlin, commented for MobiHealthNews, sharing that the initial focus on mental health applications is likely due to the vast number of available apps and evidence showing effectiveness in this space. She further stated: “There are also applications from completely different areas. Looking at the ongoing discussion and applications that are in the pipeline, we will soon see many other DiGA for various indications.”
Invirto - enables people with agoraphobia, panic disorder, or social phobia to receive home treatment for their anxiety disorder.
Velibra - a web-based program for patients with generalized anxiety disorder, panic disorder with or without agoraphobia, or social anxiety disorder.
Mindable - aims to treat adults 18 and over who suffer from the symptoms of agoraphobia and / or panic disorder.
Kalmeda - a behavioral therapy for adults suffering from chronic ringing in the ears.
Somnio - a digital application for the treatment of problems falling asleep and staying asleep (insomnia).
ViViRA - a digital application for the treatment of back, knee, and hip pain.
Zanadio - aims to help users reduce their weight by changing their exercise, nutrition, and other behavioral habits.
Elevida - designed for adults with multiple sclerosis who also have fatigue.
M-sense Migraine - offers a comprehensive digital treatment program for migraine patients.
Rehappy - supports aftercare for stroke patients.
Selfapy - offers people with depression an individual online course based on evidence-based theories and techniques of cognitive behavioral therapy.
deprexis - an interactive online-based self-help program that provides therapy support for adult patients with depression and depressive moods.
CANKADO - a web and app based digital application that supports breast cancer patients.
Mika - designed to support the alleviation of psychological and psychosomatic consequences of cancer diagnosis and therapy.
Vorv!da - designed for adult patients with harmful alcohol consumption or alcohol dependence.
Physician Awareness and Trust
It is also yet to be seen how strongly physicians will value DiGA approval and if this will increase their willingness to prescribe digital therapies to patients. So far approved DiGA apps have not seen a large increase in prescriptions as a result of their DiGA designation. In a study of 51 general practitioners conducted between April and May of 2020 and published by the Deutsches Ärzteblatt, an official journal of the German Medical Association and the National Association of Statutory Health Insurance Physician, 63% of practitioners polled described their willingness to prescribe DiGA as low or mostly low and 37% of practitioners reported their willingness as high or rather high. Our HealthXL insights show physicians are also concerned they won’t be able to answer technical questions about the apps and that it may take significant time to educate patients. As is the case for all emerging digital therapeutics, more education will be needed to increase patient and physician awareness of these new technologies and how they can be beneficial.
However, a DiGA designation may provide a stamp of approval that increases both provider trust and awareness. Unlike a drug, a DTx may continue to change and evolve once it's on the market. For example, a DTx that uses a machine learning algorithm will continue to adapt as more user information becomes available. While this is likely positive for the app and ultimately for the patient, the potential that there may be changes to the DTx that the physician is not aware of can decrease the chance that a physician will prescribe the application.
The DiGA has the potential to provide a sense of security and act as a time saver for physicians who want confirmation the app hasn’t undergone any significant changes without having to re-research the product before writing each prescription. The DiGA requires apps to report any “significant change.” According to criteria outlined by the BfArM this would not include something like an update to the design of a DiGA, but it would include changes to information published in the directory (such as price), changes to the safety or quality of the device, any changes to the application’s ability to meet DiGA requirements, changes to data protection, and any changes to the proof of positive healthcare effects. This requirement for DiGA to self-report changes or otherwise risk being removed from the database, may help build provider trust in the list of applications available on the database.
The DiGA database and others like it could be an extremely valuable tool for physician education and awareness. While the early stages haven’t shown a large uptake in prescriptions, it is likely that as DTx continue to grow in range, capability, and popularity, patients will soon be asking their physicians about these alternative treatments and physicians will need a trusted source to consult.
As this tide begins to turn, it is likely DiGA status will be a crucial component of success in the German market as well as other European markets that are following Germany’s lead. In addition to Belgium’s mhealth pyramid, we are also seeing mhealth and electronic EHR initiatives out of France, Norway, and Italy. The COVID-19 pandemic demanded innovation and acceptance of digital therapies and virtual care. Following the pandemic, we expect to see continued growth in these areas across Europe and the world.
To learn more about other routes to market check out our “Best routes to market” meeting on May 31st featuring Louis Payet and Todd Greenwood.