We cannot guarantee that the content will display correctly while using Internet Explorer. To have the best browsing experience, please upgrade to Microsoft Edge, Google Chrome or Safari.

May 20, 2022

Is DiGA still considered to be a model to replicate?

Commentary
Meaghan Schedel
&

Introduction

Following its launch in 2019, Germany’s Digital Health Apps program (DiGA) was lauded as a leader for digital health reimbursement. The program created a fast-track pathway to reimbursement for digital health solutions and included an assessment and rapid review in three months or less. Many European countries began plans to implement similar approval and reimbursement processes. In Belgium we saw the launch of mHealthBELGIUM and in October of 2021 French President, Emmanuel Macron, announced France will launch a DiGA-like expedited reimbursement process in 2022. (You can find some background reading on our previous blog.)

However, this early praise has given way to deep criticism. In this blog we explore the current state of the DiGA and the potentially changing view of DiGA as a stand-out model as compared to other reimbursement pathways.

The current state of the DiGA 

As of 18 May, 2022, 130 applications were submitted to the DiGA for review - 97 for provisional listing and 33 for final listing. Of these 130 applications, 31 have been added to the DiGA, 11 denied, 72 withdrawn, 14 currently under review and 2 removed from the directory. 

A recent report published by the Techniker Krankenkasse (TK), a major health insurer in Germany, noted that by the end of December 2021, the company had received 19,025 prescriptions for DiGA with the most commonly prescribed apps in the areas of back pain (3,947), tinnitus (3,450) and migraine (2,524). 

While solutions covering these therapeutic areas (TAs) were among some of the earlier additions to DiGA, the platform now contains solutions ranging across 18 TAs.

The report also indicated women were more likely to use DiGA apps than men with 66.5% of the prescriptions written for women. The average age of a DiGA user was 45.5 years of age with the highest percentage of users between the ages of 50-59. 

What the data doesn’t tell us is why. Are women more likely to ask their physicians about digital options? Do physicians make assumptions about the willingness of someone over the age of 60 to use a digital health app? As companies look to expand the usage and adoption of digital health solutions, digging deeper into this data may help develop strategies that foster increased prescriptions and usage.  

Criticism of progress to-date 

With only 31 approved DiGA apps, some have criticized the process as slow. When questioning the success of the DiGA, others have also pointed to low prescription numbers (about 50,000 last year) and just about a 4% physician uptake.

So why aren’t physicians prescribing DiGA apps? Some note the solutions haven’t yet proven their worth. DiGA allows applicants to apply for a permanent listing in the directory or provisional listing. Provisional listing allows a solution to be added to the directory for a trial period of typically 1 to 2 years. During this time the solution can collect the additional data needed to prove a “positive healthcare effect,” one of the key criteria for a permanent listing. Of the 31 solutions currently available, 12 have been permanently listed and 19 have been provisionally listed. 

Two solutions that were previously approved have also since been removed. In March of 2022, Mika, a solution for people with cancer developed by Fosanis, was removed from the directory. Following its removal, the company noted plans to resubmit the solution to the directory later this year when clinical trial results come through. 

The second company to be removed from the directory in April 2022 was M-sense Migraine, one of the earlier DiGA apps to be added. With the removal of M-sense, health insurers are no longer required to cover the cost of prescriptions for the app, therefore M-Sense is currently continuing to cover the cost of prescriptions to not interrupt continuity of care. 

Challenges to DiGA adoption

The potential of a solution to be removed from the directory may be limiting physician trust and willingness to prescribe preliminarily listed solutions to their patients. However, the catch-22 here is that many of the solutions need time and real world data to be able to prove their efficacy. 

Another challenge may also be physician awareness of digital health solutions. TK reported that 7,000 of 180,000 doctors had issued a DiGA prescription. A high percentage of these prescriptions were written in the area of Berlin, which happens to also be the headquarters of many of the DiGA solutions. The higher rate of prescriptions may be attributed to greater physician or patient knowledge of DiGA given their proximity to several digital health companies. 

Physicians may also just be too busy keeping up with Germany’s larger digitization plans to have time to delve deep into the possibilities of digital solutions. Recently, several laws have been put in place to improve the digitization of Germany’s healthcare system. With a focus on making sure a practice is up to new IT infrastructure standards, e-prescription capabilities, and other digitization practices, DiGA education may have been deprioritized by some physicians. 

The emergence of other reimbursement models

While the DiGA has been under criticism, experts don’t seem ready to throw the method out just yet. France is still expected to launch a version of the DiGA sometime this year and there are still talks of someday seeing a European-wide version of the DiGA. 

However, other reimbursement models are also beginning to pick up momentum in various geographies. The UK is a relatively advanced player in digital health and has developed processes for reimbursement by the NHS and its funded bodies. Though a specific national pathway for digital health reimbursement does not exist, local NHS organizations can approve solutions for coverage under the public insurance. However, at a national level, digital health technologies are recognized under the National Institute for Health and Care Excellence (NICE) Evidence for Effectiveness framework. While NICE approval does not guarantee reimbursement, it can increase the likelihood at a local level. 

In geographies such as the US, where there’s no universal health system, private insurers or employer-sponsored healthcare may be a more common reimbursement route. For more information on alternative reimbursement models, the Digital Therapeutics Alliance recently published an overview of digital therapeutic (DTx) reimbursement and regulatory pathways in nine different countries.

While reimbursement is an important component of success for digital health companies, DiGA has illustrated that it is not the only factor. For a solution to be successful, the hurdles of physician knowledge and acceptance need to be overcome as well as the question of who will provide app training and tech support to patients where needed. 

We’re just beginning to crack the code for wide-spread adoption, but there’s still a way to go. 

Interested in learning more about the DiGA in Germany or DTx Reimbursement in the US? Check out our upcoming Masterclasses

Masterclass: How to Navigate DiGA in Germany? A Real Experience from a Digital Health Company - June 8th at 10:30 am EST

Masterclass: DTx Reimbursement Success in Fully-insured Health Plans vs. Self-insured - May 31st at 10:45 am EST 

We can provide an introduction on your behalf so that you can contact them directly with any questions/queries on this topic. Simply click on the link below to request an introduction.

We can provide an introduction on your behalf so that you can contact them directly with any questions/queries on this topic. Simply click on the link below to request an introduction.

Request an Introduction

We can provide an introduction on your behalf so that you can contact them directly with any questions/queries on this topic. Simply click on the link below to request an introduction.

Request an Introduction

Ready to read more? HealthXL members can access the full peak of the report on the HealthXL Community Hub.

Not yet a member of HealthXL? Download your 11 page snapshot of the report.

Download your 11 page snapshot

Connect with peers and share insights

Don't miss out on the discussion of the latest insights and reports on digital health. Meet with peers and take a deep dive for 75 minutes. Unlike at webinars, you can freely exchange experiences and insights to solve challenges and design the future of DTx.

Digital Therapeutics (DTx)
Digital Therapeutics (DTx)
Digital Therapeutics (DTx)
Digital Therapeutics (DTx)

Masterclass: DTx Reimbursement in the US - PBMs as Coverage Scale Catalysts

10th August @ 10:45AM EDT

Are you a DTx or Pharma company seeking wide-spread reimbursement of a DTx product in the US? Join this Masterclass led by Mike Pace to learn more about this topic and share your experiences with others working in this space.

Featuring
Michael Pace
Michael Pace
CEO & Founder at PalmHealth.co
Featuring
Michael Pace
Michael Pace
CEO & Founder at PalmHealth.co
Digital Therapeutics (DTx)
Digital Therapeutics (DTx)
Digital Therapeutics (DTx)
Digital Therapeutics (DTx)

Masterclass: Value, Cost and Pricing in Regulated Digital Health Solutions

11th August @ 10:45AM EDT

Digital Health solutions are top of mind for biopharma companies in 2022, and Software as Medical Device (SaMD) is a crucial cornerstone for top-tier companies. Join this Masterclass led by BrightInsight to dive deeper into this topic and discuss this further with your peers working in this space.

Featuring
David Matthews, PhD
David Matthews, PhD
CCO, BrightInsight
Featuring
David Matthews, PhD
David Matthews, PhD
CCO, BrightInsight
Digital Therapeutics (DTx)
Digital Therapeutics (DTx)
Digital Therapeutics (DTx)
Digital Therapeutics (DTx)

Sustainable Business Models for DTx

16th August @ 10:45AM EDT

It is one of the key questions that every digital therapeutic (DTx) company must answer - what business model will set them up for success in the long run? Join this meeting to discuss this further and share your experiences with your peers working in this space.

Featuring
Elena Mustatea
Elena Mustatea
CEO, Bold Health
Rick Bartels
Rick Bartels
Managing Partner , DTxCC
Featuring
Elena Mustatea
Elena Mustatea
CEO, Bold Health
Rick Bartels
Rick Bartels
Managing Partner , DTxCC
Digital Therapeutics (DTx)
Digital Therapeutics (DTx)
Digital Therapeutics (DTx)
Digital Therapeutics (DTx)

Payers Partnerships for DTx

17th August @ 10:45AM EDT

Digital Therapeutics (DTx) vendors face many challenges on their journey to commercialization, such as generating clinical data, health economics evidence and achieving regulatory status. Join this meeting to discuss this topic further and share your experiences with others working in this space.

Featuring
Elena Mustatea
Elena Mustatea
CEO, Bold Health
Kevin Darcy
Kevin Darcy
Director, Link Strategy at Veeva Systems
Featuring
Elena Mustatea
Elena Mustatea
CEO, Bold Health
Kevin Darcy
Kevin Darcy
Director, Link Strategy at Veeva Systems

Are you a HealthXL Member? See the Full Report Here

Non-HealthXL Member? You can purchase the report HERE

HealthXL Digital Health Meetings

Want to join the discussion now?

Join our Digital Health Meetings and take a deep dive for 75 minutes into topics like digital therapeutics, patient support, telehealth, clinical trials, dermatology and many more. These Meetings are not regular webinars: No audience, no recording and no hiding behind a screen. You actively participate in a discussion to solve your present challenges and design the future of digital health. And with a free account on our Community Hub, you stay connected and up-to-date on the latest news and insights, allowing you to fully immerse yourself in the topic before, during and after.

Digital Therapeutics (DTx)
Digital Therapeutics (DTx)
Digital Therapeutics (DTx)
Digital Therapeutics (DTx)

Masterclass: DTx Reimbursement in the US - PBMs as Coverage Scale Catalysts

10th August @ 10:45AM EDT

Are you a DTx or Pharma company seeking wide-spread reimbursement of a DTx product in the US? Join this Masterclass led by Mike Pace to learn more about this topic and share your experiences with others working in this space.

Featuring
Michael Pace
Michael Pace
CEO & Founder at PalmHealth.co
Featuring
Michael Pace
Michael Pace
CEO & Founder at PalmHealth.co
Digital Therapeutics (DTx)
Digital Therapeutics (DTx)
Digital Therapeutics (DTx)
Digital Therapeutics (DTx)

Masterclass: Value, Cost and Pricing in Regulated Digital Health Solutions

11th August @ 10:45AM EDT

Digital Health solutions are top of mind for biopharma companies in 2022, and Software as Medical Device (SaMD) is a crucial cornerstone for top-tier companies. Join this Masterclass led by BrightInsight to dive deeper into this topic and discuss this further with your peers working in this space.

Featuring
David Matthews, PhD
David Matthews, PhD
CCO, BrightInsight
Featuring
David Matthews, PhD
David Matthews, PhD
CCO, BrightInsight

Executive 1-2-1 with the HealthXL Digital Health Community

15th August @11AM EDT

Do you want to network with other innovators and leaders in digital health? Are you looking to identify potential partners? Join us for the new HealthXL style of virtual speed networking and meet other members working in this space!

Featuring
Aahuti Rai
Aahuti Rai
Strategic Advisor, Healthcare Innovation at Four Points Consulting Ltd
Chris Wasden
Chris Wasden
Head of Pharma Speciality Solutions & Corporate Strategy, Twill
Featuring
Aahuti Rai
Aahuti Rai
Strategic Advisor, Healthcare Innovation at Four Points Consulting Ltd
Chris Wasden
Chris Wasden
Head of Pharma Speciality Solutions & Corporate Strategy, Twill
Digital Therapeutics (DTx)
Digital Therapeutics (DTx)
Digital Therapeutics (DTx)
Digital Therapeutics (DTx)

Sustainable Business Models for DTx

16th August @ 10:45AM EDT

It is one of the key questions that every digital therapeutic (DTx) company must answer - what business model will set them up for success in the long run? Join this meeting to discuss this further and share your experiences with your peers working in this space.

Featuring
Elena Mustatea
Elena Mustatea
CEO, Bold Health
Rick Bartels
Rick Bartels
Managing Partner , DTxCC
Featuring
Elena Mustatea
Elena Mustatea
CEO, Bold Health
Rick Bartels
Rick Bartels
Managing Partner , DTxCC

What’s a Rich Text element?

The rich text element allows you to create and format headings, paragraphs, blockquotes, images, and video all in one place instead of having to add and format them individually. Just double-click and easily create content.

Static and dynamic content editing

A rich text element can be used with static or dynamic content. For static content, just drop it into any page and begin editing. For dynamic content, add a rich text field to any collection and then connect a rich text element to that field in the settings panel. Voila!

How to customize formatting for each rich text

Headings, paragraphs, blockquotes, figures, images, and figure captions can all be styled after a class is added to the rich text element using the "When inside of" nested selector system.

We cannot guarantee that the content will display correctly while using Internet Explorer. To have the best browsing experience, please upgrade to Microsoft Edge, Google Chrome or Safari.