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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 Of these 130 applications, 31 have been added to the DiGA, 11 denied, 72 withdrawn, 14 currently under review and 2 removed from the directory.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.

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