Germany opens the DiPA reimbursement pathway

to support the adoption of digital health applications, underpinning the value of the #1 target market for Brain+’ first commercial dementia product, CST

• A significant event for Brain+ as DiPA can provide reimbursement coverage for the first Cognitive Stimulation Therapy (CST) product, expected to be launched in Germany in 2023

• The CST product fits well with the requirements of the DiPA reimbursement pathway. The goal of the DIPA is to reimburse products that stabilize patients’ health with special training programs or facilitates communication with family members and nursing care professionals, and this is the same purpose as the product.

• The CST product fits well with the requirements of the DiPA reimbursement pathway. The goal of the DIPA is to reimburse products that stabilize patients’ health with special training programs or facilitates communication with family members and nursing care professionals, and this is the same purpose as the product.

As an essential part of Germany’s far-reaching digital healthcare act from 2021, a new reimbursement pathway has now been opened for digital care applications. The pathway is abbreviated DiPA in German from Digitale Pflegeanwendungen (digital care applications). The German Federal Institute for Drugs and Medical Devices (BfArM) is setting up the new procedure for verifying the reimbursability of digital care applications through this pathway.

Germany is a key market and is leading the charge in Europe for the adoption of digital health solutions. This is an important milestone for Brain+, as a centralized reimbursement channel, like the DIPA, will provide easier access for the 1 million Germans living with mild-to-moderate dementia to our CST product, which we plan to launch in 2023. We see the German initiative as only the beginning of a Europe-wide swing towards regulatory and reimbursement support for digital health solutions. Belgium has already followed, and France is next to copy the German models – and our digital products seem to fit well to the requirements of these new reimbursement channels.

Kim Baden-Kristensen, CEO of Brain+

Launching Brain+ CST dementia products to the German market in 2023

The first dementia product of Brain+, Cognitive Stimulation Therapy (CST) – Therapist Companion, is developed to help dementia caregivers easily deliver CST to people with dementia in the clinic. It will be followed by a second product version, CST – Home Extension, which allows a person with dementia to receive CST in the comfort of their own home with the help of a caregiver.

Brain+ is progressing as planned with CST – Therapist Companion and expects to have the first product version ready before the end of 2022 and to launch in Denmark and Germany in 2023. The new German reimbursement options are key for commercial uptake, as they will allow people with dementia to get health insurance coverage for digital applications.

Brain+’ Cognitive Stimulation Therapy Product has a good fit with the DIPA requirements

A DiPA is a digital care application that is designed to help patients cope better with everyday care. DiPAs can be used by care recipients to stabilize or improve their state of health through exercises (e.g., personalized memory games for people with dementia). They can also improve communication with family members and care professionals. DiPAs can be used either as an app on mobile devices (e.g. smartphones, tablets) or as a browser-based web application on a computer or laptop.  (Source digital.iges.com).

Cognitive Stimulation Therapy is a psychosocial talk therapy, which facilitates meaningful conversations and improves communication between the person with dementia and their caregivers, and therefore has a good fit with these DiPA requirements.

Reimbursement & pricing levels in Germany of up to €600/year

The care insurance fund will pay up to 50 euros per month for a digital ’nursing’ application. 1.5 million people are living with dementia. Of these, around 1 million have mild to moderate dementia, which is the target for the Cognitive Stimulation Therapy dementia product. Given actual reimbursement levels, the present addressable market for this segment in Germany alone is around €400 million. Brain+ believes it has a favorable leading position since no other vendors are known to be as far along as Brain+.

Other EU countries are following Germany

Many European countries have begun plans to implement similar approval and reimbursement processes. Belgium has launched a process called mHealthBELGIUM and in October of 2021 French President, Emmanuel Macron, announced France will launch a DiGA-like expedited reimbursement process in 2022.

Next for DiPA

In mid-November 2020, the German Federal Ministry of Health (BMG) published a draft law on the digital modernization of care and nursing (DVPMG). The draft law is expected to come into force soon, which essentially means that the process is officially available, and the first applicants will be able to apply

More on DiPA

Here’s the link to the DiPA requirements:

https://www.bundesgesundheitsministerium.de/service/gesetze-und-verordnungen.html

A summary article on DIPA:

https://digital.iges.com/diga/dipa_-_digital_application_in_nursing_care/#!