DiGA price negotiations with the GKV-Spitzenverband

January 22, 2026
Contact Person:
Malte Bucksch

by | Jan 22, 2026 | diga-whitepaper

DiGA price negotiations with the GKV-Spitzenverband

The development of a digital health application (DiGA) costs time and money and involves many regulatory hurdles. As a manufacturer, you naturally have an interest in ensuring that this effort pays off in the end. You probably already know that even if your application is reimbursed by the statutory health insurance funds, you are not free to set the price of your DiGA forever. Sooner or later, you will have to agree on a remuneration amount with the GKV-Spitzenverband (National Association of Statutory Health Insurance Funds), which will replace the manufacturer price you have defined after approximately one year. This technical article provides you with the most important information on DiGA price negotiations.

The information in this article is based, among other things, on the framework conditions of the GKV-Spitzenverband (National Association of Statutory Health Insurance Funds) valid since February 28, 2024.

As of January 2026: With the Digital Act (DigiG), it was finally determined on March 26, 2024, that the share of performance-related price components must amount to at least 20% of the remuneration amount from January 1, 2026. This change will also play an important role in price negotiations in the future. We will discuss this new rule in detail in Chapter 4.

Table of Contents

1. The timeline of the DiGA price negotiations

It makes a difference whether you apply for permanent or provisional admission for your DiGA. Depending on the application, negotiations start earlier or later.

If your DiGA is accepted permanently right away (without a trial year):

  1. The negotiation period begins after your DiGA has been listed in the directory for 4 months.
  2. You submit all the necessary documents to the GKV-Spitzenverband.
  3. After 5 more months, the DiGA price negotiation is completed.
  4. If no agreement is reached, the arbitration board will decide on the amount of remuneration in a further 3 months.
  5. The remuneration amount negotiated or determined by the arbitration board shall generally be applied as remuneration from the 13th month after the DiGA has been entered in the directory. Until then, the actual manufacturer’s price shall apply. If the remuneration amount is determined later, a retroactive correction or repayment shall be made from the 13th month.

If your DiGA is provisionally accepted first (with a trial year):

  1. By the end of the trial period at the latest (usually 12 months; may be extended), you must submit the necessary evidence of the positive healthcare effect to the BfArM.
  2. After a further 3 months at the latest, you will receive a notification from the BfArM about the permanent admission and the negotiation period will begin.
  3. You submit all necessary documents to the GKV-Spitzenverband and agree on negotiation dates.
  4. After a further 5 months, the DiGA price negotiation is completed. If no agreement is reached, the arbitration board will decide on the amount of remuneration in a further 3 months.
  5. The remuneration amount negotiated or determined by the arbitration board is generally paid from the 13th month after (provisional) entry of the DiGA in the directory. Until the amount is determined, the actual manufacturer’s price applies. If the remuneration amount is determined later, a retroactive correction is made from the 13th month with corresponding compensation payments.

2. When does which price apply for the DiGA?

The actual manufacturer price applies from the date of entry in the DiGA directory until the remuneration agreement is concluded.

  • It is valid for 12 months (regardless of whether the DiGA was initially accepted on a provisional basis or immediately on a permanent basis).
  • Maximum amounts may already apply in the first year.
  • The manufacturer may change the actual price once within these 12 months.

From the 13th month onwards, the remuneration amount negotiated or determined by the arbitration board is generally paid. If the remuneration amount is agreed or determined at a later date, it applies retroactively from the 13th month. This may result in compensation payments.

3. Price negotiations with the GKV-Spitzenverband (National Association of Statutory Health Insurance Funds)

3.1 Start of negotiations

The start of the DiGA price negotiation with the GKV-Spitzenverband depends on whether your DiGA has been included in the list with or without a trial year. For this reason, there are two cases:

3.1.1 Your DiGA is permanently listed from the outset

In this case, the price negotiation begins 4 months after inclusion in the DiGA directory.

Note: With the DVPMG coming into force on June 9, 2021, the start of negotiations has been shortened from 6 to 4 months.

3.1.2 Your DiGA is provisionally listed

If your DiGA has only been provisionally included in the list, price negotiations will only begin as soon as you have received notification of final inclusion. With a regular trial period (12 months) and a processing time of up to 3 months, this decision is typically available by the 15th month. In the case of an extended trial period, it will be available later.

3.2 Required documents

  • BfArM decision on inclusion in the DiGA directory
  • CE conformity marking or the CE marking
  • Declaration on all points listed in DiGAV Annex 1 and Annex 2 (if available, also corresponding certificates)
  • Study reports to demonstrate the positive healthcare effects (including publications where applicable)
  • Number of activation codes/prescription codes redeemed up to 5 days before transmission of the documents
  • Information on prices for the DiGA when dispensed to self-payers
  • Information on prices for DiGA in other European countries, which are covered by payers there
  • For DiGA that have been provisionally included: the specified evidence for evaluation, which you have also submitted to the BfArM

You can also submit other documents that are useful for negotiating a remuneration amount. For example, you can submit the following documents up to 10 days before the first or second negotiation meeting:

3.3 Duration of negotiations

The DiGA price negotiations with the GKV-Spitzenverband take 5 months. Within these five months, there will be 3 negotiation meetings lasting a maximum of 3 hours. It is possible to agree on an additional fourth date.

Note: With the DVPMG coming into force on June 9, 2021, the negotiation period was shortened from 6 to 5 months.

If no agreement is reached, the arbitration board is called in after the negotiation phase, which examines all documents and decides on a remuneration amount after 3 months at the latest. The costs of the arbitration proceedings are divided between the DiGA manufacturer and the GKV-Spitzenverband.

3.4 Important factors for determining the amount of remuneration

The remuneration amount is determined on the basis of all price-relevant documents and the information published in the directory. For you as a manufacturer, however, it is important to know that the strength of the healthcare effect plays a special role in the amount. Meaningful data, studies and publications should therefore give you the most advantages here.

You can find out what you need to bear in mind when demonstrating positive healthcare effects here: DiGA: Guidelines for demonstrating positive supply effects

The prices of comparable DiGA and applications will also have an influence on your remuneration amount. So also develop arguments that emphasize the added value of your DiGA compared to other offers.

However, the amount of remuneration may be limited by group-specific maximum amounts.

3.5 Further information on price negotiations

The information in this article has been deliberately simplified for the sake of readability. The following sources are particularly relevant for a detailed, legally compliant classification of DiGA price negotiations:

These documents must always be consulted for the specific interpretation and application of the regulations.

4. Application-accompanying performance measurement (AbEM) for DiGA

With the Digital Act (DigiG), application-accompanying performance measurement (AbEM) was anchored in Section 134 of the German Social Code, Book V (SGB V) as part of the DiGA remuneration system.

Since January 1, 2026, every remuneration agreement under Section 134 SGB V has had to stipulate that at least 20% of the remuneration amount is performance-related. This also applies to existing agreements. If they did not contain any performance-related price components, the contracting parties had to agree on a new remuneration amount by January 1, 2026 at the latest. Manufacturers have been collecting the data for application-accompanying performance measurement since the second half of 2026 and report it to the BfArM for the first time by April 15, 2027.

The AbEM describes the systematic collection and evaluation of usage and outcome data for a DiGA in everyday healthcare. The aim is to map the actual healthcare effect under real conditions in a traceable way and use this as a basis for designing and evaluating performance-related price components.

The AbEM does not replace the requirement to demonstrate positive healthcare effects for inclusion in the DiGA directory. However, it can supplement this requirement in the context of price negotiations and contribute to the further evaluation of use, effectiveness, and patient-relevant effects.

It is not yet clear how the results of the performance measurement will feed into the performance-related component and whether the variable component will lead to an average increase or decrease in the remuneration amount. The GKV-Spitzenverband and the manufacturers’ associations still have to define this in the framework agreement (as of October 2026). We will inform you in our DiGA newsletter as soon as we have any news on this.

5. Any further questions?

As a service provider for the development of medical software and DiGA, we are very familiar with the current legal requirements for DiGA. That’s why you’ll find numerous other specialist articles on DiGA development in our blog.

Are you planning to develop a DiGA? Please feel free to contact us: Go to the contact form