The DiGA-Fast-Track | New opportunities for healthcare innovators in Germany

Digital Health Care Act and DiGA Fast Track 

Digital Health Care Act and DiGA Fast Track 

The German Federal Institute for Drugs and Medical Devices (Bundesinstitut für Arzneimittel und Medizinprodukte, BfArM) is in charge of DiGA assessment and approval. The BfArM’s assessment procedure opens up a new way for digital health apps to enter the reimbursement market. A DiGA that has successfully completed the assessment procedure is listed in a register of prescription health apps, the DiGA directory.

The DiGA assessment follows a Fast Track to market entry and reimbursement: The BfArM decides on the approval of a digital health app within three months of receiving the manufacturer’s application. Digital health companies can either apply for final or for provisional listing (under article 139e paragraphs 2 and 3 Book V of the Social Code, SGB V).  

A provisional listing kicks off a 1-year trial phase after which the manufacturer needs to provide proof of “positive healthcare effects” (positive Versorgungseffekte, pVE) as a basis for the final listing. The DiGA can be prescribed and is reimbursed during the entire trial year. Thus, the DiGA fast track with its possibility of a trial year is a great opportunity for accelerated market access and to offset some of the development costs already during the clinical trial phase. Time to market can be accelerated even more with purposeful planning and preparation.

Criteria Defining a DiGA

Criteria Defining a DiGA

Regulatory DiGA Requirements

Regulatory DiGA Requirements

To be listed in the DiGA directory under § 139e SGB V, each DiGA needs to conform to the requirements of §§ 3 to 6 of the DiGA ordinance (DiGA-Verordnung, DiGAV).  

DiGA need to comply with regulatory requirements pertaining to:

• Safety and suitability for use,
• data protection and information security,
• quality, and in particular interoperability.

The CE marking under the MDR regulation confirms that the digital health app complies with requirements regarding safety and suitability for use. The checklists found in DiGAV annexes 1 and 2 can be used to self-declare compliance with the remaining requirements.

Study Design and Evaluation Strategy

Study Design and Evaluation Strategy

An evaluation concept is the prerequisite of a provisional listing followed by a 1-year trial phase. It has to meet generally accepted scientific standards. The evaluation concept needs to explicate for which type of “positive healthcare effect” (pVE) evidence is to be provided, for which patient population, and why the DiGA is suited achieve the effect. In particular, the evaluation concept should establish the planned study design, the comparator with regard to the day-to-day reality of healthcare, and the chosen trial outcomes. It also needs to specify how evidence is to be produced within the 1-year trial phase.

The evaluation concept must include a study protocol and a statistical analysis plan. It also needs to adequately include and take into account the results of systematic data analysis. Data to be analyzed consist both in a systematic literature research and in data collected with the app itself. The data analysis must demonstrate to the BfArM that the app can achieve the intended positive healthcare effect for the chosen patient group. The analyzed data also provide useful information to define study parameters for the trial period, such as effect size, case number, outcome measurement instruments, and recruitment methods.

The minimum requirement for a DiGA study is a retrospective comparative study. For instance, case-control-studies, retrospective cohort studies, and intraindividual comparisons are all acceptable study types for DiGA. The DiGA manufacturer itself is free to choose a study type of a higher evidence level (see chapter 6 of the DiGA guide). However, the BfArM as well may request a prospective study if the validity of retrospective data is questionable. The DiGA study is to be conducted in Germany. If not, the manufacturer must provide proof that that the healthcare context in which the study was conducted is comparable to the one in Germany. DiGA studies should reflect the reality of German healthcare. The obtained results must be quantitative.

The study is to be registered in a public trial register (e.g., the DRKS register). Complete study results are to be published no later than 12 months after study completion.

Proof of Positive Healthcare Effects

Proof of Positive Healthcare Effects

With a (final or provisional) listing in the DiGA directory, digital health apps are reimbursable within Germany’s SHI system. One key element of the DiGA Fast-Track assessment procedure focuses on the DiGA’s positive healthcare effect.

Manufacturers who have already proven their DiGA’s positive healthcare effects in a study can directly apply for a final listing. As an alternative, an application for a provisional listing is possible. The provisionally listed DiGA has 12 months (which can be extended by another year in justified exceptional cases) to prove its positive healthcare effects.

DiGA Pricing

DiGA Pricing

A year after a digital health app has been listed in the DiGA directory, the manufacturer’s price is superseded by a reimbursement agreement between the manufacturer and the National Association of SHI Funds (GKV-Spitzenverband, GKV-SV). If both parties cannot come to an agreement, an arbitration board will set a DiGA price under § 134 paragraph 3 SGB V. The new reimbursement price retroactively takes effect from the thirteenth month after the DiGA listing.

Some principles of DiGA pricing are defined in the master agreement pursuant to § 134 paragraphs 4 and 5 SGB V. For instance, the actual self-pay app price in Germany and from other European countries is factored into the pricing process. In addition, pricing strategies may take into account the number of delivered DiGA activation codes and pay-for-performance principles.

However, the type and amount of proven additional benefit the DiGA can provide for patients remains the most important criterion for DiGA pricing.

Health app reimbursement options beyond DiGA

Health app reimbursement options beyond DiGA

In the German healthcare system, “prescription apps” are not the only reimbursement option for digital health apps. It is often unclear to digital health companies which type of contract is most advantageous from a market access and business perspective.