On 19 Dec 2019, the DVG came into force in Germany. This meant that since 2020, clinicians can prescribe and SHI funds reimburse medical apps and digital health treatments (DiGAs). To make such treatments available to patients as quickly as possible, the regulatory agency, BfArM, has developed a new process to speed up reimbursement: the DiGA fast track.
DiGA fast track process
The BfArM assesses these DiGA treatments in terms of patient benefit, data protection and information security, and quality. After an application is received, the BfArM has three months to check whether the products meet the requirements set out in the Digital Health Applications Ordinance. However, the manufacturers must also prove that the app has a positive effect on patient care. If the assessment was successful, the product can then be included in the DiGA list. The products on this list can then be prescribed and are covered by SHI funds. The legal basis is §139e SGB V.
If the evidence to demonstrate a positive effect on care is not available yet but the other requirements are fulfilled, a manufacturer can apply for the provisional inclusion of the DiGA in the DiGA list, and can complete the necessary study within 12 months in a trial phase.
Tipps from BfArM for manufacturers of digital treatments and medical applications (DiGAs):
1. Consult with the BfArM before the application
Most manufacturers withdrawing their applications did so because they needed more time to prepare and then submit a new application. Where applicants had earlier discussions with the BfArM, the submitted documents were of a significantly higher quality overall.
2. Keep an eye on deadlines
The fast-track procedure takes a maximum of three months. Unlike the approval process for drugs, there is no “clock stop”. This means the deadlines can not be stopped while the proceedings are ongoing. Manufacturers have to meet the deadlines even if the assessment reveals that additional data is needed. If these data gaps can’t be filled within the deadlines, the DiGA can’t be included in the DiGA list; not even provisionally.
3. Evidence is of high importance
The quality of the submissions so far varied, especially in terms of evidence. For example, systematic data evaluations are crucial to demonstrate an improvement in care. Often, however, the observation periods are far too short. Or manufacturers claimed positive effects that were not even addressed by the data analysis. In addition, older studies were mostly not designed for the purpose of an HTA.
The evidence is determined by the type of the assessment: Is the application for a provisional acceptance for testing? Or is it for permanent inclusion in the list?
4. RCTs are usually best suited to demonstrate medical benefits
The minimum requirement for a DiGA to prove a positive effect is a retrospective comparison. In most cases, randomized controlled trials (RCTs) are best suited to detect a benefit. In the future, however, RWE will increasingly be used as a basis – especially as evidence for improvements of procedures and structures.
5. Think holistically, and also focus on interoperability, accessibility and usability
The key factors assessed by the BfArM are patient benefits, data protection and information security. However, interoperability parameters are also very important aspects, because the DiGA should be seamlessly integrated into the digital ecosystem. In addition, accessibility and usability are important to users and patients. The requirements for this can be found in the DiGA guidelines.