Health apps and other digital medical devices are making increasingly important contributions to healthcare. While in the past such medical devices were reimbursed by statutory health insurance funds on a case-by-case basis only, in December 2019 the legislator created an independent reimbursement regime tailored to digital health applications (“DiGA”) through the Digital Supply Act (“DVG”). To implement the DVG, the Federal Ministry of Health issued the DiGA Ordinance (“DiGAV”), which has come into force today. The manufacturers of DiGA and the more than 73 million people with statutory health insurance in Germany could thus benefit from the new reimbursement rules as early as summer 2020. The Federal Institute for Drugs and Medical Devices (“BfArM”) and the German Federal Association of Health Insurance Funds (“GKV-SV”) are primarily responsible for the review and pricing procedures then applicable. BfArM has published a helpful guide to the procedures, which is still in a draft version.
Scope of Application
According to the DVG, those insured in the statutory health insurance scheme now have a genuine claim to the supply of DiGA. DiGA are low-risk medical devices whose main function is essentially based on digital technologies and which fulfil specific medical purposes for the insured or in the supply by healthcare providers. Digital technologies include in particular software and health apps. The application must serve a medical purpose, i.e. support the detection, monitoring, treatment or alleviation of disease.
Low risk classes are identified as classes I and IIa. In order to be reimbursable, the DiGA must be certified as a medical device, i.e. it must have gone through a conformity procedure and bear the CE mark. For class I medical devices, manufacturers generally carry out the conformity assessment procedure on their own, without the involvement of a notified body. Class IIa medical devices and class I medical devices, insofar as they are sterile or have a measuring function, require certification by notified bodies with regard to certain aspects.
The DiGA must be included in a BfArM register. It is reimbursable on this basis if a medical prescription or the approval of the respective health insurance fund is available in the specific case. This is to ensure the appropriate use of the DiGA within the framework of medical care.
Proof of Quality and Safety
For the inclusion of a DiGA in the BfArM register, the manufacturer must be able to prove that the DiGA meets the requirements for the safety, functionality and quality of a medical device, is designed in accordance with the applicable data protection law and guarantees sufficient data security according to the state of the art.
Compliance with the safety requirements is basically already guaranteed by CE certification. In this context, BfArM is likely to regularly check only the formal legality of the CE marking. However, BfArM may review additional performance requirements for justified reasons.
Evidence of Positive Effects in Patient Care
As a rule, the greatest hurdle on the way to the eligibility of a DiGA for reimbursement is the proof of sufficient positive effects in patient care. In addition to medical benefits, positive effects can also consist of patient-relevant structural and procedural improvements in healthcare. A medical benefit in the narrower sense may consist in an improvement in the state of health, a reduction in the duration of the disease, a prolongation of survival or an increased quality of life. Structural and procedural improvements in healthcare involve, for example, a more efficient use of medical care, better adherence to therapy recommendations or the promotion of patient safety.
The manufacturer must substantiate the positive effects in patient care with a comparative study which – retrospectively, or in exceptional cases prospectively – demonstrates the advantages of using DiGA as opposed to not using it. Depending on the research question and the endpoints investigated, the comparative study can be a clinical or epidemiological study, or a study using methods from other scientific fields such as healthcare research, or social or behavioural science. The requirements for the proof are supposed to be less stringent than in the pharmaceutical sector, as DiGA are generally considered to bear lower risks and also expected to place less of a financial burden on the statutory health insurance system. Genuine clinical trials will often not be required; instead, case reports, expert opinions and comparable evidence may in many cases suffice. The comparative study to prove the positive effects in patient care does not necessarily have to be conducted in Germany; however, if it is conducted exclusively abroad, the manufacturer must prove its transferability to the German supply context.
Application and Strategic Considerations
A DiGA is only reimbursed when it has been included in the BfArM register. BfArM includes a DiGA in the register based on an application from the manufacturer, which can be submitted in German or English. The manufacturer can request either a provisional or a final admission of their DiGA. In the application for final admission, they have to prove that all reimbursement requirements have been met, while it is possible to obtain a provisional admission before all relevant data is available. Based on the provisional admission, the DiGA is listed in the BfArM register for a trial period defined by BfArM. In this case, however, the application must be supported by at least the results of a systematic data analysis and a scientific evaluation concept in order to demonstrate the plausibility of the further procedure. In the application procedure, the manufacturer provides BfArM with free access to its DiGA.
The manufacturer may only benefit from a provisional inclusion in the BfArM register once. The applicable trial period may be extended by up to twelve months if BfArM considers it predominantly likely in view of the study results submitted that the manufacturer will be able to provide successful evidence for positive effects in patient care during this period. The case is different with an application for final admission: BfArM rejects such an application if the submitted study does not provide evidence. In this case, the manufacturer cannot change their application to a provisional inclusion, but must wait one year before they can make a new application. The manufacturer should therefore weigh up the two application options at an early stage, taking into account the results of studies already achieved and those still to be expected. BfArM offers informal advice in this context.
Further Application and Review Procedure
BfArM confirms receipt of the application documents within 14 days. If the application is incomplete, BfArM will request the manufacturer to provide the missing information within 3 months. Based on the complete application documents, BfArM reviews the DiGA with regard to its expected positive and negative effects, taking into account the particularities of the indications, possible application risks and existing supply alternatives.
BfArM will make a formal decision within 3 months of receipt of the (complete) application. If BfArM approves an application for provisional admission, it shall determine a trial period and include the DiGA in the BfArM register, subject to the subsequent proof of its positive effects in patient care. If BfArM takes a positive decision on an application for final admission, the DiGA is permanently included in the BfArM register. By way of inclusion in the BfArM register, the DiGA is considered reimbursable in the indications covered by the decision. The manufacturer has to inform BfArM without undue delay of any significant changes to the DiGA.
The principles of pricing are outlined in a framework agreement between the manufacturers’ associations and GKV-SV, which is yet to be concluded. During the first year of inclusion in the BfArM register, the manufacturer may in principle price its DiGA freely, unless the framework agreement provides for maximum prices for groups of comparable DiGA. It is to be expected that maximum prices will be set lower for provisionally than for finally admitted DiGA.
In view of the framework agreement, manufacturers and GKV-SV negotiate a reimbursement amount for the respective DiGA, which applies to all health insurance funds from the second year onwards. This reimbursement amount shall be performance related to some extent. If the manufacturer and the SHI system are unable to agree on a reimbursement amount within the first year, a reimbursement amount shall be determined by an arbitration board within 3 months. The procedure is similar in many respects to the German AMNOG procedure applicable to drugs with new active ingredients.