The German parliament decided on 7 November 2019 that from January 2020 onwards patients are entitled to have digital health applications (apps hereafter) prescribed by their physician – in both the ambulatory setting and the hospital setting (1). Included in this regulation are apps that may require CE marking and are classified as low-risk devices (risk classes I and IIa*). The apps will be included in § 139e of the German Social Code Book (1) as medical aid material used in diagnosis, treatment, support in treatment and monitoring. The costs have to be covered by statutory health insurance. Plan for new evidence requirements and price negotiation processes.
Decision planning for price and reimbursement of digital apps in the German health system
From January 2020 onwards patients in Germany are entitled to have digital medical applications (apps hereafter) prescribed by their physician – in both the ambulatory setting and the hospital setting (1). The costs have to be covered by statutory health insurance. Included in this regulation, recently enacted by German parliament, are apps that require CE marking and are classified as low-risk medical devices (risk classes I and IIa*). The apps will be included in § 139e of the German Social Code Book (1) as medical aid material used in diagnosis, treatment, support in treatment and monitoring
The adopted regulation sets out the top-line steps that should be followed by app manufacturers from January 2020 onwards (see picture 1). However, the top-line process set out has some open questions that will require further clarification.
A. The manufacturer will be required to submit to the German regulatory authority, the Bundesinstitut für Arzneimittel und Medizinprodukte (BfArM) all relevant information needed to assess the app for data security, data protection, functionality and impact on patient or care. In consequence the BfArM will decide on inclusion into a directory for apps (§ 139e). This directory will be structured along functioning and setting of use of apps. (6)
B. After inclusion in the directory the app will be provisionally reimbursed by statutory health insurance for at least one year at the sales price, which the manufacturer sets himself, § 134 para 2 SGB V. However, § 134 para 2 SGB V authorizes the Federal Ministry of Health (MoH) to regulate limits of reimbursement for this first year(3). As a result, for example, the federal MoH may determine maximum amounts for groups of comparable apps, depending on consumption volume and impact on statutory health insurance.
C. During the first year, and if not evidenced at initial submission, any app available via prescription must demonstrate to BfArM its medical benefit or patient-relevant structural and procedural improvement in care. This may be provided through a scientific evaluation prepared by a manufacturer-independent institution. Positive health care benefits can result from a medical benefit in the narrower sense of a therapeutic improvement by positively influencing patient-relevant outcomes such as quality of life, through case reports, expert opinions, observational studies, studies or other valid evidence. The new regulation specifically states that it would be disproportionate to require the same evidence level for apps as for pharmaceutical products with new active substances according to § 35a SGB V, where patient benefit can only be evidenced through clinical studies of higher evidence level.
D. After 12 months and demonstration of positive effect on patient care, the manufacturer will have to negotiate the reimbursed price with the GKV-Spitzenverband.
In addition to the price and reimbursement process, there may be additional developments over the coming months. The consortium of scientific medical societies e.V. (AWMF) intends to work with specialist associations to develop evidence-based medical guidelines which set quality requirements for apps, including suitability, risk potential, ethical safety and validity in terms of content (5).
3. DECISION PLANNING
Preparing for launch of an app in Germany requires optimized decision planning regarding stakeholder engagement, evidence generation and pricing strategy.
A. Stakeholder planning
Knowing the stakeholders who will drive decision making according to the described process is as important as supplying the needed evidence and setting pricing strategy.
Stakeholder and process mapping
• Know the typical requirements these agencies set out and expect, their timelines and which other agencies they commonly consult.
• Become familiar with type of decision maker and their typical decisions.
• Align stakeholders to the process.
• Align launch planning for Germany.
• Consider any impact of German launch planning on other markets.
• Monitor how other stakeholders, such as the AWMF, will influence the process and requirements by publishing guidelines.
B. Evidence planning for demonstration of medical benefit or patient-relevant structural and procedural improvement in care
Early consideration of evidence planning is critical. For pharmaceuticals and medical devices, evidence is typically developed before any submission for price and reimbursement. For apps, evidence will be developed while the app is in use by patients in the real-world setting. This is a new process not only for manufacturers of apps, but also for price and reimbursement decision makers. It is probably the most critical item for launch planning. Planning early for evidence generation is critical. The manufacturer will have only 12 months to develop evidence that is conclusive, valid and meaningful in demonstrating the positive impact on patient care. Hence the evidence generation plan – how to create the evidence, the methods used, the implementation process – must be set well before the first move into the German market.
• Decide early which methods of evidence generation will be accepted, appropriate for the app and indication, and scientifically valid to show a positive impact on patient care.
• This includes determination of endpoints which will be regarded by agencies, health care providers and patients as meaningful and valid to demonstrate impact on patient care.
• Assure that the selected method for the 12-month evidence generation creates information that is available in time for the price negotiations which will take place just after the 12 months.
• Ensure that evaluators of the evidence are familiar with the technology, indication and chosen evidence collection method.
• Determine which health economic parameters will round out the evidence generation plan, e.g., avoided hospital visits and other.
• Finally, develop an evidence generation strategy that may be accepted by other countries in Europe, either because those countries accept German data, or because the evidence generation strategy can be easily implemented in other countries’ health care settings.
C. Price during first 12 months
The price during the first 12 months can be set by the manufacturer and should reflect the ‘sales price’.
Determine early on the willingness to pay in Germany, and other EU markets. Price referencing for apps in Europe may not be far off.
• Build an early price negotiation model and calculate investment needs for evidence generation. Map that investment against price negotiation levers which the GKV may apply in the price negotiation after 12 months, such as price and evidence supporting other apps in the same indication, cost offsets and direct costs savings.
D. Price negotiation after 12 months
Price negotiation with the GKV may be guided by demonstration of positive effect on patient care, selling price of the app during the first 12 months and price in other countries, competitors’ evidence and prices, differentiation from competitors and health economic evidence. This requires a carefully planned process, well prepared dossier and aligned team during the negotiation.
• Prepare your price and value dossier already during the 12 months of evidence generation. Starting to prepare it after the evidence results are available may be too late.
• Have a well-developed stakeholder map available, and align the evidence and information that will be considered by the GKV.
• Start to engage early with the sickfunds (which are the members of the GKV) to determine value drivers and value barriers in price negotiations.
* Classification in accordance with Article 51 -in conjunction with Annex VIII- of the Regulation (EU) 2017/745 of the European Parliament and of the Council of 5 April 2017 on medical devices
For more information and discussion, please contact
Dr. Simone Breitkopf
Phone: + 49 177 79 98 776
Dr. Susanne Michel
Phone: + 49 151 176 301 42