What does a DiGA cost and how is this price calculated?
WIG2 Institut
Scientific Institute for Health Economics and Health System Research in Germany
In Theory
Actual manufacturer’s price: In the first year after inclusion of a digital health application (DiGA) in the DiGA directory at the Federal Institute for Drugs and Medical Devices (BfArM), manufacturers set the so-called "actual manufacturer price" regardless of whether the DiGA is provisionally or permanently listed.
Maximum product-specific amount: To avoid arbitrary pricing by the manufacturers, this price is capped by the maximum amount regulation, in which the National Association of Statutory Health Insurance Funds (GKV-SV) and the manufacturers' associations have reached a joint framework agreement and set maximum amounts for 90-day DiGA use. These maximum amounts are set twice a year for groups with at least two comparable DiGAs. When calculating these maximum amounts, the prices set in the first year of DiGA listing are considered. The listed DiGAs are categorized in two parts to determine maximum amounts for comparable applications: firstly, based on the indication area (ICD-10 code) and, secondly, based on the intended positive healthcare effect (medical benefit or patient-relevant structural and procedural improvement).
Compensation amount: After the first twelve months of the DiGA listing, the compensation amount is negotiated between the GKV-SV and the manufacturers. The basis for this joint negotiation is the added value of the DiGA for the service catalog of the statutory health insurance funds. This added value is largely determined by the quality and extent of the positive healthcare effect achieved. If no joint consensus can be reached after nine months, the compensation amount will be determined by an arbitration board within three months.
In Practice
The highest average actual manufacturer's price is €810,10 for DiGA in the nervous system indication area. The reason for this is the comparatively expensive DiGA levidex at €2,077.40. The lowest average actual manufacturer's price of €229.01 is in the area “others” (consisting of the DiGAs HelloBetter Stress and Burnout and neolexon Aphasia). For most applications, the prices were adjusted once or twice. Three price adjustments have already been made for the Endo-App, NichtraucherHelden-App and Vivira applications. For the Oviva Direkt für Adipositas, the price has been adjusted for the fourth time. A maximum product specific amount [1] was set for eleven DiGA, ranging from €441.61 (KranusEdera) to €1,049.40 (PINK! Coach).
The highest price adjustment to date — with a price reduction of -67.33%— was for the DiGA elevida from the nervous system indication area, where the price was reduced from €743.75 to €243.00. No price adjustment has been made (yet) for 2122 applications. The price was reduced for 3231 applications and increased for two applications (Kalmeda from the ears indication area by 61.68% and SmokeFree from psyche indication area by 56,22%). Looking at the respective indication area, the highest average price adjustment to date of -65.47% took place within the digestion indication area where the price fell from an average of €718.20 to €248.00. Prices have been adjusted in every indication area to date. Only within the ears indication area did the average price increase by 12.73% from €282.99 to € 319.00.
Two DiGA (Invirto – Therapy against anxiety from the psyche indication area and ProHerz from the cardiovascular indication area) can be used in combination with hardware (VR glasses as well as a blood pressure monitor, pulse oximeter, scales, and body thermometer). Additional costs are incurred for this hardware.
Good to Know
The costs for a DiGA, including its hardware, are covered in full by statutory health insurance, so there are no costs for users.
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As a scientific institute, we support DiGA manufacturers in the planning, implementation and analysis of the trial study, the results of which form the basis for a successful price negotiation with the GKV-SV. We ensure that the preparation of the results meets the formal requirements of the Federal Institute for Drugs and Medical Devices (BfArM)and that they are in line with theEvaluationconceptfor theDiGA-Fast-Track. Our DiGA expert Tonio Sch?nfelder will be happy to answer any questions you may have.
[1]
DiGA-FAQ // Good to know // Question 2: What does a DiGA cost and how is this price calculated?