Part II: Challenges to a wider usage of DiGAs
The fast-track pathway for digital health technologies, DiGA, has been introduced in Germany in 2019. It is considered an innovative initiative, as it promotes access to low risk digital health technologies for more than 76 million people in a transparent way (Part I). A recent report of six health insurance companies in Germany that cover around 28 million people, have shown a penetration rate of DiGAs lower than 1 percent . Possible reasons for the still limited prescription of DiGAs in healthcare in general, and diabetes care in particular, are multi-layered. They may include unresolved systemic challenges including the pricing of DiGAs and their integration into the workflow of healthcare provision. There is also some general scepticism towards the quality of evidence for a positive healthcare effect as compared to the evidence levels required for drugs and higher-classified medical devices.
Some obstacles in the way
For non tech-savvy doctors it might be a challenge to prescribe a DiGA. Doctors have to inform themselves proactively about DiGAs, but they don’t receive adequate remuneration for the time they invest looking for innovative treatment options . So far the remuneration for prescribing DiGAs have been very low (around 2 euros/prescription), making the time investment in informing themselves and working around bureaucratic hurdles economically unreasonable. In addition, they have to learn and practice to monitor the usage of a DiGA and evaluate captured data and make data-informed decisions about therapy adjustments jointly with patients. These tasks are time consuming and are not yet remunerated adequately.
In the field of diabetes, the prescription of a DiGA might not be such a significant challenge due to the familiarity of many diabetologists and diabetes health care teams with the usage of data within an integrated personalised diabetes management . The evaluation of blood glucose profiles, insulin dosing and lifestyle habits as well as the integration of supportive technology in a participative manner is almost common practice in the field .
The National Association of Statutory Health Insurance (GKV) has expressed some criticism about the DiGA fast track  requirements for approval and reimbursement. Among them, the GKV believes that improvements in patient relevant procedures and structures alone shouldn’t be enough to reimburse the use of a digital health technology. The core requirement should be a medical benefit to the patient proved through the gold standard of proof: randomized controlled trials (RCT). Moreover, the GKV criticizes the admission of proof of medical benefit against non-use instead of against equivalent existing care. Here, the real world clinical evaluation of Automated Insulin Delivery in randomised clinical trials controlled against the best standard of care (sensor-augmented pump therapy)  could serve as a paradigmatic example to set quality standards for a clinical evaluation of DiGAs. The use of such high standards and the peer-reviewed publication of clinical trial outcomes can give credibility to a DiGA in the eyes of key stakeholders, including payers and medical expert associations.
The MDR impact on DiGA
A specific set of challenges for manufactures of digital health technologies was brought by the new European medical device regulation (MDR). The MDR  poses a stricter classification of medical devices leading to a reclassification of many devices to a higher class. For instance, the rule 11 determines a stricter classification of stand-alone software with main function being diagnosis or therapeutic purposes. In practice, many apps that were classified as class I devices, are now class IIa or higher. This considerably increases development costs and may delay the introduction of much needed reimbursable DiGAs in European markets.
Digital health devices, such as Automated Insulin Delivery systems (artificial pancreas), that have the proved potential to substitute analog treatment regimens remain excluded from the DiGA pathway. Besides, software algorithms calculating dosage of drugs, such as insulin, without oversight by a healthcare professional, might be classified as class III as the wrong dosage of medication could lead to serious health outcomes, excluding them from the DiGA directory.
DiGA’s self-pricing dilemma
Another criticism regards the self-pricing during the first year of reimbursement despite of the limited evidence of a positive healthcare effect. According to the GKV, it has led to an excessive price strategy from DiGA manufactures: between 400 to 500% price increase in comparison to the previous costs in the self-pay market. Self-pricing is also allowed for DiGAs that are provisionally listed. It means that although these health technologies have not been able to prove a medical benefit yet, they are already entitled to setting their own market prices for up to two years. The GKV argues that relatively low entry requirements for DiGA compared to other areas of statutory health insurance together with self-pricing are not aligned with the economic efficiency requirement according to national law (§ 12 SGB V).
There is a light at the end of the tunnel
Some light was shed on the discussion of DiGA pricing. On December 15 2021, GKV and manufacturers' associations have reached a compromise on pricing of DiGAs through an arbitration . According to the agreement, dynamics in pricing, thresholds and exceptions will be used to determine the price of a DiGA.
In the new framework agreement, all DiGAs will be assigned to one of 17 indication groups, corresponding to their three-digit ICD-10-GM. In the second assignment step, within each indication group, a distinction will be made between medical benefit and evidence of patient-relevant improvement of structure and process. Within each group, a price will be calculated according to a formula based on actual daily prices and the 80% quantile when more than four DiGAs comprise a group. The maximum price of an app will be reached when 80% of the other app prices in the respective group are cheaper and 20% are higher. However, apps using artificial intelligence and tackling rare diseases will have specific rules. They will comprise a separate group, with its own pricing rules. In total, there will be 34 DiGA groups. The first validity date is expected to be August 1, 2022.
The agreement will be implemented by a joint arbitration board, in which four representatives will sit together- two from the GVK and two from the manufacturer associations. In addition, specialist committees will be created where representatives of the manufacturer associations will have an active voice.
The future of DiGA
Having a binding maximum price model for all DiGAs could be a win-win solution for health insurance funds and DiGA manufactures. If the economic efficiency of DiGAs is improved, it could also encourage health insurances to develop solutions that might help less tech savvy doctors to prescribe a DiGA to their patients and increase the number of prescriptions faster. An effective way of tackling doctor’s knowledge gap regarding digital health technologies could be adding the function of medical prescription software to refer to DiGAs directly while also suggesting corresponding pharmaceutical central numbers (in German, PZN) .
In addition, a modification of the DiGA directory, allowing the inclusion of higher classes of digital health technologies, would have a tangible impact on the health of patients with diabetes and could help increase the penetration rate of DiGA usage.