German digital health firm, Preventicus, has developed an app capable of detecting and preventing arrhythmia and stroke
In 2018 the German social health insurance system spent more than €230bn on medical care for its more than 73 million insured users. Taking into account more than eight million members of private health insurance programmes, the German healthcare system is one of the largest in the world.
Annual healthcare costs related to stroke in Germany are still higher than €45bn, of which €20bn is related to the medical costs of strokes. With incidences of stroke are expected to increase tremendously, the latest guidelines include provision for digital and mobile screening options for primary and secondary prevention.
The need for digital transformation
Digitalisation is changing all aspects of life in our society. Existing structures are strengthened by innovative ideas, which can pave the way for more efficient methods. This inexorable process of change cannot be avoided by stakeholders in the healthcare market.
The potential for new ideas and digital business models seems endless; and the big advantages are clearly in the improvement of healthcare. Especially at a time when the average age of society is getting higher, the need for a more extensive form of healthcare is growing.
Digital technologies are used here to improve both diagnosis and treatment for doctors and patients. In order to find their way into the healthcare market, manufacturers need an easy and non-bureaucratic way to showcase their new technologies and innovations – this in turn means new legislation, new rules and new regulations are needed. Therefore, two legislative amendments were put in place: The Special Care Contract in 2015 and the Digital Care Act (DVG) in 2019.
The first step into the future of digital health
In 2015, the German Bundestag adopted amendments to strengthen the provision of statutory health insurance. The central objectives of the law are to secure nationwide outpatient medical care, to improve patients’ access to medical services and to promote innovative forms of care. Through this decision, innovative benefits, which do not belong to the regular supply of the statutory health insurance, can still be included in the contracts.
In order to be considered a special care contract, the programme or technology’s health economics must demonstrate a real benefit for health insurance providers and the overall healthcare system.
Reducing treatment costs through prevention
Undetected atrial fibrillation (AF) is a major cause of stroke. In Europe alone, more than one million strokes occur per year; with total associated costs of more than €45bn. Stroke is also the main cause of disability in adulthood. Various factors, such as increasing average life expectancy, are expected to increase the number of strokes by 35% over the next 15 years.
Prevention is key, because early detection of atrial fibrillation helps to prevent strokes. Human lives are saved and the terrible consequences of a stroke for those affected and family members averted. For providers of statutory health insurance, this primarily means an immense saving on expenses; but there are a lot of uncertainties on how to best manage prevention in order to remain cost effective.
Smart detection of atrial fibrillation
Digital support for stroke prevention is the subject of extensive discussion within healthcare systems and amongst users.
Preventicus has developed an app, ‘Preventicus Heartbeats’, which enables smartphones to detect atrial fibrillation by analysing the rhythm of the user’s heartbeat with an accuracy rate comparable to that of an ECG monitor.
With a Positive Predictive Value (PPV) of 99% reported by six trials of more than 1,200 patients, the app provides almost no false positive results. 99 out of 100 patients with detected absolute arrhythmia are diagnosed with atrial fibrillation by cardiologists.
Around five million analyses – meaning approximately 3,500 per day – have been carried out so far using this app. Certified as a Class IIa medical device, it has already been validated in several European multicentre studies (the largest of their kind).
Opportunities and threats within digital healthcare
In 2019 the Apple Heart Study, conducted at Stanford University, was widely discussed as the first of its kind in digital healthcare. The enrollment of more than 400,000 participants in several months has shown the enormous potential of digital transformation in healthcare. However, while the scope of the Apple Heart Study is setting a new benchmark, it also shows the difficulty of addressing target groups.
The Apple Heart Study was designed to detect atrial fibrillation in a high risk patient group, specifically, patients aged more than 65 years old. While the total number of patients included promises a huge success of this trial and showed a theoretical success for digital inclusion and data management, only 6% of all its participants have been older than 65. Knowing that the original target of this trial – stroke prevention – relies to a degree on the input of older participants, this low inclusion rate leads to the question of how to best reach different and underrepresented target groups.
Within the participant group aged above 65, 3.2% of participants showed irregularities in their pulse curve. An ECG patch was sent to all these participants for further diagnosis; but first limitations could be observed in the fact that fewer than 50% of the patch recipients reach outed to the study doctor for diagnosis. This proves that a simple digital solution without a guided pathway is not sufficient, at least for older patients. Patches have been shipped to 70% of all participants who reached out to the telecare centre, only 68% of which have been shipped back for evaluation – another limitation of this type of programme design.
In total only 450 patients could be evaluated out of more than 400,000 participants: a rate of 0.1%. Within this group the PPV was 78%, resulting in a false positive/negative rate of more than 20%. Given the actual costs of a diagnosis, from a payer’s perspective, such a PPV will not meet the set cost-saving regulations within any special care or even regular care contract.
A different picture is visible when looking at the Watch AF trial from Preventicus: in the Watch AF trial, which included 503 individuals, patch results could be fully evaluated, achieving a PPV of 98.2%. At less than 2%, the false positive/negative group is negligible.
One issue which the Apple Heart Study did not even address is that if a measurement is done with any wearable a certain percentage of measurement has a moving error overlay, meaning approximately 20% of the data gathered is not usable for algorithms to calculate abnormalities and risks. Therefore, the algorithm plays a huge role within the programme, which once more leads to uncertainties within payer groups over which algorithm to trust when using simple applications.
Nevertheless, the evaluations and outcomes of the Apple trial resulted in the clear message that simply an application will not lead to good conversion and adoption rates in the group of 65 and older at this stage. Users have not grown up with such technologies; and therefore, should be part of a full programme leading through all necessary steps, involving physicians in person if possible, rather than simply using an application as a standalone solution.
From an app to a Special Care Programme
This concern has led to a Preventicus programme development: through the ‘RhythmusLeben’ Preventicus Special Care Programme, patients are accompanied from screening to treatment. The approval process for a special care contract is especially complex as it must be clinically proven, in line with regulations; and must be considered better than of standard care.
In addition, the contract can only be approved if the economic value shows positive outcomes within a four-year time frame. Because the German system is highly regulated and diagnosis-related group (DRG) systems are in place, new ideas and technologies often face difficulties meeting the requirements.
The last phase in being approved is through the federal insurance office, which rates the potential special care contract against a points system, scoring programmes on a scale which reflects their economic benefits or their potential for better care.
The ‘RhythmusLeben’ Special Care Programme
The ‘RhythmusLeben’ Special Care Programme was created to screen the population aged 55 and over for undetected atrial fibrillation, in order to prevent strokes. At-risk patients now have easy access to timely treatment, and the healthcare system has the opportunity to reduce costs related to AF and strokes.
The programme offers insurance providers with a clear economic value, which has been demonstrated in economic trials; and begins with the regular analysis of the patient’s heart rhythm using the ‘Preventicus Heartbeats’ smartphone app.
This app is a CE-certified medical device class IIa and is capable of measuring, documenting and analysing the heart rhythm using the smartphone’s camera facility. Using the curve of the pulse, the Preventicus app’s inbuilt algorithm precisely calculates the clustered occurrence of extra beats and/or the presence of absolute arrhythmia, which would suggest a suspicion of atrial fibrillation.
If absolute arrhythmia detected, the user receives a notification and will directly be connected to cardiologists in their region who participate in the managed care programme and can arrange appointments. The cardiologist applies the up to 14-day telemetric event ECG system, which is integrated into this Special Care Programme, to confirm and quantify the level of atrial fibrillation.
In terms of the standard of care, 14-day event recording is not covered within diagnosis-related groups; and therefore presents a strong argument for inclusion within the special care contract. On the other hand, 14-day event recording has the advantage that around three times as many patients experiencing actual atrial fibrillation can have their diagnosis confirmed in comparison to outdated 24-hour ECG scanning processes.
Data is sent to the respective cardiologist and will be used for final diagnosis. After completion of the medical examination, the cardiologist will redirect the patient back to standard care with a recommendation for long term therapy – such as permanent drug anticoagulation for stroke prevention – in the case of diagnosed atrial fibrillation.
A smart programme needs strong partners
Because the concept is so complex and involves many players, strong partnerships have been needed since the beginning. For example, the Federal Association of Practising Cardiologists (Bundesverband Niedergelassener Kardiologen – BNK) supports the rollout in the field of established cardiologists. Our contract partner GWQ facilitates easy entry for health insurance companies into the special care programme, while political influencers support changes towards digital transformation within the healthcare sector.
2019: the big leap into the digital health future
In 2019 the German Federal Ministry of Health, under the leadership of Minister of Health Jens Spahn, had ambitious goals to drive digitalisation in the healthcare sector. Measures would have to be taken to allow innovative and emerging technologies to access this typically conservative market. Finally, on 7 November 2019, the German parliament agreed to pass the new Digital Care Act (Digitales Versorgungsgesetzt – DVG).
This act will improve healthcare provision through digitalisation and innovation, opening up avenues for online video consultation, access to a secure healthcare data network; and from 2020, doctors will be able to prescribe digital health applications (Digitale Gesundheitsanwendungen – DiGA) to the statutory healthcare insured citizens.
Our overarching goal is for patients to benefit as quickly as possible from innovative approaches to care. Germany will be a global leader for digital health application prescription; and the setup is in consultation on a European level to implement similar programmes EU-wide, in order to accelerate digitalisation in healthcare not only for medical professionals, but also for insurers and patients.
Digital health applications and registration
The regulations are clear: an app is not the same as a digital health application. But it becomes one when it is certified as a Medical Product class I or IIa under MDR.
In order to receive these certifications, an app’s main function must rely on digital technologies; while its intended use must be centred around the patient, with the potential to include the doctor. A central directory lists all available digital health applications.
The procedure for recording applications in the directory is established at the Federal Institute for Drugs and Medical Devices (Bundesinstitut für Arzneimittel und Medizinprodukte – BfArM). From 2020, manufacturers will be able to register their innovations and new technologies as DiGA via the BfArM. From registration onwards, the digital application must demonstrate proof of its benefit within one year: benefits could be in terms of improving quality of life, economic benefit or disease prevention.
Requirements to apply for DiGA registration
A digital health application must meet a set of fundamental criteria. The major topics are the overall quality of the application, standards of data privacy and cybersecurity concerns.
Furthermore, the DiGA needs to show improvements in the delivery of care, medical benefits and other benefits such as cost effectiveness in healthcare. Theoretically, the ‘Preventicus Heartbeats’ application meets all requirements to be classified as a DiGA.
Therefore, as soon as the procedure for registration at the BfArM is opened, Preventicus will register its application, so that doctors can prescribe the application to all insured persons under statutory health insurance policies starting in 2020.
Not only does this mean that the at-risk group has access to this new technology, but so will people with discomfort or signs of AF who are not part of the classic risk group. As a result, the insurance standard in statutory health insurance will rise considerably.
Special care contract vs DVG: cannibalisation or completion?
Both concepts follow the same goal: fast access to new technologies before they find their way into the standard of care.
While special care contracts open doors for all new technologies which are not yet set within DRG and standard of care, the focus for this approach is clearly the economic value for payers as well as the fact that all parts need to provide a better than comparable standard of care. Within this path, technologies are accessible for insured patients before they get their own coding within the healthcare system.
With the new DVG all digital medical devices, as well as those who manage non-digital devices, will be able to participate and need to demonstrate benefit within the one-year period which is already part of a special care contract: real benefit, not only for insurers but also for payers.
In addition, within the DVG applications such as Preventicus do not need to demonstrate adherence or diagnosis rates, which limits the DVG in comparison to special care contracts.
The promise offered by the DVG is clear: fast access to digital health applications and programmes, meeting the urgent need for leading digital transformation in healthcare in Germany to the next level.
Therefore, Preventicus will follow both ways, providing fast digital access via the new DVG and strong partnership with insurances via special care contracts. The combination of both limits the weaknesses of each form access and will open doors to digital transformation.
There are still a lot of open questions within both programmes: data protection needs new regulations within digital healthcare, while MDR does not cover digital products as it should. Access within payer systems is – also within the DVG – not optimal for digital healthcare.
Preventicus operated clinical trials in Europe to better understand variances in structures and prevalence in each participating country. Within Horizon2020, the Red Stroke study has already started to lay the ground for commercialisation.
With the DVG set to be discussed in Brussels as a potential model for other healthcare systems, further clinical trials will be essential to fully understand the possibilities offered by each digital application.
Please note, this article will appear in issue 12 of Health Europa Quarterly, which will be available to read in February 2020.