Berlin, January 20, 2022 – HelloBetter, a Berlin-based digital health company, and ratiopharm, a subsidiary of Teva Pharmaceuticals, announced a partnership to market a digital therapeutic for patients suffering from chronic pain, labelled HelloBetter ratiopharm Chronic Pain.
Having received regulatory approval by the Bundesinstitut für Arzneimittel und Medizinprodukte (BfArM), the German equivalent of the FDA, their product will now be available free of charge on prescription to all adults in Germany. The partnership between a digital startup and an established pharma player is breaking new ground in the newly established and globally unique reimbursement landscape that Germany created a little over two years ago by passing the so-called Digital Care Act.
Under the exclusive distribution partnership, HelloBetter will leverage ratiopharm’s sales and marketing expertise to scale the distribution of its officially listed and thus prescribable digital health application (the German designation Digitale Gesundheitsanwendung is commonly abbreviated as DiGA). Discussions about similar partnerships with other partners targeting both Germany as well as other markets are currently underway.
A Digital Therapeutic for Chronic Pain: Addressing an Important Unmet Need
More than 12 million people in Germany suffer from chronic pain, back pain or fibromyalgia. Chronic pain often posess a significant burden to the quality of life and mental health of those affected. In the case of fibromyalgia, drug therapies usually do not help or only help temporarily. Severe, recurring pain in the muscles and at the tendon insertions as well as a multitude of accompanying symptoms, including insomnia, lack of concentration and depression, lead to both high physical and psychological suffering. Up to now, doctors had very limited means available to help those affected. At the same time, average wait time to access care is five months. The newly approved therapy course HelloBetter ratiopharm Chronic Pain can help to close this care gap.
How HelloBetter ratiopharm Chronic Pain Works
The online therapy course is based on acceptance and commitment therapy (ACT), part of the so-called “third wave” of cognitive behavioural therapies. It aims at a sustained reduction of pain interference. HelloBetter ratiopharm Chronic Pain consists of seven course units of 45 to 60 minutes each taken over a period of twelve weeks. Unlike painkillers, the course does not aim at reducing the severity of the pain itself, but rather it aims to reduce the pain interference. In this case, pain interference is the extent to which pain hinders engagement with daily, social, or work-related tasks. The course units present methods and strategies that enable patients to deal with their pain in a constructive way and help them increase their pain acceptance so that the thought of pain no longer dominates in everyday life. After each session, patients receive personal feedback in writing from a HelloBetter psychologist. These coaches also provide support should moments of crisis arise.
Dr. Hanne Horvath, Founder & VP Business Development of HelloBetter, explains: “In contrast to the approach typically used in modern societies, this therapy course does not aim to eliminate the symptoms. In many cases, this is not even possible. Instead, we empower patients to limit the space that pain takes up in their lives, allowing them to focus on the experiences and relationships that truly matter to them”.
Effectiveness of HelloBetter ratiopharm Chronic Pain Proven in Clinical Studies
Effectiveness of HelloBetter ratiopharm Chronic Pain online therapy course has already been proven in a randomised controlled trial. The results show that HelloBetter ratiopharm Chronic Pain contributes to a reduction in pain interference and results in an overall increase in patients’ quality of life. A second RCT to meet the specific requirements for regulatory approval is currently underway.
The Context: Germany as Global Leader in Digital Health
Germany is a global leader when it comes to the implementation of digital therapeutics into the standard of care. Since the enactment of Digital Care Act in October 2019, providers of digital health solutions have been able to apply to the German Federal Institute for Drugs and Medical Devices (BfArM) to prescribe their digital health applications. As a prerequisite, providers must present scientific proof of their solution’s positive long-term effect on patients’ health. Approved solutions, called DiGAs, can be prescribed by doctors and therapists to patients with statutory health insurance free of charge. Since the launch of the first DiGA in autumn of 2020, BfArM has approved nearly 30 digital health solutions for a broad spectrum of health disorders, currently including four HelloBetter courses. In the meantime, DiGA manufacturers have communicated the concept of digital therapeutics to thousands of prescribers and patients. The increasing awareness of this novel treatment option leads to an improved understanding of the value of digital therapeutics, for both: practitioners and consumers. So far, some 40,000 DiGA access codes have been used by patients across Germany and uptake has been accelerating over time. A recent survey from Stiftung Gesundheit, a public health foundation, has shown that more than 80 per cent of physicians and therapists in Germany have already heard of DiGAs, want to try prescribing them in the near future, or have already done so.
- Official information website by the German Federal Institute for Drugs and Medical Devices (BfArM): DiGA directory (digital health applications directory)
- Free trial access: hellobetter.de/Ärzte
HelloBetter is among the world’s leading providers of digital therapy courses. The company was founded in 2015 by psychologists Prof. Dr. David Ebert, Dr. Hanne Horvath and Dr. Elena Heber. David Ebert, Professor of Psychology & Digital Mental Health Care at TU Munich, is an internationally recognised expert and global pioneer of digital interventions for mental health conditions. HelloBetter prevention and treatment courses cover eight major mental health issues including depression, anxiety, insomnia and panic. Four of the company’s digital therapeutics can be prescribed by doctors and therapists to more than 70 million people with statutory health insurance free of charge in Germany. More than 30 randomised-controlled studies on the effectiveness and cost-effectiveness of their therapy courses have been published in peer-reviewed journals. No other provider globally has a comparable body of clinical evidence for the effectiveness of its solution. The company is based in Berlin and Hamburg and employs more than 70 people. For more information, please visit www.hellobetter.de