Cologne, Germany, 26.05.2021 – CANKADO’s digital health application (Digitale Gesundheitsanwendung, DiGA) called PRO-React Onco was approved by the Federal Institute for Drugs and Medical Devices (Bundesinstitut für Arzneimittel und Medizinprodukte, BfArM). PRO-React Onco is now listed in the DiGA Directory and available for breast cancer patients upon prescription.
Legal background of DiGA
The Digital Healthcare Act (Digitale-Versorgung-Gesetz, DVG) in Germany came into effect on December 19th 2019 introducing the ‘app on prescription’ as part of healthcare provided to patients. This means that patients insured in the statutory health insurance (Gesetzliche Krankenversicherung, GKV) are entitled to healthcare through DiGA. These applications can be prescribed by physicians and psychotherapists and are reimbursed by health insurances.
First DiGA for breast cancer patients – PRO-React Onco
A new and innovative tool within the Oncology sector in Germany received the DiGA approval. PRO-React Onco is now available as an ‘app on prescription’. CANKADO is the provider of this first DiGA specifically intended to accompany the treatment of breast cancer patients, diagnosed via the ICD code C50. Once prescribed, PRO-React Onco is free of charge as statutory health insurance companies will cover the cost. PRO-React Onco can be used from 03.05.2021 with prescription from doctors in Germany.
PRO-React Onco can be used as digital cancer treatment support. Using the DiGA, patients can independently record their symptoms and observations. The documentation is possible by the use of the CANKADO patient app and also via the web at www.CANKADO.com. Based on these Patient-Reported Outcomes (PROs), patients receive automated behavioural recommendations on how urgently observed symptoms need to be discussed with the attending oncologist. By doing so, patients actively participate in their own treatment and thus allow better self-management of their disease.
Additionally, the continuous patient documentation can be exported as a graphical overview report which helps the physician to receive a better clarity over the course of the disease. This enables the physician to better prepare for the respective visits and to better respond to the individual situation.
PRO-React Onco can now be prescribed as DiGA in Germany using the form Muster 16. The prescription needs to contain the product name “CANKADO PRO-React Onco” and the PZN 17491545. Alternatively, also insured patients with proof of their breast cancer diagnosis are also eligible to receive the DiGA PRO-React Onco. Further information on how to receive a DiGA prescription and a DiGA license key is available on our homepage https://diga.cankado.com/verschreibung/.
Clinical evidence of PRO-React Onco
The first clinical evidence of PRO-React Onco was evaluated within the randomized, multicenter Phase IV PreCycle study (NCT03220178) which evaluates the effect of electronic Patient-Reported Outcomes (ePRO) documentation on the quality of life of breast cancer patients. The study started in 2017 and is still ongoing, with currently 81 centers. A systematic data evaluation was carried out within the PreCycle to justify the positive effect of PRO-React Onco. The available data from the safety analysis with 261 randomized patients from October 15, 2019, showed regular CANKADO use on 59% (+/- 10%) of the days over 2 years and a clinically relevant reduction in the SAE incidence from 31.4 to 20.6 per 100 patients. This clinical observation is preceded by the step of patient competence and the ability to actively become part of the own treatment team.
Additional evidence will be generated within the AIPEC study. AIPEC is a multicenter, prospective, two-arm study for patients with breast cancer. This comparative study is intended to evaluate the positive health care effect of PRO-React on health literacy.
About CANKADO
CANKADO is a digital health platform with a web/app multilingual system. It is registered as a medical device in the European Union and compliant with the FDA classification for Mobile Medical Devices. CANKADO offers digital health solutions and develops new tools specific to the requirements and outputs of each project. It runs with a wide range of clientele that mostly covers pharmaceutical companies and Clinical Research Organisations (CROs). Click here to enquire further information regarding CANKADO”s digital health services.
