Читать книгу DiGA VADEMECUM - Jörg F. Debatin - Страница 17

Being listed in the DiGA registry is a key milestone, but your journey has not ended yet. Long-term success or failure will likely be determined by the first 12 months thereafter.

Some DiGA are only conditionally provisionally included in the Fast-Track for the first 12 months. Only if subsequent evidence confirms what was defined as a claim in the application, can a DiGA become permanently available to be prescribed and used in the German healthcare system. Why the evidence should not only validate minimal claims and how to be well prepared for price negotiations with the National Association of Statutory Health Insurance Funds (the second major milestone in the life of a DiGA)—are explained in this chapter.

It is not enough to have a good product with a large number of Weekly Active Users (WAU) and the blessing of the Federal Institute for Drugs and Medical Devices (BfArM). If you can’t clearly demonstrate added value for doctors and psychotherapists, they will hardly ever prescribe your DiGA. We give you insights into the everyday life of an outpatient physician in Germany and show you what you need to do to properly address this crucial target group.

You’ve convinced healthcare providers to prescribe your DiGA. But how exactly does the prescription process for a DiGA work—and as a manufacturer, what do you need to do to ensure that the DiGA is both prescribable and that you are bill health insurers? The DiGA manufacturers’ associations and health insurers, together with the National Association of Statutory Health Insurance Funds, have agreed in advance on a uniform technical procedure that works with physicians’ existing IT infrastructure and meets all data protection requirements.