In Germany, doctors could potentially be prescribing health apps as medicines as early as 2020. This is one of the main objectives of the draft bill on the “Law for better provision through digitalization and innovation” (Digitale Versorgung Gesetz – DVG), which is expected to be approved by the parliament early November.
The law plans a rapid market access for health apps classified as low-risk. After an initial review of an app’s safety, quality, privacy, transparency and usability, an app will be provisionally reimbursed by statutory health insurance (SHI) for one year. During this time, the manufacturer must prove to the Federal Institute for Drugs and Medical Devices (BfArM) that the service has positive effects on care. If there is a proven benefit, the reimbursement and price are negotiated between the manufacturer and the National Association of SHI Funds (GKV-SV).
The new law brings improvements for health apps, which are approved as medical devices of low-risk class (class I and IIa). But the future for high-risk health apps remains uncertain. The EU Medical Devices Directive (MDD) points to a possible solution. The MDD envisages that medical products designated as high-risk require improved post-market surveillance studies – after the CE certification. The head of the G-BA argued for that clinical evidence-based review process, which would require a lengthy assessment as “new treatment methods” by the Joint Federal Committee (G-BA).
Contact us to learn how our Berlin office can guide health care app developers by supporting evidence generation that shows the benefit of the application when the law comes into effect in January 2020.
From November 1, 2016 to September 1, 2019, the Italian Medicines Agency, AIFA evaluated a total of 166 Dossiers - 28 were related to orphan drugs, 56 to new active substances, 57 to extensions of indications for drugs already reimbursed, and 25 to other types of negotiations.
The field of DTx has gained traction over the last couple of years, with FDA approvals/clearances, the founding of a DTx specialty society, large-scale acquisitions of DTx firms, pharma investments in DTx, and pharma co-development deals, amongst other key developments.