Prescription of disease-related DiGA comes into effect

ASV is an area of care in which specialized physicians and clinicians interdisciplinary work together to provide sufficient and high-quality treatments for patients with rare and / or complex, therapy-intensive diseases. The G-BA defines which diseases can be treated and which prerequisites or general conditions must be met based on the ASV guidelines. With the G-BA resolution coming into force, the appendices of the ASV guidelines are updated. These appendices specify all services that can be provided in the respective ASV indications. To date, the G-BA has defined 19 indication groups, including, for example, various oncological indications, rheumatic diseases, and cystic fibrosis.

With the latest revision, the G-BA has expanded the remuneration fee schedule to include new examination methods in various indication groups and additionally enables the prescription and reimbursement of DiGA. Eligible for prescription are all DiGA provisionally and permanently listed in the DiGA directory by the Federal Institute for Drugs and Medical Devices (Bundesinstitut für Arzneimittel und Medizinprodukte, BfArM). The prerequisite is that the DiGA support the treatment of impediments and symptoms related to the ASV disease of the patients. With this decision, the G-BA has created further access to the currently reimbursable DiGA. Despite recent critical statements by legislators and payers, the expansion of prescription options for DiGA sends a positive signal for the perception of DiGA as an integral component of patient care in the future. For manufacturers, this prescription extension can result in various strategic opportunities for action:

• Due to the additional prescription possibilities in the ASV, more (specialized) physicians are given the opportunity to implement DiGA in their therapy regime. As a potential target group, a structured analysis and a focused stakeholder management approach can offer opportunities to increase awareness and acceptance of DiGA, as well as the number of prescriptions.
• A focused marketing approach can be used to target ASV patients leading to better public perception and offering potential for market penetration, especially in the context of increasable DiGA prescribing rates by providers.
• The new prescribing options provide access to care situations where DiGA prescription numbers are currently low. Under certain circumstances, unmet needs can be addressed generating added value for patients, where digital care offerings were non-existent priorly.
• With the additional access options to DiGA, relevant differences in the number of users may occur. Budgetary differences should be considered in the definition and alignment of the business case as well as the health economic benefit evaluation.
• The constitution of the user population may change, and new subpopulations, with different medical needs, may be identified, so that the quality and extent of the positive effects can change. Analysis of the resulting health economic impacts for both existing and planned DiGA can offer insights into the DiGA's unique value position.
• The care pathways of diseases in which, at least, some part of the patient care is provided in an ASV setting, can offer value creation opportunities and should be analysed to identify scenarios for innovative digital care offerings.

DiGA manufacturers should anticipate potential effects offered by the inclusion of DiGA in the ASV treatment regime during the DiGA strategy development, especially when analyzing different use scenarios of the DiGA in the patients' care pathway. As a strategic healthcare consulting firm with a focus on rare diseases and their therapies, and through our expertise in digital health, we are delighted to support you in developing a comprehensive DiGA strategy. This includes a thorough analysis of the diverse care situations to exploit the potential of the DiGA along the whole treatment pathway in the highly regulated DiGA market. Together and in state-of-the-art, we can improve patient care in Germany!

Sources (only in German language):
Ambulante spezialfachärztliche Versorgung um neue Diagnostik und digitale Anwendungen erweitert - Gemeinsamer Bundesausschuss
Beschluss
Ambulante spezialfachärztliche Versorgung - Gemeinsamer Bundesausschuss