[Documentation of biological treatment in asthma]

Biologics are the first-line treatment for patients with severe, poorly controlled asthma and can lead to a significant reduction (or even complete avoidance) of exacerbations and the need for systemic corticosteroids - which are associated with numerous side effects - as well as to a marked improvement in asthma control and lung function in severe asthma. Due to the high annual costs of biologic therapy, there is a legitimate interest on the part of payers in the cost-effective use of biologics for severe asthma in accordance with guidelines and regulatory approvals; conversely, there is a legitimate interest on the part of treating physicians in prescribing these biologics in a manner that protects them from liability claims.

In an analysis of the literature and regulatory approvals, combined with the experience of the participating authors, evidence was compiled regarding therapy with the biologics approved for severe asthma: omalizumab, mepolizumab, reslizumab, benralizumab, dupilumab, tezepelumab, and depemokimab.

Based on guideline recommendations and approvals, recommendations are provided for the use of the aforementioned biologics within the German healthcare system. In a joint effort by various professional societies (AeDA, DGP, BdP, GAN, DGAKI, GPP, GPA), documentation forms were created for all biologics approved for severe asthma, which can serve as a basis for documentation. Forms were developed both for initiating biologic therapy and for documenting the course of biologic therapy in severe asthma.

The new documentation forms provide a practical, one-page summary of all key points regarding the prescription of biologics and the assessment of response to biologics in severe asthma, serving both to ensure prescribing in accordance with guidelines and regulatory requirements and to prevent drug-related claims.