Position paper on the documentation of biologic therapies for severe asthma

Abstract

Background

Biologics are the first-line treatment for patients with severe, inadequately controlled asthma. They can lead to a significant reduction in (or even complete avoidance of) exacerbations, a reduction in the need for systemic glucocorticoids with their many side effects, and a marked improvement in asthma control and lung function in severe asthma. Due to the high annual costs of biologic therapy, there is legitimate interest among health insurances in guideline- and approval-compliant as well as cost-effective use of biologics in severe asthma. On the other hand, there is also legitimate interest among treating physicians in prescribing these biologics without risk of insurer repayment demands.

Methodology

Using an analysis of the literature and regulatory approvals, the evidence for treatment with currently approved biologics for severe asthma—omalizumab, mepolizumab, reslizumab, benralizumab, dupilumab, tezepelumab, and depemokimab— was documented, and supplemented by the clinical experiences of the authors.

Results

Based on the guideline recommendations and approvals, recommendations are made for the use of the aforementioned biologics in the German healthcare system. In a joint effort by various professional associations (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 the initiation of biologic therapy and for the documentation of biologic treatment responses in severe asthma.

Conclusion

The new documentation forms concisely summarize all key points related to biologic prescription in severe asthma on a single page, serving both to ensure guideline-compliant and approval-compliant prescription and to avoid drug repayment demands.