Recommendation: Indication and cost coverage for biologics within therapies of the employer's liability insurance association by the example of Dupilumab: A basis for discussion [Indikation und Kostenübernahme von Biologika im berufsgenossenschaftlichen Heilverfahren am Beispiel von Dupilumab: Eine Diskussionsgrundlage]

Abstract

Introduction: Quality assurance regarding occupational inflammatory skin diseases (so called BK 5101 according to German law) comprises guideline-based use of new systemic therapies for occupational skin diseases that occur on the basis of hereditary predispositions such as atopic dermatitis (AD). In the present work, the scientific background of new systemic therapies (here: biologics) is examined using the example of Dupilumab and case constellations with regard to cost coverage aspects. Methodology: Analysis of the available scientific literature with regard to the indication, the guideline-based use of Dupilumab and discussion of frequent case scenarios including ethical aspects. Results: The scientific data on the use of Dupilumab for the treatment of chronic hand eczema is still incomplete; use for this indication is off-label. Four case constellations for a therapy of occupational atopic hand dermatitis with Dupilumab and the safety profile in comparison to classic systemic therapies of AD are presented. Discussion: In order to formulate a scientifically sound, criteria-based recommendation for the use of Dupilumab for the therapy of occupational chronic atopic hand eczema, a dedicated consideration of individual case constellations, taking into account the German insurance law, is essential. In the future, there is a need to carry out further clinical studies, especially randomized controlled studies. Conclusions: Cost coverage for a therapy with biologics by the statutory accident insurance (GUV) will be reserved for exceptional cases and is linked to special conditions and comprehensive accompanying preventive measures. For clinically severe occupational skin ailments (which are the prerequisite for systemic therapies) a special GUV procedure (so-called Verfahren Haut) is established which requires to offer the affected individual an in-patient tertiary individual prevention (TIP) measure. In TIP, a well-founded occupational dermatological causality assessment is performed, by meticulous diagnostics the appropriate therapy and prevention options are determined and implemented. Thus, in order to guarantee quick decisions on systemic therapy indications and cost coverage in the interest of the insured persons, and sustainable support by the administration, swiftly offering TIP is recommended in these cases. © 2022 Dustri-Verlag Dr. K. Feistle.