title: Evidence vs. efficacy in allergen-specific immunotherapy: Considerations using the example of tradable products in Germany.
abstract: The recently published S2k-guideline on (allergen-) specific immunotherapy (AIT) provides an excellent overview of the evidence on allergen preparations available for AIT in Germany based on the published efficacy studies. Publications based on the guideline are currently being used by the German associations of statutory health insurance physicians and German health insurance funds to open a discussion on the reimbursement status of allergen preparations. In our view, calling the reimbursement status of perscribable and tradable AIT preparations into question on the basis of an assessment of the current body of evidence in the guideline is to be rigidly opposed. In Germany the Paul Ehrlich Institute (PEI) is the only authority empowered to decide on the marketability of AIT preparations, and decisions on the reimbursement status of AIT products need to be based on cost-benefit analyses and not solely on an evaluation of the evidence. The present article aims to examine the relationship between the evidence, efficacy, tradability, and reimbursability of AIT preparations.
authors.affiliation: Outpatient Allergology Clinic, Occupational Dermatology and Environmental Medicine, Department of Dermatology, University Hospital Münster, Von-Esmarch-Straße 58, 48149 Münster, Germany.
authors.forename: Randolf
authors.initials: R
authors.lastname: Brehler
authors.affiliation: Center for Rhinology and Allergology, Wiesbaden, Germany.
authors.forename: Ludger
authors.initials: L
authors.lastname: Klimek
authors.affiliation: Department of Pediatrics and Adolescent Medicine, Carl Gustav Carus University Hospital, Dresden, Germany.
authors.forename: Christian
authors.initials: C
authors.lastname: Vogelberg
authors.affiliation: Department of Dermatology, Venereology, and Allergology, Hannover Medical University, Hannover, Germany.
authors.forename: Thomas
authors.initials: T
authors.lastname: Werfel
authors.affiliation: Center for Rhinology and Allergology, Wiesbaden, Germany ; ENT at Mannheim University Hospital, Mannheim, Germany.
authors.forename: Oliver
authors.initials: O
authors.lastname: Pfaar
authors.affiliation: Ruhr Allergy Center, Ruhr University Bochum, Germany ; Bethel Pediatric Center, Bielefeld, Germany.
authors.forename: Eckard
authors.initials: E
authors.lastname: Hamelmann
keywords: allergic rhinoconjunctivitis; allergology; efficacy; evidence; guideline; hypersensitization