Klaas Franzen, Matthias Raspe, Matthias Urlbauer, Wulf Pankow, Karin Vitzthum, Natascha Sommer, Alexander Rupp, Stefan Andreas
Abstract: The recent resolution of the Federal Joint Committee (G-BA) amending section §14a of the Pharmaceutical Directive and introducing Annex IIa represents a major advancement in the clinical management of tobacco dependence in Germany. This editorial outlines the regulatory prerequisites for prescribing pharmacological smoking-cessation therapies, including the diagnostic confirmation of severe tobacco dependence (ICD-10 F17.2), assessment via the Fagerström Test for Cigarette Dependence, and mandatory participation in an evidence-based cessation program. Approved therapeutic options, such as mono- or combination nicotine replacement therapy and varenicline, are described alongside considerations for implementation in both outpatient and inpatient care settings. The text further discusses current limitations of the resolution, including the three-year restriction on repeat prescriptions and the insufficient integration of users of heated tobacco products and e-cigarettes. Overall, the resolution is assessed as an important milestone toward structured treatment of a chronic relapsing disorder, while highlighting areas for future improvement.