Authors: Katharina Wolff-Kuhne, PhD; Malte Glüsen, MSc; Dr. Lydia Frick, MSc, PhD; Dr. Matthias P. Schönermark, PhD, MD. Kintiga, Hannover, Germany
Abstract
OBJECTIVES
In certain cases, pharmaceutical companies market the same active substance under two trade names across different indications. This study examines the frequency and health technology assessment (HTA) implications of dual-brand strategies in the German AMNOG (Arzneimittelmarktneuordnungsgesetz) benefit assessment system, with particular focus on orphan designations, the €30 million revenue threshold and pricing
dynamics.
METHODS
A systematic qualitative analysis of all AMNOG benefit assessment procedures involving active substances marketed under two trade names was
conducted. G-BA (Gemeinsamer Bundesausschuss) benefit assessment decisions and procedural classifications were reviewed. EMA pre-authorisation guidance
on naming conventions was analyzed. Pricing and reimbursement implications at the pharmaceutical registration number (PZN) level were assessed, including
the role of confidential rebates and anticipated effects of rebate transparency reforms (sunset clause).
RESULTS:
Nine active substances were identified as having undergone AMNOG procedures under dual brand names (e.g., aflibercept [Eylea®/Zaltrap®], nintedanib [Vargatef®/Ofev®]). EMA guidelines require a separate trade name when an orphan-designated product receives a non-orphan indication extension, as a single brand cannot hold both designations. Additional constellations for access strategies within the same molecule were identified (e.g., semaglutide [Ozempic®/Wegovy®], tirzepatide [Mounjaro®]), with free pricing outside AMNOG versus parallel list pricing and confidential reimbursement. Procedural classification within AMNOG was inconsistent: earlier second-brand submissions were treated as indication extensions, whereas since 2021, all submissions were listed as initial, indicating a shift in G-BA practice. Separate brands enable PZN-level revenue tracking, potentially delaying exceedance of the €30 million orphan threshold. However, observed price differentials were modest, suggesting strategic price alignment to limit off-label use.
CONCLUSIONS
Dual-brand strategies in AMNOG are primarily driven by EMA naming rules for orphan versus non-orphan indications and offer strategic advantages regarding the €30 million threshold. While trade names do not affect G-BA assessment outcomes, they create distinct pricing and reimbursement pathways with implications for payers and prescribers.
