OBJECTIVES: For approved drugs G-BA assesses the additional benefit (AMNOG assessment). For inpatient drugs, hospitals may apply every year for add-on reimbursement to cover funding gaps for the subsequent year - so-called NUB (Neue Untersuchungs- und Behandlungsmethoden). InEK (Institut für das Entgeltsystem im Krankenhaus) evaluates the applications and finally sets a status that determines eligibility for negotiation of extra funding: Status 1 and 4 (Yes), 2 and 3 (No). Aim of this study was to analyze the NUB status over time and the duration until full implementation into the DRG system.

METHODS: A database analysis was performed on orphan drugs in oncology that underwent the AMNOG assessment. NUB status was attained by screening historical InEK data. in addition, data on price history were derived from official price list (Lauertaxe).

RESULTS: Overall, n=30 oncology drugs with orphan status were launched in the German market during the analyzed timeframe. Within the first year of market entry 3 of 30 (3/30) drugs received NUB status 1, 8/30 status 2 and 7/30 status 4. 12 of these drugs did not apply for a NUB. In the second year, 27/30 received NUB status 1. For n=3 drugs with status 2, the status changed in the second year or later. On average it took 4 years until the preferred status 1 with potential extra funding was declined. For these drugs manufacturers are now able to negotiate hospital individual additional fees (Zusatzentgelt). In the timeframe between market entry and change of NUB status, prices decreased by 26%.

CONCLUSIONS: Almost all new drugs received a positive NUB status 1. High or low prices are not the only indicator if a status 1 will be granted. To bridge reimbursement gaps after launch, even in orphan indications with few patients, ensuring NUB is of paramount importance for every new drug in Germany.