Nub Status - A 2014 Situation Analysis for Drugs: Oncology As Leading Therapeutic Area.

Abstract

In the German hospital landscape NuB`s (Neue Untersuchungs- und Behandlungsmethoden) are essentially the precursor for cost-intensive drugs to be reimbursed within the G-DRG system. Hospitals can only start SHI negotiations for reimbursement once drugs have been given a NuB 1 status. The objective of this research was to provide an overview on the proportion of drugs (vs. Methods, medicinal products) and their respective indications, which submitted NuB applications for 2014. The German DRG database issued by the InEK (Institute for the Hospital Remuneration System) was used to analyse NuB subgroups sorted according to key therapeutic indications. In parallel, the number of NuB 1 status products that went through the AMNOG process was analysed. Out of 618 NuB submissions, only 133 (22%) were classified as drugs. In total, 114 (18%) of all NuB applications received a NuB 1 status, out of these 43 (38%) were drugs. The leading therapeutic area of the NuB 1 status drugs was oncology with 28 drugs (65%), followed by 5 ophthalmic products (12%). NuB 2 status was given to 465 (75%) procedures out of which 82 (18%) were drugs. The analysis reveals that, the success rate to receive the essential NuB 1 status is relatively low. Chances to receive a successfull NuB 1 status approval is one in three for drugs, however only one in six for other procedures. Out of the 43 drugs that were given NuB 1 status, already 24 (55%) passed through the AMNOG process and were given equal proportions from important additional benefit to no additional benefit. Drug applications are more likely than procedures to be given NuB 1 status and thereby initiate reimbursement negotiations with the SHI. The application quality and support by the scientific societies and treatment centres is essential to make a NuB application successful.