OVERVIEW OF NUB PROCESS FOR IN-PATIENT DRUGS AND DEVICES IN GERMANY
Author(s)
Aggarwal S1, Kumar S2, Topaloglu H1
1NOVEL Health Strategies, Chevy Chase, MD, USA, 2GLOBAL ACCESS Monitor, Bethesda, MD, USA
OBJECTIVES: In Germany, the reimbursement and pricing of innovative in-patient drugs and devices is managed through the NUB application process. These applications are submitted by the hospital stakeholder and are approved or rejected by the Institute for the Hospital Remuneration System (InEK ). The objective of this research was to assess the NUB trends in Germany in 2012-2014. METHODS: We developed a database of NUB approvals and rejections based on the Institute for the Hospital Remuneration System’s (InEK )’s reports. All information was extracted into Excel format. The following data was extracted: product name, indication, year of submission, number of NUB applications submitted, status score, type of evidence available and lack of evidence for NUB rejection. Additionally, the number of re-applications and re-rejections were also analyzed. RESULTS: In 2013 and 2014, a total of 21264 and 25634 NUB applications were submitted for 612 and 613 medical products, respectively. Of these applications in 2013 and 2014, 10% and 16% were approved for NUB (as Status 1) and 82% and 75% were rejected (as Status 2), respectively. In 2014, the median number of hospital applications for NUBs with Status 1 and Status 2 were 37 and 3, demonstrating the importance of hospital participation for seeking NUB approval. Among approved NUBs, 37% of the applications were for drugs and 63% were for devices. Interestingly, the median NUB hospital applications for approved drugs was 192, while for devices, the median was 9 applications. In 2014, 447 NUB applications for products were re-submitted, of which 5 were approved and the remaining were re-rejected. The evidence requirements analysis suggests the need for hospital focused economic data. CONCLUSIONS: The NUB process plays a critical role in market access for in-patient drugs and devices. For approval, two key components are: hospital focused economic evidence and provider stakeholder involvement.
Conference/Value in Health Info
2015-11, ISPOR Europe 2015, Milan, Italy
Value in Health, Vol. 18, No. 7 (November 2015)
Code
PHP184
Topic
Health Policy & Regulatory
Topic Subcategory
Reimbursement & Access Policy
Disease
Multiple Diseases