PSY148 - Price Negotiations for Orphan Drugs in Germany

Abstract

Based on limited data it has been observed that reimbursement for orphan drugs in Germany seems to be inverse to epidemiology, i.e. reimbursement per patient increases with the rarity of the disease. The objective of the present study is to verify if this relationship is still true, especially if renegotiations due to reassessments or assessments of new indications still follow this general observation. Our analysis is based on all first price negotiations completed until June 2016. For each drug the estimated population and the retail price post negotiation are captured. To analyze this hypothesis we used an “inverse” regression approach of the type y=ax^-n, where y is the reimbursement per patient per year, x the patient potential for Germany and a, n are real numbers. Based on previous observations separate regressions have been performed for Orphan Drugs in oncology and outside oncology. For sensitivity analysis all renegotiations due to reassessments or assessments of new indications are checked if they follow the general hypothesis. 23 first price negotiations and 3 renegotiations have been completed so far. For Orphan Drugs outside oncology prices do in fact increase with the rarity of the disease. The precision of the estimate even increases when taking renegotiations into account. For Orphan Drugs in oncology a relevant statistical inverse relation could not be observed. New data confirm the observation on a negative inverse relationship between disease rarity and level of reimbursement for Orphan Drugs outside oncology. Renegotiations are consistent with these observations.