Abstract
Reimbursement of Orphan Drugs is a highly disputed issue. In 2011 Germany introduced an early benefit assessment for all new drugs – including Orphans. The subsequent price negotiation with payers gave them a say in the reimbursement. The objective of the present study is to assess if and how this impacted reimbursement levels of Orphan Drugs in Germany, especially if it is still possible to achieve a price premium to reflect the rarity of a disease. Assessment was based on all first price negotiations completed until November 2015. For each drug the estimated population and the price pre and post negotiation was captured. Prices are expressed on retail level. All information is available from publically available sources. For sensitivity analysis a differentiation is made between oncological drugs and non-oncological drugs. 19 price negotiations have been completed so far. No Orphan Drug was withdrawn from the German market due to the outcome of the price negotiation. Negotiated drug prices are between 30 to 498 k€ per year. Rebates range between 7 and 28% and are in line with rebates for other, non-orphan drugs. A negative correlation still exists between epidemiology and price with allowing for higher prices with increasing rarity of the disease. There seems not to exist a threshold for reimbursement regarding costs per year. Whereas the new laws in Germany modified rules of reimbursement for pharmaceuticals in a drastic way this still allowed to take the specific reimbursement challenges of Orphan Drugs into account.
Sign-in/Register to access full text options 
Free) 
Talk to us
Join us for a 30 min session where you can share your feedback and ask us any queries you have
Schedule a call
