Join industry executives in staying informed on the market access and HTA process in Portugal.  1. What are the pricing models, processes and principles for originator drugs? Prices of medicinal products are regulated by the System of Assessment of Health Technologies (SiNATS), approved by Decree-Law 97/2015, 1 June 2015, which established the provisions applicable to…

Join industry executives in staying informed on the market access and HTA process in Switzerland.  1. What are the pricing models, processes and principles for originator drugs? An original drug is defined as a drug approved by Swissmedic as the first drug with a specific active ingredient, including all dosage forms approved at the same…

Join industry executives in staying informed on the market access and HTA process in Denmark.    1. What are the pricing principles and processes in your country? As mentioned above, there are two main markets for medicines in Denmark: the primary healthcare sector (prescription medicines) and the secondary sector (hospitals). A third market consists with…

Join industry executives in staying informed on the market access and HTA process in Romania.  1. What are the pricing models, processes and principles for originator drugs? The main enactment setting out the pricing models and approval procedures for medicines is Ministry of Health’s Order no. 368/2017 approving the Norms regarding the calculation method and…

Join industry executives in staying informed on the market access and HTA process in Brazil.  1. What are the pricing models, processes and principles for originator drugs? To set the price of originator drugs, CMED uses Health Technology Assessment (“HTA”) to evaluate whether a drug provides an additional therapeutic benefit over comparators (which are drugs…

1. What are the pricing models, processes and principles for originator drugs? Originator medicinal products must go through price and reimbursement proceedings (P&R Procedure) where it is decided if they are to be reimbursed or not. If reimbursed, the PVL is also fixed. To determine whether a medicinal product is reimbursed or not, the DGCC/CIPM…