The Spanish Association of Orphan and Ultra-Orphan Drug Laboratories (AELMHU) has published its first Quarterly Report on Access to Orphan Drugs in Spain, which analyzes the situation of products with European orphan designation as of April 30, 2024.
According to the main results of the study, during the first four months of this year a total of 202 products with trade name and orphan designation were reached. Of these, 149 already have marketing authorization in the European Union.
In our country, between January and April 2024, 9 new National Codes were assigned and 9 new drugs obtained orphan designation, bringingthe total to 128 orphan products with a National Code, of which 85 products are already funded (66%).
To date, 86% of the orphan drugs authorized in the EU have reached Spain . However, only 57% of these are financed.
As for the 85 drugs already financed, it should be noted that 41 of these are financed with restrictions, such as limitations on indications or unfunded indications.
One aspect that continues to be of concern is the waiting time between obtaining the national code and its financing, which in Spain is still 23 months, unchanged from 2023.
Currently, there are 43 orphan drugs with a National Code that are not financed in our country, of which 23 are not financed by resolution and the other 20 are under study or without request for financing.
The sources used for this report include the European Medicines Agency (EMA), the Community Register of Orphan Medicinal Products, the Spanish Agency for Medicines and Health Products (AEMPS), and the Ministry of Health.
Read the full report here.
