orphan drugs
Insider Insights

Financing of new orphan drugs in Spain increases in 2023 


Last year was a positive one for patients with rare diseases as for the first time in 5 years Spain has financed more than half of the orphan drugs authorised by the EMA, with the National Health System (SNS) containing 78 of the 147 orphan drugs with EMA marketing authorization. 

In total 21 new orphan drugs were approved for funding in Spain last year, an increase of 12 compared to 2022, whilst the waiting time to reach a funding decision also improved, going from 34 months in 2022 to 23 months in 2023. However, despite this, all new orphan products are subject to conditional financing and of the new orphan products with positive pricing and reimbursement decisions, none were advanced therapies. A report by the Spanish Association of Orphan and Ultra-Orphan Drug Laboratories (AELMHU) also points out that although there have been improvements compared to 2022, there is still work to do to reduce processing times back to the 14 month average in 2019.  

Although there has been a slowdown in access to orphan medicines in recent years this signals that Spain is looking to improve timelines and become a more attractive place for orphan drug access, although there are still improvements to be made, especially in relation to advanced therapies.

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  1. resumen_ejecutivo_informe_de_acceso_aelmhu_2023_def.pdf 
  1. Spain funds more than half of orphan drugs approved by the EMA for the first time in five years ( 
  1. Orphan drugs: funding and incorporation into the system rebounded in 2023 | @diariofarma 

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