Spotlight on access to orphan drugs
Insider Insights

Spain: MOH spotlight on access to orphan drugs


The Ministry of Health (MOH, Ministerio de Sanidad) has published a report on the “evolution of funding and fixing of the price of orphan drugs in the SNS [sistema nacional de salud; national health service]”.  

According to the report, as at February 2022 there are 131 orphan drugs authorised at the EU-level, 111 of which are registered in Spain (for the other 20 drugs, the manufacturers had opted not to market their product in Spain). Of these 111: 

  • 57 (51.4% of orphan drugs registered in Spain) are funded in the SNS 
  • 29 are not funded (26.1% of orphan drugs registered in Spain)- although one will be from March 2022.  
  • 25 (22.5% of orphan drugs registered in Spain) are under assessment for funding.  

For the 28 orphan drugs which are not funded, the reasons behind the decision are as follows: 

  • For 3 drugs (11%), no price was requested by the manufacturer 
  • For 5 drugs (18%), the decision reflects the “rationalisation of public spending” and high budget impact 
  • For 9 drugs (32%), there were therapeutic alternatives available at a lower cost 
  • For 11 drugs (39%), there was uncertainty over the drugs’ clinical benefit.  

In 2021, 21 new orphan drugs were evaluated; 14 of these received a positive funding decision (+56% compared to 2019).  

In terms of timelines, according to the MOH: 

  • The average time from European authorisation to the manufacturer requesting marketing authorisation in Spain is 180.3 days.  
  • The average time “from the start of the financing and price study until the manufacturer presents the dossier with the first price proposal” is 107.3 days. Companies typically make at least two pricing proposals, with 3-5 offers in each proposal.  
  • The average time from submission of the first price proposal to a final decision from the Interministerial Commission on Medicines Prices (Comisión interministerial de precios de medicamentos, CIPM) is 320.8 days.  

In 2020 spending on orphan drugs through hospitals and pharmacies totalled €882.5 million, corresponding to 5.2% of spending on medicines. For 2021, spending on orphan drugs is estimated at €1,003.6 million, a rise of 13.7% compared to 2020. The Ministry notes that spending on orphan drugs is increasing year on year.  

The report also states that “the average price of orphan drug presentations is more than 3,000 times higher than that of non-orphan drugs”. 



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