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On National Day of Cystic Fibrosis we claim access to new drugs for Cystic Fibrosis without having to wait for a deterioration of health.
The importance of rapid management
When the European Medicines Agency approves the indication of certain drugs, it is then up to each country to approve it. Once approved, the laboratory must negotiate a price agreement with the Ministry of Health in the case of Spain. Once the price has been agreed, it is then up to each Community, through certain bureaucratic processes, to proceed with the purchase. This is simply incomprehensible.
Time is very important
When we are talking about drugs with remarkable results, approved by a European Agency that has representatives from all countries, including Spain, it does not make sense to delay for months the approval by the Spanish Agency of Medicines and Health Products (AEMPS). Neither does it make sense that there are communities, such as the Balearic Islands, that add months of delay because their bureaucratic processes are so complicated that they put at risk the health of people with Cystic Fibrosis, which is the case we are dealing with.
Trailing in Spain
When most of the people with Cystic Fibrosis and at least one copy of the F508del mutation in the rest of the communities of Spain are already taking the drug Kaftrio©, while in the Balearic Islands it has taken more than 4 months and a half.
“It is disconcerting the delay with which this drug has been processed in the Balearic Islands, both by the medical team and by the General Directorate of Pharmacy, all this with the excuse of Covid-19. From here we demand more speed and simplicity in the management of the bureaucratic procedures of this type of medicines in order not to harm the health of our group.”, explains Ana Mª Amate, president of the Cystic Fibrosis Balearic Association.
In our community, of the 79 people with Cystic Fibrosis that we know of, 40 of them have a copy of the F508del mutation, of which 5 have been transplanted and, therefore, cannot take Kaftrio©. Of the remaining 35, 25 are 12 years old or older and could already be taking this drug with the indications approved by the AEMPS on December 1, 2021.
New drugs knocking on the door
The pediatric indications for Kalydeco© for 6 months to 2 years, Orkambi© for 2 to 5 years and Symkevi© for 6 to 11 years are already in the process of being included in the SNS, so we are living in a time full of hope for all the families of our group.
The decision rests with the medical team
Since the Ministry of Health has already authorized the purchase of the drug, it is now up to the medical team to establish the priorities when it comes to giving it to people with Cystic Fibrosis. We must not fall into the temptation of influencing the medical criterion when establishing these priorities.