Juan Da Silva, president of the Spanish Cystic Fibrosis Foundation and the Spanish Cystic Fibrosis Federation.
The pediatric access to Kaftrio, treatment for cystic fibrosis patients, has not yet been approved in Spain through public funding. Last May, the Interministerial Commission on Drug Prices (CIMP) proposed using half the currently funded dose of Kaftrio for children over 12 years of age with children 6 to 11 years of age, a decision that, from the Federation Spanish of Cystic Fibrosis, branded as “insufficient”.
The approval might arrive at the end of this month of September, when the Interministerial Commission publishes the new drugs and indications with permission for sale. Thus, it will be the first approval with Cesar Hernandez as new general director of the Common Portfolio of Services of the National Health System (SNS) and of Pharmacy, replacing Patricia Lacruz. From the Spanish Federation of Cystic Fibrosis they assure that they see the change of direction “with very good eyes”. “Hernandez’s entry assures us of an interest in access to innovation in Spain,” declares Juan Da Silva, president of the Spanish Cystic Fibrosis Foundation and of the aforementioned Spanish Federation, who highlights Hernández’s career. “He knows the processes very well and has a great deal of experience,” he says.
Still, he explains that the only concern is that the relay slows down the negotiation: “Everything indicates that it will not be like that, but we have a small concern with the new appointment interfering with the approval of Kaftrio.”
“Adult” doses adapted to children
Right now, in the absence of approval of the pediatric indication, the norm is that the dose of adults be adapted to children. “This may be a transitory option until pediatric approval arrives, but in no case can it remain the only option,” says Da Silva. Thus, the president hopes that “At the next meeting the Interministerial Commission reaches a financing agreement for the pediatric indication and that it may be available in November”.
The overall drug approval with this specific use in children was approved by the Ministry, according to Da Silva “with conditions that were not those agreed with the laboratory”. In this case, Vertex Pharmaceuticals. “The pharmacist is presenting claims because she does not agree. They claim that there is a pediatric indication available that is the most appropriate,” he explains.
Indication already approved by the EMA
On the other hand, the president of the Federation claims that This indication has undergone a safety process and was approved by the European Medicines Agency (EMA) last January. “We were confident that the approval for Spain would arrive in May, so the drug would have been available in June or July: we are once once more facing a delay compared to Europe,” explains Da Silva, adding that “our country follows the lag behind its neighboring countries when it comes to the arrival of innovation.
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“Spain follows the tail of Europe in terms of the arrival of innovation” |
Ministerial review is only part of the process for marketing approval of a drug. Once published, the laboratory in question must accept the proposal. Once all the procedures have been carried out, the drug begins to be available. In this case, as the laboratory has presented allegations, approval still up in the air. “It shouldn’t be normal for laboratories to present one proposal and the Commission a different one. All this does is lengthen the process,” denounces Da Silva, although he ends with a message of hope. “Everything points to the approval coming in September.”
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