Infarmed President Rui Santos Ivo guaranteed this Wednesday that “nobody” is pressuring him to authorize the use of Zolgensma, the most expensive drug in the world, which was used to treat the Portuguese-Brazilian twins in Santa Maria.
Ruy Santos Ivo also stated in the Health Committee of the Assembly of the Republic that the approval time for the request for access to the medicine prescribed to the twins is normal.
“Such deadlines are normal. The average permit period is five days. There are times when from zero to two days. Infarmed learns about the processes only when they are referred to us from medical institutions. And so it happened. Here. The request began to be analyzed from the moment it was referred to by the Santa Maria Hospital,” said Rui Ivo.
Regarding the timing, Ruy Santos Ivo specified that Infarmed works “seven days a week, 365 or 366 days a year” if necessary, since a “very sensitive area” is at stake. “The weekend is a day like any other, dedicated to certain types of activities. [da Autoridade Nacional do Medicamento e Produtos de Saúde]”, he added.
The request for access to Zolgensma for the twins, who also received Portuguese citizenship in a short period of time, was approved in two working days, submitted on Saturday, February 29, 2020, and approved by Infarmed the following Tuesday.
Rui Santos Ivo said that currently 31 patients are being treated with Zolgensma, with most of them receiving positive results.
However, there is a negative and one more uncertain case, he listed.
As for payment for medications, according to the person in charge, this occurs through a “risk sharing agreement” based on the characteristics of the patient.
At the same time, the person in charge explained that for patients with negative results, “the payment is stopped,” and for those who are “unsure,” there is a “reduction in the percentage paid.”
An internal audit of Santa Maria Hospital concluded that the state Department of Health’s initial hospital appointment was the only exception to compliance in this case.
It is worth remembering that two Portuguese-Brazilian twins came to Portugal in 2019 to receive one of the most expensive drugs in the world, Zolgensma, for spinal muscular atrophy, the total cost of which was four million euros.