Background on Zolgensma's Approval
The director of the Santa Maria Hospital contacted the Infarmed president via email and phone before the medication request was submitted electronically. Rui Santos Ivo acknowledged a process of 'desformalization' during a parliamentary hearing regarding the approval of Zolgensma for Portuguese-Brazilian twins, Lorena and Maîte.
Communication Prior to Submission
Rui Santos Ivo confirmed that he received an email from the former clinical director, Luís Pinheiro, to initiate the Zolgensma availability process. This email served to 'signal cases' before they were formally submitted through the Infarmed platform. Ivo emphasized that this kind of preliminary communication is not uncommon in urgent cases.
Infarmed's Normal Procedures
Ivo highlighted that the request was made through Infarmed's medication information center, a standard procedure. He noted that Luís Pinheiro also called to express the intention to enroll the twins in the Zolgensma access program.
Denial of Procedure Violations
In response to an inspection report alleging procedural violations, Ivo firmly denied any wrongdoing. He stated that Infarmed had adhered to all procedures and that the 'desformalization' was a step taken to efficiently serve the recipients. He insisted that all subsequent processes followed the required platforms.
Quick Approval Timeline
The Infarmed president noted that the approval for Zolgensma occurred within just three days after the submission, which is not unusual according to data from 2023. He stated that 30% of similar requests were approved in less than two days, asserting that the rapid evaluation is a regular occurrence.
Cost Clarification
Ivo also refuted claims regarding the treatment costs, clarifying that the maximum price is significantly lower than the €2 million often cited. He explained that the contract with Novartis involves risk-sharing based on treatment outcomes, with full payment contingent on positive evaluations.
Long-term Efficacy Assessment
While he confirmed the therapeutic and economic benefits of Zolgensma, Ivo acknowledged that the long-term efficacy of the treatment still needs to be assessed. The ongoing discussions around the approval process and treatment efficacy continue to raise questions within the healthcare system.
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