A national reimbursement agreement according to an accelerated procedure has been reached between the Italian Medicines Agency and Gilead Sciences in relation to the new anti-hepatitis C drugs based on sofosbuvir (Sovaldi) and a combination of sofosbuvir and ledipasvir ( Harvoni). This was confirmed yesterday by the American pharmaceutical company itself, after AIFA had announced in recent days, with regard to Sovaldi, the conclusion of "a negotiating agreement at an average price far lower than all of Europe".
The regulatory agency had added that patients currently registered in treatment with this drug are over seven thousand throughout Italy, even if the regional variability had been defined as worrying.
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It is not true that the State has not allocated the resources nor that these must reach the individual centers before the drug can be prescribed. – the Agency specified – The law clearly speaks of reimbursement and given that the contract with the pharmaceutical company is made according to a price/volume agreement, the more patients who enter treatment, the less we pay for it. Anyone who is not prescribing or dispensing the drug despite the patients falling within the criteria identified by AIFA will have to take responsibility for such a choice".
In this way, the Medicines Agency intervened on the controversy arising from the news that the prosecutor Raffaele Guariniello, in the investigation opened on the too high cost of the drug, would be investigating the hypothesis of the crime of manslaughter. The Turin magistrate would in fact have asked the Nas carabinieri to verify whether there have been deaths of patients who have not been able to be treated with Sofosbuvir, which has already been on the market for several months but has not yet been widely distributed.
Thus AIFA does not support Guariniello's hypothesis, according to which the Regions, despite having taken action to treat the most serious patients, would not have received the funding from the State, provided for by the law approved last winter in relation to innovative drugs.
Renato Torlaschi – Friday, May 22, 2015 – Doctor33
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