Some have not even communicated where to administer it.
Paolo Russo – 13 January 2015 – THE PRESS
The super drug against hepatitis C remains a chimera for a large part of the 50,000 patients in serious conditions, who a month ago toasted the inclusion of Sofosbuvir in the list of medicines reimbursed by the state. I am reporting itparliamentary question of the deputy Pd Frederick Gelli and the Epac patient association. The president, Ivan Gardini, is monitoring the situation and, at the moment, the pill that promises to eradicate the virus in just 12 weeks would be administered by the public health service only in Veneto, Lazio and Lombardy.
Elsewhere, those who want to be treated have to take out a mortgage, because buying the cans needed to complete a therapeutic cycle at the pharmacy costs a whopping 70,000 euros.
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The race for the drug that defeats hepatitis C: "Only 50,000 doses are ready"
ROME - There is a drug capable of eliminating a disease that was once almost unbeatable, there is a large but limited number of people to whom it will be given free of charge and an even greater number of patients who ask for information, call the associations and centers liver diseases to find out if and when it will be their turn too. In short, the race to cure has begun. Sofosbuvir (trade name Sovaldi) is a very expensive and revolutionary medicine, because it is able to cure a widespread disease such as hepatitis C. In Italy it finally entered the formulary last December, 11 months after the European approval. Thanks to one exhausting negotiation with Aifa (Drug Agency) claims to have torn a favorable price which in order not to damage the manufacturer, Gilead Sciences, is not disclosed. The contract would provide for the purchase of as many as 50,000 doses in two years. They will serve those who belong to one of the six categories of serious patients (for example those with cirrhosis) identified by Aifa. There are now two practical problems: actually putting these people under treatment in the centers of the various Regions, some of which are still far behind, and explaining to the sick who are not risking their lives that they have to wait.
Unless they want to spend 70,000 euros out of their own pocket, the cost of the drug for the private citizen. It is not clear how many have hepatitis C in Italy. There would be at least between 4 and 500 thousand people diagnosed with the disease, of which 70-80 thousand in serious or serious conditions. The agreed payment system would be this: the pharmaceutical company will make each treatment available for 12 weeks for 50 thousand euros and then, as the number of doses purchased by the Regions increases, it will return an increasingly large part of the money. There are three or four discount ranges, the last one will allow Sovaldi to pay a few thousand euros. When all 50 thousand doses have been purchased, the average cost for a patient will be between 20 and 30 thousand euros. That could be enough to pay Gilead the billion euro in two years put into the Stability law by Health Minister Lorenzin and taken from the national health fund. The arrival of sofosbuvir in Italy is a great achievement but there are still hurdles to overcome. Some Regions are behind. “Lazio and Lombardy have started with the administration but other realities have yet to identify the hepatological centers that will follow the patients.
There is even someone who has reduced the number of these structures. If by the end of January they haven't all left well, we'll get angry ". Speaking is Ivan Gardini, the president of EpaC, which with its 10,000 members is the largest patient association. Regarding the way in which the first patients are selected, he has nothing to say: “Aifa has identified the most serious. But there is still a race for drugs, people contact us who want to know if they fall within the categories that will have the Sovaldi. And someone has asked us about any legal action to take to get the medicine. We say that for now it's up to those who are worse off but later we have to open up to everyone. Let us not forget that in six months new drugs similar to sofosbuvir and very effective will arrive. At that point, thanks to the competition, the treatment will have to be given to everyone, not just to 50,000 patients: they must remove the access restrictions.
Aceti (Tdm): sofosbuvir is Lea, Government intervenes on defaulting Regions
That there are slowdowns by the Regions in accessing therapy is confirmed by the reports we receive and for this reason we expect an intervention from the Government with respect to the defaulting regions. We are aware of the economic difficulties of the administrations and for this reason we hope that the fund foreseen in the Stability law will be immediately available. To take stock of the situation of access to sofosbuvir, after the protests reported by the national press, is Tonino Aceti, national coordinator of the Tribunal for patients' rights-Cittadinanzattiva. "We have received reports from some local sections of the patient's courts," he explains. «There is therefore a difficulty in concretely accessing the drug with a situation that seems to replicate what happened about two years ago, with the previous therapy (Boceprevir and telaprevir), in which there was a slowdown in access for patients by the regions entitled due to the timing in identifying the prescribing centres, which in some cases required up to six months. And the problem is that, once this phase is completed, there are then all the bureaucratic obligations that also collide with the question of the resources that are missing". A situation therefore «on which we ask the attention of the Government right now so that it guarantees access to therapy for patients who are entitled to it and intervenes in the case of defaulting Regions. We essentially expect subsidiary action by the Government, as required by the Constitution, because it should not be forgotten that this drug is included in the Lea". Having said this, «we are clear about the economic problems of the Regions linked both to the high price of the drug and to the Stability rule which has imposed further contributions to the general public finance of four billion. There is a resource problem. But it is also for this reason that, in order to facilitate the Regions in guaranteeing access to therapy, we expect the provision on the fund for innovative drugs contained in the Stability, which should put one billion euros on the plate in two years, to be concretely activated and not remain a prediction only on paper. This measure "we consider an important signal in guaranteeing access to innovative medicines, but towards which we cannot fail to point out a series of open questions which we hope, should they have repercussions on the immediate use of the fund, will be resolved at the earliest sooner". Among these, "we note that this is a fund that adds to an already existing one intended for innovative people (moreover with the hope that for sofosbuvir all the procedures to enjoy this right have been completed), not to mention the fact that still today there is no definition of which drugs can be said to be innovative and which are not. And then we must not forget that the money was taken from the national health fund and in particular from funds destined for national plan objectives, with the risk that they will be stolen from other welfare areas ». It is clear that in this context, "as far as we are concerned, we have taken steps to be present to the maximum degree as observers and for the protection of patients, putting in place all the necessary support actions".
Francesca Giani- Thursday, 15 January 2015 – Doctor33
