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TAR. "Naïve" patients: biosimilar drugs to be preferred

Those who have undergone a transplant now have to pay between 31 and 85 euros for a box of Sandimmun Neoral, a drug that prevents transplanted organs from being rejected: "An unaffordable expense for the families of the sick"

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Taking into account AIFA's prescriptions regarding biosimilar drugs, according to which they not only constitute a therapeutic option available to healthcare professionals, but are to be preferred if they constitute an economic advantage, in particular for the treatment of "naïve" subjects (who have not had previous therapeutic exposures or for whom previous exposures, based on the clinician's judgement, are sufficiently distant in time), the TAR considered that the regional provisions dictating guidelines to the General Managers of the Health Trusts regarding the reaching a number of prescriptions for biosimilar drugs equal to the incidence of newly diagnosed patients, establish a reasonable balance between the need to contain public health expenditure and the constitutionally guaranteed right to health, to be considered not absolute but increasingly commensurate with actual financial resources.
[Adv. Ennio Grassini – www.dirittosanitario.net]

Thursday, April 23, 2015 – Doctor33

Related news: Cuts in Healthcare, with biosimilars possible savings of up to 500 million a year

Preferring biosimilars to biologicals, the circular from the Puglia Region that infuriates doctors

They pay 300 euros a month for a drug that saves their lives

Those who have undergone a transplant now have to pay between 31 and 85 euros for a box of Sandimmun Neoral, a drug that prevents transplanted organs from being rejected: "An unaffordable expense for the families of the sick"

April 22, 2015 – TODAY

From 16 April, those who have undergone a transplant will have to pay a co-payment of between 31 and 85 euros to collect the medicines to prevent the rejection of the transplanted organ. "An unsustainable expense for families and a meaningless choice" explain fromaned, the National Hemodialysis and Transplant Association. “On average, a transplant who takes a daily therapy of about 200 milligrams a day: this means that he would pay out between 250 and 300 euros per month – Dr. Valentina Paris, doctor and president of the non-profit organization explains on the phone – Just think that there are 22,000 kidney transplant recipients in our country. There are reports coming from all over Italy.

The drug in question is called "Sandimmum Neoral" and following the determination of Aifa 533/2015, from 16 April it can only be collected in Italian pharmacies for a fee. A life-saving drug par excellence, because those who undergo a transplant cannot avoid rejection, but only sedate it with this drug: “How can this note be issued from evening to morning, without notifying health professionals? All of this has created a great deal of confusion among the sick,” continues Paris.

After a new organ is transplanted into our body, our body's first reaction is to "reject" it and attack it, as happens with every external guest that is introduced: cyclosporine (the molecule at the base of Sandimmum Neoral) prevents our body from having this reaction. In short those who have undergone a transplant cannot do without these drugs, which should be guaranteed by the national health system. "What is or should be the foundation of ethics and common sense has been missing, that of informing medical specialists who should control the conversion from the original drug to the generic, in order to avoid any problem related to this delicate therapeutic maneuver" explains Francesco Niglio, delegate of Aned.

For all these reasons the association has launched a petition on the change.org website in which users are asked to sign to stop the ticket on the life-saving drug. Furthermore the non-profit organization has already written to the Minister of Health Beatrice Lorenzin:“

Madam Minister, we turn to you to ask that transplant patients be allowed to continue, with due serenity, a life-saving therapy that has amply guaranteed a high level of benefit without creating inequality and economic harm to the many transplant patients. We also ask you that the decision to switch from a branded drug to a generic drug is not hiddenly imposed but mediated by the specialists who follow all Italian organ transplant recipients on a daily basis.“

Now the ball passes to the Ministry of Health: “Meanwhile, like Aned, we have sent all councilors to avert this situation, because we really don't know how it would end. I'm sure Minister Lorenzin has the situation in hand. But until certainties arrive from the ministry, we will continue. The crazy risk is that sufferers who can't afford to pay will simply lose their lives” concludes Dr. Paris.

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