LONG TIMES TO ENTER DRUGS IN THERAPEUTIC REPORTS. LIFE-SAVING MOLECULES BLOCKED TO SAVE. FEDERALISM HAS ACCEPTED INEQUALITY IN THE CARE OF SERIOUS PATIENTS: FROM VENETO TO SICILY
In Veneto Mr. Mario C. filed an appeal. And in the end, only through the Tar, was he able to get what his hospital denied him. An innovative drug for the treatment of multiple myeloma, a rare disease that affects around 10,000 people in Italy. One year after the "centralized" approval of the EMEA, the European drug agency, the molecule has not yet arrived in half of our hematological departments. Although the green light for distribution in the H range (that of hospitals, in fact) was triggered in mid-March with the publication in the Gazzetta of the Aifa resolution, the ministry agency now in the eye of the storm for an investigation opened by the Turin prosecutor's office, some of the Regions have not included the new product in their handbooks. The result is an unequal treatment of patients who, based on the diagnosis, should have the right to receive it. Example. In Lombardy the cure is already available. But it is enough to cross the border into Emilia Romagna to discover that lenalidomide is not on the reimbursement list. The regional technical commission called for a definitive opinion on products intended for trade has not concluded the preliminary work, which is superfluous. What need is there to deepen the examination of the scientific dossier if that drug has passed the examination by the EMEA and AIFA? It does not end here. In Emilia, as if that weren't enough, there are provincial therapeutic handbooks which in turn must incorporate the regional updates. In conclusion: a patient with multiple myeloma waits several months longer if he lives in Bologna rather than in Milan The start of a treatment is postponed which, on the basis of the studies conducted, lengthens the survival of those who do not respond to traditional treatments and is effective in 90% of cases. It is not an isolated story. Federalism has generated a system sensitive to inequalities. Result. We are not all the same when it comes to healthcare. Sometimes the discrepancies in accessing therapies even vary from local health authority to local health authority. Let's look at what is happening, for example, for vaccination against HPV, the virus responsible for uterine cancer. It is not a "lifesaver", it is given free to 12-year-old girls before sexual intercourse. There are two types that are effective against two and four strains of human papillomavirus, respectively. The cost is also different. One is cheaper than the other and a healthcare company is free to decide which one to buy, based on savings estimates. There are no national guidelines.
DOCTORS DO WHAT THEY CAN The problem is even more serious and questionable on an ethical level when life-saving molecules are at stake. Doctors in the oncology and hematology departments are scrambling to avoid disappointing the patient. This is especially true for oncological products or so-called orphan diseases, with an incidence of less than 5 cases per 10,000 inhabitants. Treatments usually very expensive. Several thousand euros per month for each patient. And we understand how hospitals tend to stall. Or to deviate from national guidelines. Again in Emilia Romagna, a new oral therapy for thalassemia, to be prescribed as an alternative to injections, is reimbursed on a discretionary basis and not exactly on the basis of AIFA provisions. Antonio Gaudioso, vice president of Cittadinanza Attiva-Tribunale del patient, speaks of the schizophrenic system: «Federalism in healthcare should have
