THANKS to vaccines and a favorable epidemiological situation, Italian rheumatology is slowly returning to pre-pandemic normality. But old vices and organizational problems of the health system continue to complicate the lives of the more than five million rheumatological patients living in our country. In particular, the lack of therapeutic continuity and health migration, old problems that are returning to be reported throughout the peninsula, now that patients start to go to hospitals again. This is what emerges from the conference “Pandemic and rheumatology: early diagnosis, chronicity, vaccination and therapeutic continuity. Together for a sustainable and efficient national health system ”, organized in Rome today, 7 October, by ANMAR Onlus (National Association of Rheumatic Diseases) and the CAPIRE Observatory, in view of the World Day of the Rheumatic Patient on 12 October.
“The ‘great fear’ of last year, linked to the infection from Covid-19 is fortunately over”, says Silvia Tonolo, President of ANMAR Onlus. “Nonetheless, the heavy legacy of 2020, in terms of late diagnosis and non-administered treatments, will continue to weigh on the entire national health system. Complicating the already difficult pre-pandemic situation, especially as regards therapeutic continuity “. As reported by the patient associations, in fact, an increasing number of patients are forced to take a drug other than that initially indicated by the doctor, even in the case of serious diseases such as rheumatoid arthritis or spondyloarthritis.
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200 multiswitch cases
“From the practice of the switch, the passage from a biological originator to a biosimilar, we have increasingly come to that of the multiswitch”, underlined Tonolo. “In our White Paper, which we launched last year, we have already collected over 200 cases of transition from a first to a second biosimilar. All these changes in the type of drug are only dictated by economic and non-clinical reasons. It is a situation that as sick people, but also citizens, we can no longer tolerate ”.
The replacement of a drug that is giving results with a biosilimate, a similar molecule, but not the same, is possible, as also published by the Italian Medicines Agency. As is the multiswitch possible. But as long as – underlines Tonolo – it is the doctor who decides in agreement with the patient and not, as happened, the pharmacist, otherwise there is a risk of undermining adherence, trust and continuity of care. “We want to strongly reiterate that any replacement of a drug can only be carried out on the decision of the prescriber – adds Mauro Galeazzi, Scientific Director of the CAPIRE Observatory -. The variation of a therapy that works, and that is giving positive results, can have very dangerous effects on the health of the individual patient. Several studies have shown that the forced passage from one molecule to another, similar but not the same, can lead to side effects or the reappearance of the disease “.
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A project funded by Aifa is collecting data on switches and multiswitches, in order to generate indications based on data and evidence, which can then be applied universally. Which is not the case today. Recent rulings by some Italian courts have also reiterated the importance of the doctor’s decision-making autonomy in indicating the best treatment to the patient, as recalled by Patrizia Comite, legal advocate of the ANMAR Understanding Observatory: “In many Regions or individual ASLs this the right is de facto not guaranteed to clinicians and consequently also to patients. Then there is the problem of intra-territorial and regional inhomogeneities. Often in some territories there is a lack of class H drugs and this forces patients and caregivers to ‘migrate’ to other and more distant health facilities. All this is contrary to the most elementary constitutional principles, and in our opinion, requires effective participation of patients in the decision-making processes regarding pharmacological treatment for the treatment of chronic diseases ”.
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Influenza vaccination and third dose
Another theme that found ample space during the conference is that of vaccinations. And in particular, the anti-flu one, always recommended for patients with rheumatological diseases. Even more so this year, in which it also becomes precious to help distinguish a contagion from simple seasonal flu, from the much more worrying one from Covid 19. “As regards, however, the third dose of the anti-Coronavirus vaccination must evaluate each individual case ”, explained Francesco Ciccia, Professor of Rheumatology at the Luigi Vanvitelli University of Naples. “Not all rheumatological patients are immunosuppressed as only some use immunosuppressive drugs. It is therefore up to the rheumatologist to indicate when it is necessary to extend the protections against an extremely dangerous virus “.
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