(Adnkronos) – Psoriasis is a chronic, multifactorial, relapsing, and non-contagious autoimmune inflammatory disease. It manifests with the appearance of red patches of skin, with a devastating impact on the quality of life and daily activities of sufferers in its most severe forms. The press conference held today at the Chamber of Deputies – an institutional step in the run-up to World Psoriasis Day, celebrated annually on October 29 – placed the need to expand patient protections at the center of the broader discussion on patient rights, with a view to greater equity and consistency with the degree of severity.
The meeting was opened by Luciano Ciocchetti, Vice President of the XII Social Affairs Commission of the Chamber of Deputies, who outlined the reasons that led him to promote the initiative: “Psoriasis, especially in its more severe forms, is a chronic disease that can profoundly impact people's quality of life and deserves increasing attention from the institutions.
I wanted to promote this initiative ahead of World Psoriasis Day to foster discussion among patient representatives, the scientific community, and experts, starting with concrete evidence on unmet healthcare needs. It is essential to maintain high institutional attention on diseases like psoriasis, leveraging the contribution of the scientific community and patient associations, with a view to a healthcare system that is increasingly attentive to people's needs and capable of ensuring equity, appropriateness, and quality of care.
Valeria Corazza, president of Apiafco (Italian Psoriasis Association, Friends of the Corazza Foundation), spoke on the topic, highlighting the crux of the discussion: “Even today, those suffering from severe plaque psoriasis are denied access to the 045 exemption code within the LEA (Lea) care pathway, the extension of which would create an economic impact that is largely sustainable by the NHS, estimated at between 6,3 and 9,9 million euros per year.
Even today, these citizens are forced to pay for the costs of tests to access and monitor treatment out of their own pockets. This is an unacceptable financial burden, which contradicts the principles of universality and equity on which our National Health System is founded, or should be founded.
Providing solid scientific support are data from the 'Radar-Psoriasis' project, a real-world evidence analysis promoted by Apiafco and conducted by CliCon using administrative data from Italian local health authorities (ASLs) covering approximately six million patients. The project's objective, as outlined by sole director Luca Degli Esposti, according to a press release, is to provide a snapshot of psoriasis management in real-world clinical practice, assessing the epidemiological, clinical, healthcare, and economic burden in the Italian context. This starts with data of high epidemiological significance: approximately 1,4 million people are affected by psoriasis, with an annual incidence (179,4 new cases per 100.000 inhabitants) higher than that found for Crohn's disease and rheumatoid arthritis, chronic conditions already included in the National Chronic Disease Plan. Another particularly significant finding – explained in detail by Marco Romanelli, member of the Board of Directors of Sidemast (Italian Society of Dermatology and Sexually Transmitted Diseases) – is the complexity of the disease, also due to the statistically significant presence of comorbidities (including autoimmune, cardiometabolic, renal, hepatic, infectious, and oncological diseases), which exposes patients to a 1,1-fold increased risk of mortality compared to the general population.
Aldo Cuccia, national councilor for Adoi (Italian Association of Hospital and Public Health Dermatologists and Venereologists) and coordinator of the Inflammatory Skin Diseases Area, offers further insight into the dramatic care gap: despite the disease's impact, only 9% of psoriasis patients benefit from the 045 exemption; among non-exempt patients, 3% are treated with biologics and 7% with non-biologic systemic therapies, for a total of 137 patients without exemptions are treated with systemic medications, including biologics. In this context, the statement states, it is clear that to more effectively respond to the needs of patients with chronic diseases, overcome regional disparities, and ensure appropriate treatment and monitoring pathways, it is necessary to intervene on the Essential Levels of Assistance (LEA), updating them based on the severity of the disease, which directly impacts the economic sustainability of the patient. For Tonino Aceti, president of Salutequità, the levers for ensuring uniformity and appropriateness of care pathways "are, on the one hand, strengthening protections within the Essential Levels of Assistance (LEA), with particular reference to the expansion of the scope of exemptions, and, on the other, updating national healthcare planning, with particular reference to the next National Health Plan and the National Chronic Disease Plan."
Finally, the institutional call to action for uniform protection and equal access to care, launched by Ilenia Malavasi (member of the XII Social Affairs Commission, Chamber of Deputies), Luciano Ciocchetti (Vice President of the XII Social Affairs Commission, Chamber of Deputies), and Ylenia Lucaselli (FdI group leader in the Budget Committee, Chamber of Deputies): for everyone, the real-world evidence from the "Radar-Psoriasis" project allows us to address the issue on a concrete basis, providing insights into the potential economic impact that an extension of the exemption would have on the NHS.
"The value of the Radar-Psoriasis project lies in the ability of real-world data to provide a concrete representation of disease management in clinical practice," explained Luca Degli Esposti, CEO of CliCon. "The analysis highlights how psoriasis cannot be considered exclusively a dermatological disease, but must be viewed as a complex chronic disease, often associated with comorbidities and significant healthcare needs. Evidence generated by real-world clinical practice allows us to better understand patient outcomes, identify healthcare needs that have not yet been adequately addressed, and pinpoint areas where healthcare organization can be improved." Severe plaque psoriasis "is a chronic and complex inflammatory disease whose impact extends well beyond skin manifestations. The severity of the disease, potential comorbidities, and impact on quality of life require ongoing treatment and regular specialist monitoring. The findings from the Radar-Psoriasis project confirm the importance of recognizing patients' care needs based on the actual severity of the disease, ensuring appropriate care and equitable access to protection," added Marco Romanelli.
"Patients with psoriasis, especially moderate and severe forms, are treated in National Health Service hospitals, but today we are faced with a worrying shortage of dermatologists in public facilities," emphasized Aldo Cuccia. "It is necessary to intervene by holding new competitive exams in hospitals with the greatest staffing constraints and promoting effective training integration between universities and hospitals, with the aim of attracting, developing, and retaining young specialists within the public service."
For Tonino Aceti, "the data presented today demonstrates the extraordinary value that could be generated for the National Health Service (NHS) and for people with psoriasis if we proceeded with the expansion of exemption protections, as requested by APIAFCO. Moreover, the necessary financial coverage for this initiative could easily be identified within the NHS budget, given the significant amount of resources earmarked and not fully spent by the Regions, as well as the availability of specific resources earmarked each year for updating the Essential Levels of Assistance (LEA). However, to be fully capitalized on, this initiative requires clear diagnostic, therapeutic, and care pathways and national and regional healthcare planning for psoriasis that is up to the challenges we face. For this reason, it is also necessary to proceed with the inclusion of psoriasis in the second part of the National Chronic Disease Plan."
"The protection of people with chronic conditions is a key issue in ensuring the right to health and equitable access to care," remarked MP Ilenia Malavasi. "The evidence presented today draws attention to the plight of people with severe plaque psoriasis, who, despite facing complex and ongoing care needs, currently do not benefit from the exemptions provided for other forms of the condition. It is essential to leverage the voice of patients and the contribution of the scientific community, so that health policies can increasingly respond to health needs, ensuring continuity of care and reducing inequalities." For Ylenia Lucaselli, "improving healthcare requires careful discussion, balancing patient needs with the sustainability of the National Health Service. From this perspective, the real-world evidence presented through the Radar-Psoriasis project represents an important contribution to knowledge, as it allows us to explore not only the clinical and healthcare burden of the disease, but also the potential economic implications of an evolution of current healthcare systems. Having solid data is essential to foster informed institutional discussion, focused on the appropriateness of interventions and the effective use of public resources, in the best interests of citizens and patients."
Finally, Francesco Saverio Mennini, head of the Department for Planning, Medical Devices, and Drugs for National Health Service Policies at the Ministry of Health, stated: "On October 20, I signed the agreement to establish a Technical Working Group within the Department to evaluate the inclusion of psoriasis in the National Chronic Disease Plan. This is an important step, based on the extensive evidence currently available on this disease. The group will use this data to conduct the necessary technical and scientific assessment and to identify organizational and care models consistent with the principle of appropriateness. I believe this could represent a real turning point: leveraging the evidence, delving deeper into areas where information is lacking, and engaging in direct dialogue, will finally achieve this goal."
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