[Early access programs and managed entry agreements for medicines in Italy: results of a Focus Group (Early Access Programs and Managed Entry Agreement).] / Programmi di early access dei farmaci e managed entry agreement in Italia: i risultati di un Focus Group (programmi di early access e managed entry agreement).

BACKGROUND: Early access of medicines occurs with an uncertainty in the evidence even higher than the one experienced when price and reimbursement status is negotiated. Our aim is discussing the role of managed entry agreements (MEA) within early access programs (EAP) in Italy. METHODS: The discussion relied on a Focus Group, participated by twelve experts, including clinicians and representatives of regulatory authorities, regional and local pharmaceutical departments, pharmaceutical companies, and an association advocating for active citizenship. RESULTS: The Focus Group emphasised that the topic under discussion should be embedded into a more general reform of EAP in Italy. The 648 List mostly includes mature products and indications that are rarely launched into the market afterwards. The 5% Fund is affected by an important administrative burden uncertainty of the timing of reimbursement. CONCLUSIONS: Starting from the discussion on MEA and EAP, the Focus Group recommended a new legislation better regulating EAP, that early access concerns specific classes of medicines selected on the grounds of the need to guarantee a rapid access and to collect real world data, that early access can be accompanied by outcome-based and population-based MEA, and that MEA are embedded into the subsequent price and reimbursement negotiation.

Is administered competition suitable for dealing with a public health emergency? Lessons from the local healthcare system at the centre of early COVID-19 outbreak in Italy.

OBJECTIVES: The Lombardy Region, Italy, was the most severely affected by the COVID-19 outbreak. In absence of effective treatments and with basic hygiene measures made mandatory, Lombardy response to COVID-19 relied on its healthcare system characteristics, the administered competition or "quasi-market" model. The aim of the study was to review the strengths and weaknesses of Lombardy's response during the first wave of the COVID-19 epidemic, to explore whether the healthcare model influenced crisis management and describe which policies could help to contain future outbreaks. The results are expected to provide similar healthcare systems with lessons to avoid mistakes and learn from best practice. METHODS: Data for quantitative analyses on the performance of the Lombardy and Veneto Regions healthcare systems were derived from existing government sources including the Italian Civil Protection Agency and the Ministry of Health. RESULTS: Lombardian quasi-market model, traditionally characterized by a strong hospital network, was held responsible for many suboptimal outcomes. According to critics, years of disinvestments in community care resulted in a hospital overload. However, the same model was responsible for other positive outcomes which have been substantially neglected, such as the opportunity to test for effective containment treatments in a safe environment and rapidly extend the number of beds. CONCLUSIONS: The performance of a quasi-market model against public health emergencies largely depends on integration between policy-makers and balance between healthcare providers, which require clear regulation. Reducing institutional fragmentation between levels of governance, improving the coordination of healthcare facilities and adopting telemedicine technologies are means by which healthcare networks could strengthen their resilience against future outbreaks.

[The chronically ill and the odyssey of care: how can we improve assistance and quality of life?] / Il malato cronico e l'odissea della cura: quali soluzioni per migliorare assistenza e qualità di vita?

The life of people suffering from chronic diseases is even more difficult due to the bureaucratic and administrative burden imposed by a health system that does not respond in a personalized way to the needs of citizens. The origin of the problem is in the culture of the country and in a mentality that seems to be afraid of innovations. A health system that actually takes care of the chronically ill should update the classifications of the diseases on which the diagnostic and therapeutic path is based (DRGs) and constantly update the essential levels of assistance (LEA). The regulatory activity of therapies and devices should also ensure that the citizen's point of view is taken into consideration. This is a fundamental contribution to the constant improvement of care and to the organizational flows of the health system.

The MoSt Project--more steps in multiple sclerosis: a Delphi method consensus initiative for the evaluation of mobility management of MS patients in Italy.

The aim of the study was to identify the main factors that impact mobility impairment in multiple sclerosis (MS) patients in Italy. Clinicians from a large number of Italian MS centers took part in a Delphi process aimed at obtaining consensus statements among the participants. Large consensus was obtained for statements grouped under the following main MS themes: identification of the most useful scales to evaluate mobility, integration of objective evaluation with patient perceptions, impact of walking impairment on daily life, management of the disabled patient using a rehabilitative and pharmacological approach. The consensus statements developed by a large number of experts may be used as a practical reference tool to help physicians treat MS patients with motor impairment.