Medicines: we can move beyond the current payback model by planning healthcare needs

It is now possible to curb the surge in pharmaceutical expenditure through a new governance mechanism that improves the allocation of resources, optimises the provision of treatments to patients and moves beyond the current control framework, which is based exclusively on the existing payback mechanism. On one condition: that the vast wealth of data and the tools for classifying, stratifying and forecasting healthcare needs – in which the Ministries of Health and the Economy have been investing in recent years – are systematised. This is the conclusion reached in the technical document that LS CUBE is making available to the institutions.

The point is not to abolish the payback scheme, but rather to move beyond the logic of the current system – based on rigid caps and ex post reallocation mechanisms – which risks creating distortions. It is not a question of spending more or less, but of spending more effectively. From this perspective, medicines are not merely a cost item, but a strategic lever for achieving the objectives of the National Health Service. These objectives can be achieved by introducing corrective measures designed to prevent regions with more advanced care networks, greater diagnostic capacity and higher use of therapeutic innovation from exceeding spending limits – not due to inefficiency, but in order to meet genuine healthcare needs.

To systematise the information infrastructure so as to prioritise clinical and epidemiological needs, organised by disease area, based on regional prevalence and incidence estimates, supplemented by indicators of clinical severity, comorbidity, and social and demographic vulnerability. This will be achieved, on the one hand, by implementing adaptive ceilings capable of capturing the value of a medicine’s impact through HTA tools integrated with real-world evidence and clinical outcome indicators; and, on the other hand, by introducing differentiated regional accountability with dynamic quotas, based on specific needs and on the efficiency of organisational models and the results achieved. This new model would allow for the gradual replacement of the current retroactive payback mechanism – based on rigid, linear ceilings – with smart, adaptive ceilings based on ex ante accountability models calibrated to projected needs and the regions’ management capacity.

LS CUBE’s proposal is based on an observation: the system of spending caps and payback was developed in a historical context in which the tools to accurately assess the population’s healthcare needs were lacking. Today, however, the National Health Service has access to an unprecedented wealth of information which, if organised in a systematic and structural manner, enables resources to be planned effectively.

A paradigm shift that moves the focus from retrospective expenditure control to forward-looking planning of needs, finally putting data at the service of public decision-making. This shift now presents a unique and concrete opportunity in the draft enabling bill for the Consolidated Act on Pharmaceutical Legislation, which aims to rationalise and modernise the sector’s regulatory framework.