For over twenty years, the system of pharmaceutical spending caps and payback has been the main tool Italy uses to try to govern the growth of healthcare spending. It is a mechanism born in a specific historical context: a time when there were no tools to accurately read the population’s health needs, when real-world data were virtually non-existent, and when the only way to contain spending was, in practice, to set a cap and ask companies to cover the overshoot. Today that context has changed profoundly, but the mechanism that came out of it has remained essentially the same.
It is from this observation that the work we at LS CUBE have made available to institutions was born: a technical document that does not propose abolishing payback, but moving beyond its logic. The point, in fact, is not to spend more or less, but to spend better, restoring to medicines their role as a strategic lever for the National Health Service, and not as a simple cost item to be contained.
The National Health Service now has an unprecedented information asset: the Electronic Health Record, the pharmaceutical dossier, the Health Data Ecosystem, the flows of the National Waiting Lists Plan. If brought together structurally, these tools would make it possible to plan resources instead of merely checking them ex post. This is the paradigm shift at the heart of our proposal: shifting the center of governance from retrospective spending control to forward-looking planning of needs.
Concretely, the model we propose is based on two complementary levers. On the one hand, smart and adaptive spending caps, able to capture the real value of a medicine’s impact thanks to integration between Health Technology Assessment tools, Real World Evidence data and clinical outcome indicators, and to be calculated not on historical consumption but on actual clinical-epidemiological need, broken down by disease areas and by regional specificities of prevalence, incidence, comorbidities and social and demographic fragility. On the other hand, differentiated regional accountability, with dynamic shares built on the specific needs of each territory and on the efficiency of organizational models, thus moving beyond a linear, one-size-fits-all allocation. The result would be the gradual replacement of payback based on rigid caps with ex ante responsibility models calibrated to Regions’ management capacity and to expected need.
The issue closely affects the system’s equity. Today the clawback mechanism is anchored almost exclusively to market share, regardless of the medicine’s therapeutic value: a setup that ends up penalizing precisely the Regions that invest more in innovation and that have to manage the most clinically complex needs. Correcting this distortion means finally aligning the spending-control tool with the appropriateness and equity objectives the National Health Service has set itself.
That this issue has entered the public agenda is also shown by the article Il Sole 24 Ore devoted to our proposal last June, "Medicines, moving beyond the current payback logic is possible by planning care needs". Meanwhile, the parliamentary process offers a concrete window for implementation: the enabling bill on the Consolidated Text on Pharmaceuticals concluded its committee-stage examination in the Senate’s 10th Committee on 8 July, when, among others, an amendment signed by Sen. Silvestroni was approved, explicitly linking the strengthening of national and regional information systems (letter c) to the revision of spending caps and payback (letter b), thus making the data infrastructure an integral, not ancillary, part of the future reform of pharmaceutical governance. The measure is now expected in the Chamber.
The road from here to full implementation is long, and also goes through pilot trials shared between the State and the Regions, able to test the new model in territories that differ in care structure and intensity of care before extending it at scale. But the direction, in our view, is the right one: a medicines governance based on evidence, allocative responsibility and predictive capacity, finally consistent with the National Health Service we have today, and with the one we want to build for the future.
Silvia Mandarino
Partner, LS Cube
