In a healthcare system under increasing — demographic, epidemiological and financial pressures — the question of resource allocation can no longer be left to intuition or tradition. Today, clinical decision-makers are called upon to integrate an additional dimension into their perspective: that of systemic sustainability. It is in this space that Health Technology Assessment (HTA) asserts itself not as a bureaucratic tool, but as a strategic lever for mature clinical governance.
What is meant by a resource in health care;
Before talking about optimisation, it is necessary to clarify what is meant by “resource” in healthcare. It is not only about budgets or beds: resources include the time of professionals, the availability of diagnostic and therapeutic technologies, the organisational capacity of facilities and — often neglected — the cognitive focus of operators. Wasting a resource, in this context, is not only an economic problem: it is a clinical risk.
An inappropriate examination takes up machine time from those who actually need it; an ineffective therapy exposes the patient to adverse effects without expected benefit; a poorly co-ordinated pathway generates redundancies that increase the likelihood of error. The best use of resources, therefore, coincides structurally with patient safety. They are not objectives in tension, but sides of the same coin.
What is HTA: an operational definition
Health Technology Assessment (HTA) è a systematic, multidimensional process of assessing health technologies — drugs, medical devices, diagnostic and therapeutic procedures, and organisational programmes — aimed at informing health policy and resource allocation decisions. It is not a simple cost-effectiveness analysis: HTA integrates at least nine evaluative domains in a structured manner, according to the European EUnetHTA 21 framework, including relative clinical effectiveness, safety, organisational impact, ethical implications, legal implications, social implications, patient impact and cost-effectiveness.
The result of an HTA assessment is not a number, but an appraisal (“perizia” in Italian): a structured recommendation that can be oriented towards technology use, non-use, use conditional on specific populations or contexts, or use only in research to generate further evidence. In Italy, for medical devices, this judgement is adopted by the HTA Steering Committee — coordinated by the Ministry of Health and AGENAS — through an Appraisal Commission that reviews and approves the multidimensional technical evaluation reports produced by the accredited Collaborating Centres.
Understanding what the HTA è in practice also means understanding what it è is not: not a tool to cut resources, nor an obstacle to innovation. It is, on the contrary, the mechanism through which innovation is introduced into the healthcare system in a governed, transparent and sustainable way, protecting both the patient and the collective resources.
Benefits and obligations arising from HTA: what changes for healthcare companies
HTA produces concrete effects at two distinct but complementary levels: on the one hand it generates operational and strategic advantages for the healthcare organisations that adopt it; on the other hand it imposes increasing obligations in the national regulatory framework, which companies cannot ignore.
On the benefits side, adopting HTA processes at enterprise level allows:
• Making evidence-based purchasing decisions: HTA recommendations provide healthcare managers and procurement officers with a validated scientific reference for evaluating medical devices, reducing the risk of choices influenced by commercial pressures or established habits.
• Optimising the technology portfolio: organisational and economic impact analysis allows redundant or obsolete technologies to be identified and decommissioned, freeing up resources to be reallocated to care pathways with high clinical value.
• Strengthening negotiating position: companies with their own HTA assessments or adopting national ones can negotiate with suppliers in a more informed way, potentially obtaining more favourable contract terms or value-based access agreements.
• Govern innovation proactively: the structured stakeholder engagement envisaged by the PNHTA-DM 2026–2028 — through territorial InfoDays and the Network of Stakeholders — offers healthcare companies a privileged channel to report emerging technologies and participate in the national evaluation process.
On the obligations side, the regulatory framework è become progressively more stringent:
• Obligation to inform decision-making with HTA evidence: Legislative Decrees 137/2022 and 138/2022, implementing the European Regulations on medical devices, stipulate that NHS decision-making processes must be informed by scientific evidence on the clinical, organisational, economic, social, legal and ethical impact of health technologies. This is not a recommendation: it is a regulatory constraint.
• Innovative technology reporting: healthcare companies are required to report innovative and emerging healthcare technologies through the channels provided by the regional and national HTA structures, contributing to the construction of the PNHTA's evaluation priority list.
• Adaptation to the appraisal recommendations: the recommendations adopted by the HTA Steering Committee constitute binding references for purchasing decisions by the NHS, with direct implications on tender and procurement procedures.
• National training participation: the PNHTA-DM 2026–2028 provides training pathways for users of HTA assessments, with the’aim of involving up to 1.500 operators each year, supported by 250 scholarships for advanced training courses and 50 scholarships for 2nd level university masters.
|
With approximately EUR 13 million of resources released and the agreement in the State-Regions Conference in December 2025, the PNHTA-DM 2026–2028 è now fully operational. In 2026 alone, between 50 and 100 HTA evaluations on medical devices with a high clinical, organisational and economic impact — with priority focus on artificial intelligence platforms and digital therapies. For healthcare companies, this is no longer a future horizon: it is the present. |
HTA as a compass for clinical decision makers
At the national level, the HTA system è coordinated by the AIFA for drugs and by the Cabina di Regia for medical devices, with an active role of the Regions through the Regional Technical Nuclei — structures that perform an essential linking function between the central scientific evaluation and the operational choices of the healthcare companies. The PNHTA-DM 2026–2028, drawn up by AGENAS and with an Agreement in the State-Regions Conference obtained in December 2025, represents the main planning and coordination tool, in line with the European regulatory framework updated in 2024.
For corporate clinical decision-makers, the concrete challenge è to transform HTA recommendations — produced at national or regional level — into coherent local operational choices: updating PDTAs in the light of appraisal judgments, reorienting monitoring systems towards the value indicators identified by the assessments, and feeding the cycle with its own real world evidence. It is a profound change of perspective, requiring analytical skills, dedicated structures and an evidence-oriented organisational culture.
The virtuous cycle: PDTA → Dashboard → HTA → Resource Allocation
The real qualitative leap in clinical governance is made when the three tools — PDTA, digital monitoring dashboards and HTA — stop operating in separate silos and integrate in a continuous cycle of knowledge production and use. Each feeds the next, and the whole guides resource allocation decisions in an objective and transparent way.
|
PDTAs define the expected pathway → dashboards measure deviations in real time → real-world evidence data feed HTA assessments → HTA guides allocation decisions → resources are redistributed to update PDTAs. The cycle begins again, more informed than before. |
PDTAs encode the best available evidence into standardised operational pathways, defining what to do, when, with which technology and by which professionals. The digital dashboards, as discussed in the previous contribution (Interactive dashboards for PDTAs computerised monitoring of indicators - Icmed Magazine no.5), make visible in real time the adherence to these paths through process and outcome indicators, reporting deviations and trends. But the next step is one that is often overlooked: these data must not remain confined to day-to-day operational use. They must become structured input for HTA evaluation.
Concretely, the deviations detected in the monitoring of a PDTA — an above-standard rate of prescription of imaging examinations, frequent recourse to avoidable admissions, insufficient therapeutic adherence — raise a systemic question: is the technology currently prescribed in the pathway still the most appropriate one? Are there alternatives with a better value profile? This is the rationale that the National HTA Medical Devices Programme 2026–2028 intends to systematise on a national scale, and which healthcare companies must replicate locally.
The benefits of this integration are manifested on several levels:
• Prescriptive appropriateness: actual utilisation data compared with pathway standards highlight over- or under-use of specific technologies, guiding procurement and protocol revision choices.
• Priority of investment: healthcare companies can methodically identify which technologies are generating measurable clinical value and which, on the contrary, are absorbing resources without impacting outcomes.
• Informed negotiation: having local real world evidence strengthens the position of companies in negotiations with suppliers and in funding requests to regions.
• Equity in access: benchmarking between centres or between periods, made possible by the dashboards, reveals disparities in the delivery of pathways that a purely economic evaluation would not be able to capture.
The role of clinical decision-makers
In this scenario, clinical decision-makers assume an integrating function that goes beyond the episodic management of critical issues. They are the professionals who can transversally read the signals coming from monitoring systems, clinical audit and appropriateness analyses, giving back to corporate management a systemic vision of the risks linked to the sub-optimal use of resources.
An appropriate drug administered in the wrong context è a risk. An effective procedure performed on a patient for whom it is not indicated è a risk. A high-precision diagnostic device used without selection criteria è a waste which, indirectly, è also a risk — because it diverts resources away from those who would actually benefit. Clinical decision-makers who integrate the HTA perspective into their work are able to build an alert system not only on errors but also on inappropriateness, making visible risks that would otherwise remain submerged in aggregated data.
Towards a culture of appropriateness
The main obstacle to the integration of HTA and clinical governance in daily practice is not technological, but cultural. It requires healthcare professionals to accept that they are confronted with system data, not just the individual clinical case; that corporate clinical decision-makers invest in analytical skills, not just infrastructure; that organisations develop continuous review processes in which technology assessment is not an extraordinary act, but a routine practice.
The National HTA Medical Devices Programme 2026–2028 offers a valuable operational framework in this respect: It defines shared criteria, priorities and methods that healthcare companies can — and must — make their own, translating them into local evaluation and monitoring processes. Investing in computerised monitoring systems, training professionals in the critical reading of data and building operational HTA nuclei are not luxuries reserved for large university hospitals: they are enabling conditions for any healthcare organisation that wishes to exercise clinical governance that is equal to contemporary complexity.
In the final analysis, appropriateness and sustainability are not constraints imposed on medicine from outside: they are, when correctly understood, the highest form of responsibility towards the patient and the community. In an ever-changing healthcare environment, equipping oneself with the tools for better decision-making — up-to-date PDTAs, intelligent dashboards and integrated HTA assessments — is no longer an option: it is the premise of any effective and modern clinical governance.
