The health system in Italy

Italy has a universal national health system, mainly funded by taxes (Italian National Health Service, NHS). The Italian NHS is organised in two levels, national (represented by the Italian Ministry of Health, MoH), and regional (represented by 19 Regions and 2 Autonomous Provinces – Regions hereafter). Regions are allocated a budget for health care from the Central Government and are accountable for health care spending. They can use co-payments, regional taxes and cost-containment policies if the budget is overrun, provided that they guarantee the national benefit package (Livelli Essenziali di Assistenza) defined at central level. Regions regulate, organise and deliver health care, through public and accredited private health care organisations. Policies affecting the relationships between the Central Government and the Regions (including health care funds allocation) are approved by the State-Region Conference (Conferenza Stato-Regioni). Further details of the Italian health system can be found in the series of Health Systems in Transition.

A roadmap for new technologies

The value assessments of medicines and medical devices are managed separately.

Assessment of medical devices

The Italian MoH, AGENAS (National Agency for Regional Health Services), and the Regions are responsible for the assessment of medical devices.  A National HTA Plan for medical devices was envisaged in 2016 and, after a complex preparatory work, released in 2019. The plan has not been implemented so far, but its deployment is expected in the present year. Medical device policies (such as price negotiation, reimbursement, and entry agreement negotiations) are mostly managed by the Regions.

Assessment of medicines

The assessment of new medicines is managed by the HTA & Pharmaceutical Economics Department of AIFA (National Medicines Agency), supported by a Technical Scientific Committee (CTS), that provides scientific advice to Price and Reimbursement (P&R) negotiations, and a P&R Committee (CPR), that negotiates the P&R with the marketing authorization holder, integrating the scientific evaluation with economic aspects. The P&R Request Form, which includes most of the HTA domains, is published on the AIFA’s website.

The assessment of medicines and P&R negotiation relies on a multi-criteria approach. Key criteria considered are: disease burden and target population size, unmet need, added therapeutic value, cost of comparators, budget impact and cost-effectiveness of the new medicine (without official thresholds over the Incremental Cost-Effectiveness Ratio, ICER).

There is evidence of the impact of the target population size and added therapeutic value on the price of orphan medicines (Jommi et al, 2021); of the added therapeutic value on the actual prices of cancer treatments (Russo et al, 2021); and of cost-effectiveness on the percentage difference between the list price requested by manufacturers and the final actual price negotiated (Russo et al, 2023). The P&R dossiers are not published, with the exception of a few advanced therapies.

Pharmaceutical companies may also apply for innovativeness status that provides immediate access to regional markets and a dedicated fund. Drugs innovativeness is appraised on the grounds of unmet therapeutic need, therapeutic added value, and quality of the evidence. All appraisals are published on the AIFA’s website. Recently published evidence showed that the main drivers of the innovativeness status are the added therapeutic value and quality of evidence (Jommi et al, 2023).

Regions usually implement other policies, including co-payment, regional formularies, procurement policies, and actions on prescribing behaviour.

Current challenges of HTA for medicines

The Italian HTA for medicines presents four main challenges:

• The assessment is affected by the existence of two spending caps (one for drugs procured by health authorities and the other for drugs distributed through the retail market). Silos budgeting is driving the economic assessment which is more focused on drugs budget impact.
• The second critical aspect is stakeholders’ participation. Patients’ representatives are rarely engaged in the assessment process and involvement of clinicians is affected by very strict conflict of interest rules on one side and low transparency on the other.
• Fragmentation of the assessment is another problem. Despite medicines are centrally assessed, many regions are used to re-assess drugs to include them into regional formularies. Regional formularies generate delays to access to medicines, whereas a reimbursed drug is very rarely excluded from regional formularies.
• The last challenge is the current separation of HTA for medicines and other technologies. This is critical since there is not a general HTA framework adopted for all health technologies, and, more specifically, for integrated technologies, like companions.

Next steps for the Italian HTA

Two important changes are expected in the coming year.

The first one is the implementation of the HTA Plan for Medical Devices, that should make the HTA process for medical devices more structured, uniform and centrally-driven.

The second is the expected re-organisation of AIFA . This reform should introduce a new governance , where two committees will be merged into one (Scientific-Economic Committee). This decision was inspired by the expectations of a more rapid assessment and appraisal process compared to the current one, although this process doesn’t take more time in Italy than in other similar markets (EFPIA, 2022).

However, it is not clear if this reform will address the main critical aspects of the assessment process, i.e. a low level of transparency (with the exception of the innovativeness appraisal) and a limited and non-structured stakeholders’ involvement. Furthermore, there is no explicit mention of changes in the cost perspective, i.e. shifting the focus from drug spending to overall health care costs and costs outside the health care sector.

The future political agenda should prioritise these critical aspects, together with a higher integration between HTA for drugs and other health care technologies and a clear positioning on the implementation of the EU Joint Clinical Assessment.

Citations

Jommi, C., Galeone, C. The Evaluation of Drug Innovativeness in Italy: Key Determinants and Internal Consistency. Pharmacoecon Open. 2023 Feb 10.

Jommi, C., Listorti, E,, Villa, F., et al. Variables affecting pricing of orphan drugs: the Italian case. Orphanet J Rare Dis. 2021 Oct 19;16(1):439.

Russo, P., Zanuzzi, M., Carletto, A., et al. Role of Economic Evaluations on Pricing of Medicines Reimbursed by the Italian National Health Service. Pharmacoeconomics. 2023 Jan;41(1):107-117.

Russo, P., Marcellusi, A., Zanuzzi, M., et al. Drug Prices and Value of Oncology Drugs in Italy. Value Health 2021;24(9):1273-1278.