An Incremental Cost Effectiveness Ratio (ICER) of €33,004 per Quality Adjusted Life Year (QALY) is the average following pricing negotiation in Italy with the Drug Agency (AIFA), according to a recent analysis (bit.ly/40RXvTK). The negotiation process granted mean incremental costs of €64,688 and mean incremental QALYs of 1.96. The authors—from AIFA and the Centre for Health Economics in York—analyzed 48 dossiers submitted from October 2016 to January 2021. Beta-based regression analyses were used to test the effect of ICER and other variables on the outcome of price negotiation. The study found “the ICER before negotiation to be one of the variables with a major impact on [the outcome of price negotiation] and the only one with a statistically significant impact when its value was ≥ €40,000/QALY.”
By comparison, “no statistically significant effect was found for the expected pharmaceutical expenditure, although a greater price reduction was negotiated for medicines with higher financial impact, consistent with the need for expenditure restraint and sustainability of the healthcare system. Furthermore, the impact of innovativeness status on [the outcome of price negotiation] was not statistically significant, although it seemed to be related to a higher price reduction compared with non-innovative medicines.”
A ministerial decree in August 2019 required health economic evaluation (HEE) for new indications, active substances, and orphan drugs. However, HEEs were formally integrated into decision-making only after the adoption of new AIFA guidelines in March 2021.
In 2022, the agency received 106 dossiers containing HEEs: 30% were just budget impact analyses, whereas 69% included both budget impact and cost-effectiveness analyses. One submission featured just a cost-effectiveness analysis.
Read more here.
References
- Russo, P., Zanuzzi, M. G., Carletto, A., Sammarco, A., Romano, F., & Manca, A. (2022). Role of Economic Evaluations on Pricing of Medicines Reimbursed by the Italian National Health Service. PharmacoEconomics, 41(1), 107–117. https://doi.org/10.1007/s40273-022-01215-w
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