Abstract
While international reference pricing (IRP) is recognized as a prevalent tool, there is some debate surrounding its continued relevance amid the rise of confidential discounting. In a country such as Italy, where IRP is used informally and managed-entry agreements (MEAs) are relatively common, its continued influence is uncertain. The present analysis sought to identify whether there is evidence that IRP continues to hold relevance in the Italian context. An Excel model was developed to simulate IRP application, drawing on ex-manufacturer prices in potential reference countries from three months prior, and calculating the delta relative to historic Italian prices. A basket of 22 drugs representing the top prescribed molecules in oncology (as reported by OsMed, the National Observatory on the Use of Medicines), supplemented by one known to be subject to MEA, was used. Controlling for active ingredient, pack size, strength, form and market authorization holder, Italian prices were compared to simulated prices in individual EU countries and the EU-wide average. 73% of the molecules exhibited simulated prices falling within a delta of ±5% of actual launch prices in Italy. In general, the smallest deltas were observed with reference to the EU-wide average simulated price, as opposed to simulated prices in individual reference countries. Actual Italian prices tended to remain largely stable, despite increasing deltas relative to simulated prices over time. The present analysis suggests that IRP continues to exert influence on Italian prices, particularly at time of launch. Moreover, the EU average price may be an important benchmark in price negotiations. Although pricing contracts may be re-negotiated every couple of years, the present results suggest that IRP may not be an extensive driver of price erosion downstream of launch. Additional analysis on larger sample sizes is needed to clarify the generalizability of these findings.
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