OBJECTIVES: In April 2017, AIFA (Italian Medicines Agency) adopted a revised algorithm to determine the innovativeness of new drugs. The objective of this new HTA process was to improve transparency and standardize the process and dimensions considered in evaluation of pharmaceuticals. This new algorithm can be imagined as a step towards alignment to other European HTA evaluations, such as HAS in France and G-BA in Germany, with greater focus on additional therapeutic benefit, therapeutic need and quality of evidence. The aim of this research was to review early empiric evidence to assess the degree of alignment between AIFA’s innovation assessment and analogous HTA appraisals in France and Germany.

METHODS: Secondary research was carried out in order to retrieve information on final HTA outcomes for all drugs that have been evaluated through the new innovation algorithm in Italy since April 2017. HTA results were compared to understand if the final outcomes in Italy are comparable to those in France and Germany.

RESULTS: Since April 2017, 13 evaluations of innovativeness were carried out in Italy. Seven assessments resulted in the “Not Innovative” decision, one resulted in “Conditional Innovation”, while five drugs were assigned “Innovative” status. Comparing these results to ASMR scores granted by HAS in France, drugs considered “Innovative” in Italy achieved ASMR III or IV, with none achieving ASMR V. Similarly, drugs deemed “Not Innovative” in Italy usually achieved ASMR V, with none achieving ASMR III or higher. The comparison with G-BA’s additional benefit gives similar results, with only two exceptions, which were considered “Innovative” in Italy but were not able to prove additional benefit in Germany.

CONCLUSIONS: AIFA’s new algorithm not only offers a more structured and transparent way of evaluating new drugs, and aligns Italian HTA practices closer to those of other major European HTA processes.