Navigating the Italian HTA Process: Essentials to a Favorable Review

From November 1, 2016 to September 1, 2019, the Italian Medicines Agency, AIFA (Agenzia Italiana del Farmaco) evaluated a total of 166 Dossiers – 28 were related to orphan drugs, 56 to new active substances, 57 to extensions of indications for drugs already reimbursed, and 25 to other types of negotiations. Economic analysis most often used by pharmaceutical companies to support the request for pricing and reimbursement in these dossiers were budget impact analysis (63%), followed by cost-effectiveness analysis (33%) and other types of analysis (4% – for example: ‘modification of the unit dosage’, ‘new packaging’, ‘change of the reimbursement scheme’, ‘renegotiation of the price’ or ‘association of known active substances’).  Budget impact was primarily used in the dossiers of orphan drugs and new drugs. The cost-effectiveness analysis was reported as QALY (Quality Adjusted Life-Year) and LY (Life Year) in 67% of the total cost-effectiveness analysis (N=70), as QALY in 23%, as LY in 3% and with other metrics in the remaining 7%.

The growing complexities of successfully navigating markets outside the US requires innovators to develop robust market access and go to market strategies that considers local nuance and requirements.  At Veranex (formerly Boston Healthcare Associates), our experienced team assists our clients in developing and implementing successful strategies. Contact us for assistance navigating the HTA process in Italy and other EU countries.