Will AIFA’s net price disclosure requirement be a game-changer for Orphan Drug access?

By Akshay Kumar, Partner & Andrea Bernardini, Analyst

Email: [email protected] [email protected]

In the latest guidelines for Pricing and Reimbursement (P&R) dossier submissions, Italian Medicines Agency (AIFA) requires manufacturers to self-report prices, including the percentage discounts and/or Management Entry Agreements (MEAs) agreed with other EU countries and the UK. If these are confidential agreements, AIFA in the very least requires the manufacturer to report the date of the agreement, its duration, and the counterparty involved. AIFA then reserves the right to obtain this ‘confidential’ net price information from the counterparty.

Will this new disclosure requirement impact P&R negotiations, and commercial potential of medicines in Italy and across Europe? It is unclear how many manufacturers will proactively disclose the confidential net prices agreed in other markets. If manufacturers do not comply, would payers in other countries willingly provide this information officially? Ultimately, what is in it for them, when AIFA does not offer a two-way ‘transparency’ on net prices? Also, could the process of getting this information from other countries delay negotiations timelines and hence patient access?

Orphan Drugs (ODs) manufacturers currently undergoing Health Technology Assessment (HTA) submissions or P&R negotiations should engage with AIFA to assess how critical this newly requested information is to their submission and how this data will be used by AIFA’s Pricing and Reimbursement Committee (CRP). This will help manufacturers conduct a thorough risk analysis before deciding whether to proactively disclose this information or not.

We at P4A have started to track the impact of this new disclosure requirement on OD price and access negotiations with AIFA and will keep on advising our clients on how to best optimise their strategy for entering the Italian market.

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