AIFA Introduces Simplified Pricing, Reimbursement Negotiation Procedure for Parallel Imported Drugs

ROME, Italy – The Italian Medicines Agency (AIFA) has published on its website the new simplified procedure for negotiating the price and reimbursement of parallel imported medicines, which pursues cost savings in Italy for these medicines.

AIFA’s new procedure introduces possible automatisms in the definition of prices and drastically reduces the timeframe for concluding the reimbursement procedure. Furthermore, it establishes transparent criteria for simplified negotiations that fosters price controls and achieves an immediate reduction in expenditure for both the national health service (SSN) and Italian citizens.

To take advantage of this new procedure, interested companies must submit a dossier to AIFA’s health technology assessment (HTA) and drug economics sector with a proposed price reflecting a 7% discount compared to the retail price of the corresponding drug already on the market. After this sector verifies the dossier, it will reach out regarding any further contractual conditions required, and if all criteria are met, the dossier will be submitted to AIFA’s Board of Directors for a green light.

If negotiations fail—i.e. a 7% price reduction is not agreed—the simplified procedure is no longer applicable, and the parallel imported product will be subject to standard negotiations.

There are special pathways for drugs under continuous monitoring or those that were granted conditional approval, as well as products included in transparency lists.

At the same time, AIFA has issued its first Osmed Report on the parallel import and export of medicines covering 2016-2018, which had a total value of 450 million euros. Overall, of the total of 51 million packs part of parallel importing, most (58.5%) were purchased directly by citizens, and many (41.5%) were Class C drugs reimbursable by the SSN.