Is Italy a favourable market for Orphan Drugs? The latest OSSFOR Booklet paints a promising picture for the Italian landscape

By Andrea Bernardini, Analyst & Akshay Kumar, Partner

Email: [email protected] [email protected]

On the 12th of February the Orphan Drugs Observatory and the Italian Society of Hospital Pharmacy  and Pharmaceutical Services for Healthcare (OSSFOR) have produced the 5th Report on orphan drugs receiving Innovative Status by AIFA in Italy.

Although AIFA’s algorithm for assigning innovation status is very rigorous and quite stringent, ODs (Orphan Drugs) performed well under such scrutiny. 72% of ODs were granted innovative status, while this stood at 62% for non orphan drugs. The full and/or conditional innovative status confers several advantages such as the direct inclusion in regional formularies and coverage under specific funds with a total annual budget of ~€1bn. For full innovation status the manufacturer is also exempt from the mandatory 5%+5% discount and the payback in case of budget over-run.

Additionally, Italy was rated in second place across the EU5 in terms of OD access.  87,4% of OD indications are partially or totally reimbursed, including via EAP (Early Access Program) routes. Although still far from the AIFA’s 100-day threshold, after Germany, Italy now has the shortest time between EMA authorisation and reimbursed access. In Italy it took on average “only 18.6 months” while in France 19.5 months, in Spain 23 months and in England 27.6 months. Italy also has  established registries that enables  effective real world outcomes monitoring which brings numerous benefits in establishing the value of ODs which at the point of launch inherently have data uncertainties.

ODs manufacturers have well-justified reasons to include Italy as a priority market in Europe. When planning the Italian launch, manufacturers of ODs should focus on demonstrating innovativeness using AIFA’s three criteria: therapeutic need, added therapeutic value and the quality of evidence. Any uncertainty across these three pillars could potentially be resolved by using the extensive Italian registry system either to gain insights or to drive risk-sharing contracting schemes.

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