Italy’s Insights from Access Briefing Q2

Be informed with actual HTA-insights from Italy. Here are the outcomes compiled by MTA.

Highlights:

🏛️ In Q2 2025, 7 new chemical entities, 4 orphan drugs, and 13 new therapeutic indications were reimbursed in Italy

✅ 6 of them with the addition “monitoring registry”

🚀 2 of them have been granted “full innovative” status

🤝 2 of them have been granted “conditionally innovative” status

⛔️ 5 drugs received a denial of their request for innovativeness, often due to poor added therapeutic value or low quality of evidence, despite a therapeutic need assessed as “moderate” or “maximum”

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