Italian Medicines Agency's reform and time until pricing and reimbursement decisions: a time-to-event analysis.

Glob Reg Health Technol Assess · 2026 · PMC13071805 · PMID 41982932

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did not reach statistical significanceno p-value reported

This was evident for orphan medicines (38 observations pre-reform; 16 post-reform), where reclassification hazards did not reach statistical significance despite observed numerical shortenings in negotiation times.

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