Italy: Council of State upholds physician prescription freedom

The Italian Council of State has upheld the legality of regional spending objectives that encourage the use of less expensive drugs when efficacy is equal, provided they do not mandate automatic therapeutic switches. A pharmaceutical company challenged regional guidelines that required prescribing leuprorelin for at least 75% of oncological treatments instead of the more costly triptorelin, arguing this violated medical prescriptive freedom and therapeutic equivalence standards. The court ruled that these guidelines are merely tendential spending targets and do not override the clinical responsibility of physicians to choose the most suitable molecule for specific cases.

Parallel to these legal developments, the regional level remains a critical and often overlooked phase in the Italian pharmaceutical market access process. While national reimbursement is determined by AIFA, actual patient access depends on regional implementation. Data from the Regional Access Observatory (ORA) indicates significant variability in the time required for drug availability across Italy. On average, it takes 165 days between the official AIFA publication and actual patient access, with regional delays ranging from 100 to 400 days.