Class Cmm Drugs in Italy: Purchase and Prescription Behaviour in Hospitals

Value in Health, Vol. 21, Suppl. 3 S. 165, October, 2018 · Jan 1, 2018

The 2012 Law Decree (D.L. n. 158/12 “Decreto Balduzzi”), introduced new regulation regarding authorization and classification of EMA authorised drugs, awaiting AIFA price and reimbursement (P&R) assessment. Under this Decree, drugs are temporarily classified as “class C non-negotiated” (Cnn) with the treatment cost being borne directly by patients (retail prescription market) or by hospitals. Scope of Cnn class introduction was to accelerate availability of novel treatments, just after EMA approval. Pending AIFA evaluation and finalisation of the P&R scheme (class H, A, A-PHT, C), manufacturers can decide whether to market it or not. This circumstance left hospitals and part of the industry with some uncertainty on the practicability of Cnn-drugs acquisition. Scope of our research was to understand and map hospital purchasing attitudes towards Cnn-drugs across all 20 Italian regions.