OBJECTIVES

: 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.

METHODS

: Desk-research on web-sites of National and Regional Authorities and Hospitals, was supplemented where necessary, by primary research conducted via structured questionnaire-based phone interviews to hospital pharmacy directors. Initial web-search produced law-references for 8/20 regions. Information for the remaining regions (12) was collected through telephone interviews to 30 selected hospitals (ca. 100 calls; 29 questionnaires submitted, 16 positive replies).

RESULTS

: Overall, 17/20 Regions allow Cnn-drugs purchase, yet hospital implementation occurs very rarely (1 or 2 patient cases/hospital in the past 12 months, according to the interviews). Across all analysis 14/20 Regional/Hospital policies allow Cnn-drug purchase only in the absence of valid AIFA-approved therapeutic alternative, or if manufacturer offers the drug at a very small nominal price (13/20).

CONCLUSIONS

: Italian hospitals can purchase Cnn-drugs, although their cost is not reimbursed by the NHS until AIFA reclassification. However, our research shows that this process is seldomly applied. Full AIFA P&R appraisal still represents the most significant and most undertaken approach to bring pharmaceuticals under the NHS reimbursement scheme in Italian market.