OBJECTIVES: In Europe, centralised marketing authorisation applications are assessed by the European Medicines Agency (EMA). Italy, a European member state, ratifies the approval and starts a national price and reimbursement process, regulated by AIFA. In this study, we assessed Italian access to immunotherapy for the treatment of SCCHN at a discrete period in their regulatory and reimbursement timeline.

METHODS: Marketing authorisation and AIFA reimbursement approval dates were obtained from the EMA and Italian Official Journal websites. Real-world data were gathered using the Adelphi Real World SCCHN Programme^TM (DSP) –a retrospective chart review combined with a cross-sectional survey conducted in Italy. Participating oncologists provided information on the perceived administrative controls on the use of Immunotherapy agents ranging from; 1) available within label, 2) available with restrictions other than label and 3) not available. The full DSP methodology has been published previously. The Access Index (AI), a composite scoring system, was developed to describe the level of availability (1=unrestricted to 0=excluded). Scores allocated per respondent as 1, 0.5, or 0 for unrestricted, restricted and excluded access respectively. Wilcoxon signed-rank test was used to explore differences in access between Immunotherapy A and B.

RESULTS: At the point of data collection; Immunotherapy A had EMA approval and AIFA reimbursed approval in SCCHN; Immunotherapy B had EMA approval and was not AIFA reviewed in SCCHN. 41 oncologists reported on perceived administrative controls, and results were converted into an AI score. Immunotherapy A (AI:0.68, SD:0.38) was more available than Immunotherapy B (AI:0.44, SD:0.39), p=0.001.

CONCLUSIONS: This study demonstrates real-world evidence of variation in access to Immunotherapy drugs in the period prior and post national reimbursement. It is interesting to observe that Immunotherapy B benefited from a level of formulary access prior to receiving AIFA reimbursement in SCCHN, albeit lower than the reimbursed Immunotherapy A.