OBJECTIVES: Italian healthcare delivery is highly decentralised, with governance by 20 autonomous regions. Inter-regional inequality is a long-standing concern driven in part by differences in population, policy and fiscal capacity. This study assessed regional variation in access to SERMs, a sub-class of endocrine therapy [ET] recommended in European consensus guidelines for the treatment of hormone-receptor-positive advanced breast cancer. Approximately 60-75% of all breast cancers are estrogen-receptor-positive [ER+], and ET is recommended for all patients with detectable ER expression. The choice of agent is determined by biomarker expression, prior ET exposure, line of therapy and menopausal status.

METHODS: Real-world data were gathered using the Adelphi Real World Advanced Breast Cancer Programme ^TM (DSP), a retrospective chart review combined with a cross-sectional survey conducted in Italy Q2-3, 2017. In the survey, Oncologists identified their region of practice and the perceived administrative controls on the use of SERMs 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 restrictiveness within the region for the class (1=unrestricted; 0=excluded). Scores allocated per respondent as 1, 0.5, or 0 for unrestricted, restricted and excluded access respectively.

RESULTS: 41 oncologists participated, based in 10 Italian regions. Mean regional AI scores ranged from 1-0.3, mean:0.7 [mean scores per region – Campania: 1, Calabria: 0.9, Sardinia: 0.8, Tuscany: 0.8, Sicily: 0.8, Apulia: 0.8, Piedmont: 0.6, Lazio: 0.6, Veneto: 0.5, Friuli-venezia-giulia: 0.3].

CONCLUSIONS: All studied regions allow SERM’s for breast cancer treatment, but there is real-world evidence of regional variation in prescribers’ freedom to select which SERM. Further research is required to asses the AI in other treatment classes and/or different indications to understand if specific regions are consistently more restrictive than others.