Multi-tier drugs assessment in a decentralised health care system. The Italian case-study

Objective: To investigate the organisation and decision-making processes of regional andlocal therapeutic committees in Italy, as a case-study of decentralised health care systems.Methods: A structured questionnaire was designed, validated, and self-administered torespondents. Committee members, prioritisation, assessment process and criteria, andtransparency of committees were investigated.Results: The respondents represent 100% of the 17 regional committees out of 21 regions(in 4 regions there is not any regional formulary), 88% of the 16 hospital networks and42% of the 183 public hospitals. The assessment process appears fragmented and may takea long time: drugs inclusion into hospital formularies requires two steps in most regions(regional and local assessment). Most of the therapeutic committees are closed to industryand patients associations involvement. Prioritisation in the assessment is mostly drivenby disease severity, clinical evidence, and the absence of therapeutic alternatives. Only 13out of the 17 regional committees have a public application form for drugs inclusion intoregional formulary. Regional and local committees (i) often re-assess the clinical evidencealready evaluated at central level and (ii) mostly rely on comparative drug unit prices perDDD and drug budget impact. The level of transparency is quite low.Conclusions: The Italian case-study provides useful insights into an appropriate manage-ment of multi-tier drugs assessment, which is particularly complex in decentralised healthcare systems, but exists also in centralised systems where drugs are assessed by local thera-peutic committees. A clear definition of regulatory competences at different levels, a highercollaboration between central, regional and local actors, and increased transparency arenecessary to pursue consistency between central policies on price and reimbursement and budget accountability at the regional and local levels.