Patients’ associations and HTA for medicines: actual and future role in Italy

Introduction: This paper aims at investigating the role of Patients’ Associations in drugs assessment and appraisal in Italy. Methods: Information were gathered through a mostly structured (forced ranking) questionnaire. The questionnaire, once validated, was administered to two national HTA organisations (AIFA and ISS) and Therapeutic Committees / Departments of five regions (Lombardy, Veneto, Emilia Romagna, Latium, Sicily). The average rank and the Kendall rank correlation coefficient were calculated where respondents were forced ranking. Results: The interactions with Patients’ Associations are very different across HTA organisations, with only three respondents declaring a systematic relationship with these Associations and a focus on therapeutic targets more affected by new drugs launches. Patients’ Associations are perceived more expert on the organisation of the Italian health care system and drugs reimbursement process than on technical issues (e.g. PROs – Patient Reported Outcomes). Respondents declared that fragmentation of relationships, with many associations involved, is the most important barrier to a systematic interaction with Patients’ Associations and advocated for a stronger integration among them. Discussion: The interaction between HTA organisations and Patients’ Associations is expected to increase in the future. To make this interaction more useful, Patients’ Associations should improve their knowledge on drugs assessment techniques - mainly PRO - and enhance their awareness on budget issues for payers: the former could create a virtuous cycle that may drive HTA organisations paying more attention to PROs; the latter may help Patients’ Associations and payers agreeing on actions aimed at making drugs more sustainable.