Open AccessSteps forward in regulatory pathways for acute and chronic heart failure
Author(s) -
Pani Luca,
Pecorelli Sergio,
Rosano Giuseppe,
Anker Stefan D.,
Peracino Andrea,
Fregonese Laura,
Prasad Krishna,
Rasi Guido
Publication year - 2014
Publication title -
esc heart failure
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 0.787
H-Index - 25
ISSN - 2055-5822
DOI - 10.1002/ehf2.12015
Subject(s) - context (archaeology) , medicine , multidisciplinary approach , heart failure , health care , authorization , intensive care medicine , computer science , economic growth , sociology , paleontology , social science , computer security , economics , biology
Abstract A workshop was organized by the Agenzia Italiana del Farmaco (AIFA) to discuss unmet needs and ways forward in the development of medicines in heart failure, their rationale, and cost‐effective use. An integrated, multidisciplinary approach, including patients' needs and perspectives, was advocated by all the participants as the way to the most effective treatment regimens. More work is needed for reaching consensus on clinical and functional endpoints, for validating patient reported outcomes and measurements of well‐being. Similarly, the integration into the clinical programmes of the health technology assessment/payers perspective, in particular, the evaluation of ‘real‐life’ treatment effectiveness and of health as a value, would help in shifting the development and authorization of medicines from the molecule paradigm to their evaluation in the context of the whole health care regimen. Through this kind of workshop, AIFA is trying to build a template for meetings devoted to debate unmet needs with all stakeholders towards tentative road maps for the future.