title: The assessment of new drugs for asthma and COPD: a Delphi study examining the perspectives of Italian payers and clinicians.
abstract: BACKGROUND
  Asthma and chronic obstructive pulmonary disease (COPD) are disorders of the lungs characterized by airflow obstruction, inflammation and tissue remodeling. Management of patients with these diseases is complex and the improvement of diagnostic-therapeutic strategies represents a critical challenge for the healthcare system. In this context, investigating the criteria and information needed for an appropriate and effective evaluation of incoming treatment options is crucial to ensure that clinicians and policy-makers are provided with the best available evidence to make decisions aimed at improving patient outcomes. Therefore, the objective of this study was to investigate the degree of agreement among Health Technology Assessment (HTA) experts on issues crucial to the evaluation of new drugs for asthma and COPD and to appropriately manage the clinical pathway for patients.
  
  
  METHODS
  This research was conducted using an e-Delphi technique organized in three subsequent rounds and involving a panel of ten experts (six regional and local payers and four clinicians). Panelists were asked to comment in written form on a set of statements, explaining qualitatively the extent to which they agreed or disagreed with the assertions. Statements were subsequently modified and resubmitted for assessment.
  
  
  RESULTS
  Panelists expressed their opinions during each round and, after round III, a consensus document was finalized. The degree of consensus was high among experts and concerned five main topics: (a) the need to address current unmet needs of patients with asthma or COPD, (b) the importance of further studies and real-life information in the evaluation of treatments, (c) existing evidence and evidence needed to assess drugs, (d) critical issues in obtaining a positive evaluation from regional and local authorities for new treatments to be included in regional formularies and to have an important place in therapeutic categories, and (e) the major obstacles to the appropriate administration of drugs and management of patients.
  
  
  CONCLUSIONS
  The final document highlights that no proof of difference among drugs exists, that evidence on final endpoints (and particularly on mortality) should be strengthened and that actions regarding risk factors, appropriate diagnosis, patient staging and adherence to therapy are particularly important for a better clinical management.
authors.affiliation: Centre for Research on Health and Social Care Management, Bocconi University, Milan, Italy ; Università Bocconi - CERGAS, Via Roentgen, 1, 20136 Milano, Italy.
authors.forename: Silvia
authors.initials: S
authors.lastname: Sommariva
authors.affiliation: Centre for Research on Health and Social Care Management, Bocconi University, Milan, Italy.
authors.forename: Aureliano P
authors.initials: AP
authors.lastname: Finch
authors.affiliation: Centre for Research on Health and Social Care Management, Bocconi University, Milan, Italy ; Department of Pharmaceutical Sciences, Università del Piemonte Orientale A. Avogadro, Novara, Italy.
authors.forename: Claudio
authors.initials: C
authors.lastname: Jommi
keywords: Asthma; COPD; Delphi
references.citation: Int J Chron Obstruct Pulmon Dis. 2013;8:405-23
references.pmid: 24043936
references.citation: Respir Med. 2005 Sep;99(9):1115-24
references.pmid: 15921904
references.citation: Respir Med. 2003 Mar;97 Suppl C:S3-14
references.pmid: 12647938
references.citation: Int J Qual Health Care. 2003 Dec;15(6):509-21
references.pmid: 14660534
references.citation: Am J Respir Crit Care Med. 2013 Apr 1;187(7):668-71
references.pmid: 23540872
references.citation: Respir Med. 2003 Mar;97 Suppl C:S43-50
references.pmid: 12647942
references.citation: Chest. 2000 Feb;117(2 Suppl):5S-9S
references.pmid: 10673466
references.citation: BMC Pulm Med. 2012 Jun 22;12:27
references.pmid: 22726610
references.citation: BMC Med Inform Decis Mak. 2014 Sep 09;14:82
references.pmid: 25204381
references.citation: J Occup Environ Med. 2008 Oct;50(10):1130-8
references.pmid: 18849758
references.citation: BMC Pulm Med. 2014 Apr 25;14:70
references.pmid: 24762026
references.citation: Am J Respir Crit Care Med. 2001 Apr;163(5):1256-76
references.pmid: 11316667
references.citation: Int J Chron Obstruct Pulmon Dis. 2012;7:211-9
references.pmid: 22500121
references.citation: Respir Med. 2011 Mar;105(3):386-91
references.pmid: 20951017
references.citation: J Intern Med. 2013 Jun;273(6):584-94
references.pmid: 23495860
references.citation: Thorax. 2007 Nov;62(11):938-43
references.pmid: 17557771
references.citation: J Health Organ Manag. 2003;17(1):37-52
references.pmid: 12800279
references.citation: Eur Respir J. 2008 Jan;31(1):204-12
references.pmid: 18166598
references.citation: Respir Med. 2012 May;106(5):668-76
references.pmid: 22277996
references.citation: Med J Aust. 1999 Jan 18;170(2):59-62
references.pmid: 10026684
references.citation: Respir Med. 2011 Jun;105(6):930-8
references.pmid: 21367593
references.citation: N Engl J Med. 2007 Feb 22;356(8):775-89
references.pmid: 17314337
references.citation: Ir J Med Sci. 1999 Jul-Sep;168(3):174-9
references.pmid: 10540783
references.citation: Health Technol Assess. 2008 May;12(19):iii-iv, 1-360
references.pmid: 18485271
references.citation: Eur J Clin Invest. 2011 Dec;41(12):1339-52
references.pmid: 21615731
references.citation: Int J Circumpolar Health. 2011 Sep;70(4):417-27
references.pmid: 21924008
references.citation: Respir Med. 2002 Aug;96 Suppl C:S3-10
references.pmid: 12199489
references.citation: Pharmacoeconomics. 2008;26(1):5-15
references.pmid: 18088155
references.citation: J Aerosol Med. 2006 Summer;19(2):127-36
references.pmid: 16796537
references.citation: Health Educ Res. 2005 Apr;20(2):195-205
references.pmid: 15328302
references.citation: Respir Med. 2008 Apr;102(4):593-604
references.pmid: 18083019