TY - JOUR
T1 - Uncertainty and Coverage With Evidence Development
T2 - Does Practice Meet Theory?
AU - Pouwels, Xavier G. L. V.
AU - Grutters, Janneke P. C.
AU - Bindels, Jill
AU - Ramaekers, Bram L. T.
AU - Joore, Manuela A.
N1 - Funding Information:
This work was supported by The Netherlands Organisation for Health Research and Development , Grant Number 152002052 . We thank all interviewees who accepted to participate in this study. We thank Sabine Grimm for her thorough review of the article.
Publisher Copyright:
© 2018 ISPOR–The Professional Society for Health Economics and Outcomes Research
PY - 2019/7
Y1 - 2019/7
N2 - Objectives: In theory, a successful coverage with evidence development (CED) scheme is one that addresses the most important uncertainties in a given assessment. We investigated the following: (1) which uncertainties were present during the initial assessment of 3 Dutch CED cases, (2) how these uncertainties were integrated in the initial assessments, (3) whether CED research plans included the identified uncertainties, and (4) issues with managing uncertainty in CED research and ways forward from these issues.Methods: Three CED initial assessment dossiers were analyzed and 16 stakeholders were interviewed. Uncertainties were identified in interviews and dossiers and were categorized in different causes: unavailability, indirectness, and imprecision of evidence. Identified uncertainties could be mentioned, described, and explored. Issues and ways forward to address uncertainty in CED schemes were discussed during the interviews.Results: Forty-two uncertainties were identified. Thirteen (31%) were caused by unavailability, 17 (40%) by indirectness, and 12 (29%) by imprecision. Thirty-four uncertainties (81%) were only mentioned, 19 (45%) were described, and the impact of 3 (7%) uncertainties on the results was explored in the assessment dossiers. Seventeen uncertainties (40%) were included in the CED research plans. According to stakeholders, research did not address the identified uncertainty, but CED research should be designed to focus on these.Conclusions: In practice, uncertainties were neither systematically nor completely identified in the analyzed CED schemes. A framework would help to systematically identify uncertainty, and this process should involve all stakeholders. Value of information analysis, and the uncertainties that are not included in this analysis should inform CED research design.
AB - Objectives: In theory, a successful coverage with evidence development (CED) scheme is one that addresses the most important uncertainties in a given assessment. We investigated the following: (1) which uncertainties were present during the initial assessment of 3 Dutch CED cases, (2) how these uncertainties were integrated in the initial assessments, (3) whether CED research plans included the identified uncertainties, and (4) issues with managing uncertainty in CED research and ways forward from these issues.Methods: Three CED initial assessment dossiers were analyzed and 16 stakeholders were interviewed. Uncertainties were identified in interviews and dossiers and were categorized in different causes: unavailability, indirectness, and imprecision of evidence. Identified uncertainties could be mentioned, described, and explored. Issues and ways forward to address uncertainty in CED schemes were discussed during the interviews.Results: Forty-two uncertainties were identified. Thirteen (31%) were caused by unavailability, 17 (40%) by indirectness, and 12 (29%) by imprecision. Thirty-four uncertainties (81%) were only mentioned, 19 (45%) were described, and the impact of 3 (7%) uncertainties on the results was explored in the assessment dossiers. Seventeen uncertainties (40%) were included in the CED research plans. According to stakeholders, research did not address the identified uncertainty, but CED research should be designed to focus on these.Conclusions: In practice, uncertainties were neither systematically nor completely identified in the analyzed CED schemes. A framework would help to systematically identify uncertainty, and this process should involve all stakeholders. Value of information analysis, and the uncertainties that are not included in this analysis should inform CED research design.
KW - RISK-SHARING ARRANGEMENTS
KW - MANAGED ENTRY AGREEMENTS
KW - HEALTH TECHNOLOGIES
KW - DECISION-MAKING
KW - FRAMEWORK
KW - INFORMATION
KW - PRINCIPLES
KW - ACCESS
KW - DESIGN
KW - SCHEME
U2 - 10.1016/j.jval.2018.11.010
DO - 10.1016/j.jval.2018.11.010
M3 - Article
C2 - 31277827
SN - 1098-3015
VL - 22
SP - 799
EP - 807
JO - Value in Health
JF - Value in Health
IS - 7
ER -