TY - JOUR
T1 - Health Technology Assessment (HTA) Case Studies
T2 - Factors Influencing Divergent HTA Reimbursement Recommendations in Australia, Canada, England, and Scotland
AU - Allen, Nicola
AU - Walker, Stuart R
AU - Liberti, Lawrence
AU - Salek, Sam
N1 - This document is the accepted manuscript version of the following article: Nicola Allen, Stuart R. Walker, Lawrence Liberti, and Sam Salek, ‘Health Technology Assessment (HTA) Case Studies: Factors Influencing Divergent HTA Reimbursement Recommendations in Australia, Canada, England, and Scotland’, Vol. 20 (3): 320-328, 2017, is made available under the terms of the Creative Commons Attribution-NonCommercial-NoDerivatives License CC BY NC-ND 4.0
( http://creativecommons.org/licenses/by-nc-nd/4.0/ ), which permits non-commercial re-use, distribution, and reproduction in any medium, provided the original work is properly cited, and is not altered, transformed, or built upon in any way.
The final, definitive version is available online at doi:https://doi.org/10.1016/j.jval.2016.10.014.
PY - 2017/3/31
Y1 - 2017/3/31
N2 - OBJECTIVES: To evaluate the national regulatory, health technology assessment (HTA), and reimbursement pathways for public health care in Australia, Canada, England, and Scotland, to compare initial Canadian national HTA recommendations with the initial decisions of the other HTA agencies, and to identify factors for differing national HTA recommendations between the four HTA agencies.METHODS: Information from the public domain was used to develop a regulatory process map for each jurisdiction and to compare the HTA agencies' reimbursement recommendations. Medicines that were reviewed by all four agencies and received a negative recommendation from only one agency were selected as case studies.RESULTS: All four countries have a national HTA agency. Their reimbursement recommendations are guided by both clinical efficacy and cost-effectiveness, and the necessity for patient input. Their activities, however, vary because of different mandates and their unique political, social, and population needs. All have an implicit or explicit quality-adjusted life-year threshold. The seven divergent case studies demonstrate examples in which new medicine-indication pairs have been rejected because of uncertainties surrounding a range of factors including cost-effectiveness, comparator choice, clinical benefit, safety, trial design, and submission timing.CONCLUSIONS: The four HTA agencies selected for inclusion in this study share common factors, including a focus on clinical efficacy and cost-effectiveness in their decision-making processes. The differences in recommendations could be considered to be due to an individual agency's approach to risk perception, and the comparator choice used in clinical and cost-effectiveness studies.
AB - OBJECTIVES: To evaluate the national regulatory, health technology assessment (HTA), and reimbursement pathways for public health care in Australia, Canada, England, and Scotland, to compare initial Canadian national HTA recommendations with the initial decisions of the other HTA agencies, and to identify factors for differing national HTA recommendations between the four HTA agencies.METHODS: Information from the public domain was used to develop a regulatory process map for each jurisdiction and to compare the HTA agencies' reimbursement recommendations. Medicines that were reviewed by all four agencies and received a negative recommendation from only one agency were selected as case studies.RESULTS: All four countries have a national HTA agency. Their reimbursement recommendations are guided by both clinical efficacy and cost-effectiveness, and the necessity for patient input. Their activities, however, vary because of different mandates and their unique political, social, and population needs. All have an implicit or explicit quality-adjusted life-year threshold. The seven divergent case studies demonstrate examples in which new medicine-indication pairs have been rejected because of uncertainties surrounding a range of factors including cost-effectiveness, comparator choice, clinical benefit, safety, trial design, and submission timing.CONCLUSIONS: The four HTA agencies selected for inclusion in this study share common factors, including a focus on clinical efficacy and cost-effectiveness in their decision-making processes. The differences in recommendations could be considered to be due to an individual agency's approach to risk perception, and the comparator choice used in clinical and cost-effectiveness studies.
KW - Australia
KW - Canada
KW - Cost-Benefit Analysis
KW - Decision Making
KW - Decision Making, Organizational
KW - Drug Approval
KW - England
KW - Government Agencies
KW - Health Policy
KW - Humans
KW - Internationality
KW - Organizational Case Studies
KW - Prescription Drugs
KW - Scotland
KW - Technology Assessment, Biomedical
KW - Comparative Study
KW - Journal Article
U2 - 10.1016/j.jval.2016.10.014
DO - 10.1016/j.jval.2016.10.014
M3 - Article
C2 - 28292476
SN - 1098-3015
VL - 20
SP - 320
EP - 328
JO - Value in Health
JF - Value in Health
IS - 3
ER -