A Health Technology Assessment Framework for Ethics Analysis in Drug Reimbursement Reviews at Canada's Drug Agency
Author(s)
Renata Axler, PhD1, Ana Komparic, PhD2, Farah Husein, PharmD1;
1Canada's Drug Agency, Ottawa, ON, Canada, 2University of British Columbia, School of Population and Public Health, Vancouver, BC, Canada
1Canada's Drug Agency, Ottawa, ON, Canada, 2University of British Columbia, School of Population and Public Health, Vancouver, BC, Canada
OBJECTIVES: In order to address the ethical complexities of certain drugs submitted for reimbursement review at Canada’s Drug Agency (CDA-AMC), we developed a comprehensive framework for the assessment of the ethical dimensions of drug products. This Health Technology Assessment framework is intended to recognize the embedded nature of ethical considerations, and identify relevant elements for decision-making.
METHODS: We developed a series of guiding questions identified from the EUnetHTA Core Model 3.0, Ethics Domain, and Benkhalti et al’s 2021 Equity Checklist for Health Technology Assessment. These questions or prompts were divided into four analytic domains covering ethical considerations across the technology and drug reimbursement lifecycle and adapted to the specific context of each review. The framework addresses ethical considerations in:
RESULTS: This framework has been applied to 31 CDA-AMC drug reimbursement reviews as of December 2024. Modified versions of this approach are being trialed and implemented across an increasing number of review types. Alongside clinical and economic evaluations, the ethics report is used as one of the inputs to inform deliberative committees and other decision-makers.
CONCLUSIONS: This framework offers a consistent and transparent way to highlight ethical considerations for drug products under review at CDA-AMC.
METHODS: We developed a series of guiding questions identified from the EUnetHTA Core Model 3.0, Ethics Domain, and Benkhalti et al’s 2021 Equity Checklist for Health Technology Assessment. These questions or prompts were divided into four analytic domains covering ethical considerations across the technology and drug reimbursement lifecycle and adapted to the specific context of each review. The framework addresses ethical considerations in:
- Disease context, including considerations related to disparities in incidence, treatment, or outcomes; challenges or burdens related to diagnosis or clinical care; factors that might prevent patients from gaining access to therapies;
- The evidence used to evaluate the drug product, including the representativeness of clinical trials, the appropriateness of outcome measures and analytical methods used, data or assumptions in the economic evaluation;
- Clinical use and implementation, including considerations related to benefits and harms to patients, relatives, caregivers, clinicians, and society, as well as considerations related to access to the drug;
- Health system impact, including considerations related to the just distribution of healthcare resources.
RESULTS: This framework has been applied to 31 CDA-AMC drug reimbursement reviews as of December 2024. Modified versions of this approach are being trialed and implemented across an increasing number of review types. Alongside clinical and economic evaluations, the ethics report is used as one of the inputs to inform deliberative committees and other decision-makers.
CONCLUSIONS: This framework offers a consistent and transparent way to highlight ethical considerations for drug products under review at CDA-AMC.
Conference/Value in Health Info
2025-05, ISPOR 2025, Montréal, Quebec, CA
Value in Health, Volume 28, Issue S1
Code
P49
Topic
Health Technology Assessment
Topic Subcategory
Value Frameworks & Dossier Format
Disease
No Additional Disease & Conditions/Specialized Treatment Areas