Ethical and Social Values for Paediatric Health Technology Assessment and Drug Policy.

Avram E Denburg,Julia Abelson,Wendy Ungar,Mita Giacomini

doi:10.34172/ijhpm.2020.144

Abstract

Background: Public policy approaches to funding paediatric medicines in advanced health systems remain understudied. In particular, the ethical and social values dimensions of health technology assessment (HTA) and drug coverage decisions for children have received almost no attention in research or policy. Methods: To elicit and understand the social values that influence decision-making for public funding of paediatric drugs, we undertook a series of in-depth, semi-structured interviews with a stratified purposive sample (n = 22) of stakeholders involved with or affected by drug funding decisions for children at the provincial (Ontario) and national levels in Canada. Constructivist grounded theory methodology guided data collection and thematic analysis. Results: Our study provides empirical evidence about the unique ethical and social values dimensions of HTA for children, and describes a novel social values typology for paediatric drug policy decision-making. Three principal categories of values emerged from stakeholder reflections on HTA and drug policy-making for children: procedural values, structural values, and sociocultural values. Key findings include the importance of attention to the procedural legitimacy of HTA for children, with emphasis on the inclusion of child health voices in processes of technology appraisal and policy uptake; a role for HTA institutions to consider the equity impacts of technologies, both in setting review priorities and in assessing the value of technologies for public coverage; and the potential benefits of a distinct national framework to guide drug policy for children. Conclusion: Current approaches to HTA are not well designed for the realities of child health and illness, nor the societal priorities regarding children that our study identified. This research generates new knowledge to inform decision-making on paediatric drugs by HTA institutions and government payers in Canada and other publicly-funded health systems, through insights into the relevant social values for child drug funding decisions from varied stakeholder groups.

Highlights

Public policies on the regulation and funding of medicines for children vary considerably across developed health systems.[1,2,3] Health technology assessment (HTA) institutions and processes are central to public drug funding decisions in a growing array of developed health systems, including Canada.[4]
Three main types of values emerged from stakeholder reflections on health technology assessment (HTA) and drug policy-making for children: procedural values, structural values, and sociocultural values
Procedural Values We define procedural values as those that relate to the processes underlying HTA and health system priority-setting on drugs for children

Summary

Introduction

Public policies on the regulation and funding of medicines for children vary considerably across developed health systems.[1,2,3] Health technology assessment (HTA) institutions and processes are central to public drug funding decisions in a growing array of developed health systems, including Canada.[4]. Current approaches to HTA and drug policymaking in most countries take little account of the unique features of child health and illness.[7,8] In particular, the ethical and social values dimensions of HTA and drug coverage decisions for children have received almost no attention in research or policy, despite their stated importance as a foundational component of HTA in most jurisdictions with public drug funding programs.[9,10] This article explores the social values that influence decision-making for public funding of paediatric drugs, through analysis of interviews with stakeholders involved in or impacted by HTA and policy-making for child health technologies at the provincial (Ontario) and national levels in Canada. It contributes novel data to inform the design of prioritization and assessment frameworks for paediatric drugs and health technologies, with direct policy relevance to healthcare priority-setting bodies and government funders in Canada; it may have implications for comparable health systems internationally

Methods

Results

Discussion

Conclusion