Decision-Making on New Non-Drug Health Technologies by Hospitals and Health Authorities in Canada.

INTRODUCTION: Unlike those for publicly funded drugs in Canada, coverage decision-making processes for non-drug health technologies (NDTs) are not well understood. OBJECTIVES: This paper aims to describe existing NDT decision-making processes in different healthcare organizations across Canada. METHODS: A self-administered survey was used to determine demographic and financial characteristics of organizations, followed by in-depth interviews with senior leadership of consenting organizations to understand the processes for making funding decisions on NDTs. RESULTS: Seventy-three and 48 organizations completed self-administered surveys and telephone interviews, respectively (with 45 participating in both ways). Fifty-five different processes were identified, the majority of which addressed capital equipment. Most involved multidisciplinary committees (with medical and non-medical representation), but the types of information used to inform deliberations varied. Across all processes, decision-making criteria included local considerations such as alignment with organizational priorities. CONCLUSIONS: NDT decision-making processes vary in complexity, depending on characteristics of the healthcare organization and context.

Engagement of Canadian Patients with Rare Diseases and Their Families in the Lifecycle of Therapy: A Qualitative Study.

INTRODUCTION: Patient involvement is increasingly recognized as critical to the development, introduction and use (i.e. the lifecycle) of new and effective therapies, particularly those for rare diseases, where natural histories and the impact on patients and families are less well-understood than for common diseases. However, little is known about how patients and families would like to be involved during the lifecycle. OBJECTIVE: The aim of this study was to explore ways in which Canadian patients with rare diseases and their families would like to be involved in the lifecycle of therapies and identify their priorities for involvement. METHODS: Patients with rare diseases and their families were recruited to participate in two deliberative sessions, during which concepts related to decision-making uncertainty and the technology lifecycle were introduced before eliciting input around ways in which they could be involved. This was followed by a webinar, which was used to further identify opportunities for involvement. The data were then analyzed qualitatively using eclectic coding. RESULTS: Patients and families identified opportunities that fell into three goals: (1) incorporation of their 'lived experience' in coverage decision making (i.e. decisions by governments on funding new therapies); (2) improved care for patients; and (3) greater awareness of rare diseases, with the first being a priority. CONCLUSIONS: Opportunities for patients and families to contribute their 'lived experience' are needed throughout the orphan drug lifecycle, but the ideal mechanisms for providing this input have yet to be determined.

Access with evidence development: an approach to introducing promising new technologies into healthcare.

The rapid development of new health technologies for which there is limited, but promising, evidence has resulted in a daunting challenge - to provide care that meets population health needs and optimizes patient outcomes, demonstrates an efficient use of healthcare resources, and upholds basic principles of equity, access, and choice. In this paper, we introduce 'Access with Evidence Development' as a possible mechanism for addressing this challenge and discuss its application to the "Zamboni procedure" for Multiple Sclerosis.