HTA decision-making for drugs for rare diseases: comparison of processes across countries.

Introduction: Drugs for rare diseases (DRDs) offer important health benefits, but challenge traditional health technology assessment, reimbursement, and pricing processes due to limited effectiveness evidence. Recently, modified processes to address these challenges while improving patient access have been proposed in Canada. This review examined processes in 12 jurisdictions to develop recommendations for consideration during formal government-led multi-sectoral discussions currently taking place in Canada.

Closing the Gaps to Timely Patient Access: Perspectives on Conditional Funding Models.

The Canadian system for approval of new cancer drugs is complex with multiple steps. Health Canada grants a license for a drug to be marketed and prescribed. The Canadian Agency for Drugs and Technologies in Health (CADTH) and Institut national d'excellence en santé et services sociaux (INESSS) make recommendations by way of health technology assessments (HTA).

Sensor-Based Technology: Bringing Value to People with Diabetes and the Healthcare System in an Evolving World.

Purpose: Evidence demonstrates that glucose-sensing technologies have enabled effective glycemic control for adults and children with type 1 diabetes (T1DM) or adults with type 2 diabetes (T2DM) on insulin therapy or non-insulin therapy. Here, we report on the wider value of glucose-sensing technology from the perspectives of person living with diabetes (PWD), healthcare providers (HCPs), and healthcare policy stakeholders.

Methodology: Literature searches were conducted to identify published records and analysis, including across various healthcare organizations and agencies, of the impact of the FreeStyle Libre flash glucose monitoring system in diabetes.

Bringing patient centricity to diabetes medication access in Canada.

Canada must become proactive in addressing type 2 diabetes. With the second highest rate of diabetes prevalence in the developed world, the number of Canadians living with diabetes will soon reach epidemic levels. Against international comparisons, Canada also performs poorly with respect to diabetes-related hospitalizations, mortality rates, and access to medications.

Evolution of health technology assessment: best practices of the pan-Canadian Oncology Drug Review.

Background: In 2007, Canada chose to develop a separate and distinct path for oncology drug health technology assessment (HTA). In 2013, the decision was made to transfer the pan-Canadian Oncology Drug Review (pCODR) to the Canadian Agency for Drugs and Technologies in Health (CADTH), to align the pCODR and CADTH Common Drug Review processes while building on the best practices of both. The objective of this research was to conduct an examination of the best practices established by the pCODR.

Health-related quality of life and regulatory issues in the US and Canada.

The purpose of this paper is to examine the utilisation of HR-QOL information by US and Canadian federal regulatory bodies, with a focus on pre- and postmarket product review processes. There are a number of challenges facing regulators in using HR-QOL data derived from clinical trials and/or pharmacoeconomic analyses. Some of these challenges are inherent to HR-QOL tools and methodologies, while others relate to their inappropriate application in clinical studies.