Legal and Regulatory Enablers and Barriers to Conditional Regulatory and Reimbursement Alternatives in Canadian Health Systems

Abstract

Precision oncology represents a paradigm shift in cancer care. Existing regulatory and reimbursement processes are not well suited to address this new reality. Novel regulatory and reimbursement approaches are needed to support the adoption of precision oncology technologies (therapeutics and diagnostics) and the development of post-market evidence. This can be achieved through conditional regulatory and reimbursement mechanisms. The purpose of this document is to provide a comprehensive overview of the legal, regulatory, and policy barriers, enablers, and considerations for: 1. The continued use of conditional regulatory authorizations, including the use of terms and conditions; and, 2. The use of Managed Access Agreements (MAAs) as a mechanism to enable equitable access to promising precision oncology technologies while decreasing uncertainties for reimbursement decision-makers via the generation of additional evidence of clinical and cost-effectiveness.

Note:
Funding Information: This research was supported by Genome British Columbia / Genome Canada [G05CHS] and its funding partners.

Conflict of Interests: The authors declare no conflicts of interest.

Keywords: Drug Regulation, Conditional Approval, Managed Access Agreements, Health Policy, Precision Oncology