Harmonization of reimbursement and regulatory approval processes: a systematic review of international experiences

Abstract

A considerable degree of overlap exists between reimbursement and regulatory approval of health technologies, and harmonization of certain aspects is both possible and feasible. Various models to harmonization have been suggested in which a number of practical attempts have been drawn from. Based on a review of the literature, approaches can be categorized into those focused on reducing uncertainty and developing economies of scale in the evidentiary requirements; and/or aligning timeframes and logistical aspects of the review process. These strategies can further be classified based on the expected level of structural and organizational change required to implement them into the existing processes. Passive processes require less modification, whereas active processes are associated with greater restructuring. Attempts so far at harmonization have raised numerous legal and practical issues and these must be considered when introducing a more harmonized framework into the existing regulatory and reimbursement arrangements.

Keywords::

• government regulation
• health technology assessment
• insurance coverage
• policy making
• regulatory approval
• reimbursement

Acknowledgments

The authors would like to acknowledge the support and the guidance of the staff from the Office of Pharmaceuticals Management Strategies.

Financial & competing interests’ disclosure

Funding for this study was provided by a Health Canada grant although the views and perspectives are solely that of the authors and do not necessarily represent the views of Health Canada. Tsoi B is supported by an award from the Father Sean O’Sullivan Research Centre, St. Joseph’s Healthcare Hamilton and the CIHR Drug Safety and Effectiveness Cross-Disciplinary Training program. The authors have no other potential relevant affiliations or financial involvement with any organization or entity with a financial interest in or financial conflict with the subject matter or materials discussed in the manuscript apart from those disclosed.

No writing assistance was utilized in the production of this manuscript.