OBJECTIVES

To understand the challenges and similarities in demonstrating cost-effectiveness across CAN (CADTH), GBR (NICE), and in the USA (via the ICER organization).

METHODS

The study employed a pragmatic literature, industry, and policy review to understand the challenges faced by manufacturers for therapies in a variety of treatment areas, the differences and similarities of challenges faced in cost-effectiveness assessment across markets, and ways in which CADTH, NICE, and ICER have each contributed to the evolving definition of cost-effectiveness internationally.METHODS

RESULTS

CADTH, NICE, and ICER each employ drastically different definitions of cost-effectiveness and make equally divergent usage of their determinations. While CADTH leverages a CAD 20,000-100,000 / QALY threshold (dynamically adjusting based on key factors), NICE employs a lower and less flexible GBP 30,000-50,000 cutoff, and ICER uses a more directional systemic analysis where cost-effectiveness falls in the USD 100,000-150,000 range. Subsequently, CADTH seems to propose discounts that would achieve cost-effectiveness as a leverage bolster for the pan-Canadian Pharmaceutical Alliance payer negotiations, whereas NICE is more firmly committed to recommending reimbursement based on cost-effectiveness, and while ICER has no direct authority, the organization has seen its influence grow with strategic private and public partnerships leveraging its determinations. Despite differences, these three bodies often challenge products’ cost-effectiveness claims on similar grounds, with similar shortcomings highlighted by all three. Comparator selection, duration of data, and economic modelling assumptions are all routinely highlighted across these organizations in decisions that rule products to not be cost-effective. These factors contribute to uncertainty in financial calculations and can result in cost-ineffective determinations for even highly effective therapies.

CONCLUSIONS : While the definition of cost-effectiveness varies internationally, similar challenges to achieving this status across markets are consistently identified and should be acknowledged and thoroughly assessed by manufacturers of novel therapeutics in their economic modelling.