Dealing with performance-based health technology assessment outcomes for medical devices: A South African perspective

Abstract

The rising costs of healthcare have resulted in the rise of health technology assessment (HTA) in efforts to manage health budgets that are under pressure. Disruptive health technologies have necessitated the adoption of relatively new contracting mechanisms where prices require real-world evidence to prove their claims. The emergence of performance-linked market entry agreements (MEA) is one such contracting mechanism where payments are linked to health-outcomes. The rise of these outcomes-based contracts (OBCs) also knows as PBAs has been inundated with challenges that have led to questions about their effectiveness. The challenges in PBAs for medical devices are unique due to the features of medical devices, in particular their dependency on use by physicians.

Qualitative research on dealing with HTA outcomes that require PBAs in medical devices was undertaken to explore the implementation considerations of coverage with evidence development (CED) and performance-based risk sharing agreements (PBRSAs) including the funding mechanisms. A total of 12 interviews was conducted with actors in South Africa from different backgrounds who are experienced in conducting the implementation of CED schemes and PBRSAs for medical devices. The heterogenous sample of representatives from payers, medical device manufacturers and hospitals allowed for different perspectives to be considered in efforts to gain insight into the challenges of implementing these medical device PBAs and how they are overcome.

The key findings of the study highlight the need to contextualize the health economic tool used in the HTA submission to the local country environment. Other key findings supported the themes in literature with a unique finding that defines the risk in PBRSAs as the risk to profitability. The findings were consolidated and compiled into a model framework that proposes adaptive pathway design planning for uncertainty in emerging markets. The research adds to the growing body of literature on the implementation and practical considerations related to PBAs in medical devices.