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.
