Presentation (CTI)

OBJECTIVES: A novel polymeric heart valve for aortic position made from styrene-block-ethylene/butylene-block-styrene copolymers (SEBS) for use in surgical aortic valve replacement is in development. The valve is expected to improve patient mortality, reoperation, and symptomatic disease outcomes while being significantly cheaper to produce than its bioprosthetic valve comparators. However, there is no in-human evidence which means there is uncertainty in its clinical effect and consequently in its value to the health system. Decisions about investment in research and development activities and pricing can be optimised for manufacturers by considering that funding and uptake of new technologies by health systems depends on clinical and economic value to patients and health systems and on uncertainty over this value. We estimate the SEBS valve’s lifecycle value to manufacturers and the UK health system.
METHODS: We first estimate clinical and economic value of the novel SEBS valve in comparison to bioprosthetic heart valves using a de novo early economic model. Relative treatment effects on patient outcomes for the SEBS valve were derived via structured expert elicitation from clinical experts. In evaluating lifecycle value, we make considerations for the level of uncertainty at launch, whether research is conducted post-launch, whether price is renegotiated post reporting of research results, and technology patent and non-patent periods.
RESULTS: Probabilistic results suggest a headroom of up to £2107 above the current bioprosthetic valve price, driven by incremental QALYs gains of 0.101. The lifecycle value results suggest that the minimum price at which manufacturers are willing to market the new valve will determine the value of additional research.
CONCLUSIONS: The SEBS valve’s low production costs, combined with the potential for improvements in health outcomes means it can offer significant value to both manufacturers and health systems. Quantification of lifecycle value is a useful tool to inform decisions about research, development and pricing.