Using health technology assessment to set priority, inform target product profiles, and design clinical study for health innovation

Abstract

Early health technology assessment (early HTA) is a useful tool in guiding the innovation development process in medical technology development. However, the application of early HTA is sub-optimal amongst research and development (R&D) communities due to several challenges. In this paper, we presented a case study of application of early HTA by drawing on the experience from a workshop conducted for the Singapore government's medical technology innovation agency. The framework developed can help maximise the chance of the newly developed technology being accepted and widely used. By providing step-by-step guidance, this work aims to translate early HTA into a practical tool and promote the application of early HTA amongst R&D communities.

Keywords: Decision support; Early health technology assessment; Priority setting; Target product profiles; Uncertainty.

Fig. 1

Decision Tree. Notes: S represents the current standard practice. C represents the competitor's technology. I represents the innovator's technology.

Fig. 2

Targeted Product Profile Criteria. Notes: This figure demonstrates the minimally acceptable target, acceptable target, and ideal target using a cost-effective plane. The x-axis is incremental outcome measure (e.g.: QALYs) and the y-axis is incremental cost. S represents the standard practice. Line 1 represents the cost-effective threshold used in the society. Line 2 passes through C, the competitor's technology, and is parallel to the line 1. Assume the competitor's technology is cost-effective and represents the current best practice. The red points represent the innovator's technology. To satisfy the minimally acceptable target, the innovator's technology should be below the cost-effective threshold line 1. To satisfy the acceptable target, the innovator's technology should be below line 2. To satisfy the ideal target, the innovator's technology should be below line 3. (For interpretation of the references to colour in this figure legend, the reader is referred to the web version of this article.)

Fig. 3

Cost-effectiveness Acceptability Curve and Cost-effectiveness Acceptability Frontier. Notes: Panel A shows the cost-effectiveness acceptability curve. Panel B shows the cost-effectiveness acceptability frontier. .

Fig. 4

One-way sensitivity analysis of I versus S. Notes: Full descriptions of the parameters can be obtained from Table 1. The top 10 parameters are shown in this figure. S represents the current standard practice. I represents the innovator's technology.

Fig. 5

One-way sensitivity analysis of I versus C. Notes: Full descriptions of the parameters can be obtained from Table 1. The top 10 parameters are shown in this figure. C represents the competitor's technology. I represents the innovator's technology.

Fig. 6

Target Product Profiles – Two-way Analysis. Notes: RR stands for relative risk. S represents the current standard practice. I represents the innovator's technology. Deter MAT stands for deterministic minimally acceptable target. Deter AT stands for deterministic acceptable target. Deter IT stands for deterministic ideal target. SIT stands for stochastic ideal target. .

Fig. 7

EVPI versus Ceiling Threshold per QALY Gained. Notes: The unit of EVPI is USD per patient. Deter MAT stands for deterministic minimally acceptable target. Deter AT stands for deterministic acceptable target. Deter IT stands for deterministic ideal target. SIT stands for stochastic ideal target. QALY stands for quality-adjusted life-year.