Improving early cycle economic evaluation of diagnostic technologies

Abstract

The rapidly increasing range and expense of new diagnostics, compels consideration of a different, more proactive approach to health economic evaluation of diagnostic technologies. Early cycle economic evaluation is a decision analytic approach to evaluate technologies in development so as to increase the return on investment as well as patient and societal impact. This paper describes examples of ‘early cycle economic evaluations’ as applied to diagnostic technologies and highlights challenges in its real-time application. It shows that especially in the field of diagnostics, with rapid technological developments and a changing regulatory climate, early cycle economic evaluation can have a guiding role to improve the efficiency of the diagnostics innovation process. In the next five years the attention will move beyond the methodological and analytic challenges of early cycle economic evaluation towards the challenge of effectively applying it to improve diagnostic research and development and patient value. Future work in this area should therefore be ‘strong on principles and soft on metrics’, that is, the metrics that resonate most clearly with the various decision makers in this field.

Keywords::

• decision makers
• diagnostics
• economic evaluation
• value of information

Financial & competing interests disclosure

The authors have no relevant affiliations or financial involvement with any organization or entity with a financial interest in or financial conflict with the subject matter or materials discussed in the manuscript. This includes employment, consultancies, honoraria, stock ownership or options, expert testimony, grants or patents received or pending, or royalties.

No writing assistance was utilized in the production of this manuscript.

Key issues

• Rapid developments in diagnostic imaging, molecular diagnostics and genetic testing require a strategy to managing development and uptake of diagnostic techniques, in order to maximize health benefit for expenditure.

• Early cycle economic evaluation is a proactive approach to economic evaluation of diagnostic technologies, which identifies key drivers of diagnostic value as early as possible and herewith guides the efficiency of the diagnostics innovation process.

• Exploratory economic evaluations can be applied alongside preclinical studies to inform the most valuable diagnostic development.

• Value of Information analyses can prioritize further data collection and inform the design of clinical and comparative effectiveness studies.

• Grand challenges in early cycle economic evaluation include: the use of belief elicitation to populate early models; timeliness of the economic analyses alongside the development process and the usability of early evaluation and value of information results to stakeholders.

• In the next 5 years, early economic evaluation will move beyond the methodological and analytic challenges toward the challenge of effectively applying it to improve diagnostic research and development and patient value.