International Journal of Technology Assessment in Health Care



GENERAL ESSAYS

CONFRONTING THE “GRAY ZONES” OF TECHNOLOGY ASSESSMENT: EVALUATING GENETIC TESTING SERVICES FOR PUBLIC INSURANCE COVERAGE IN CANADA


Mita Giacomini a1, Fiona Miller a1 and George Browman a2
a1 McMaster University
a2 McMaster University, Hamilton Regional Cancer Centre

Abstract

We describe an evaluation model to guide public coverage of new predictive genetic tests in Ontario, Canada. The model confronts common “gray zones” in evaluation and coverage policy for challenging new technologies. Analysis addresses three domains of the evaluation picture. The first specifies evaluative criteria (purpose, effectiveness, additional effects, unit cost, demand, cost-effectiveness). The second induces or deduces acceptable cutoffs for each criterion. The third domain addresses the need to make decisions under uncertainty and to respond to “gray” evaluations with conditional-coverage decisions. The evaluation criteria should be applied within sound decision-making processes.


Key Words: Decision making; Organizational; Health priorities/*organization & administration; Technology assessment; Biomedical/*organization & administration; Health care rationing; Genetics/legislation & jurisprudence.