Factors influencing health insurers' decisions to cover new genetic technologies

Objective: To examine the relative importance of factors influencing health insurers' coverage of new genetic technologies. Methods: A national survey in which the decision makers for private health insurers were asked whether they would cover cystic fibrosis (CF) carrier s creening, testing for genetic susceptibility to breast cancer (BRCA test), and medical costs of a clinical trial of gene therapy for CF under a variet y of conditions. Results: Respondents' coverage of the two tests and of medical costs of cli nical trials was low at the time of the study (4%-15.5% of insurers.) Their coverage of CF carrier screening and BRCA testing would be increased signi ficantly if the group tested was restricted to those at high risk, if detec tion rates were higher and costs lower, and if testing was endorsed by a na tional professional group or consensus conference. Coverage of the medical costs of a trial of CF gene therapy would be significantly more likely if t he trial was restricted to children or adults with severe CF, safety and ef fectiveness was proven, and therapy could be administered in a regional hos pital or an outpatient setting rather than in a research hospital. Conclusions: Health insurers play a critical role in the diffusion of new g enetic technologies. The validity of genetic tests and the safety and effec tiveness of new therapies are primary factors influencing health insurers' coverage. Lower costs and approval of professional groups are other factors associated with increased coverage.