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 screening, testing for genetic susceptibility to breast cancer
(BRCA test), and medical costs of a clinical trial of gene therapy for CF
under a variety of conditions.
Results: Respondents' coverage of the two tests and of
medical costs of clinical 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 significantly if the group tested was restricted to
those at high risk, if detection rates were higher and costs lower, and if
testing was endorsed by a national professional group or consensus conference.
Coverage of the medical costs of a trial of CF gene therapy would be
significantly more likely if the trial was restricted to children or adults
with severe CF, safety and effectiveness was proven, and therapy could be
administered in a regional hospital or an outpatient setting rather than in a
Conclusions: Health insurers play a critical role in the diffusion
of new genetic technologies. The validity of genetic tests and the safety and
effectiveness of new therapies are primary factors influencing health
insurers' coverage. Lower costs and approval of professional groups are
other factors associated with increased coverage.