At that time, the Council was unable to recommend passage of Senate Bill 1334. Our position on the issue of mandating coverage of patient costs for participants in cancer clinical trials remains unchanged. In fact, supporters and opponents re-submitted the identical information as they did for the previous review. The Council, therefore, confirms our original position with regard to mandating coverage of patient care costs for participants in cancer clinical trials.
Clinical trials are experimental in nature.
One reason for conducting Phase I and Phase II trials is to determine if the proposed treatment is safe. In Phase III and Phase IV trials, the efficacy of the treatment is studied. In considering mandated benefits, the Council contends that recommendation be reserved only for measures which are of both proven efficacy and cost effectiveness. Since treatments provided in cancer clinical trials are experimental, they cannot be considered to have proven efficacy. The Council, therefore, reiterates our 1996 position that one possible option may be to limit coverage to treatments provided in Phase III or Phase IV cancer clinical trials where the safety of the treatment has been established and preliminary evidence suggests the treatment is effective.