Economic incentives for evidence generation: promoting an efficient path to personalized medicine.

The preceding articles in this volume have identified and discussed a wide range of methodological and practical issues in the development of personalized medicine. This concluding article uses the resulting insights to identify implications for the economic incentives for evidence generation. It argues that promoting an efficient path to personalized medicine is going to require appropriate incentives for evidence generation including: 1) a greater willingness on the part of payers to accept prices that reflect value; 2) consideration of some form of intellectual property protection (e.g., data exclusivity) for diagnostics to incentivize generation of evidence of clinical utility; 3) realistic expectations around the standards for evidence; and 4) public investment in evidence collection to complement the efforts of payers and manufacturers. It concludes that such incentives could build and maintain a balance among: 1) realistic thresholds for evidence and the need for payers to have confidence in the clinical utility of the drugs and tests they use; 2) payment for value, with prices that ensure cost-effectiveness for health systems; and 3) levels of intellectual property protection for evidence generation that provide a return for those financing research and development, while encouraging competition to produce both better and more efficient tests.