ABSTRACT
The future of oncology drug development lies in identifying subsets of patients who will benet from particular therapies, using predictive biomarkers. Increasingly, national health authorities and insurers are demanding value from medicines. For example, the United Kingdom’s National Institute for Clinical Excellence (NICE) demands a cost of less than or equal to 30,000 British pounds per quality-adjusted life year (QALY). Most cancer medicines are far more expensive than this. The low value of cancer medicines is largely driven by two factors: (1) the low average benet of cancer medicines because they benet only a subset of the population, and (2) the high cost of oncology drug development due to its high failure rate, and to the need for large pivotal trials to detect small average benets.
