Clinical impact summary for Sipuleucel-T in the treatment of prostate cancer

Outcome measure	Evidence	Implication
Disease-oriented evidence	– Sipuleucel-T leads to recruitment of T-cells to the tumor. –Sipuleucel-T may increase PSA doubling time.	– Basic mechanism of action.
Patient-oriented evidence	– Sipuleucel-T increases overall survival in patients with mCRPC. –Sipuleucel-T does not decrease tumor size or prolong time to progression. –Sipuleucel-T may prolong time to use of opiate pain medications.	– Very important outcome and led to approval of this agent. – Important because it should not be used in someone with rapidly progressing mCRPC. –Very preliminary finding, but could suggest some delayed effect on the disease.
Economic evidence	– A single analysis using the cost of sipuleucel-T in US dollars ($140,536) and a gain of 0.37 quality-adjusted life years determined that there was 96.5% certainty it was not cost-effective.	– The current cost to outcomes ratio seen in the IMPACT study does not support the use of sipuleucel-T. If the price goes down, or the improvement in survival goes up, this may be adjusted.