Rationing in urologic oncology: lessons from sipuleucel-T for advanced prostate cancer.
OBJECTIVE
As complex novel cancer drugs are developed, supply may transiently fail to meet demand as production capacity established for research purposes is scaled up to meet anticipated clinical volume. There are no clear guidelines for how clinicians and medical centers should allocate scarce cancer care resources among patients who may benefit from the intervention.


METHODS
We describe a recent scenario in which demand exceeded supply for a novel immunotherapy, sipuleucel-T, that was newly approved by the FDA for castration-resistant prostate cancer. Production of this autologous cellular therapy was initially limited to one facility with supply projected to serve only 2,000 out of approximately 30,000 potentially eligible patients in the United States.


CONCLUSIONS
We propose basic guidelines that should be followed when allocating scarce cancer therapies and highlight ongoing challenges that must be resolved both with regard to rationing cancer care and with regard to access to high cost novel interventions in oncology in general.
Duke University Medical Center, Durham, NC 27710, USA. Electronic address: jeffrey.peppercorn@duke.edu.
Jeffrey
J
Peppercorn
Andrew
A
Armstrong
David W
DW
Zaas
Daniel
D
George
D019496:Cancer Vaccines / Q000600:supply & distribution / Q000627:therapeutic use; D017277:Drug Approval; D006801:Humans; D007167:Immunotherapy / Q000379:methods; D008297:Male; D008495:Medical Oncology / Q000379:methods*; D017410:Practice Guidelines as Topic; D064129:Prostatic Neoplasms, Castration-Resistant / Q000628:therapy*; D014020:Tissue Extracts / Q000600:supply & distribution / Q000627:therapeutic use*; D014481:United States; D014486:United States Food and Drug Administration; D014571:Urologic Neoplasms / Q000628:therapy*
D019496:Cancer Vaccines; D014020:Tissue Extracts; C511774:sipuleucel-T