text_1: Prostate Cancer Drug Gets Lukewarm Review
text_2: This story reports on an analysis done for the agency that oversees Medicare of the evidence of the effects of Provenge (sipuleucel-T) in certain men with advanced prostate cancer. It summarizes some of the conclusions and includes comments about how the analysis might influence a decision about whether Medicare and Medicaid will pay for the expensive new treatment. But the story leaves readers with the impression that the drug has been proven to extend the life of the average patient by about four months when actually there are many uncertainties about that estimate due to weaknesses in the clinical trials sponsored by the maker of the Provenge. The assessment done for Medicare underscores the questions that still need to be answered in order for doctors and patients to know whether and how to use Provenge, but that perspective is largely missing from this story. This story portrays debates about insurance coverage of Provenge as a matter of how much value to place on four months of life. But what the federal analysis of the Provenge trials actually focuses on is uncertainty about the amount of additional survival and questions about how other factors besides Provenge (including other treatments that were given to the trial participants) might have affected the trial results. Prostate cancer is the most common cancer occurring in men, though most tumors grow slowly and men diagnosed with the disease typically die of something other than their prostate cancer. Some tumors are aggressive and more effective treatments are needed for these cases. Provenge’s novel immunotherapy approach offers an attractive alternative to existing treatments, but the initial application for FDA approval was rejected in 2007. A new clinical trial was done and the treatment was approved for sale in the U.S. earlier this year. Although historically Medicare and Medicaid have covered treatments deemed safe and effective without considering the magnitude of the expected benefit, the limited additional survival and the high cost of Provenge treatment have highlighted debates about whether and how to consider these factors in deciding whether a particular treatment should be reimbursed.