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.
The story appropriately reports that Provenge treatment costs $93,000 per patient and is satisfactory based on the criterion. However, the costs should ideally be put into context and compared to alternative treatments. An editorial published along with the Provenge trial in the New England Journal of Medicine noted the costs of alternative treatment is $1,800 per patient.
The story reports that in clinical trials Provenge extended the lives of certain men with advanced prostate cancer by about four months. However, the story does not tell readers that the expert reviewers who analyzed the available evidence for Medicare wrote that the actual quantity of the benefit is “less certain” because of weaknesses in the trials. As a result, readers are likely to believe that the “four months” additional survival is a firm estimate of the average benefit when in fact there are important questions about that conclusion. Also, the story does not report that according to the clinical trials Provenge did not make any difference in how long it took for prostate cancer to progress in these men.
The story does not mention harms. The clinical trials reported that patients treated with Provenge experienced infusion reactions and infections. The review for Medicare also noted that the FDA ordered further study of strokes in people who get Provenge.
The story does not give readers an adequate understanding of why the reviewers question the quality of the evidence indicating patients treated with Provenge lived longer. The story does report that the analysis of the clinical trials of Provenge treatment raised questions about the design of the trials, including that the treatment given patients in the “placebo” arm of the trials “was not really inert.” However, the analysis of the evidence done for Medicare concluded that the actual amount of a survival benefit from this treatment is “less certain” because of issues with the designs of the key trials. Readers were not told that the reviewers rated the quality of evidence on survival as only “fair” and that the reviewers spelled out the sort of clinical trials that are still needed in order to provide more reliable estimates of the effects of Provenge. Because trial design is central to understanding how to judge the merits of this treatment, the story should have done more to explain the shortcomings identified by the expert reviewers. For example, although two clinical trials did report that patients receiving the treatment lived about four months longer on average, there was no significant difference in the amount of time before the disease progressed. Also, there were differences in the other treatments (including chemotherapy) given to the patients in the treatment and control arms of the trials. The reviewers also recommended that future trials look at possible interactions between Provenge and chemotherapy and other post-progression treatments, in order to find out if they might shed light on the survival differences.
The story reports that Provenge treatment is approved only for patients with “advanced prostate cancer that is resistant to hormone-deprivation therapy but who are experiencing no or minimal symptoms.”
Although the story uses excerpts of written statements from a financial analyst and the president of a cancer advocacy group, it does not include an independent source who addresses the scientific issues raised by the analysis of Provenge done for Medicare. The story does not tell readers that the cancer advocacy group it cites receives support from and promotes its services to health care corporations, including pharmaceutical companies.
Although the available treatments for men with advanced prostate cancer are limited, there are other approaches that could have been mentioned. The omission is of particular importance because the analysis done for Medicare specifically highlighted questions about whether other treatments, including chemotherapy, that were given to patients in the Provenge trials might have influenced the outcomes.
The story reports that treatment with Provenge has been approved for certain patients with advanced prostate cancer but that availability is limited by manufacturing capacity.
The story reports that Provenge is the first approved treatment that is designed to try to stimulate a patient’s immune system to attack tumors.
The story does not rely on a news release.