Wednesday, September 1, 2010

Provenge (Sipuleucel-T) revisited

Unique Treatment Raises Tricky Bioethical Issues
Vaccine for advanced castration-resistant(hormone resistant)prostate cancer prolongs life by a median of four months, but at an extremely high cost

The question is whether it is worth it?

The typical patient might be an "active, mentally acute man with prostate cancer..... twenty-two years after a radical prostatectomy, the man now has extensive disease, including liver metastasis, but continues to enjoy a good quality of life. The man is a strong and eager candidate for a brand-new treatment that could extend his life by several months with relatively few side effects that will allow him to maintain a pleasant existence."

"The treatment is administered in 3 doses-one intravenous infusion approximately every two weeks-at a cost of about $31,000 per infusion, or $93,000 for the full regimen, and yields a 4.1-month median improvement in survival(25.8 months for treated patients vs 21.7 months in controls"

"Balancing the cost to some degree is Provenge's favorable risk profile: The most common complaints are chills, fatigue, fever, back pain, nausea, joint ache, and headache, although more serious respiratory or cardiovascular disorders are possible."

Medicare CMS is likely to issue a decision sometime around early summer 2011. Private insurance will likely respond similarly. The results will certainly be affected by the available dollars allocated for healthcare in this rapidly changing healthcare environment.

Renal and Urology News August 2010 Volume 9, Numer 8

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