The popular drug dutasteride (Avodart, GlaxoSmithKline) may not be a cost-effective way to prevent prostate cancer in men who are at elevated risk of developing the disease, according to findings by a UT Southwestern Medical Center researcher.

Dutasteride, a 5-alpha reductase inhibitor, is indicated for the treatment of benign prostatic hyperplasia, or BPH, it is also widely prescribed for chemoprevention. The drug works by blocking the production of a natural substance that enlarges the prostate. This shrinks the prostate, relieves symptoms of BPH, such as frequent and difficult urination, and decreases the chance that surgery will be needed to treat this condition.

In a study published in the January issue of Cancer Prevention Research, investigators found that the medication, at an annual cost of $1,400, is impractical when compared to the marginal impact on survival and quality of life in at-risk groups.

?Because prostate cancer is the most common cancer in men, the implications of this data are significant since there could be millions of men who would be eligible for anti-cancer drugs,? said Dr. Yair Lotan, associate professor of urology at UT Southwestern. ?Prior to instituting a chemoprevention strategy to a large population, the utility and cost need to be well understood. Whether a medication improves survival, how it affects quality of life, and what its financial implications will be are all critical issues. Because dutasteride typically is prescribed for the lifetime of the patient, and therefore taken daily for decades, the cost issue is particularly relevant.?

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Prior research has shown that dutasteride reduced the relative risk of prostate cancer over a four-year period by 22.8%, but questions have remained about its cost-effectiveness. The current study analyzed the lifetime health-related costs of the drug in patients at greater risk of developing prostate cancer and compared them to other factors, such as quality and length of life.

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Dr. Lotan and his colleague, Dr. Robert Svatek of UT Health Science Center at San Antonio, used a Markov probability model to compare the lifetime cost of taking dutasteride with no therapy. They used data from a previous trial and studies that evaluated outcomes of patients with prostate cancer, including treatment-related complications to create the model. The primary outcome was measured in quality-adjusted life years (QALY), which takes into account both quality and quantity of life.

?The study found that dutasteride was not cost-effective for chemoprevention unless and until a strategy is developed for targeting very high-risk patients and the cost of the drug decreases,? said Dr. Lotan. ?For the average man, the drug provides minimal survival benefits, and the reduction on treatment-related complications does not compensate for the high costs of every man taking the drug for many years.?

While the authors conclude that dutasteride is unlikely to be cost effective when considering the impact on survival differences among treated versus untreated groups, they also note that chemoprevention may be cost effective in high-risk populations when taking into consideration adjustments for the impact on quality of life.

For more information:
Svatek RS, Lotan Y. Cost utility of prostate cancer chemoprevention with dutasteride in men with an elevated prostate specific antigen.Cancer Prev Res (Phila). 2011 Feb;4(2):277-83. Epub 2010 Dec 16.

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