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Impact of adoption of a decision algorithm including PCA3 for repeat biopsy on the costs for prostate cancer diagnosis in France, "Beyond the Abstract," by Bernard Malavaud, MD, PhD

BERKELEY, CA (UroToday.com) - This retrospective budget impact study applied 2 RAM (RAND Appropriateness Method) models, without and with PCA3 (Prostate CAncer gene 3),[1] to a sample of 808 French men who had a prostate biopsy in 2010. It aimed to estimate, in a real-life cohort, the costs that the French healthcare system would incur if the PROGENSA® PCA3 Assay would be introduced in the decision-making process for indicating a prostate biopsy. Briefly, the results show that adopting PCA3 testing into the current diagnostic practice in France would reduce the number of repeat prostate biopsies and the costs associated with prostate biopsy.

The PROGENSA® PCA3 Assay is available as a CE-mark in Europe since November 2006 and was been approved by the FDA in the US in 2012 for guiding repeat biopsy decisions. The guidelines of the European Association of Urology also recommend PCA3 for repeat biopsy decisions. PCA3 has the ability to detect and quantify PCA3 mRNA in urine samples. Its development was based on the finding that PCA3 mRNA has a much higher expression in malignant (i.e. tumour or metastatic) than in benign and normal prostate tissue. Therefore, it was believed that PCA3 might act as a marker for prostate cancer (PCa). Since then several large, multicentre, prospective studies have shown that the PROGENSA® PCA3 Assay may aid in guiding initial and repeat prostate biopsy decisions and in differentiating clinically significant from insignificant (indolent) PCa.[2,3,4,5,6,7,8,9,10]

In the present study, the budget impact model was constructed by applying 2 RAM models to a cohort of 808 French men undergoing prostate biopsy. The RAM models included recommendations on the appropriateness of prostate biopsy for a set of hypothetical patient profiles with different clinical variables, which were developed by a panel of 12 European urologists.[1] The variables included life expectancy, DRE outcome, PSA, prostate volume, and number of prior biopsies. One model also included the PCA3 score while the other model did not.

For 698 men in the cohort, information was available for all clinical variables that were used in the RAM models and these were included in the analyses. When the model without the PCA3 Score was used, 2% of biopsies were judged inappropriate. However, when PCA3 was included in the model 9% of biopsies were considered inappropriate. This difference was mainly attributable to the impact of the PCA3 score on repeat biopsy decisions. A repeat biopsy was judged inappropriate in 5% of men when the model without PCA3 was used and in 37% of men when the model with PCA3 was used. In other words, when introducing systematic PCA3 testing in the decision-making process for repeat biopsy, 37% of unnecessary repeat biopsies could be avoided according to the recommendations of the RAM model.

But does this reduction in number of repeat biopsies actually reduce costs? The budget impact model included the number of biopsies performed in France (N=225 000, with 78% being initial biopsies), the mean cost of biopsy (800 Euro), the mean cost of the PROGENSA® PCA3 Assay (300 Euro) and the mean cost of biopsy-related complications. Three scenarios were taken into consideration for biopsy-related complications:

1) no costs,
2) costs estimated at 100 Euro, and
3) costs comparable to that estimated in the U.S.: 280 Euro.

The results showed that should systematic PCA3 testing be introduced to guide repeat biopsy-decisions in the first scenario, it would be budget-neutral compared to current clinical practice. The additional costs for PCA3 testing would be neutralized by a reduction in costs for biopsy. It should be noted that the assumption that there are no costs for biopsy-related complications is very unlikely as studies have shown that about 17% of prostate biopsies are associated with at least one complication and that 4% of men with a negative biopsy are hospitalised because of associated complications.[11,12] If the costs for managing complications were estimated at 100 and 280 Euro, which are more realistic figures, PCA3 testing would reduce the total costs by 1.7 million Euro and 5 million Euro, respectively. The additional costs for PCA3 testing would be less than the reduction in costs for biopsy and managing associated complications.

Adopting the PROGENSA® PCA3 Assay into diagnostic practice thus seems to reduce costs, as unnecessary repeat biopsies will be avoided. Moreover, this may also reduce the anxiety, discomfort, and pain generally associated with prostate biopsy, as well as biopsy-related complications, including hospitalization and urosepsis.[11,13,12,14,15]

It can be concluded that introducing systematic PCA3 testing (PROGENSA® PCA3 Assay) to guide repeat biopsy decisions into the daily clinical practice in France seems to reduce the number of unnecessary biopsies and reduce costs incurred by the health care system. Further randomized, prospective trials are needed to confirm these promising findings.

References:

  1. Tombal B, Ameye F, de la Taille A et al. Biopsy and treatment decisions in the initial management of prostate cancer and the role of PCA3; a systematic analysis of expert opinion. World J Urol 2012;30:251-6.
  2. Marks LS, Fradet Y, Deras IL et al. PCA3 molecular urine assay for prostate cancer in men undergoing repeat biopsy. Urology 2007;69:532-5.
  3. Haese A, de la Taille A, Van Poppel H et al. Clinical utility of the PCA3 urine assay in European men scheduled for repeat biopsy. Eur Urol 2008;54:1081-8.
  4. Deras IL, Aubin SM, Blase A et al. PCA3: a molecular urine assay for predicting prostate biopsy outcome. J Urol 2008;179:1587-92.
  5. Nakanishi H, Groskopf J, Fritsche HA et al. PCA3 molecular urine assay correlates with prostate cancer tumor volume: implication in selecting candidates for active surveillance. J Urol 2008;179:1804-9.
  6. Whitman EJ, Groskopf J, Ali A et al. PCA3 score before radical prostatectomy predicts extracapsular extension and tumor volume. J Urol 2008;180:1975-8.
  7. Aubin SMJ, Reid J, Sarno MJ et al. PCA3 molecular urine test for predicting repeat prostate biopsy outcome in populations at risk: validation in the placebo arm of the dutasteride REDUCE trial. J Urol 2010;184:1947-52.
  8. Ploussard G, Durand X, Xylinas E et al. Prostate cancer antigen 3 score accurately predicts tumour volume and might help in selecting prostate cancer patients for active surveillance. Eur Urol 2011;59:422-9.
  9. de la Taille A, Irani J, Graefen M et al. Clinical evaluation of the PCA3 assay in guiding initial biopsy decisions. J Urol 2011;185:2119-25.
  10. Gittelman M, Hertzman B, Bailen J et al. PROGENSA®PCA3 molecular urine test as a predictor of repeat prostate biopsy outcome in men with previous negative biopsies: a prospective multicenter clinical study. J Urol 2013;doi:10.1016/j.juro.2013.02.018:
  11. Nam RK, Saskin R, Lee Y et al. Increasing hospital admission rates for urological complications after transrectal ultrasound guided prostate biopsy. J Urol 2010;183:963-8.
  12. Roberts RO, Bergstralh EJ, Besse JA, Lieber MM, Jacobsen SJ. Trends and risk factors for prostate biopsy complications in the pre-PSA and PSA eras, 1980 to 1997. Urology 2002;59:79-84.
  13. Nickel JC, Furuta A, Chancellor MB et al. Best of the AUA Annual Meeting. Highlights from the 2010 American Urological Association Meeting, May 29-June 3, 2010, San Francisco, CA. Rev Urol 2010;12:e134-e146.
  14. Seitz C, Palermo S, Djavan B. Prostate biopsy. Minerva Urol Nefrol 2003;55:205-18.
  15. Autorino R, De Sio M, Di Lorenzo G et al. How to decrease pain during transrectal ultrasound guided prostate biopsy: a look at the literature. J Urol 2005;174:2091-7.

 

Written by:
Bernard Malavaud, MD, PhD as part of Beyond the Abstract on UroToday.com. This initiative offers a method of publishing for the professional urology community. Authors are given an opportunity to expand on the circumstances, limitations etc... of their research by referencing the published abstract.

CHU de Toulouse, Hopital de Rangueil, 1, avenue Jean-Poulhes, TSA 50032, 31059 Toulouse Cedex 9, France.

Impact of adoption of a decision algorithm including PCA3 for repeat biopsy on the costs for prostate cancer diagnosis in France - Abstract

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