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

Abstract

Objective:

A recent expert study (RAND Appropriateness Method (RAM)) including a panel of 12 European urologists reported that the PCA3 score may be instrumental in taking appropriate prostate biopsy (PBx) decisions, mainly for repeat PBx. This study determined the cost/benefit balance of introducing PCA3 in the decision-making for PBx in France.

Methods:

Two RAM models, without and with PCA3, were retrospectively applied to a sample of 808 French men who had PBx in 2010 (78% first, 22% repeat). Outcome measures included the proportion of PBx that could have been avoided (i.e., judged inappropriate) in the French sample according to both RAM models, and the estimated impact of application of these models on the annual number of PBx and associated costs for France (based on most recent published data).

Results:

Complete profiles were available for 698 men. In the model without PCA3, 2% of PBx were deemed inappropriate. Knowledge of PCA3 would have avoided another 7% of PBx. Repeat PBx would have been avoided in 5% of cases without PCA3 and in 37% with PCA3. For France, application of the RAM model including PCA3 would result in 18,345 fewer repeat PBx. It would be budget-neutral in the unlikely hypothesis of no complications or no costs incurred by complications and would save €1.7 million for a mean cost for complications of €100/procedure or €5 million for a mean cost for complications of €280/procedure, calculated based on US and Canadian data.

Limitations:

Limitations of the study are the theoretical nature of the analysis and the fact that PCA3 distributions had to be derived from other sources.

Conclusions:

Adoption of RAM expert recommendations including PCA3 for repeat PBx decisions in clinical practice in France would reduce the number of repeat PBx and control costs.

Keywords::

• Prostate biopsy
• Diagnosis
• France
• PCA3
• Prostate cancer
• Costs

Transparency

Declaration of funding

Gen-Probe Inc funded the study and manuscript writing but did not participate in data acquisition, analysis, interpretation, and preparation of the manuscript.

Declaration of financial/other relationships

Louis Smets and Herman Stoevelaar received financial support from Gen-Probe for elaboration of the study design and data analysis. Bernard Malavaud, Olivier Cussenot, Nicolas Mottet, François Rozet, and Alain Ruffion have no conflicts of interest. JME Peer Reviewers on this manuscript have no relevant financial relationships to disclose.

Acknowledgments

The authors are grateful to Ismar Healthcare for their assistance in the design of the study, the analysis of the data, and the writing of the manuscript.