Controversy over the lack of a survival benefit associated with early diagnosis of prostate cancer through prostate-specific antigen (PSA) screening has led to uncertainty in the determination of PSA coverage and its place in payer oncology strategies. We explore the intricacies of using PSA screening and urge influential stakeholders to clarify how screening can be more usefully applied to cost-effectively support the diagnosis and management of prostate cancer in the large population of men over 50 years of age.
In 2012, the US Preventive Services Task Force (USPSTF) recommended that prostate-specific antigen (PSA) levels no longer be used as a means of screening for prostate cancer, determining that a PSA-based diagnosis exposed many patients to the harms of treatment of a disease that may have remained asymptomatic throughout their lives.1 The decision was based largely on results from the Prostate, Lung, Colorectal, and Ovarian (PLCO) Cancer Screening Trial, which found that, despite identifying more prostate cancer cases, annual screening (using PSA testing or digital rectal examination) did not result in a statistically significant 10-year survival benefit versus not screening.2 Based on its assessment, the USPSTF determined that the benefits of PSA screening did not outweigh the harms of screening and treatment, which can include erectile dysfunction and urinary incontinence.1
Not surprisingly, the USPSTF recommendations have been associated with a marked drop in PSA screening. One study using National Health Interview Survey data found that 31% of men over the age of 50 years surveyed in 2013 reported having a PSA test in the prior year, down from 38% in 2010 and 41% in 2008.3 The same analysis found a corresponding decrease in new diagnoses of prostate cancer in men over the age of 50 years, from 540.8 cases per 100,000 in 2008 to 416.2 per 100,000 in 2012.3 Data from the Surveillance, Epidemiology and End Results (SEER) program also reported a decline of early stage disease diagnosis during the period of 2012-2013.4 If the scientific foundation of the policy change is sound, the USPSTF recommendations would appear to have reduced costs, spared patient morbidity, and improved the overall value to the health care system while not negatively affecting mortality.
This may not be the whole story, however. Data through 2015 indicate that declining PSA screening may have negative implications. A study utilizing the National Cancer Database found that the annual incidence of metastatic prostate cancer had risen by 72% between 2004 and 2013; the authors noted the incidence may be due in part to, though not completely explained by, the USPSTF recommendations.5 SEER data did not detect a difference in incidence of distant disease between 2012 and 2013.4 Opinion leaders have begun to criticize the PLCO study cited in the USPSTF recommendations. A commentary in the Journal of Clinical Oncology argued that a significant portion of the “unscreened” population in the PLCO study had actually been screened for PSA previously, thereby skewing the results.6
Payers rely on these guidelines and other recommendations from respected bodies in order to inform coverage decisions. Definitive recommendations can have a broad-ranging impact on coverage, such as the Centers for Medicare and Medicaid Services (CMS) National Coverage Determination regarding treatment with erythropoiesis-stimulating agents and the recognition of the National Comprehensive Cancer Network Drugs & Biologics Compendium (NCCN Compendium®) regarding CMS coverage determinations.7,8 Payers have been known to follow USPSTF recommendations and/or CMS guidance when developing coverage policy for both government and commercial books of business. The state of coverage for PSA screening is not entirely clear, but, as of 2016, Medicare still covers an annual PSA test in men over 50 years of age.9
For payers, the implications of getting PSA screening “wrong” are significant. A PSA screening test and associated office visit are generally inexpensive; however, they become more expensive when considering that more than 40 million men are 50 years of age or older.10 Broad PSA testing would also cause payers to incur costs associated with treatment of the additional prostate cancer diagnoses. If the PLCO study is accurate, the added costs would not have an effect on patient life expectancy; but the cost to manage patients with metastatic prostate cancer is a major cause for concern. Patients dying of prostate cancer incur costs in the last year of life that are far greater than patients with less advanced disease.11 These intricacies mean that payers may struggle at either extreme of the PSA testing discussion and that a more nuanced approach may be beneficial.
Oncology has benefited from a value-based approach. Drugs to treat cancer are increasingly moving away from the nonspecific nature of traditional chemotherapy to targeted therapies leveraging the use of biomarkers. Oncology value tools assist providers in choosing the most efficacious and cost-effective therapies for a variety of cancer types. The same value approach is needed for PSA testing. Decision-making bodies should leverage the wealth of epidemiological data to determine what factors place a man most at risk of developing prostate cancer. Risk factors can then be blended with outcomes data to determine which specific populations would benefit most from PSA screening, so that high-risk patients can be identified at an early stage, before the disease becomes metastatic. A value-based approach to PSA screening may be more efficient compared with a broad screening approach and may also mitigate the increase of metastatic disease thought to be associated with a narrow screening strategy. A value-based approach would also maximize cost-effective care by allowing payers to allocate greater resources toward broad access to therapies for metastatic disease.
References
1. Moyer VA; US Preventive Services Task Force. Screening for prostate cancer: US preventive services task force recommendation statement. Ann Intern Med. 2012;157(2):120-134.
2. Andriole GL, Crawford ED, Grubb RL 3rd, et al; for the PLCO Project Team. Mortality results from a randomized prostate-cancer screening trial. N Engl J Med. 2009;360(13):1310-1319.
3. Cristol H. Prostate cancer screening detection and decline. American Cancer Society web site. https://www.cancer.org/research/acsresearchupdates/prostatecancer/prostate-cancer-screening-and-detection-decline. Published December 2, 2015. Accessed July 27, 2016.
4. Jemal A, Ma J, Siegel R, et al. Prostate Cancer Incidence Rates 2 Years After the US Preventive Services Task Force Recommendations Against Screening. [published online August 18, 2016]. JAMA Oncol. 2016. doi:10.1001/jamaoncol.2016.2667.
5. Weiner, AB, Matulewicz RS, Eggener SE, Schaeffer EM. Increasing incidence of metastatic prostate cancer in the United States (2004-2013) [published online July 19, 2016]. Prostate Cancer Prostatic Dis. 2016. doi:10.1038/pcan.2016.30.
6. Shoag JE, Schlegel PN, Hu JC. Prostate-specific antigen screening: time to change the dominant forces on the pendulum [published online July 18, 2016]. J Clin Oncol. 2016. doi:10.1200/JCP.2016.67.8938.
7. Centers for Medicare & Medicaid Services. Decision memo for erythropoiesis stimulating agents (ESAs) for non-renal disease indications (CAG-00383N). https://www.cms.gov/medicare-coverage-database/details/nca-decision-memo.aspx?NCAId=203&ver=12&NcaName=Erythropoiesis+Stimulating+Agents+&bc=BEAAAAAAIAAA. Published July 30, 2007. Accessed July 27, 2016.
8. McGivney WT. Medicare recognizes NCCN Compendium. J Natl Compr Cancer Netw. 2008;6(7):635.
9. Centers for Medicare & Medicaid Services. Prostate cancer screenings. https://www.medicare.gov/coverage/prostate-cancer-screenings.html. Accessed July 27, 2016.
10. Central Intelligence Agency. The world factbook—United States. https://www.cia.gov/library/publications/the-world-factbook/geos/us.html. Accessed July 27, 2015.
11. Mariotto AB, Yabroff KR, Shao Y. Projections of the cost of cancer care in the United States: 2010-2020. J Natl Cancer Inst. 2011;103:117-128. Erratum in: J Natl Cancer Inst 2011;103:699.
