Clinical Policy Title: Prostate-specific antigen screening

Transcription

1 Clinical Policy Title: Prostate-specific antigen screening Clinical Policy Number: Effective Date: May 1, 2017 Initial Review Date: April 19, 2017 Most Recent Review Date: April 19, 2017 Next Review Date: April 2018 Policy contains: Prostate cancer. Prostate-specific antigen. Related policies: CP# CP# Fluorescence spectroscopy for prostate cancer diagnosis Genetic tests for prostate cancer diagnosis ABOUT THIS POLICY: AmeriHealth Caritas Louisiana has developed clinical policies to assist with making coverage determinations. AmeriHealth Caritas Louisiana s clinical policies are based on guidelines from established indu stry sources, such as the Centers for Medicare & Medicaid Services (CMS), state regulatory agencies, the American Medical Association (AMA), medical specialty professional societies, and peerreviewed professional literature. These clinical policies along with other sources, such as plan benefits and state and federal laws and regulatory requirements, including any state- or plan-specific definition of medically necessary, and the specific facts of the particular situation are considered by AmeriHealth Caritas Louisiana when making coverage determinations. In the event of conflict between this clinical policy and plan benefits and/or state or federal laws and/or regulatory requirements, the plan benefits and/or state and federal laws and/or regulatory requirements shall control. AmeriHealth Caritas Louisiana s clinical policies are for informational purposes only and not intended as medical advice or to direct treatment. Physicians and other health care providers are solely responsible for the treatment decisions for their patients. AmeriHealth Caritas Louisiana s clinical policies are reflective of evidence-based medicine at the time of review. As medical science evolves, AmeriHealth Caritas Louisiana will update its clinical policies as necessary. AmeriHealth Caritas Louisiana s clinical policies are not guarantees of payment. Coverage Policy An initial prostate-specific antigen (PSA) test is considered medically necessary for asymptomatic men after discussion of potential risks and benefits of prostate cancer diagnosis and treatment between the patient and provider, and the patient elects screening. Such screening is only considered medically necessary: For average-risk males beginning at age 50 with a life expectancy at least 10 years. For African Americans beginning at age 45. For males with a father or brother diagnosed with prostate cancer at an early age beginning at age 40. Annual follow-up PSA tests are considered medically necessary if the value is greater than or equal to 2.5 ng/ml; biannual tests are considered medically necessary if the value is less than 2.5 ng/ml. 1

2 An annual PSA test is considered medically necessary when used for surveillance after diagnosis and/or treatment of prostate cancer. Limitations: None. Alternative covered services: Cystoscopy or bladder scope test. Digital rectal examination. Prostate ultrasound and biopsy. Background Prostate cancer is the third most commonly diagnosed cancer in the United States and has the highest incidence of any cancer among men. In 2016, an estimated 180,890 cases were diagnosed in the United States, with 26,120 deaths due to the disease. Incidence of prostate cancer has fallen by more than half since the early 1990s, largely due to less screening in men. The mortality rate has also fallen by just over 50 percent. African Americans have a 70 percent greater incidence rate of the disease than non-hispanic whites; Hispanics, Asians, and American Indians have rates well below that of non-hispanic whites (Howlader, 2016). PSA is a protein found in prostate cells. In 1986, the U.S. Food and Drug Administration approved the PSA blood test to monitor the progress of males with prostate cancer and followed in 1994 with approval for a disease screening. PSA is a simple test that costs roughly $40. PSA levels are often elevated in males with prostate cancer, prostatitis, or benign prostatic hyperplasia (BPH). However, men with prostatitis or BPH are not necessarily at higher risk for developing prostate cancer. False positives and false negatives can occur in the test. A level of 4.0 ng/ml or less is considered normal. However, levels below 4.0 can exist in males with prostate cancer, and levels above 4.0 can occur in males without the disease (Thompson, 2004). False positives can lead to unnecessary biopsies with accompanying risks, while false negatives may delay needed treatment. Prostate cancer is largely a disease affecting elderly men, raising the question of whether screening for an often slow-growing disease is needed in males with relatively short expected life spans. Autopsy studies have reported prostate cancer rates in undiagnosed and asymptomatic men between 18.5 and 38.5 percent (Loeb, 2014). The ability of frail elderly to tolerate treatments such as biopsy, surgery, and radiation is also called into question, leaving physicians to weigh risks and benefits of screening. 2

3 The false-positive rate of PSA tests has long been a concern. One early study estimated that 75 percent of men with PSA results over 4 ng/ml did not have prostate cancer after biopsy (Barry, 2001). Even if a positive PSA test results in confirmation of a prostate cancer diagnosis, there is concern about whether or not to treat the disease. Surveillance of relatively small and slow-growing cancers has become more common in recent years, especially after a 2011 conference at the National Institutes of Health (NIH, 2011). One study of 290 men with prostate cancer who met criteria for active surveillance found that 65 percent remained on active surveillance after a median of 2.9 years, prompting authors to conclude that PSA results alone are less effective for monitoring than annual surveillance biopsy (Ross, 2010). Searches AmeriHealth Caritas Louisiana searched PubMed and the databases of: UK National Health Services Centre for Reviews and Dissemination. Agency for Healthcare Research and Quality s National Guideline Clearinghouse and other evidence-based practice centers. The Centers for Medicare & Medicaid Services (CMS). We conducted searches on February 15, Search terms were: prostate specific antigen and mortality. We included: Systematic reviews, which pool results from multiple studies to achieve larger sample sizes and greater precision of effect estimation than in smaller primary studies. Systematic reviews use predetermined transparent methods to minimize bias, effectively treating the review as a scientific endeavor, and are thus rated highest in evidence-grading hierarchies. Guidelines based on systematic reviews. Economic analyses, such as cost-effectiveness, and benefit or utility studies (but not simple cost studies), reporting both costs and outcomes sometimes referred to as efficiency studies which also rank near the top of evidence hierarchies. Findings Numerous studies that showed insufficient evidence to determine if treatment after PSA screening improves outcomes more than treatment after clinical detection caused professional societies to alter their recommendations. The U.S. Preventive Services Task Force (USPSTF) recommended against PSAbased screening for prostate cancer, for all U.S. males, regardless of age (Moyer, 2012). Guidelines from other organizations resemble that of the USPSTF. The American College of Physicians recommends no PSA screening in average-risk men under age 50 or over age 69 or men with a life 3

4 expectancy less than years, and suggests clinicians inform men age of the risks and benefits of screening (Qaseem, 2013). The American Society of Clinical Oncology discourages prostate cancer screening in males with a life expectancy under 10 years and recommends patients with a life expectancy over 10 years to discuss risks and benefits with physicians (Nam, 2013). The American Cancer Society recommendation is the same for men with life expectancy over 10 years, stipulating that those at average risk begin discussions at age 50 (Brooks, 2010), and those at high risk (from family history or being African American) receive this information at an earlier age (Wolf, 2010). The American Urological Association (AUA) statement supports men first being informed of PSA screening risks and benefits, with routine screening not recommended for average-risk males age 40 to 54. For men under 55 who are African-American or have a family history of the disease, decisions to test should be individualized as should decisions for all men ages The AUA does not recommend PSA screening in men over age 70 or men with less than a year life expectancy (Greene, 2009). One review of the literature assessed whether separate screening guidelines were needed for African- American men. Authors who point out that studies often include small numbers of African Americans concluded separate guidelines were needed, due to elevated incidence and mortality rates, clinical course of the disease, genetic differences, and social barriers (Shenoy, 2016). Studies of PSA screening effectiveness typically focus on reductions in prostate cancer-specific and allcause mortality. Some studies address overdiagnosis of the disease leading to unneeded therapy. An estimate of overdiagnosis 22 percent and 33 percent of screen-detected cases for white and black Americans (Telesca, 2008) was matched (23, 28, and 42 percent) by estimates using three models (Draisma, 2009). A consensus has formed supporting clinician-patient discussion of the pros and cons of PSA screening, and only performing the test for those men who express a preference for it (Hayes, 2014). In addition, a risk-based approach on decisions to perform the test has been suggested (Zhu, 2011). One search of five systematic reviews and six randomized controlled trials (RCTs) failed to show a significant reduction in prostate cancer mortality or overall mortality with PSA-based screening (Pron, 2015). Two studies have played a major influence in professional opinion on PSA screening. One was the prostate component of the Prostate, Lung, Colorectal, and Ovarian Cancer Screening Trial. A total of 76,685 American men ages were either given an annual PSA screening for six years and an annual digital rectal examination (DRE) for four years, or not screened. After 13 years, prostate cancer deaths per 10,000 person years were 3.7 and 3.4 for the screening and control groups (Andriole, 2012). All-cause mortality in the screening group was a (non-significant) 3 percent lower than controls (Andriole, 2010). 4

5 The other large-scale study (European Randomized Screening for Prostate Cancer) consisted of 162,388 European men ages 50 74, who were offered PSA every four years, which 82 percent accepted, or no PSA (control). After nine years median follow-up, incidence of prostate cancer was higher (8.2 percent versus 4.8 percent), and prostate cancer mortality was 20 percent lower for the intervention group (Schroeder, 2009). All cause mortality was 1 percent lower for the screening group (18.2 versus 18.5 deaths per 1000 person-years a non-significant difference (Schroeder, 2012). In a study of 19,904 men ages in Goteborg, Sweden, half were given the opportunity for a PSA test every two years, and screening was not discussed with the other half. After 14 years, the incidence was higher in the screening group (12.7 percent versus 8.2 percent). Forty-four percent fewer prostate cancer deaths occurred in the screening group, but non-prostate cancer death rates were higher in the screening group (9.6 versus 7.5 percent). The number of men invited to be screened needed to prevent one prostate cancer death was calculated to be 293 (Hugosson, 2010). A systematic review and meta-analysis of five RCTs and 341,342 participants that updated 2006 and 2010 Cochrane reviews found that only the European study showed a significantly lower risk of prostate cancer deaths due to screening. Diagnosed prostate cancer cases were significantly (30 percent) greater in screening groups, and all-cause mortality was equal in both screening and control groups. Harm from overtreatment after screening included infection, blood loss requiring transfusion, pneumonia, erectile dysfunction, incontinence, bleeding, bruising, and short-term anxiety (Ilic, 2013). A systematic review of seven RCTs with 571,594 participants found screening had no significant effect on prostate cancer and all-cause mortality (12 percent and 10 percent lower), even though screening detected 81 percent more localized prostate cancers (Lumen, 2011). A systematic review and meta-analysis of six RCTs with 387,286 participants found a 46 percent higher probability of diagnosing prostate cancer in the screening group, with no significant effect of death from prostate cancer and all causes (12 percent and 1 percent lower) in the screening groups. The authors conclude that routine screening is not supported (Djulbegivic, 2010). A systematic review of six RCTs found prostate cancer and all-cause mortality were not significantly reduced (7 percent and 1 percent lower) for the screening group, but detection of prostate cancer was significantly (45 percent) higher (Lee, 2013). Prostate cancer screening was included in a systematic review of six diseases for which screening evaluation is available from the U.S. Preventive Services Task Force. The research team from Stanford University School of Medicine concluded that for all available screening for high-mortality disease, reductions in disease-specific mortality are uncommon, and reductions in all-cause mortality are very rare or non-existent (Saquib, 2015). A cost effectiveness analysis of PSA screening found that, compared to outcomes for a screened 40 year old man, the incremental cost from screening men ages every four years was $36,300 per life year gained, a figure that rose to $588,300 per life year gained for screening men ages every two 5

6 years. However, these figures were based on the large European study, the only large review that found significant reductions in prostate cancer mortality from PSA screening (Pataky, 2014). Policy updates: None. Summary of clinical evidence: Citation Pataky, 2014 Cost-effectiveness of PSA prostate cancer screening Ilic, 2013 Review of PSA screening ability to reduce prostate cancer and all-cause mortality Andriole, 2012 PSA screening ability to reduce prostate cancer mortality Schroeder, 2012 Follow up study on effect of PSA screening on prostate cancer mortality Schroeder, 2009 Content, Methods, Recommendations Key points: A modeling of cost-benefit in British Columbia, based on results from the European Study of Randomized Screening for Prostate Cancer. The incremental cost-effectiveness of regular screening ranged from $36,300 per life year gained (screening every four years) to $588,300 (screening every two years). Key points: Cochrane review of five RCTs with 341,342 participants. Screened group s prostate cancer mortality equal to controls (RR = 1.00). Screened group s all-cause mortality equal to controls (RR = 1.00). European Randomized Study of Screening for Prostate Cancer was only study to find significant reductions in prostate cancer for screened groups. Localized prostate cancer 79% more commonly diagnosed in screening group; advanced prostate cancer 20% more likely to be diagnosed in controls. Key points: Prostate component of Prostate, Lung, Colorectal, and Ovarian Cancer Screening Trial. 76,685 U.S. men ages 55 74, 10 centers, randomized to screening group (annual PSA for six years, annual DRE for four years) and controls (some opportunistic screening). After 13 years, screening group had 12% higher chance of prostate cancer diagnosis. Prostate cancer mortality higher for screening group versus controls (3.7 versus 3.4 deaths per 10,000 person-years) difference not significant. Key points: Large European study of 162,388 men ages in screening and controlled groups. After median follow-up of 11 years, 21% reduction in prostate cancer deaths in screening groups. 1,055 men would need to be screened to prevent one death from prostate cancer. Key points: Study on effect of PSA screening on prostate cancer mortality Study of 162,243 European men ages 55 69, randomly assigned to a group offered PSA every four years versus a group who was not. In the screening group, 82% accepted at least one offer of screening. After a median follow-up of nine years, incidence of prostate cancer higher in screening group (8.2% vs. 4.8%). 6

7 Citation Content, Methods, Recommendations Prostate cancer mortality 20% lower in screening group (significant, p <.04). References Professional society guidelines/other: Barry MJ. Clinical practice. Prostate-specific-antigen testing for early diagnosis of prostate. N Engl J Med. 2001;344(18): Brooks DD, Wolf AM, Smith RA, Dash C, Guessous I. Prostate cancer screening 2010: updated recommendations from the American Cancer Society. J Natl Med Assoc.2010;102(5): Greene KL, Albertsen PC, Babaian RJ, et al. Prostate specific antigen best practice statement: 2009 update. J Urol. 2009;182(5): Howlader N, Noone AM, Krapcho M, et al (eds.). SEER Cancer Statistics Review, , National Cancer Institute (NCI). April, Bethesda MD: NCI. Accessed February 15, Moyer VA, U.S. Preventive Services Task Force. Screening for Prostate Cancer: U.S. Preventive Services Task Force recommendation statement. Ann Intern Med. 2012;157(2): Muhlem E, Fulbright N, Duncan N. Prostate cancer screening. American Family Physician, October 15, American Academy of Family Physicians. Leawood KS: American Academy of Family Physicians. Accessed February 14, Nam RK, Oliver TK, Vickers AJ, et al. Prostate-specific antigen test for prostate cancer screening: American Society of Clinical Oncology provisional clinical opinion. J Oncol Pract. 2012;8(5): National Institutes of Health (NIH). NIH State-of-the-cience Conference: Role of Active Surveillance in the Management of Men with Localized Prostate Cancer. Bethesda MD: NIH. December 5-7, Accessed February 15, Qaseem A, Barry MJ, Denberg TD, Owens DK, Shekelle P, for the Clinical Guidelines Committee of the American College of Physicians. Screening for prostate cancer: a guidance statement from the Clinical Guidelines Committee of the American College of Physicians. Ann Int Med. 2013;158(10): Wolf AM, Wender RC, Etzioni RB, et al. American Cancer Society guideline for the early detection of prostate cancer: update CA Cancer J Clin. 2010;60(2):

8 Zhu X, Albertsen PC, Andriole GL, Roobol MJ, Schroder FH, Vickers AJ. Risk-based prostate cancer screening. Eur Urol. 2012;61(4): Peer-reviewed references: Andriole GL. Screening for prostate cancer. BMJ. 2010;341(1):c Andriole GL, Crawford ED, Grubb RL, et al. Prostate cancer screening in the randomized Prostate, Lung, Colorectal, and Ovarian Cancer Screening Trial: mortality results after 13 years of follow-up. J Natl Cancer Inst. 2012;104(2): Barry MJ, Albertsen PC, Bagshaw MA, et al. Outcomes for men with clinically nonmetastatic prostate carcinoma managed with radical prostatectomy, external beam radiotherapy, or expectant management: a retrospective analysis. Cancer. 2001;91(12): Djulbegovic M, Beyth RJ, Neuberger MM, et al. Screening for prostate cancer: systematic review and meta-analysis of randomized controlled trials. BMJ (Online). 2010;341(7773): Draisma G, Etzioni R, Tsodikov A, et al. Lead time and overdiagnosis in prostate-specific antigen screening: importance of methods and context. J Natl Cancer Inst. 2009;101: Hayes JH, Barry MJ. Screening for prostate cancer with the prostate-specific antigen test: a review of current evidence. JAMA. 2014;311(11): Hugosson J, Carlsson S, Aus G, et al. Mortality results from the Goteborg randomized prostate cancer screening trial. Lancet Oncol. 2010;11(8): Ilic D, Neuberger MM, Djulbegovic M, Dahm P. Screening for prostate cancer. Cochrane Database Syst Rev. 2013;(1):CD Lee YJ, Park JE, Jeon BR, Lee SM, Kim SY, Lee YK. Is prostate-specific antigen effective for population screening of prostate cancer? A systematic review. Ann Lab Med. 2013;33(4): Loeb S, Bjurlin MA, Nicholson J, et al. Overdiagnosis and overtreatment of prostate cancer. Eur Urol. 2014;65(6): Lumen N, Fonteyne V, de MG, et al. Population screening for prostate cancer: an overview of available studies and meta-analysis. Int J. Urol. 2012;19(2): Pataky R, Gulati R, Etzioni R, et al. Is prostate cancer screening cost-effective? A microsimulation model of prostate-specific antigen-based screening for British Columbia, Canada. Int J Cancer. 2014;135(4):

9 Pron G. Prostate-specific antigen (PSA)-based population screening for prostate cancer: an evidencebased analysis. Ont Health Technol Assess Ser. 2015;15(10):1 64. Ross AE, Loeb S, Landis P, et al. Prostate-specific antigen kinetics during follow-up are an unreliable trigger for intervention in a prostate cancer surveillance program. J Clin Oncol. 2010;28(17): Saquib N, Sabuib J, Ioannidis JP. Does screening for disease save lives in asymptomatic adults? Systematic review of meta-analyses and randomized trials. Int J Epidemiol. 2015;44(1): Schroeder FH, Hugosson J, Roobol MJ, et al. Screening and prostate-cancer mortality in a randomized European study. N Eng J Med. 2009;360(13): Scroeder FH, Hugosson J, Roobol MJ, et al. Prostate-cancer mortality at 11 years of follow-up. N Engl J Med. 2012;366(11): Shenoy D, Packianathan S, Chen AM, Vijayakumar S. Do African-American men need separate prostate cancer screening guidelines? BMC Urol. 2016;16(1):19. Thompson IM, Pauler DK, Goodman PJ, et al. Prevalence of prostate cancer among men with a prostatespecific antigen level &It; or =4.0 ng per milliliter. N Engl J Med. 2004;350(22): CMS National Coverage Determinations (NCDs): Prostate cancer screening tests (210.1). CMS website: KeyWord=prostate+cancer+screening&KeyWordLookUp=Title&KeyWordSearchType=And&bc=gAAAACA AAAAAAA%3d%3d&. Accessed February 17, Local Coverage Determinations (LCDs): No LCDs identified as of the writing of this policy. Commonly submitted codes Below are the most commonly submitted codes for the service(s)/item(s) subject to this policy. This is not an exhaustive list of codes. Providers are expected to consult the appropriate coding manuals and bill accordingly. CPT Code Description Comments Prostate specific antigen (PSA); complexed (direct measurement) 9

10 84153 Prostate specific antigen (PSA); total Prostate specific antigen (PSA); free ICD-10 Code Description Comments C61 Malignant neoplasm prostate Z12.5 Screening for malignant neoplasm, prostate HCPCS Level II Code N/A Description Comments 10