Medical Policy: 02.04.25
Original Effective Date: October 2009
Reviewed: June 2017
Revised: June 2017
Benefit determinations are based on the applicable contract language in effect at the time the services were rendered. Exclusions, limitations or exceptions may apply. Benefits may vary based on contract, and individual member benefits must be verified. Wellmark determines medical necessity only if the benefit exists and no contract exclusions are applicable. This medical policy may not apply to FEP. Benefits are determined by the Federal Employee Program.
This Medical Policy document describes the status of medical technology at the time the document was developed. Since that time, new technology may have emerged or new medical literature may have been published. This Medical Policy will be reviewed regularly and be updated as scientific and medical literature becomes available.
Prostate cancer is the most commonly diagnosed cancer and the second leading cause of cancer deaths in American geno typical men. In 2017, it is estimated that 161,360 geno typical men will be diagnosed with prostate cancer and 26,730 will die of this disease. During the same period, nearly 20 million geno typical men in the United States will be confronted with important decisions regarding early detection for prostate cancer. Geno typical men in the United States have about one chance in 7 of eventually being diagnosed with this malignancy and about one chance in 30 of eventually dying of it.
The primary goal of prostate cancer screening is to reduce deaths due to prostate cancer, therefore, increasing length of life. An additional important outcome would be a reduction in the development of symptomatic metastatic disease. Screening asymptomatic geno typical men for prostate cancer has become a widespread practice in the United States. Test procedures used for prostate cancer screening include digital rectal examination (DRE) and serum prostate specific antigen (PSA).
Many experts continue to recommend DRE for screening, as some clinically significant cancers may potentially be missed using serum PSA cut-point alone. Studies have consistently shown that prostate cancer cases detected through PSA testing are more often confined to the prostate than those detected solely by DRE. Currently, 81% of prostate cancers are pathologically organ-confined at time of diagnosis.
The value of DRE as a stand-alone test for prostate detection is limited, even though DRE picks up some cases of advanced cancer that would otherwise be missed. DRE is recommended to be used as a complementary test with serum PSA in asymptomatic geno typical men who had a risk/benefit discussion and decided to pursue screening for prostate cancer. Those individuals with a very suspicious DRE should be considered for biopsy referral regardless of PSA results, because it may identify high-grade cancers in such situations. DRE should be considered in all geno typical men with an abnormal serum PSA to aid in decisions regarding biopsy.
Although PSA was originally introduced as a tumor marker to detect cancer recurrence or disease progression following treatment, it became widely adopted for cancer screening. PSA is a glycoprotein produced by the prostate epithelial cells. PSA levels may be elevated in geno typical men with prostate cancer because PSA production is increased and because tissue barriers between the prostate gland lumen and the capillary are disrupted, releasing more PSA into the serum. Elevations of serum PSA may also be associated with other prostatic diseases including benign prostatic hypertrophy (BPH) which is a major clinical problem with PSA screening. It is recommended that the interpretation of PSA values should always take into account age, the presence of urinary tract infection or prostate disease, recent diagnostic procedures and prostate directed treatments.
Prostate cancer screening has been a controversial issue. There is evidence that PSA based screening leads to substantial overdiagnosis of prostate tumors and there is a high incidence for physicians and patients to elect to treat most cases of screen detected cancer, given the current inability to distinguish tumors that will remain indolent from those destined to be lethal. Thus, many geno typical men are being subjected to the harms of treatment of prostate cancer that will never become symptomatic. Even for geno typical men whose screen-detected cancer would otherwise have been later identified without screening, most experience the same outcome and are, therefore, subjected to the harms of treatment for much longer period. There is convincing evidence that PSA based screening for prostate cancer results in considerable overtreatment and its associated harms.
Prostate cancer risk calculators have been developed to estimate an individual’s risk for prostate cancer from multiple factors. Common calculators are the Sunnybrook, ERSPC, and PCPT based risk calculators. These online tools combine clinical variables including but not limited to age, family history, race, DRE and PSA, to estimate both the risk for biopsy detectable prostate cancer and the risk for biopsy detectable high grade prostate cancer. Such information potentially allows for more informed decision-making. However, such calculators have not been assessed in RCTs, and cut-points of risk associated with reductions in prostate cancer mortality remain unknown. Such calculators have as much value in determining who might not need biopsy as in identifying those at higher risk. The use of risk calculators alone to determine whether a biopsy is indicated is not recommended.
Even though some guidelines (i.e. USPSTF) discourage the use of screening tests for which the benefits do not outweigh the harms in the target population, they do recognize the common use of PSA screening in practice today and that some physicians will continue to offer it. The decision to initiate or continue PSA screening should reflect an understanding of the possible benefits and harms and respect the patient’s preferences. Physicians should not offer or order PSA screening unless they are prepared to engage in shared decision making that enables an informed choice by the patient. Similarly, patients requesting PSA screening should be provided with the opportunity to make informed choices to be screened that reflect their values about specific benefits and harms.
Serum total PSA was the only PSA based test available in early detection programs for prostate cancer. Since then, several PSA derivatives have been developed and proposed to improve the performance of the PSA measurement, thus possibly increasing specificity and decreasing unnecessary biopsies. These PSA derivatives include:
Professional Society guidelines recognize the common use of PSA screening in practice today and understand that some geno typical men will continue to request screening and some physicians will continue to offer it. The decision to initiate or continue PSA screening should reflect an explicit understanding of the possible benefits and harms and respect patients’ preferences. Physicians should not offer or order PSA screening unless they are prepared to engage in shared decision making that enables an informed choice by patients. Similarly, patients requesting PSA screening should be provided with the opportunity to make informed choices to be screened that reflect their values about specific benefits and harms. The primary goal of PSA based screening is to find men from whom treatment would reduce morbidity and mortality.
In 2012, The USPSTF published recommendations for prostate cancer screening that recommends against prostate specific antigen (PSA) based screening for prostate cancer. The USPSTF assigned a Grade D recommendation to this statement since there is moderate or high certainty that the service has no net benefit or that harms outweigh the benefits.
Although the USPSTF discourages the use of screening tests for which the benefits do not outweigh the harms in the target population, it recognizes the common use of PSA screening in practice today and understands that some men will continue to request screening and some physicians will continue to offer it. The decision to initiate or continue PSA screening should reflect an explicit understanding of the possible benefits and harms and respect the patients’ preferences. Physicians should not offer or order PSA screening unless they are prepared to engage in shared decision making that enables an informed choice by the patients. Similarly, patients requesting PSA screening should be provided with the opportunity to make informed choices to be screened that reflect their values about specific benefits and harms.
In 2013, the American Urological Association (AUA) published guidelines for the early detection of prostate cancer:
The Panel recommends against PSA screening men under age 40 years. (Recommendation; Evidence Strength Grade C). In this age group there is a low prevalence of clinically detectable prostate cancer, no evidence demonstrating benefit of screening and likely the same harms of screening as in other age groups.
The Panel does not recommend routine screening in me between ages 40 to 54 years at average risk. (Recommendation; Evidence Strength Grade C). For men younger than age 55 years at higher risk (e.g. positive family history or African American race), decisions regarding prostate cancer screening should be individualized.
For men ages 55 to 69 years the Panel recognizes that the decision to undergo PSA screening involves weighing the benefits of prostate cancer mortality in 1 man for every 1,000 men screened over a decade against the known potential harms associated with screening and treatment. For this reason, the Panel strongly recommends shared decision making for men age 55 to 69 years that are considering PSA screening, and proceeding based on a man’s values and preferences. (Standard; Evidence Strength Grade B). The greatest benefit of screening appears to be in men ages 55 to 69 years.
To reduce the harms of screening, a routine screening interval of two years or more may be preferred over annual screening in those men who have participated in shared decision making and decided on screening. As compared to annual screening, it is expected that screening intervals of two years preserve the majority of the benefits and reduce overdiagnosis and false positives. (Option; Evidence Strength Grade C). Additionally, intervals for rescreening can be individualized by a baseline PSA level.
The Panel does not recommend routine PSA screening in men age 70+ years or any man with less than a 10 to 15 year life expectancy. (Recommendation; Evidence Strength Grade C).
Some men age 70+ years who are in excellent health may benefit from prostate cancer screening.
The panel concluded that PSA based screening should not be performed in the absence of shared decision making. Thus, they recommend against organized screening in settings where shared decision making is not part of routine practice (e.g., including but not limited to health fairs, health system promotions, community organizations).
The Panel believes that annual PSA screening as a routine should be discouraged for those who choose to be screened, that two year PSA intervals are reasonable approach and will be unlikely to miss a curable prostate cancer in most men, and that for men over 60 with PSA levels below 1.0ng/ml, longer PSA screening intervals (e.g. of four years) could be considered.
History and Physical Including
*African American men have a higher incidence of prostate cancer, increased prostate cancer mortality, and earlier age of diagnosis compared to Caucasian-American men. However, the effects of earlier or more intensive screening on cancer outcomes and on screening related harms in African-American men remain unclear. Therefore, although these men may require a higher level of vigilance and different considerations when analyzing the results of screening tests, the panel cannot provide separate screening recommendations for these men until more data become available.
Most Panel members favor informed testing beginning at age 45 years. Repeat testing at 1 to 2 year intervals is recommended for men who have a PSA value ≥ 1.0 ng/mL and at 2 to 4 year intervals for men with PSA <1 ng/mL.
The panel recommends repeat teating every 2 to 4 years if PSA is <1 ng/mL and every 1 to 2 years if PSA 1 to 3 ng/mL in men aged 45 to 75 years. The panel notes that a younger man on the higher end of PSA (e.g. 45 year old man with PSA 0.9 ng/mL) might be screened in 2 years, whereas an older man with a lower PSA might be screened in 4 years. Clinical judgment should be used.
The Panel supports screening in men until age 75, and then continuing screening only in very select patients (category 2B). The panel notes that although some men in this older age group present with high-risk disease, very few men older than age 75 years benefit from PSA screening.
African-American men and men with a first degree relative with prostate cancer (especially cancer found at a younger age) have a higher risk of developing prostate cancer. In fact, having a first degree relative with prostate cancer diagnosed before theage of 60 increases the likelihood of prostate cancer diagnosis by 2.1 to 2.5 fold. Data, however, suggest that prostate cancer in men with a family history of prostate cancer is not more likely to be aggressive, and cancer specific outcomes are similar between those with and without a family history.
African-American men and men with a family history of prostate cancer represent high-risk groups. However, the panel believes that current data are insufficient to inform the best strategy for prostate cancer screening in these populations and also note that baseline PSA value is a stronger predictive factor that a positive family history or race. Therefore, although these individuals may require a higher level of vigilance and potentially different considerations when analyzing the results of screening tests, the panel does not give separate screening recommendations for these men at this time. Race is, however, included as a baseline evaluation factor for risk assessment that can be used to help decide when a man should begin the early detection process within the NCCN recommended ages of 45 to 75 years.
In 2016, the American Cancer Society recommends that men make an informed decision with their health care provider about whether to be screened for prostate cancer. The decision should be made after getting information about the uncertainties, risk, and potential benefits of prostate cancer screening. Men should not be screened unless they have received this information. The discussion about screening should take place at:
After this discussion men who want to be screened should be tested with the prostate specific antigen (PSA) blood test. The digital rectal exam (DRE) may also be done as part of screening.
If, after this discussion, a man is unable to decide if testing is right for him, the screening decision can be made by the health care provider, who should take into account the man’s general health preferences and values.
If no prostate cancer is found as a result of screening, the time between future screenings depends on the results of the PSA blood test:
Because prostate cancer often grows slowly, men without symptoms of prostate cancer who do not have a 10-year life expectancy should not be offered testing since they are not likely to benefit. Overall health status, and not age alone, is important when making decisions about screening.
Even after a decision about testing has been made, the discussion about the pros and cons of testing should be repeated as new information about the benefits and risks of testing becomes available. Further discussions are also needed to take into account changes in a man’s health, values, and preferences.
See Related Medical Policies
Prostate Specific Antigen (PSA) Screening for Prostate Cancer
Prostate cancer screening using prostate specific antigen (PSA) may be considered medically necessary for any of the following indications after informed decision with a health care provider:
After the initial PSA is determined, the time interval for repeat testing is dependent upon the PSA value. For those men with a PSA of:
All other screening indications are considered not medically necessary.
Wellmark medical policies address the complex issue of technology assessment of new and emerging treatments, devices, drugs, etc. They are developed to assist in administering plan benefits and constitute neither offers of coverage nor medical advice. Wellmark medical policies contain only a partial, general description of plan or program benefits and do not constitute a contract. Wellmark does not provide health care services and, therefore, cannot guarantee any results or outcomes. Participating providers are independent contractors in private practice and are neither employees nor agents of Wellmark or its affiliates. Treating providers are solely responsible for medical advice and treatment of members. Our medical policies may be updated and therefore are subject to change without notice.
*CPT® is a registered trademark of the American Medical Association.