MEDICAL POLICY – 2.04.514
Protein Biomarkers for Diagnosis and Risk Assessment of
Prostate Cancer
BCBSA Ref. Policy: 2.04.33
Effective Date: Jan. 1, 2020
Last Revised: Dec. 10, 2019
Replaces: 12.04.33
RELATED MEDICAL POLICIES:
None
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POLICY CRITERIA | CODING | RELATED INFORMATION
EVIDENCE REVIEW | REFERENCES | HISTORY
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Introduction
A biomarker is a chemical in the body. Certain biomarkers can show when something unusual is
going on with certain bodily processes. One of the most commonly known and tested
biomarkers is prostate specific antigen (PSA). Higher levels of PSA in the blood indicate a
problem with the prostate. The difficulty is that the PSA test doesn’t tell us what kind of problem
is affecting the prostate – whether it’s simply an enlarged prostate or cancer. If the PSA is high,
the usual next step is a biopsy. A biopsy is taking small bits of tissue to see if cancer is present.
Other biomarker tests have been developed in recent years with the hope of telling doctors
which patients should have a biopsy and who can skip it. Published medical studies about these
newer prostate biomarker tests are contradictory. That means some studies show the tests
detect what they’re supposed to and other studies don’t. At this time, there is not enough
medical evidence to show that newer prostate cancer biomarker tests are effective.
Note: The Introduction section is for your general knowledge and is not to be taken as policy coverage criteria. The
rest of the policy uses specific words and concepts familiar to medical professionals. It is intended for
providers. A provider can be a person, such as a doctor, nurse, psychologist, or dentist. A provider also can
be a place where medical care is given, like a hospital, clinic, or lab. This policy informs them about when a
service may be covered.
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Policy Coverage Criteria
Test Investigational Protein biomarkers The following protein biomarkers for the diagnosis of prostate
cancer are considered investigational:
• Autoantibodies ARF 6, NKX3-1, 5′-UTR-BMI1, CEP 164, 3′-UTR-
Ropporin, Desmocollin, AURKAIP-1, CSNK2A2 (eg, Apinifi)
• Kallikrein markers (eg, 4Kscore™ Test)
Coding
Code Description
CPT 81539 Oncology (high-grade prostate cancer), biochemical assay of four proteins (Total PSA,
Free PSA, Intact PSA, and human kallikrein-2 [hK2]), utilizing plasma or serum,
prognostic algorithm reported as a probability score (4KScore)
0021U Oncology (prostate), detection of 8 autoantibodies (ARF 6, NKX3-1, 5'-UTR-BMI1, CEP
164, 3'-UTR-Ropporin, Desmocollin, AURKAIP-1, CSNK2A2), multiplexed immunoassay
and flow cytometry serum, algorithm reported as risk score (Apinifi)
Note: CPT codes, descriptions and materials are copyrighted by the American Medical Association (AMA). HCPCS
codes, descriptions and materials are copyrighted by Centers for Medicare Services (CMS).
Related Information
N/A
Evidence Review
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Description
Various protein biomarkers are associated with prostate cancer. These tests have the potential to
improve the accuracy of differentiating between which men should undergo prostate biopsy
and which should undergo rebiopsy after a prior negative biopsy. This policy addresses these
types of tests for cancer risk assessment.
Background
Prostate Cancer
Prostate cancer is the most common cancer, and the second most common cause of cancer
death in men, with a predicted 174,650 incidence cases and 31,620 deaths expected in the
United States in 2019.1
Prostate cancer is a complex, heterogeneous disease, ranging from microscopic tumors unlikely
to be life-threatening to aggressive tumors that can metastasize, leading to morbidity or death.
Early localized disease can usually be treated with surgery and radiotherapy, although active
surveillance may be adopted in men whose cancer is unlikely to cause major health problems
during their lifespan or for whom the treatment might be dangerous. In patients with inoperable
or metastatic disease, treatment consists of hormonal therapy and possibly chemotherapy. The
lifetime risk of being diagnosed with prostate cancer for men in the United States is
approximately 16%, while the risk of dying of prostate cancer is 3%.2 African American men have
the highest prostate cancer risk in the United States; the incidence of prostate cancer is about
60% higher and the mortality rate is more than 2 to 3 times greater than that of white men.3
Autopsy results have suggested that about 30% of men age 55 and 60% of men age 80 who die
of other causes have incidental prostate cancer,4 indicating that many cases of prostate cancer
are unlikely to pose a threat during a man’s life expectancy.
Grading
The most widely used grading scheme for prostate cancer is the Gleason system.5 It is an
architectural grading system ranging from 1 (well-differentiated) to 5 (poorly-differentiated); the
score is the sum of the primary and secondary patterns. A Gleason score of 6 or less is low-
grade prostate cancer that usually grows slowly; 7 is an intermediate grade; 8 to 10 is high-
grade cancer that grows more quickly. A revised prostate cancer grading system has been
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adopted by the National Cancer Institute and the World Health Organization.6 A cross-walk of
these grading systems is shown in Table 1.
Table 1. Prostate Cancer Grading Systems
Grade Group Gleason Score (Primary and
Secondary Pattern)
Cells
1 6 or less Well-differentiated (low grade)
2 7 (3 + 4) Moderately differentiated (moderate
grade)
3 7 (4 + 3) Poorly differentiated (high grade)
4 8 Undifferentiated (high grade)
5 9-10 Undifferentiated (high grade)
Numerous genetic alterations associated with the development or progression of prostate
cancer have been described, with the potential for the use of these molecular markers to
improve the selection process of men who should undergo prostate biopsy or rebiopsy after an
initial negative biopsy.
Summary of Evidence
For individuals who are being considered for an initial prostate biopsy who receive testing for
protein biomarkers of prostate cancer (eg, kallikreins biomarkers and 4Kscore Test and Apifiny),
the evidence includes systematic reviews, meta-analyses, and primarily observational studies.
The relevant outcomes are overall survival, disease-specific survival, test validity, resource
utilization, and quality of life. The evidence supporting clinical utility varies by the test but has
not been directly shown for any biomarker test. Absent direct evidence of clinical utility, a chain
of evidence might be constructed. However, the performance of biomarker testing for directing
biopsy referrals is uncertain. While some studies have shown a reduction or delay in biopsy
based on testing, a chain of evidence for clinical utility cannot be constructed due to limitations
in clinical validity. Test validation populations have included men with positive digital rectal
exam (DRE), a PSA level outside of the gray zone (between 3 or 4 ng/mL and 10 ng/mL), or older
men for whom the information from test results are less likely to be informative. Many
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biomarker tests do not have standardized cutoffs to recommend a biopsy. In addition,
comparative studies of the many biomarkers are lacking. The evidence is insufficient to
determine the effects of the technology on health outcomes.
For individuals who are being considered for repeat biopsy who receive testing for protein
biomarkers of prostate cancer, the evidence includes systematic reviews, meta-analyses, and
primarily observational studies. The relevant outcomes are overall survival, disease-specific
survival, test validity, resource utilization, and quality of life. The performance of biomarker
testing for guiding rebiopsy decisions is lacking. The tests are associated with a diagnosis of
prostate cancer and aggressive prostate cancer, but studies on clinical validity are limited and
did not compare performance characteristics with standard risk prediction models. Direct
evidence supporting clinical utility has not been shown. No data are currently available on
physician decisions on rebiopsy or on the longer-term clinical outcomes of men who did not
have a biopsy based on test results. The evidence is insufficient to determine the effects of the
technology on health outcomes
Practice Guidelines and Position Statements
American Urological Association et al
The American Urological Association (2013; confirmed in 2018) published guidelines on the early
detection of prostate cancer. 63 The association concluded that “the literature supporting the
efficacy of digital rectal exam (DRE), PSA [prostate-specific antigen] derivatives and isoforms (eg,
free PSA, -2proPSA, prostate health index, hK2, PSA velocity or PSA doubling time) and novel
urinary markers and biomarkers (eg, PCA3) for screening with the goal of reducing prostate
cancer mortality provide limited evidence to draw conclusions. While some data suggest use of
these secondary screening tools may reduce unnecessary biopsies (ie, reduce harms) while
maintaining the ability to detect aggressive prostate cancer (ie, maintain the benefits of PSA
screening), more research is needed to confirm this.”
The American Urological Association and the Society of Abdominal Radiology (2016) published
joint guidelines on prostate magnetic resonance imaging and magnetic resonance imaging -
targeted biopsy.27 The associations recommended:
In patients with negative or low suspicion magnetic resonance imaging (PI-RADS
[Prostate Imaging Reporting and Data System] assessment category of 1 or 2,
respectively), other ancillary markers (ie, PSA [prostate-specific antigen], PSAD [PSA
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density], PSAV [PSA velocity], PCA3, PHI, 4K) may be of value in identifying patients
warranting repeat systematic biopsy, although further data are needed on this topic.
Guidelines published by the American Cancer Society and the American Urological Association
have endorsed consideration of PSA screening based on age, other risk factors, and estimated
life expectancy.17,64,65
National Comprehensive Cancer Network
The National Comprehensive Cancer Network (NCCN) guidelines (v.2.2019) recommend that any
man with a PSA level greater than 3 ng/mL undergo workup for benign disease, repeat PSA, and
digital rectal examination.1 The guidelines also recommend consideration of biomarkers that
improve the specificity of screening including percent free PSA, phi, ExoDx Prostate (IntelliScore)
(EPI), and 4Kscore in patients with a PSA level greater than 3 ng/mL who have not yet had a
biopsy, and consideration of percent free PSA, phi, 4Kscore, PCA3, ExoDx Prostate (IntelliScore)
(EPI), and ConfirmMDx in men who had a negative biopsy but are thought to be at higher risk
(category 2A evidence). The NCCN noted that these tests may be especially useful in men with
PSA levels between 3 ng/mL and 10 ng/mL. The NCCN considers the Mi-Prostate Score (MiPS)
and Select MDx to be investigational at the time of the update. NCCN indicated that:
... no biomarker test can be recommended over any other at this time. The optimal order of
biomarker tests and imaging is unknown; and it remains unclear how to interpret results of
multiple tests in individual patients – especially when results are contradictory.
National Institute for Health and Care Excellence
The National Institute for Health and Care Excellence (2019) did not recommend the Progensa
PCA3 Assay or the phi test for use in men with suspicion of prostate cancer who had a negative
or inconclusive prostate biopsy.66
U.S. Preventive Services Task Force Recommendations
The U.S. Preventive Services Task Force (2018) updated recommendations for prostate cancer
screening.67 Protein biomarkers addressed in this policy, including PCA3, were not mentioned.
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The U.S. Preventive Services Task Force advises individualized decision making about screening
for prostate cancer after discussion with a clinician for men ages 55 to 69 (C recommendation)
and recommends against PSA-based screening in men 70 and older (D recommendation).
Medicare National Coverage
There is no national coverage determination. At least one LCD will cover percent free PSA, phi,
or 4K score once prior to initial biopsy in men who meet criteria.
Ongoing and Unpublished Clinical Trials
Some currently ongoing and unpublished trials that might influence this policy are listed in
Table 2.
Table 2. Summary of Key Trials
NCT No. Trial Name Planned
Enrollment
Completion
Date
Ongoing
NCT00773773 A Study to Assess if a Combination of Serum Measurements of
Molecular Biomarkers and Serum Protein Profiling Can be Used
to Predict Which Patients Undergoing Prostatic Biopsy Will be
Diagnosed With Cancer
500 Oct 2019
NCT03082274a Prospective Validation of Prostate Biomarkers for Repeat Biopsy:
The PRIORITY Study
1000 Dec 2019
NCT01739062 Prostate Cancer Risk Assessment Using Genetic Markers in
General Practice (ProCaRis)
5000 Jan 2024
NCT01632930 Medical Economics of Urinary PCSA3 Test for Prostate Cancer
Diagnosis
962 Nov 2020
NCT04079699 Predicting Prostate Cancer Using a Panel of Plasma and Urine
Biomarkers Combined in an Algorithm in Elderly Men Above 70
Years
700 Oct 2039
https://clinicaltrials.gov/ct2/show/NCT00773773?term=NCT00773773&rank=1https://www.clinicaltrials.gov/ct2/show/NCT03082274?term=NCT03082274&rank=1https://clinicaltrials.gov/ct2/show/NCT01739062?term=NCT01739062&rank=1https://clinicaltrials.gov/ct2/show/NCT01632930?term=NCT01632930&rank=1https://clinicaltrials.gov/ct2/show/NCT04079699?term=NCT04079699&draw=1&rank=1
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NCT No. Trial Name Planned
Enrollment
Completion
Date
NCT02241122 Improved Prostate Cancer Diagnosis - Combination of Magnetic
Resonance Imaging Targeted Biopsies and Biomarkers (Multi-
IMPROD)
350 Apr 2018
(completed)
NCT: national clinical trial.
a Denotes industry-sponsored or cosponsored trial.
Regulatory Status
Clinical laboratories may develop and validate tests in-house and market them as a laboratory
service; laboratory-developed tests must meet the general regulatory standards of the Clinical
Laboratory Improvement Amendments. Laboratories that offer laboratory-developed tests must
be licensed under the Clinical Laboratory Improvement Amendments for high-complexity
testing. The following laboratories are certified under the Clinical Laboratory Improvement
Amendments: BioReference Laboratories and GenPath Diagnostics (subsidiaries of OPKO Health;
4Kscore®), ARUP Laboratories, Mayo Medical Laboratories, LabCorp, BioVantra, others (PCA3
assay), Clinical Research Laboratory (Prostate Core Mitomic Test™), MDx Health (SelectMDx,
ConfirMDx), Innovative Diagnostics (phiTM), and ExoDx® Prostate (Exosome Diagnostics). To
date, the U.S. Food and Drug Administration (FDA) has chosen not to require any regulatory
review of these tests.
References
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https://www.nice.org.uk/guidance/ng131/chapter/Recommendations#assessment-and-diagnosis Accessed December
2019.
67. U. S. Preventive Services Task Force. Prostate Cancer: Screening. 2018;
https://www.uspreventiveservicestaskforce.org/Page/Document/RecommendationStatementFinal/prostate-cancer-
screening1 Accessed December 2019.
History
Date Comments 01/04/19 New policy, approved December 13, 2018, effective January 4, 2019. This policy
replaces policy 12.04.33. Policy updated with literature review through September
2018; references 6, 32-34, and 39, added. Apinifi added as investigational. Candidate
gene panels, ConfirmMDx, Prostate Core Mitomics test, PCA3 (Progensa) ExoDx
Prostate IntelliScore, Prostate Health Index (phi), Select MDx, and TMPRSS ERG fusion
gene removed from policy. Removed codes 81229, 81313, 81479, 81541, and 81551 as
they are now reviewed by AIM Specialty Health.
02/01/19 Minor update, title changed from “Protein Biomarkers for the Diagnosis and Cancer
Risk Assessment of Prostate Cancer“ to “Protein Biomarkers for Diagnosis and Risk
Assessment of Prostate Cancer”.
05/01/19 Minor update, History section updated for clarity.
01/01/20 Annual Review, approved December 10, 2019. Policy updated with literature review
through September 2019; references added. Policy statements unchanged.
Disclaimer: This medical policy is a guide in evaluating the medical necessity of a particular service or treatment. The
Company adopts policies after careful review of published peer-reviewed scientific literature, national guidelines and
local standards of practice. Since medical technology is constantly changing, the Company reserves the right to review
and update policies as appropriate. Member contracts differ in their benefits. Always consult the member benefit
booklet or contact a member service representative to determine coverage for a specific medical service or supply.
CPT codes, descriptions and materials are copyrighted by the American Medical Association (AMA). ©2020 Premera
All Rights Reserved.
Scope: Medical policies are systematically developed guidelines that serve as a resource for Company staff when
determining coverage for specific medical procedures, drugs or devices. Coverage for medical services is subject to
https://www.nice.org.uk/guidance/ng131/chapter/Recommendations#assessment-and-diagnosishttps://www.uspreventiveservicestaskforce.org/Page/Document/RecommendationStatementFinal/prostate-cancer-screening1https://www.uspreventiveservicestaskforce.org/Page/Document/RecommendationStatementFinal/prostate-cancer-screening1
Page | 13 of 13 ∞
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benefit booklet or contact a customer service representative to determine whether there are any benefit limitations
applicable to this service or supply. This medical policy does not apply to Medicare Advantage.
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ਅੰ
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ពទ
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ganitong impormasyon at tulong sa iyong wika ng walang gastos. Tumawag ਕਦਮ ਚੁਕਣ ਦੀ ਲੜ ਹੋ ਸਕਦੀ ਹ ੈ,ਤੁ ੰ ੂ ਮੁ ੱ ਚ ਤੇ ੱ ਚ ਜਾਣਕਾਰੀ ਅਤੇ ੱ ੋ ਹਾਨ ਫ਼ਤ ਿਵ ਆਪਣੀ ਭਾਸ਼ਾ ਿਵ ਮਦਦ sa 800-592-6804 (TTY: 800-842-5357). ਪ੍ਰ ੈਾਪਤ ਕਰਨ ਦਾ ਅਿਧਕਾਰ ਹ ,ਕਾਲ 800-592-6804 (TTY: 800-842-5357).
ਪੰ
Tagalog (Tagalog): Ang Paunawa na ito ay naglalaman ng mahalagang impormasyon. Ang
ไทย (Thai): ประกาศน ้ีมีข้อมลูสําคญั ประกาศน ้ีอาจมีข้อมลูที่สําคญัเกี่ยวกบัการการสมคัรหรือขอบเขตประกนั
(Farsi): فارسی فرم بارهدر ھمم اطالعات حاوی است ممکن يهمالعا اين . ميباشد ھمم اطالعات یوحا يهمالعا اين
สขุภาพของคณุผ่าน LifeWise Health Plan of Washington และอาจมีกําหนดการในประกาศ طريق از ماش ای مهبي وششپ يا و تقاضا LifeWise Health Plan of Washington به .باشدี น جهتو يهمالعا اين در ھمم ھای خيتار يا تان بيمه وششپ حقظ برای است کنمم ماش . يدماين کمک คณุอาจจะต้องดําเนินการภายในกําหนดระยะเวลาที่แน่นอนเพื่อจะรักษาการประกนัสขุภาพของคณุ
اجتياح صیاخ کارھای امانج برای صیمشخ ھای خيتار به تان، انیمدر ھای زينهھ پرداخت درหรือการช่วยเหลือที่มีค่าใช้จ่าย คณุมีสิทธิที่จะได้รับข้อมลูและความช่วยเหลือน ้ีในภาษาของคณุโดยไม่ม ีباشيد داشته . رايگان ورط به ودخ انزب به را مکک و اطالعات اين که داريد را اين حق ماش
(ค่าใช้จ่าย โทร 800-592-6804 (TTY: 800-842-5357 مارهش با اطالعات سبک برای . نماييد دريافت 800-592-6804 . اييد نم برقرار استم ) 5357-842-800 مارهباش اس تم TTY کاربران(
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