Download Circulating Tumor DNA and Circulating Tumor Cells for Cancer

MEDICAL COVERAGE GUIDELINES
SECTION:
LABORATORY
ORIGINAL EFFECTIVE DATE:
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LAST CRITERIA REVISION DATE:
ARCHIVE DATE:
06/14/16
CIRCULATING TUMOR DNA AND CIRCULATING TUMOR CELLS FOR CANCER
MANAGEMENT
Coverage for services, procedures, medical devices and drugs are dependent upon benefit
eligibility as outlined in the member's specific benefit plan. This Medical Coverage Guideline must
be read in its entirety to determine coverage eligibility, if any.
This Medical Coverage Guideline provides information related to coverage determinations only
and does not imply that a service or treatment is clinically appropriate or inappropriate. The
provider and the member are responsible for all decisions regarding the appropriateness of care.
Providers should provide BCBSAZ complete medical rationale when requesting any exc eptions to
these guidelines.
The section identified as “Description” defines or describes a service, procedure, medical device
or drug and is in no way intended as a statement of medical necessity and/or coverage.
The section identified as “Criteria” defines criteria to determine whether a service, procedure,
medical device or drug is considered medically necessary or experimental or investigational.
State or federal mandates, e.g., FEP program, may dictate that any drug, device or biological
product approved by the U.S. Food and Drug Administration (FDA) may not be considered
experimental or investigational and thus the drug, device or biological product may be assessed
only on the basis of medical necessity.
Medical Coverage Guidelines are subject to change as new information becomes available.
For purposes of this Medical Coverage Guideline, the terms "experimental" and "investigational"
are considered to be interchangeable.
BLUE CROSS®, BLUE SHIELD® and the Cross and Shield Symbols are registered service marks
of the Blue Cross and Blue Shield Association, an association of independent Blue Cross and
Blue Shield Plans. All other trademarks and service marks contained in this guideline are the
property of their respective owners, which are not affiliated with BCBSAZ.
O482.13.docx
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MEDICAL COVERAGE GUIDELINES
SECTION:
LABORATORY
ORIGINAL EFFECTIVE DATE:
LAST REVIEW DATE:
LAST CRITERIA REVISION DATE:
ARCHIVE DATE:
06/14/16
CIRCULATING TUMOR DNA AND CIRCULATING TUMOR CELLS FOR CANCER
MANAGEMENT (cont.)
Description:
Circulating tumor DNA (ctDNA) or circulating tumor cells (CTCs) in peripheral blood, also referred to as
liquid biopsy, have been investigated as a noninvasive alternative to tissue biopsy for therapeutic decision
making and clinical prognosis in individuals with cancer.
Laboratories offering liquid biopsy tests, include, but are not limited to:
▪
▪
▪
▪
▪
Biocept Inc.
Circulogene Theranostics
Foundation Medicine® (test referred to as FoundationACT™)
Genomic Health (test referred to as Oncotype SEQ™)
Pathway Genomics® (test referred to as CancerIntercept™ Monitor)
Criteria:

The use of ctDNA and/or CTCs for all indications is considered experimental or investigational
based upon:
1.
2.
3.
4.
Insufficient scientific evidence to permit conclusions concerning the effect on health outcomes,
and
Insufficient evidence to support improvement of the net health outcome, and
Insufficient evidence to support improvement of the net health outcome as much as, or more
than, established alternatives, and
Insufficient evidence to support improvement outside the investigational setting.
O482.13.docx
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MEDICAL COVERAGE GUIDELINES
SECTION:
LABORATORY
ORIGINAL EFFECTIVE DATE:
LAST REVIEW DATE:
LAST CRITERIA REVISION DATE:
ARCHIVE DATE:
06/14/16
CIRCULATING TUMOR DNA AND CIRCULATING TUMOR CELLS FOR CANCER
MANAGEMENT (cont.)
Resources:
Literature reviewed 06/14/16. We do not include marketing materials, poster boards and nonpublished literature in our review.
The BCBS Association Medical Policy Reference Manual (MPRM) policy is included in our
guideline review. References cited in the MPRM policy are not duplicated on this guideline.
1.
2.04.37 BCBS Association Medical Policy Reference Manual. Detection of Circulating Tumor
Cells in the Management of Patients With Cancer. Re-issue date 06/11/2015, issue date
11/09/2004.
2.
2.04.141 BCBS Association Medical Policy Reference Manual. Circulating Tumor DNA and
Circulating Tumor Cells for Cancer Mangement (Liquid Biopsy). Issue date 05/19/2016.
3.
Allard WJ, Matera J, Miller MC, et al. Tumor cells circulate in the peripheral blood of all major
carcinomas but not in healthy subjects or patients with nonmalignant diseases. Clin Cancer Res.
2004 Oct 15;10(20):6897-6904.
4.
Apostolaki S, Perraki M, Pallis A, et al. Circulating HER2 mRNA -positive cells in the peripheral
blood of patients with stage I and II breast cancer after the administration of adjuvant
chemotherapy: evaluation of their clinical relevance. Ann Oncol. 2007 May;18(5):851-858.
5.
Bidard FC, Vincent-Salomon A, Sigal-Zafrani B, et al. Prognosis of women with stage IV breast
cancer depends on detection of circulating tumor cells rather than disseminated tumor cells. Ann
Oncol. 2008 Jan 10.
6.
Cristofanilli M. Circulating tumor cells, disease progression, and survival in metastatic breast
cancer. Semin Oncol. 2006 Jun;33(3 Suppl 9):S9-14.
7.
Cristofanilli M, Broglio KR, Guarneri V, et al. Circulating tumor cells in metastatic breast cancer:
biologic staging beyond tumor burden. Clin Breast Cancer. 2007 Feb;7(6):471-479.
8.
Fizazi K, Morat L, Chauveinc L, et al. High detection rate of circulating tumor cells in blood of
patients with prostate cancer using telomerase activity. Ann Oncol. 2007 Mar;18(3):518-521.
9.
Hayes DF, Cristofanilli M, Budd GT, et al. Circulating tumor cells at each follow-up time point
during therapy of metastatic breast cancer patients predict progression-free and overall survival.
Clin Cancer Res. 2006 Jul 15;12(14 Pt 1):4218-4224.
10.
Ignatiadis M, Georgoulias V, Mavroudis D. Circulating tumor cells in breast cancer. Curr Opin
Obstet Gynecol. 2008 Feb;20(1):55-60.
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MEDICAL COVERAGE GUIDELINES
SECTION:
LABORATORY
ORIGINAL EFFECTIVE DATE:
LAST REVIEW DATE:
LAST CRITERIA REVISION DATE:
ARCHIVE DATE:
06/14/16
CIRCULATING TUMOR DNA AND CIRCULATING TUMOR CELLS FOR CANCER
MANAGEMENT (cont.)
Resources: (cont.)
11.
Ignatiadis M, Xenidis N, Perraki M, et al. Different prognostic value of cytokeratin-19 mRNA
positive circulating tumor cells according to estrogen receptor and HER2 status in early -stage
breast cancer. J Clin Oncol. 2007 Nov 20;25(33):5194-5202.
12.
Jacob K, Sollier C, Jabado N. Circulating tumor cells: detection, molecular profiling and future
prospects. Expert Rev Proteomics. 2007 Dec;4(6):741-756.
13.
Mocellin S, Hoon D, Ambrosi A, Nitti D, Rossi CR. The prognostic value of circulating tumor cells
in patients with melanoma: a systematic review and meta-analysis. Clin Cancer Res. 2006 Aug
1;12(15):4605-4613.
14.
Molloy TJ, Bosma AJ, Van't Veer LJ. Towards an optimized platform for the detection,
enrichment, and semi-quantitation circulating tumor cells. Breast Cancer Res Treat. 2008 Jan 23.
15.
Nakagawa T, Martinez SR, Goto Y, et al. Detection of circulating tumor cells in early -stage breast
cancer metastasis to axillary lymph nodes. Clin Cancer Res. 2007 Jul 15;13(14):4105-4110.
16.
Nole F, Munzone E, Zorzino L, et al. Variation of circulating tumor cell levels during treatment of
metastatic breast cancer: prognostic and therapeutic implications. Ann Oncol. 2007 Dec 4.
17.
Ntoulia M, Stathopoulou A, Ignatiadis M, et al. Detection of Mammaglobin A -mRNA-positive
circulating tumor cells in peripheral blood of patients with operable breast cancer with nested RTPCR. Clin Biochem. 2006 Sep;39(9):879-887.
18.
Riethdorf S, Fritsche H, Muller V, et al. Detection of circulating tumor cells in peripheral blood of
patients with metastatic breast cancer: a validation study of the CellSearch system. Clin Cancer
Res. 2007 Feb 1;13(3):920-928.
19.
Sastre J, Maestro ML, Puente J, et al. Circulating tumor cells in colorectal cancer: correlation with
clinical and pathological variables. Ann Oncol. 2008 Jan 22.
20.
Wu CH, Lin SR, Hsieh JS, et al. Molecular detection of disseminated tumor cells in the peripheral
blood of patients with gastric cancer: evaluation of their prognostic significance. Dis Mark ers.
2006;22(3):103-109.
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MEDICAL COVERAGE GUIDELINES
SECTION:
LABORATORY
ORIGINAL EFFECTIVE DATE:
LAST REVIEW DATE:
LAST CRITERIA REVISION DATE:
ARCHIVE DATE:
06/14/16
CIRCULATING TUMOR DNA AND CIRCULATING TUMOR CELLS FOR CANCER
MANAGEMENT (cont.)
Resources: (cont.)
21.
Xi L, Nicastri DG, El-Hefnawy T, Hughes SJ, Luketich JD, Godfrey TE. Optimal markers for realtime quantitative reverse transcription PCR detection of circulating tumor cells from melanoma,
breast, colon, esophageal, head and neck, and lung cancers. Clin Chem. 2007 Jul;53(7):12061215.
FDA 510K Summary for CellSearch Epithelial Cell Kit/Cell Spotter Analyzer (Veridex, LLC):
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FDA-approved indication: Intended for use in adjunctively monitoring and predicting cancer
disease progression and response to therapy.
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