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Effective Date: 06/01/2012 |
Title: OVA1, Test for Ovarian Cancer
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Revision Date: 10/01/2015
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Document: BI355:00
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CPT Code(s): 81503, 82172, 82232, 84134, 84466, 86304
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Public Statement
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Effective Date:
a)
This policy
will apply to all services performed on or after the above Revision date which
will become the new effective date.
b)
For all
services referred to in this policy that were performed before the revision
date, contact customer service for the rules that would apply.
OVA-1
requires pre-authorization.
The OVA-1
test is a blood test that combines several other tests into a single score.
This test is covered only for certain women planning to undergo surgery for a
pelvic mass that appears to be benign. The test is indicated only if a positive
test would lead to referral to a gynecologic oncologist prior to surgery.
If this test
does not meet standards for medical necessity, the patient may be responsible
for the entire cost of the test.
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Medical Statement
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The proteomics-based OVA1™ test is covered as an aid to further assess the
likelihood that malignancy is present when the physician’s (other than
gynecologic oncologist) independent clinical and radiological preoperative
evaluations do not indicate malignancy in a patient with an ovarian (adnexal)
mass who meets
ALL
of the following criteria:
1)
Older than 18 years;
2)
Adnexal, presumed ovarian, mass present;
3)
Surgery is planned for treatment of the mass;
4)
The patient has not been referred to a gynecologic oncologist;
5)
A
positive test would lead to referral to a gynecologic oncologist prior to
surgery.
Codes Used In This BI:
81503 Oncology (ovarian), biochemical assays of five proteins
82172 Assay of apolipoprotein
82232 Assay of beta-2 protein
84134 Assay of prealbumin
84466 Assay of transferring
86304 Immunoassay tumor ca 125
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Limits
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OVA1™ is
considered investigational for any other use, including screening for ovarian
cancer, selecting patients with an adnexal mass for surgery, evaluation of
patients with clinical or radiological evidence of malignancy, or detection of
recurrent malignant disease following surgery.
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Background
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The OVA1™
test (Vermillion, Inc., Fremont, CA) is a qualitative serum test that combines
immunoassay results for 5 analytes (CA 125, prealbumin, apolipoprotein A-1,
beta2 microglobulin, and transferrin) into a single numerical score. It
is intended to be used in women with adnexal masses who are planning to have
surgery by a non-gynecologic oncologist for disease considered benign using
routine clinical and radiologic evaluation. In this patient subset, the test
serves as an aid to further assess the likelihood that malignancy is present.
This test will be covered only for this patient subset.
In 2009, it was estimated that more than 21,000 women in the U.S. were diagnosed
with ovarian cancer and more than 14,000 died of this disease (Bristow, 2009).
The mortality rate depends on three variables: 1) characteristics of the
patient; 2) the biology of the tumor (grade, stage and type); and 3) the quality
of treatment (nature of staging, surgery and chemotherapy used) (du Bois, 2009).
In particular, comprehensive staging and completeness of tumor resection
appear to have a positive impact on patient outcome.
In 1997, the Society of Surgical Oncology first recommended ovarian cancer
surgery and follow-up treatment be performed by physicians with ovarian cancer
disease expertise (Hoskins, 1997). To date dozens of articles and several
meta-analyses or systemic reviews have been published relevant to this
recommendation looking at long-term outcomes, short-term outcomes and process
measures (types of treatment such as complete staging or tumor debulking).
At least two meta-analyses have been performed concluding improved outcomes in
patients with ovarian cancer when treated by gynecologic oncologists. Data is
most convincing for patients with advanced stage disease. Median improvements in
survival for patients treated by non-gynecologic oncologists versus gynecologic
oncologists have been variable but impressive with increases recently reported
to be up to 8 months (12 to 21 months) (Tingulstad, 2003). In at least some
reports, important differences have also been observed showing improved survival
in patients with early stage disease as well when treated by gynecologic
oncologists (Giede, 2005).
A
recent systematic review of 198 studies addressing the role of specialty
treatment by gynecologic oncologists and evaluation of other practice related
factors (type of hospital, surgical volume, etc.) was more guarded in its
analysis (duBois, 2009). This review noted that not all reports confirmed these
findings of improved performance based on sub-specialty. It also noted that in
some reports only patients presenting with certain stages of disease (in most
cases advanced stage although in some cases early stage) were studied and found
to exhibit treatment differences. Nevertheless, this review also concluded that
the use of sub-specialists and better education of treatment options for both
primary care physicians and patients was warranted.
In an analysis of predictors of comprehensive surgical treatment (meticulous and
extensive disease staging, efforts at debulking of the tumor with removal of all
visible lesions, lymphadenectomy) in patients with ovarian cancer, Goff et al.
observed that comprehensive treatment was linked not only to physician factors
but also to a number of simple demographic factors including age, race,
insurance status and geographic location (urban versus rural) (Goff, 2007).
Optimization of treatment for ovarian cancer may clearly be complicated by these
factors.
Adult women presenting with an adnexal mass have an estimated 68% likelihood of
having a benign lesion (Van Holsbeke, 2010). About 6% have borderline tumors,
22% invasive lesions, and 3% metastatic disease.
Obviously a majority of patients can be treated without use of surgical oncology
expertise. To date no existing diagnostic modalities have been identified to
discriminate reliably between benign and malignant lesions. Recent publications
have appeared describing the use of CA 125 with a symptom index (Anderson,
2009), the use of an “ovarian crescent sign” on ultrasound (Van Holsbeke, 2010),
and the use of three-dimensional ultrasound (Alcazar, 2009) to provide increased
diagnostic reliability in this decision-making process, but all of these appear
to require further validation before being considered for routine clinical use.
The OVA1™ is a new proteomic test that has been developed specifically to triage
patients thought to have benign adnexal masses with planned treatment by a
non-gynecologic-oncologist physician. Patients with positive results should be
considered candidates for referral to a gynecologic oncologist for treatment. As
described above, this treatment is likely to produce improved patient outcomes.
Regulatory Status
On July 16, 2009, the Vermillion OVA1™ test was cleared for market by the FDA as
510(k) submission. No predicate was identified and the review decision was based
on the de novo (automatic classification of class III devices) 510(k) review
process. The intended use carried a boxed warning: “PRECAUTION: The OVA1TM test
should not be used without an independent clinical/radiological evaluation and
is
not intended to be a screening test or to determine whether a
patient should proceed to surgery. Incorrect use of the OVA1™ test carries the
risk of unnecessary testing, surgery, and/or delayed diagnosis.”
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Reference
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A
recipe for proteomics diagnostic test development: the OVA1™ test from biomarker
discovery to FDA clearance. Clin Chem 2010; 56(2):327-9.
ACOG Committee Opinion: number 280, December 2002. (2002) The role of the
generalist obstetrician-gynecologist in the early detection of ovarian cancer.
Obstet Gynecol 2002; 100(6):1413-6.
Alcazar JL, Rodriguez D.(2009) Three-dimensional power Doppler vascular
sonographic sampling for predicting ovarian cancer in cystic-solid and solid
vascularized masses. J Ultrasound Med 2009; 28(3):275-81.
Andersen MR, Goff BA, Lowe KA et al.(2009) Combining a symptom index with CA 125
to improve detection of ovarian cancer. Cancer 2009; 113(3):484-9.
Andersen MR, Goff BA, Lowe KA et al.(2010) Use of a Symptom Index, CA125, and
HE4 to predict ovarian cancer. Gynecol Oncol 2010; 116(3):378-83.
Bristow RE, Zahurak ML, Diaz-Montes TP et al.(2009) Impact of surgeon and
hospital ovarian cancer surgical case volume on in-hospital mortality and
related short-term outcomes. Gynecol Oncol 2009; 115(3):334-8.
Dearking AC, Aletti GD, McGree ME et al. (2007) How relevant are ACOG and SGO
guidelines for referral of adnexal mass? Obstet Gynecol 2007; 110(4):841-8.
du Bois A, Rochon J, Pfisterer J et al.(2009) Variation in institutional
infrastructure, physician specialization and experience, and outcome in ovarian
cancer: a systematic review. Gynecol Oncol 2009; 112(2):422-36.
Giede KC, Kieser K, Dodge J et al.(2005) Who should operate on patients with
ovarian cancer? An evidence-based review. Gynecol Oncol 2005; 99(2):447-61.
Goff BA, Matthews BJ, Larson EH et al. (2007) Predictors of comprehensive
surgical treatment in patients with ovarian cancer. Cancer 2007;
109(10):2031-42.
Hoskins W, Rice L, Rubin S. (1997) Ovarian cancer surgical practice guidelines.
Oncology 1997; 11(6):896-904.
Muller CY. (2010) Doctor, should I get this new ovarian cancer test-OVA1? Obstet
Gynecol 2010; 116(2 Pt 1):246-7.
Tingulstad S, Skjeldestad FE, Hagen B. (2003) The effect of centralization of
primary surgery on survival in ovarian cancer patients. Obstet Gynecol 2003;
102(3):499-505.
U.S. Food and Drug Administration. 510(k) Substantial Equivalence Determination
Decision Summary: OVA1™ Test (K081754). Available online at: http://www.accessdata.fda.gov/cdrh_docs/reviews/K081754.pdf.
Last accessed May 2010.
Ueland F, DeSimone C, Seamon L et al. (2010) The OVA1 test improves the
preoperative assessment of ovarian tumors. Gynecol Oncol 2010; 116(3 suppl
1):S23.
Van Holsbeke C, Van Belle V, Leone F et al. (2010) Prospective external
validation of the “ovarian crescent sign” as a single ultrasound parameter to
distinguish between benign and malignant adnexal pathology. Ultrasound Obstet
Gynecol 2010 [E-pub ahead of print].
Vernooij F, Heintz P, Witteveen E et al. (2007) The outcomes of ovarian cancer
treatment are better when provided by gynecologic oncologists and in specialized
hospitals: a systematic review. Gynecol Oncol 2007; 105(3):801-12.
Zhang Z, Chan DW. (2010) The road from discovery to clinical diagnostics:
lessons learned from the first FDA-cleared in vitro diagnostic multivariate
index assay of proteomic biomarkers. Cancer Epidemiol Biomarkers Prev 2010;
19(12):2995-9.
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Application to Products
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This policy applies to all health plans administered by QualChoice, both those insured by QualChoice and those that are self-funded by the sponsoring employer, unless there is indication in this policy otherwise or a stated exclusion in your medical plan booklet. Consult the individual plan sponsor Summary Plan Description (SPD) for self-insured plans or the specific Evidence of Coverage (EOC) for those plans insured by QualChoice. In the event of a discrepancy between this policy and a self-insured customer’s SPD or the specific QualChoice EOC, the SPD or EOC, as applicable, will prevail. State and federal mandates will be followed as they apply.
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Changes: QualChoice reserves the right to alter, amend, change or supplement benefit interpretations as needed.
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