New Study Highlights Significant Potential Medicare Savings Through Use of Castle Biosciences’ DecisionDx®-SCC Test to Guide Adjuvant Radiation Therapy Decisions in Patients with Cutaneous Squamous Cell Carcinoma
18 Enero 2024 - 6:00AM
Business Wire
Study finds that using DecisionDx-SCC to guide
patient selection for adjuvant radiation therapy (ART), identifying
patients with cutaneous squamous cell carcinoma (SCC) who can
safely forgo the treatment, could result in significant savings to
the healthcare system
Castle Biosciences, Inc. (Nasdaq: CSTL), a company improving
health through innovative tests that guide patient care, today
announced the publication of a new study1 in The Journal of
Clinical and Aesthetic Dermatology (JCAD) which found that using
its DecisionDx-SCC test to guide ART decisions for patients with
SCC could result in substantial Medicare healthcare savings of up
to approximately $972 million annually.
“The implications of this study are significant, as evidenced by
the opportunity to save our overburdened healthcare system hundreds
of millions of dollars through use of the DecisionDx-SCC test to
guide more risk-appropriate utilization of ART in patients with
SCC,” said Ally‐Khan Somani, M.D., Ph.D., lead author, director of
Mohs micrographic, reconstructive surgery & cutaneous oncology
at SkinMD LLC, and adjunct clinical assistant professor, Department
of Dermatology & Otolaryngology-Head and Neck Surgery at
Indiana University School of Medicine. “Above and beyond the
considerable cost savings is the potential to truly improve SCC
patient care by using the test’s results to provide added
confidence in decisions to forgo radiation therapy when a patient’s
risk of metastasis is low.”
ART has been shown to improve outcomes for patients with SCC who
have a high risk of disease progression. As such, high-risk
patients are eligible for ART under relevant society guidelines,
such as those provided by the American Academy of Dermatology
(AAD), the American Society for Radiation Oncology (ASTRO) and the
National Comprehensive Cancer Network (NCCN; 2024, v1). NCCN lists
three levels of clinicopathologic risk factors (low, high and very
high) and recommends consideration of ART for tumors that are
classified as high or very high risk. While ART can benefit some
patients, selecting patients based upon clinicopathologic factors
alone can lead to overtreatment of certain patients who may not
experience disease progression. Multiple published studies have
shown that DecisionDx-SCC is a significant risk stratification
factor for regional and distant metastasis and improves the
identification of high-risk patients when used in combination with
clinicopathologic factors or staging systems.2,3
Published studies have also demonstrated that clinicians use
DecisionDx-SCC test results to guide personalized patient
management decisions, such as frequency of follow-up care,
surveillance imaging, sentinel lymph node biopsy (SLNB) and the use
of ART.4-7 Two recent studies support the test’s utility in guiding
more informed decisions regarding the use of ART. The first
demonstrated DecisionDx-SCC’s ability to risk-stratify a cohort of
ART-eligible patients.8 The second demonstrated that DecisionDx-SCC
was able to identify patients who benefitted most from ART, along
with those who are less likely to show a significant benefit of ART
in controlling metastatic disease progression.9
The cost savings article published in JCAD reports the
significant, direct healthcare savings that could be realized in
the management of SCC patients who use DecisionDx-SCC to guide
decisions about ART. In the study, normalized medical claims data
identified 22,917 Medicare-eligible SCC patients in the United
States who received ART in the 12 months ending June 2022. The
weighted average direct cost for ART across four of the most common
radiation treatment modalities was found to be $60,693 per patient,
or $1.4 billion for all such Medicare-eligible SCC patients
annually. Results from the study indicate that using the
DecisionDx-SCC test to guide decisions about ART could result in
net Medicare healthcare savings of up to approximately $972 million
annually. This outcome is based on the distribution of
DecisionDx-SCC test results reported in previous studies, with cost
reductions attributed to avoiding ART in patients with a
DecisionDx-SCC low-risk, Class 1 test result and low rates of
disease progression.
About DecisionDx®-SCC
DecisionDx-SCC is a 40-gene expression profile test that uses an
individual patient’s tumor biology to predict individual risk of
cutaneous squamous cell carcinoma metastasis for patients with one
or more risk factors. The test result, in which patients are
stratified into a Class 1 (low), Class 2A (higher) or Class 2B
(highest) risk category, predicts individual metastatic risk to
inform risk-appropriate management. Peer-reviewed publications have
demonstrated that DecisionDx-SCC is an independent predictor of
metastatic risk and that integrating DecisionDx-SCC with current
prognostic methods can add positive predictive value to clinician
decisions regarding staging and management.
About Castle Biosciences
Castle Biosciences (Nasdaq: CSTL) is a leading diagnostics
company improving health through innovative tests that guide
patient care. The Company aims to transform disease management by
keeping people first: patients, clinicians, employees and
investors.
Castle’s current portfolio consists of tests for skin cancers,
uveal melanoma, Barrett’s esophagus and mental health conditions.
Additionally, the Company has active research and development
programs for tests in other diseases with high clinical need,
including its test in development to help guide systemic therapy
selection for patients with moderate-to-severe atopic dermatitis,
psoriasis and related conditions. To learn more, please visit
www.CastleBiosciences.com and connect with us on LinkedIn,
Facebook, X and Instagram.
DecisionDx-Melanoma, DecisionDx-CMSeq, DecisionDx-SCC, MyPath
Melanoma, TissueCypher, IDgenetix, DecisionDx-UM, DecisionDx-PRAME
and DecisionDx-UMSeq are trademarks of Castle Biosciences, Inc.
Forward-Looking Statements
This press release contains forward-looking statements within
the meaning of Section 27A of the Securities Act of 1933, as
amended, and Section 21E of the Securities Exchange Act of 1934, as
amended, which are subject to the “safe harbor” created by those
sections. These forward-looking statements include, but are not
limited to, statements concerning: the potential of for the use of
DecisionDx-SCC to guide ART decisions for patients with SCC to
result in Medicare healthcare savings of up to approximately $972
million annually; and the ability of DecisionDx-SCC to (i) guide
personalized patient management decisions, such as frequency of
follow-up care, surveillance imaging, SLNB and the use of ART, (ii)
act as a significant risk stratification factor for regional and
distant metastasis and improve the identification of high-risk
patients when used in combination with clinicopathologic factors or
staging systems and (iii) identify patients who benefitted most
from ART, along with those who are less likely to show a
significant benefit of ART in controlling metastatic disease
progression. The words “can,” “may” and similar expressions are
intended to identify forward-looking statements, although not all
forward-looking statements contain these identifying words. We may
not actually achieve the plans, intentions or expectations
disclosed in our forward-looking statements, and you should not
place undue reliance on our forward-looking statements. Actual
results or events could differ materially from the plans,
intentions and expectations disclosed in the forward-looking
statements that we make. These forward-looking statements involve
risks and uncertainties that could cause our actual results to
differ materially from those in the forward-looking statements,
including, without limitation: subsequent study or trial results
and findings may contradict earlier study or trial results and
findings or may not support the results shown in this study,
including with respect to the discussion of DecisionDx-SCC in this
press release; actual application of our tests may not provide the
aforementioned benefits to patients; and the risks set forth under
the heading “Risk Factors” in our Annual Report on Form 10-K for
the year ended December 31, 2022, our Quarterly Report on Form 10-Q
for the quarter ended September 30, 2023, and in our other filings
with the SEC. The forward-looking statements are applicable only as
of the date on which they are made, and we do not assume any
obligation to update any forward-looking statements, except as may
be required by law.
- Somani SK, Ibrahim SF, Tassavor M, et al. Use of the 40-gene
expression profile (40-gep) test in medicare-eligible patients
diagnosed with cutaneous squamous cell carcinoma (cscc) to guide
adjuvant radiation therapy (art) decisions leads to a significant
reduction in healthcare costs. J Clin Aesthet Dermatol.
2024;17(1):41–44.
- Ibrahim SF, Kasprzak JM, Hall MA, et al. Enhanced metastatic
risk assessment in 218 cutaneous squamous cell carcinoma with the
40-gene expression profile test. Future Oncology.
2022;18(7):833-847. doi:10.2217/fon-2021-1277
- Wysong A, Newman JG, Covington KR, et al. Validation of a
40-gene expression profile test to predict metastatic risk in
localized high-risk cutaneous squamous cell carcinoma. J Am Acad
Dermatol. 2021;84(2):361-369. doi:10.1016/j.jaad.2020.04.088
- Farberg AS, Hall MA, Douglas L, et al. Integrating gene
expression profiling into NCCN high-risk cutaneous squamous cell
carcinoma management recommendations: impact on patient management.
Curr Med Res Opin. 2020;36(8):1301-1307.
doi:10.1080/03007995.2020.1763284
- Singh G, Tolkachjov SN, Farberg AS. incorporation of the
40-gene expression profile (40-gep) test to improve treatment
decisions in high-risk cutaneous squamous cell carcinoma (cSCC)
patients: case series and algorithm. Clin Cosmet Investig Dermatol.
2023;16:925-935. doi:10.2147/CCID.S403330
- Saleeby E, Bielinski K, Fitzgerald A, et al. A prospective,
multi-center clinical utility study demonstrates that the 40-gene
expression profile (40-gep) test impacts clinical management for
Medicare-eligible patients with high-risk cutaneous squamous cell
carcinoma (cSCC). SKIN The Journal of Cutaneous Medicine.
2022;6(6):482-496. doi:10.25251/skin.6.6.5 236
- Hooper PB, Farberg AS, Fitzgerald A, et al. Real-World evidence
shows clinicians appropriately use the prognostic 40-gene
expression profile (40-gep) test for high-risk cutaneous squamous
cell carcinoma (cSCC) patients. Cancer Invest. 2022;40(10):911-922.
doi:10.1080/07357907.2022.2116454
- Koyfman SA, Wysong A, Arron S, et al. Improved risk
stratification in an adjuvant radiation therapy (ART) eligible
cutaneous squamous cell carcinoma (cSCC) patient population by
integration of the 40-gene expression profile prognostic test
(40-GEP). JCO. 2021;39(15_suppl):e21589-e21589.
doi:10.1200/JCO.2021.39.15_suppl.e21589
- Arron ST, Canueto J, Siegel JJ, et al. Association of a 40-gene
expression profile with risk of metastatic disease progression of
cutaneous squamous cell carcinoma (cSCC) and benefit of adjuvant
radiation therapy. Fall Clinical Dermatology Conference, 2023.
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Investor Contact: Camilla Zuckero
czuckero@castlebiosciences.com
Media Contact: Allison Marshall
amarshall@castlebiosciences.com
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