Status Report: Oncogenomic Testing in the Wake of ...

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Annals of Public Health and Research

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*Corresponding author Stephen M. Modell, Department of Epidemiology, University of Michigan School of Public Health, 4628 SPH Tower, 1415 Washington Hts., Ann Arbor, MI 481092029 USA, Tel: 7346153141; Fax: 7347641357; Email:

Status Report: Oncogenomic Testing in the Wake of Health Care Reform

Submitted: 02 March 2015 Accepted: 13 July 2015 Published: 20 July 2015 Copyright

Stephen M Modell1*, Esha Mathew2 and Samantha E Greenberg3,4

© 2015 Modell et al.

1

Department of Epidemiology, Health Management and Policy, University of Michigan School of Public Health, USA 2 Department of Cellular and Molecular Biology, University of Michigan Medical School, USA 3 Department of Health Behavior and Health Education, University of Michigan School of Public Health, USA 4 Department of Human Genetics, University of Michigan Medical School, USA

Abstract

OPEN ACCESS

Keywords • Genetic counseling • Genetic testing • Cancer • Public Health • Health care reform

This review argues that though the Patient Protection and Affordable Care Act (ACA) and Medicaid Expansion have made headway into including genomic counseling and testing in the list of preventive services available to those at-risk for cancer, further steps may be taken. Cancer remains the second leading cause of death in the United States, with an aging population and an increasing proportion of racialethnic minorities. The ACA, and Medicaid and Medicare, have addressed hereditary breast and ovarian cancer in the general population and the underserved, following recommendations issued by the United States Preventive Services Task Force and interpretations by U.S. federal health agencies that allow for coverage of both counseling and testing. The loosening of gene patenting rules by the U.S. Supreme Court has also had a positive impact. Nevertheless, many low-income families remain ineligible for BRCA1/2 counseling and testing under Medicaid and Medicare, despite the recent expansions, and provision under the ACA depends on whether the individual meets qualifying criteria that are not monolithic. Coverage policy of another cancer condition of public health concern, Lynch syndrome, is still evolving. Our review outlines various gaps that remain in coverage policy, and identifies the roles that advocacy organizations and public health officials can play in fully realizing the availability of oncogenomic services to those in need.

ABBREVIATIONS ACA: Patient Protection and Affordable Care Act; C.I.: Confidence Interval; CMS: Centers for Medicare & Medicaid Services; FORCE: Facing Our Risk of Cancer Empowered; HBOC: Hereditary Breast and Ovarian Cancer; HHS: United States Department of Health and Human Services; USPSTF: United States Preventive Services Task Force

INTRODUCTION

Cancer is the second leading cause of death in the United States, and its overall incidence is expected to increase. Although this projection is partially attributable to the aging of the population, an increase in the proportion of the population that is minority may also be a contributing factor. While breast cancer is more common among White women, its mortality at every stage is higher in African American and Latina women [1] (Table 1). Moreover, African American women have a significantly higher incidence of early-onset breast cancer [2-3]. African

Americans continue to experience increased mortality from early-stage premenopausal and early-stage postmenopausal breast (multivariate adjusted hazard ratios for death = 1.43 [95% C.I. = 1.11 to 1.84] and 1.48 [C.I. = 1.27 to 1.72], respectively), advanced-stage ovarian (1.65 [C.I. = 1.21 to 2.24]), and advancedstage prostate cancer (1.19 [C.I. = 1.05 to 1.35])compared to other groups [4] (Table 2). Techniques to identify, monitor and offer prevention and follow-up to individuals at a higher risk of developing hereditary cancers are incredibly important. Provision of services needs to be done in an equitable way. The passage of the Patent Protection and Affordable Care Act (ACA) and Medicaid Expansion have improved access to preventive genetic cancer screens by removing BRCA counseling and in many instances BRCA genetic testing co-pays (ACA), a commonly cited barrier, and enlarging the criteria for coverage of BRCA genetic testing (Medicaid). Oncogenomic services continue to remain unavailable to many underserved families, however. A Harvard/ MGH Center on Genomics review of claims data showed that

Cite this article: Modell SM, Mathew E, Greenberg SE (2015) Status Report: Oncogenomic Testing in the Wake of Health Care Reform. Ann Public Health Res 2(3): 1022.

Modell et al. (2015) Email:

Central Whites were almost twice as likely as African Americans to have received BRCA1/2 breast-ovarian and MLH1/MSH2 colorectal cancer predictive testing [5]. Ultimately the epidemiology of cancer disparities and gaps in oncogenomic services translate into the need for action at multiple levels, both grassroots and governmental.

a BRCA1 mutation have a 39% risk of developing ovarian cancer, and those with an inherited BRCA2 mutation have an 11-17% risk of developing ovarian cancer by age 70. The United States Preventive Services Task Force (USPSTF) recommends, “Women with certain high-risk family health history patterns for breast and ovarian cancer could benefit from receiving genetic counseling to learn about genetic testing for BRCA1/2.” For women with BRCA1/2 mutations, surgery could potentially reduce the risk of breast and ovarian cancer by 85 percent or more [6-7].

DISCUSSION

Hereditary Breast and Ovarian Cancer Policy

For the first time in history, genomics, specifically breast and colorectal cancer genomics, have been added to the Healthy People objectives in order to “improve health and prevent harm through valid and useful genomic tools in clinical and public health practices.” Healthy People 2020 objective G-1 aims to “Increase the proportion of women with a family history of breast and/ or ovarian cancer who receive genetic counseling,” providing an increased need for a public health focus on the provision of genetic services [7]. Access to genetic services needs to be increased given that standard breast and colorectal cancer screening are lagging

Addressing hereditary breast and ovarian cancer at the national level: Hereditary Breast and Ovarian Cancer (HBOC) account for approximately 5-10% of breast cancer diagnoses and 20-25% of all hereditary breast cancers, as diagnosed by BRCA1 and BRCA2 mutations. Additionally, 10% of ovarian cancers have genetic or hereditary causes. A mutation in the BRCA1 gene increases the risk of breast cancer from 12% to 55-65%, whereas a BRCA2 mutation raises the risk to around 45% of developing breast cancer by the age of 70. Similarly, though the general population risk for ovarian cancer is 1.4%, women who inherit Table 1: Association between race and survival for breast cancer*,**.

Hazard ratio***

95% Lower CI

95% Upper CI

Non-Latina White

1.0

ref

ref

Latina

1.1****

1.0

1.2

African American

1.5****

Asian

1.4

0.9

Pacific Islander

0.8

1.5

American Indian / Alaska Native

1.6 1.0

1.2

1.1

1.9

0.8

1.4

*Source: Ooi SL et al. Disparities in breast cancer characteristics and outcomes by ace and ethnicity. Breast Canc Res Treat (2011) **N = 229,594 females, 40-79 years of age, cancer stages I-IV inclusive, enrolled in 17 population-based cancer registries in the Surveillance, Epidemiology, and End results (SEER) program ***Adjusted for clinical prognostic factors, cancer stage, SEER registry, measures of poverty, and education ****P < .05 Table 2: Association between race and survival for various cancers*,**. African Americans

All Other Races 10-Year (and 10-Year (and Median) Median) Survival Survival 77% (Not 68% (Not reached reached at 20 at 20 yrs.) yrs.)

Early-stage premenopausal breast cancer Early-stage 62% (13.5 postmenopausal breast 52% (10.2 years) years) cancer Advanced-stage ovarian 17% (2.3 13% (1.3 years) cancer years) Advanced-stage prostate 6% (2.2 years) 9% (2.7 years) cancer Early-stage colon cancer

…..

…..

African Americans

Hazard Ratio***

95% Lower CI

95% Upper CI

1.43****

1.11

1.84

1.48

1.27

1.72

1.65

1.21

2.24

0.98

0.69

1.4

1.19

1.05

1.35

*Source: Albain KS et al. Racial disparities in cancer survival among randomized clinical trials patients of the Southwest Oncology Group. JNCI (2009) **N = 1,244 (colon cancer) to 4,316 (postmenopausal breast cancer) adult patients enrolled in 35 Southwest Oncology Group phase III clinical trials ***Adjusted for clinical prognostic factors, income, and education ****P