Association of Medicaid Expansion With Timely Receipt of Treatment and Survival Among Patients With HR-Negative, HER2-Positive Breast Cancer

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Kewei Sylvia Shi Surveillance and Health Equity Science, American Cancer Society, Atlanta, GA

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Xu Ji Department of Pediatrics, Emory University School of Medicine, Atlanta, GA
Aflac Cancer & Blood Disorders Center, Children’s Healthcare of Atlanta, Atlanta, GA

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Changchuan Jiang Division of Hematology and Oncology, Department of Internal Medicine, University of Texas Southwestern Medical Center, Dallas, TX

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Kathryn J. Ruddy Department of Oncology, Mayo Clinic, Rochester, MN

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Sharon M. Castellino Department of Pediatrics, Emory University School of Medicine, Atlanta, GA
Aflac Cancer & Blood Disorders Center, Children’s Healthcare of Atlanta, Atlanta, GA

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K. Robin Yabroff Surveillance and Health Equity Science, American Cancer Society, Atlanta, GA

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Xuesong Han Surveillance and Health Equity Science, American Cancer Society, Atlanta, GA

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Background: Hormone receptor (HR)–negative, HER2-positive (also called HER2-enriched) breast cancer has no worse prognosis than other breast cancers if it is treated with HER2-targeted therapy. Medicaid expansion under the Affordable Care Act (ACA) has been shown to be associated with improved access to care and outcomes for many cancers, but its association with receipt of care for HR-negative, HER2-positive breast cancer is unknown. We examined the association of Medicaid expansion with receipt of guideline-concordant treatment, time to treatment initiation, and survival among nonelderly women newly diagnosed with HR-negative, HER2-positive breast cancer. Patients and Methods: Women aged 18 to 62 years newly diagnosed with HR-negative, HER2-positive breast cancer between 2010 and 2018 were identified from the National Cancer Database. Outcomes included receipt of stage-based guideline-concordant treatment, timely initiation of treatment (<30 days, <60 days, <90 days from diagnosis), and stage-specific 2-year overall survival. A difference-in-differences (DID) analytic approach compared outcome changes following Medicaid expansion in expansion versus nonexpansion states. Multivariable linear probability models were used to estimate treatment outcomes, and flexible parametric survival models were used to evaluate survival, adjusting for sociodemographic and clinical confounders. Results: A total of 31,401 patients were included. Medicaid expansion was associated with an increase of 0.58 percentage points (ppt; 95% CI, 0.01–1.16) in receipt of guideline-concordant treatment overall, a 2.43-ppt (95% CI, 0.68–4.18) increase in initiating guideline-concordant treatment <60 days after diagnosis, and a 1.17-ppt (95% CI, 0.02–2.32) increase in 2-year survival rate. The increase in 2-year survival associated with Medicaid expansion was most prominent for patients with stage III disease (DID, 3.81; 95% CI, 0.82–6.80). Conclusions: Medicaid expansion was associated with improved care and survival for patients with HR-negative, HER2-positive breast cancer, an aggressive cancer type for which prognosis largely depends on access to effective treatment.

Background

Hormone receptor (HR)–negative, HER2-positive (also called HER2-enriched) tumors, found in approximately 5% of all patients with breast cancer,1 are characterized by an overexpression of the HER2 protein and a lack of estrogen and progesterone receptors. Although it is an aggressive subtype, it is also notably sensitive to targeted therapies aimed at the HER2 protein.2 However, targeted therapies are expensive,3 and with substantial price increases over the past decade,4 patients without health insurance may not be able to afford treatment. This may limit the potential benefits of these targeted treatments if they are not accessible and affordable, especially among medically underserved patients without health insurance coverage or with limited economic resources.5 Barriers to effective treatment and delays in treatment initiation can lead to worse health outcomes.6 Although the introduction of the Breast and Cervical Cancer Treatment Program (BCCTP) in 20027 by the federal government helped many uninsured women gain access to treatment, the program’s eligibility and coverage vary by state.8 Therefore, ensuring equitable and timely access to treatment is crucial for improving health outcomes for patients with HR-negative, HER2-positive breast cancer.

The Affordable Care Act (ACA) expanded health insurance coverage options, with significant implications for access to care and health.9 Medicaid expansion is a major provision of the ACA, increasing income eligibility to 138% of the federal poverty level (FPL). It has been shown to be associated with reduced uninsured rates, increased access to cancer screening and certain treatments, and improved survival.1013 Thus far, 40 states and the District of Columbia have adopted Medicaid expansion, leaving 10 states yet to implement it.14 In states that have not yet expanded Medicaid eligibility, a considerable number of low-income adults, including adult women with HR-negative, HER2-positive breast cancer, are still uninsured and face barriers to accessing recommended health care services.15

Although accumulating evidence has demonstrated the positive effects of Medicaid expansion for access to care and outcomes for patients with many types of cancer,13,16,17 its impact on care for HR-negative, HER2-positive breast cancer is unknown. In this study, we evaluated the association of Medicaid expansion with receipt of guideline-concordant treatment, time to treatment initiation (TTI), and 2-year overall survival (OS) among nonelderly (age 18–62 years) women newly diagnosed with HR-negative, HER2-positive breast cancer.

Patients and Methods

Data Source

Data for our study were sourced from the National Cancer Database (NCDB), a hospital-based cancer registry across the United States jointly sponsored by the American College of Surgeons and the American Cancer Society.18 It receives data from >1,500 Commission on Cancer (CoC)–accredited hospitals and captures approximately 70% of newly diagnosed cancer cases in the United States annually.19

The Institutional Review Boards of Morehouse School of Medicine and Emory University both granted an exemption for our study due to the deidentified nature of data from the NCDB.

Study Sample

We identified women aged 18 to 62 years who were newly diagnosed with HR-negative, HER2-positive breast cancer between 2010 and 2018 from all 50 states and the District of Columbia. Our follow-up period lasted from cancer diagnosis until the date of death or 3 months prior to the implementation of Medicaid expansion for preexpansion patients, and the date of death or December 31, 2019, for postexpansion patients, whichever came first. We chose 62 years as the upper age cutoff to allow for up to 2 years of survival following diagnosis for women not yet age-eligible for Medicare coverage at 65 years. We excluded the following: (1) diagnoses made <15 months before a state’s Medicaid expansion to ensure a minimum of 12 months of follow-up for all patients; (2) cases of noninvasive cancers or those with unknown stage; and (3) patients with missing information on diagnosis date, vital status, treatment dates, follow-up months, race and ethnicity, or zip code–level income. Figure S1 in the supplementary material (available online with this article) provides further details on the inclusion/exclusion criteria.

Measures

Breast cancer stage was defined according to the AJCC 7th and 8th edition pathologic stage, and clinical stage if pathologic stage was not available.20 HR and HER2 status were defined by the Collaborative Stage (CS) Site-Specific Factors (SSFs) for cases diagnosed before 2018, and Site-Specific Data Items (SSDIs) for cases diagnosed in 2018 and afterward.21,22

The main independent variables were the state’s Medicaid expansion status and preexpansion versus postexpansion period. Expansion states included 24 states and the District of Columbia that had expanded Medicaid by January 2014, as well as 7 late expansion states. Nonexpansion states included 19 states that had not expanded Medicaid eligibility by December 31, 2019 (Supplementary Table S1). For states that expanded in January 2014 and nonexpansion states, cancer diagnoses from 2010 to 2012 were considered preexpansion, and those from 2014 to 2018 were considered postexpansion. For late-expansion states, actual expansion dates were used as cutoff to determine preexpansion and postexpansion periods.

The 3 outcomes for our study were (1) receipt of stage-based guideline-concordant treatment, (2) timely initiation of treatment, and (3) 2-year OS. Guideline-concordant treatment receipt was defined as (1) receiving surgery, chemotherapy, or targeted therapy for all stages combined; (2) receiving surgery for patients diagnosed with stage I–III breast cancer; (3) receiving chemotherapy or targeted therapy (eg, trastuzumab, pertuzumab) for patients diagnosed with stage II, III, and IV, respectively. TTI was calculated as days between time of diagnosis and time of first guideline-concordant treatment (surgery/chemotherapy/targeted therapy) and was categorized into <30 days, <60 days, and <90 days from cancer diagnosis.

The following socioeconomic, demographic, and clinical characteristics are shown in the descriptive table: age group at diagnosis, race/ethnicity, insurance type (uninsured, private, Medicaid, other), zip code–level median household income (≤138% of federal poverty level [FPL], 139%–400% of FPL, ≥401% of FPL), region of residence (Northeast, Midwest, South, West), metropolitan status of residence (metropolitan, nonmetropolitan), Charlson-Deyo comorbidity score (0, ≥1),23 and facility type (community cancer program, academic cancer program, other). Race and ethnicity were dichotomized as non-Hispanic White and other. Sample characteristics of baseline year 2010 are shown in Supplementary Table S2.

Statistical Analysis

Descriptive statistics of patients’ socioeconomic, demographic, and clinical characteristics in expansion and nonexpansion states were calculated. Unadjusted Kaplan-Meier survival curves were constructed for patients in expansion and nonexpansion states during the preexpansion and postexpansion periods.

The difference-in-differences (DID) approach was used to investigate the association between Medicaid expansion and each outcome. Linear probability models were used to compare receipt of stage-specific guideline-concordant treatment and TTI between preexpansion and postexpansion for expansion and nonexpansion states. Flexible parametric survival models were used to estimate 2-year OS.24,25 All models incorporated a continuous variable representing the year of diagnosis to adjust for secular trends and also adjusted for age group, race/ethnicity, zip code–level income, metropolitan status, and comorbidity score. Random effects accounted for clustering at the state level. A similar supplemental analysis was conducted to examine associations of Medicaid expansion and insurance coverage and stage at diagnosis. All analyses were performed using SAS 9.4 (SAS Institute Inc.) and R version 4.0.4 (R Development Core Team). All tests were 2-sided with a significance level of 0.05.

Results

We identified 31,401 patients with HR-negative, HER2-positive breast cancer diagnosed between 2010 and 2018, with 19,248 women in Medicaid expansion states and 12,153 women in nonexpansion states (Table 1). Patients in nonexpansion states were more likely to be racial/ethnic minorities (36.2% vs 32.0%), uninsured (6.4% vs 2.4%), living in lower income areas (9.5% vs 5.7%) and nonmetropolitan areas (14.5% vs 9.5%), and not treated at an academic cancer program (29.1% vs 35.0%) compared with patients in expansion states. The change of insurance coverage and stage of diagnosis preexpansion and postexpansion are presented in Supplementary Table S3. The proportion of uninsured patients decreased from 3.2% to 1.9% in expansion states and from 6.5% to 6.3% in nonexpansion states. The percentage of patients with stage I breast cancer diagnosis increased from 36.1% to 36.9% in expansion states and decreased from 34.0% to 33.8% in nonexpansion states, although not statistically significant.

Table 1.

Patient Characteristics

Table 1.

Figure 1 displays the Kaplan-Meier survival curves for expansion and nonexpansion states, preexpansion and postexpansion. Survival in Medicaid expansion states improved after expansion, with the 2-year survival rate increasing from 93.9% to 95.0%. In contrast, in nonexpansion states, there was an initial downward trend of survival after expansion, although by the end of the 2-year period, the rate was almost unchanged from 94.0% to 93.9%.

Figure 1.
Figure 1.

Kaplan-Meier survival curves, by expansion versus nonexpansion states and preexpansion versus postexpansion, for women aged 18 to 62 years with newly diagnosed HR-negative, HER2-positive breast cancer.

Abbreviation: HR, hormone receptor.

Citation: Journal of the National Comprehensive Cancer Network 2024; 10.6004/jnccn.2024.7041

Changes in receipt of treatment, TTI, and survival by Medicaid expansion status are shown in Table 2. Overall, Medicaid expansion was significantly associated with an increase of 0.58 percentage points (ppt; 95% CI, 0.01 to 1.16) in the receipt of guideline-concordant treatment, with a decrease from 98.7% preexpansion to 98.5% postexpansion in expansion states and a larger decrease from 99.0% to 98.2% in nonexpansion states.

Table 2.

Changes in Cancer Outcomes by Medicaid Expansion Status

Table 2.

Medicaid expansion was significantly associated with an increase in initiating guideline-concordant treatment <60 days from diagnosis (DID, 2.43 ppt; 95% CI, 0.68 to 4.18) and <90 days from diagnosis (DID, 1.41 ppt; 95% CI, 0.24 to 2.58). There was a difference in treatment initiation <30 days from diagnosis, although it was not statistically significant (DID, 1.23 ppt; 95% CI, −1.11 to 3.56). Furthermore, there was a 1.17-ppt (95% CI, 0.02 to 2.32) increase in 2-year survival rate in the full cohort associated with Medicaid expansion, with the largest improvement observed among patients newly diagnosed with stage III disease who experienced a 3.81-ppt increase (95% CI, 0.82 to 6.80).

Discussion

In this nationwide study of patients newly diagnosed with HR-negative, HER2-positive breast cancer, we found a declining trend in receipt of guideline-concordant treatment and timely initiation of treatment. However, the decline was slower in Medicaid expansion states, leading to a 0.58-ppt net increase in receipt of guideline-concordant treatment overall and a 2.43-ppt net increase in timely treatment initiation within 60 days of diagnosis associated with Medicaid expansion. Moreover, Medicaid expansion was associated with a 1.17-ppt net increase in 2-year OS, especially among patients with stage III disease (3.81 ppt). The associations of Medicaid expansion with HR-negative, HER2-positive breast cancer care and outcomes identified in our study are more prominent compared with prior studies on all subtypes of breast cancer or breast cancer among young adult population.13,26 Medicaid expansion has multiple health benefits, including increasing health insurance coverage, recommended service utilization, quality of care, survivorship care, and health outcomes across a variety of diseases.16,2729 Focusing on a common cancer type with effective treatments, this study adds to the growing evidence by demonstrating the positive effects of Medicaid expansion on increased access to care and improved health outcomes among patients with breast cancer.11,30

Clinical trials of HER2-targeted therapy found significant improvement in OS among patients with HR-negative, HER2-positive breast cancer.31 However, HER2-targeted drugs such as trastuzumab deruxtecan and tucatinib are expensive and can cost thousands of dollars per month for patients without health insurance coverage.3 In addition, with >70% of the Medicaid programs across states operating through managed care plans and the observed higher enrollment in expansion states,32 variations in these plans’ features (eg, provider networks, scope of service coverage, and cost-sharing) may further impact access to care.33,34 Exploring how these differences in managed care plans affect health care delivery and outcomes is warranted for future research. Furthermore, the HER2 protein has been found on a variety of solid tumors beyond breast cancer, including gastric, colorectal, non–small cell lung, and bladder cancers,35 suggesting that the demand for HER2-targeted therapy may increase. Notably, the federal BCCTP program has been shown to bring benefits in care delivery for many women with breast or cervical cancer, especially in states that have not expanded Medicaid. However, a recent study found that patients who benefited from the BCCTP program still faced lower survival rates compared with the general population of patients with cancer.36 This underscores the need for programs like BCCTP to reach more patients with more types of cancer and ensure continuous, long-term coverage for optimal cancer outcomes.

Although many previous studies have focused on the benefits of Medicaid expansion under the ACA on cancer screening and early diagnosis,10,37,38 our study examined timely receipt of guideline-concordant treatment and survival among patients with HR-negative, HER2-positive breast cancer. The improvements in treatment and survival associated with Medicaid expansion could be explained, at least in part, by the insurance coverage gain resulting from Medicaid expansion. Previous studies showed that uninsured women with cancer were less likely to receive certain treatments compared with insured counterparts.39,40 Moreover, Medicaid expansion has been shown to reduce disparities in access to surgical care in high-volume hospitals between uninsured/Medicaid insured patients and privately insured patients with cancer.41,42 Furthermore, Medicaid expansion is associated with increased clinical trial enrollment among socioeconomically vulnerable patients with cancer and Medicaid coverage.43 Our study adds to this literature by providing new evidence from patients with HR-negative, HER2-positive breast cancer, and reinforces the importance of policies that can improve insurance coverage for access to effective cancer treatments.

We found larger improvement of OS in expansion states compared with nonexpansion states, and this benefit was most pronounced for patients with stage III breast cancer. Stage III is a critical juncture in the course of the disease because it can easily progress to become incurable if undertreated, making it a pivotal stage for interventions that can influence patient outcomes. Although we did not have information in the NCDB to comprehensively evaluate every type of care received by patients with stage III disease, it is possible that with health insurance coverage, patients were more likely to receive timely and comprehensive access to life-saving neoadjuvant or adjuvant therapies, to have better medication adherence, and to complete treatment, which lead to better survival outcomes.

Although we identified a significant improvement in TTI among expansion states compared with nonexpansion states, we observed that the time frame of treatment initiation in HR-negative, HER2-positive breast cancer was delayed post-2014 in all states. Prior studies found that TTI has been prolonged during the years of our study for all cancers.4447 The necessity for health insurance prior authorizations might be a contributing factor to these delays in care delivery.44 Another possible reason might be related to higher volumes of patients with newly diagnosed breast cancer requiring treatment during the past years.48,49 Furthermore, patient preferences, physician workforce, and increasing complexity of care and adoption of advanced technologies such as genomic testing may also contribute to the increased TTI.46

It is noteworthy that a delay in treatment initiation does not always correlate with poorer survival outcomes. In other research, associations between treatment delays and survival were mixed and varied largely by stage at diagnosis, cancer type, and length of delay.50 A previous study reported that a lag of 4 weeks in cancer treatment initiation was associated with a 6% to 8% increase in mortality rates.6 For breast cancer, a study identified a proportional increase of mortality risk with every 60-day delay period.51 Another study showed that delayed surgery was associated with worse survival.52 Research has also indicated that any effects of delayed chemotherapy initiation on breast cancer survival were larger for more aggressive subtypes.53

Our study has limitations. First, the NCDB is a hospital-based cancer registry and not population-based, limiting the generalizability of our findings. However, the demographics of NCDB patients have been shown to be comparable to those of the SEER registries54,55 and include 70% of all patients with newly diagnosed cancer. Second, we only measured OS because the NCDB lacks data on cause of death. Future studies could examine the associations of Medicaid expansion on breast cancer–specific survival using other data sources with a smaller percentage of newly diagnosed patients in a subset of states but containing cause of death information. Third, we did not examine disparities in receipt of treatment or survival by age, race and ethnicity, comorbidity burden, or type of treating facility due to small sample sizes. Prior studies have indicated that patients who are older, of Black race, have more comorbidities, and are treated at comprehensive cancer centers or Veteran’s Affairs hospitals are more likely to experience treatment delays.44,45 Future studies should examine whether Medicaid expansion mitigates these disparities.

Conclusions

Medicaid expansion was associated with a slower decrease in receipt of guideline-concordant treatment, reduced delays in treatment initiation, and improved 2-year survival among nonelderly women newly diagnosed with HR-negative, HER2-positive breast cancer. Expanding insurance coverage to individuals with cancer can allow them to benefit from access to life-saving treatments.

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Submitted September 14, 2023; final revision received March 28, 2024; accepted for publication May 20, 2024. Published online October 23, 2024.

Author contributions: Study concept & design: All authors. Data interpretation: All authors. Formal analysis: Shi, Han. Project administration: Han. Writing—original draft: Shi. Writing—review & editing: All authors.

Disclosures: Dr. Castellino has disclosed serving as a scientific advisor for Seattle Genetics. Dr. Yabroff has disclosed serving as a scientific advisor for Flatiron Health. Dr. Han has disclosed receiving grant/research support from AstraZeneca. The remaining authors have disclosed that they have not received any financial consideration from any person or organization to support the preparation, analysis, results, or discussion of this article.

Funding: This work was supported by grant R03CA259665 (X. Ji, S.M. Castellino, X. Han) from the National Cancer Institute of the National Institutes of Health.

Disclaimer: The content is solely the responsibility of the authors and does not necessarily represent the official views of the National Institutes of Health. None of the funders had no role in the design of the study; collection, analysis, and interpretation of the data; writing of the manuscript; and decision to submit the manuscript for publication.

Supplementary material: Supplementary material associated with this article is available online at https://doi.org/10.6004/jnccn.2024.7041. The supplementary material has been supplied by the author(s) and appears in its originally submitted form. It has not been edited or vetted by JNCCN. All contents and opinions are solely those of the author. Any comments or questions related to the supplementary materials should be directed to the corresponding author.

Correspondence: Kewei Sylvia Shi, MPH, American Cancer Society, Surveillance and Health Equity Science, 270 Peachtree Street NW, Suite 1300, Atlanta, GA 30303. Email: sylvia.shi@cancer.org

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    Mohanty S, Bilimoria KY. Comparing national cancer registries: the National Cancer Data Base (NCDB) and the Surveillance, Epidemiology, and End Results (SEER) program. J Surg Oncol 2014;109:629630.

    • PubMed
    • Search Google Scholar
    • Export Citation

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