Расовые различия в выживании нескольких миелом: ассоциации с трансплантацией стволовых клеток, страхованием и расширением сети медицинских учреждений.

INTRODUCTION

Multiple myeloma (MM) is the most common hematologic cancer in Black individuals in the United States, accounting for nearly 20% of cases. Incidence and mortality in Black individuals are about twice as high as among White individuals. 1 Advances in novel therapies, increased use of autologous stem cell transplantation (ASCT), and improvements in supportive care have dramatically improved 5‐year survival, rising from 35.5% to 52.6% between 2000 and 2011. 2 Despite these gains, survival comparisons between Black and White patients remain inconsistent. 3 , 4 Some studies suggest that disparities narrow when both groups have comparable access to therapy and transplantation, 5 , 6 underscoring the central role of equitable health care access in shaping outcomes.

Racial differences in access to advanced MM care may reflect structural socioeconomic inequities, including disparities in employment‐based private health insurance coverage and income, shaped by long‐standing discriminatory policies and practices in the United States. 7 For many, Medicaid is the primary source of coverage, 8 yet prior studies suggest that Medicaid beneficiaries are less likely to undergo transplantation and have poorer survival. 9 , 10 , 11 Differential access to Medicaid expansion under the Affordable Care Act may further influence these inequities. We sought to investigate the relations among race, ASCT utilization, health insurance type, and survival in MM and to explore the potential role of Medicaid expansion among those younger than 65 years through a retrospective observational study of Black and White patients who had MM diagnosed between 2011 and 2021 using real‐world data. We hypothesized that differential access to insurance and ASCT may contribute to racial differences in MM survival and that diagnosis in states after Medicaid expansion may be associated with higher ASCT utilization and better survival.

MATERIALS AND METHODS

We used the Flatiron Health research database, an electronic health record–derived, longitudinal database of de‐identified patient‐level data. This data set includes structured and unstructured information curated through technology‐enabled abstraction from approximately 280 US cancer clinics and 800 care sites at the time of data extraction. 12 The database captures routinely collected clinical data, including demographics, diagnoses, tumor characteristics, laboratory values, treatment patterns, and outcomes, primarily from community oncology practices, with a smaller proportion from academic centers. The City of Hope Institutional Review Board determined that this study did not constitute human subjects research.

Eligible patients were adults (aged 18 years and older) newly diagnosed with MM between January 1, 2011, and December 1, 2021, who identified as non‐Hispanic Black or non‐Hispanic White (hereafter referred to as Black and White, respectively) and had data on state of residence at diagnosis and first‐line therapy (LoT1). Health insurance information was longitudinal, classified as Commercial Health Plan , Medicaid , Medicare , other government program , other payer—type unknown , patient assistance program , self‐pay , and Workers Compensation . A patient could have multiple insurance types, each with start and end date of coverage. If only one of these dates was available, the coverage period was assumed to extend 1 year before or after the recorded date. Insurance type at diagnosis was determined by comparing coverage periods with the date of MM diagnosis. If no insurance coverage overlapped with the diagnosis date or if coverage data were missing, the patient was classified as having unknown insurance. We grouped self‐pay only ( n = 10) and patient assistance program only ( n = 146) into unknown because actual coverage could not be determined. For analysis, insurance was further classified as private (commercial only), Medicare (any Medicare without Medicaid), any Medicaid, or other (non‐Medicaid, non‐Medicare government program or unknown payer type). Medicare–Medicaid dual‐eligible patients were classified as Medicaid, consistent with the Surveillance, Epidemiology, and End Results program classification and prior evidence indicating greater socioeconomic and health care vulnerability compared with Medicare‐only beneficiaries. 13 , 14 , 15 Patients with del(17p), t(14;16), t(4;14), or amp(1q21) were classified as high cytogenetic risk 16 ; those with documented absence of these abnormalities were considered standard risk. Medicaid expansion status and adoption dates were obtained from publicly available sources. 17

Statistical analysis

Real‐world overall survival (rwOS) was analyzed using Cox proportional hazard regression, with ASCT treated as a time‐varying covariate. The likelihood of ASCT was evaluated with a Fine and Gray subdistribution hazard regression, treating death as competing risk. Factors associated with insurance were identified using polytomous regression. The time‐to‐event was defined from MM diagnosis to death for Cox regression and from diagnosis to ASCT for Fine and Gray regression; in both analyses, patients were censored at the last activity in the Flatiron Health database through December 31, 2022. Proportional hazards assumptions were tested using interactions between covariates and survival time. Candidate covariates included International Staging System stage, cytogenetic risk, age at diagnosis, sex, year of diagnosis, race, years to LoT1, receipt of bortezomib + lenalidomide + dexamethasone as LoT1, and ASCT (for rwOS outcome). Age was modeled continuously, with separate effects examined for patients younger than 65 years and those aged 65 years and older. Parsimonious multivariable models were constructed using stepwise selection, retaining covariates with p < .05. Effects of ASCT, insurance, and Medicaid expansion on rwOS were incorporated individually into multivariable models, with ASCT and Medicaid expansion treated as time‐varying covariates. Analyses of Medicaid expansion status at the time of diagnosis were limited to patients younger than 65 years diagnosed in Medicaid expansion states, with within‐state clustering accounted for using multilevel methods. Treatment and insurance status were excluded as covariables given their role as mediators. Missing data were addressed using multiple imputation with 20 replications (see Supporting Methods) and the estimates combined. 18 Analyses were performed using SAS version 9.4 (SAS Institute Inc.). Two‐sided p < .05 was considered statistically significant. No adjustment was made for multiple testing.

RESULTS

The cohort included 4932 patients, of whom 24% were Black (Table 1 ; see Figure S1 ), all diagnosed in the community oncology setting. Compared with White patients, Black patients were more often women (54.0% vs. 44.0%), were diagnosed at a younger age (median, 67.1 vs. 71.5 years), and more frequently lived in states without Medicaid expansion at diagnosis (72.9% vs. 55.2%; see Figure S2 ). They also presented with more favorable disease profiles (International Staging System stage I, 40.4% vs. 29.6%; standard cytogenetic risk, 42.1% vs. 34.6%) and were more likely to have Medicaid insurance (16.0% vs. 4.8%). These trends were consistent across both younger (younger than 65 years) and older (65 years and older) subgroups (see Table S1 ). During a median follow‐up of 3.1 years, 42.5% of Black patients and 48.4% of White patients died ( p < .001).

ASCT was performed at a younger median age among Black versus White patients (aged 59.7 vs. 63.4 years; p < .001). Stratified by age (see Table S1 ), Black patients were less likely to receive ASCT (younger than 65 years: 46.2% vs. 58.5%; p < .001; 65 years and older: 11.8% vs. 15.2%; p = .027). The time from diagnosis to ASCT was also longer for Black patients (younger than 65 years: 8.1 vs. 7.2 months; p < .001; 65 years and older: 7.9 vs. 7.1 months; p = .059). The most common LoT1 was bortezomib + lenalidomide + dexamethasone (41.0%). Overall, 74.7% of patients received proteasome inhibitors, 65.9% received immunomodulatory drugs, and 3.5% received monoclonal antibodies. Except for lower proteasome inhibitor use in Black versus White patients younger than 65 years, LoT1 receipt and timing did not differ by race ( p > .05).

Real‐world OS

Unadjusted mortality risk was lower for Black patients than for White patients (hazard ratio [HR] 0.84; 95% confidence interval [CI], 0.76–0.93; data not shown). However, after adjustment for age, sex, International Staging System stage, cytogenetic risk, time to LoT1, and receipt of bortezomib + lenalidomide + dexamethasone as LoT1, Black patients overall had higher mortality (adjusted HR [aHR], 1.11; 95% CI, 1.00–1.23; Table 2 , model 2A), which was not modified by age at diagnosis (younger than 65 years, 65 years and older; p = .93; data not shown). Overall mortality was reduced with receipt of ASCT (aHR, 0.59; 95% CI, 0.51–0.67; model 2B). Adjusting for ASCT also rendered overall racial differences as statistically not significant (aHR, 1.07; 95% CI, 0.96–1.19). Similar changes in aHR were observed across age groups (models 2Aa–2Ba and 2Ab–2Bb; see Table S2 ), although the race effect did not reach statistical significance, likely reflecting reduced power because of the small sample size. These findings suggest that differential access to ASCT accounts for much of the survival disparity between Black and White patients.

Compared with private insurance, rwOS among patients diagnosed when younger than at 65 years was worse for those with Medicaid coverage (aHR, 1.61; 95% CI, 1.16–2.24), whereas no difference was observed for Medicare coverage (aHR, 0.88; 95% CI, 0.64–1.20; model 2Ca; see Table S2 ). Among patients aged 65 years and older, Medicare was associated with a trend toward improved rwOS (aHR, 0.77; 95% CI, 0.60–1.01), whereas no difference was observed for Medicaid (aHR, 0.92; 95% CI, 0.62–1.34; model 2Cb; see Table S2 ).

Access to ASCT

As shown in Table 3 , Black patients were less likely to undergo ASCT (younger than 65 years: adjusted subdistribution HR [asHR], 0.63; 95% CI, 0.54–0.74; 65 years and older: asHR, 0.54; 95% CI, 0.42–0.69) after adjusting for demographic and clinical factors (models 3A and 3D). ASCT was significantly less likely under Medicaid for those younger than 65 years (asHR, 0.50; 95% CI, 0.38–0.67) but not for those 65 years and older (asHR, 0.67; 95% CI, 0.31–1.47), although estimates in the older group were limited by the small sample size; no significant difference was observed for Medicare compared with private insurance (models 3B and 3E). Adjusted for insurance, Black patients remained less likely to receive ASCT (younger than 65 years: asHR, 0.70; 95% CI, 0.60–0.82; 65 years and older: asHR, 0.54; 95% CI, 0.42–0.69). Among patients who received ASCT, the median time from diagnosis to transplantation remained longer for Black patients (younger than 65 years: 8.1 vs. 7.2 months; p < .001 [aHR, 0.82; 95% CI, 0.71–0.95]; 65 years and older: 7.9 vs. 7.1 months; p = .059 [aHR, 0.84; 95% CI, 0.67–1.06] see Tables S1 and S3 ).

Health insurance

Table 4 shows the adjusted odds ratios (aORs) for insurance type at diagnosis relative to private insurance. Among patients diagnosed at when younger than 65 years in both expanded and nonexpanded states, the odds for those with Medicare coverage increased with age, whereas the odds for those with Medicaid coverage remained unchanged. Among patients aged 65 years and older in expansion states, the odds for patients who had both Medicare and Medicaid coverage decreased in more recent years, with no significant time trends observed in nonexpansion states. Across all strata, Black patients were more likely than White patients to have Medicaid coverage at diagnosis (younger than 65 years in expansion states: aOR, 3.25; 95% CI, 1.94–5.44; nonexpansion states: aOR, 4.38; 95% CI, 2.33–8.23; 65 years and older in expansion states: aOR, 2.81; 95% CI, 1.34–5.93; nonexpansion states: aOR, 2.92; 95% CI, 1.29–6.61).

Medicaid expansion

The association between Medicaid expansion and outcomes was evaluated among 935 patients diagnosed at when younger than 65 years in expansion states. In this subset, expansion status at diagnosis was not associated with rwOS (model 2Da; see Table S2 ) or receipt of ASCT (model 3C; Table 3 ). However, expansion was associated with a reduction in the odds of Medicare coverage (aOR, 0.64; 95% CI, 0.44–0.93), with a nonsignificant increased odds of Medicaid coverage (aOR, 1.24; 95% CI, 0.72–2.14; Tables 4 and 5 ).

DISCUSSION

Differences in survival after MM are shaped in part by access to care, including insurance coverage and access to effective therapies like ASCT. Medicaid, in particular, is an important source of coverage for socioeconomically vulnerable populations, 8 yet it has been consistently associated with lower rates of transplantation and poorer survival relative to private insurance. 5 , 9 , 10 , 14 Prior studies have also demonstrated that Black patients are less likely to undergo ASCT than White patients. 11 , 19 , 20 , 21 These factors have often been examined in isolation, with limited prior work jointly evaluating them, including one study of patients aged 65 years and older in the Surveillance, Epidemiology, and End Results–Medicare database. 19 By using a contemporary electronic health record–derived data set, we evaluated the joint associations of race, insurance coverage, ASCT, and survival within a unified framework and further examined the potential effect of Medicaid expansion among patients younger than 65 years, the population most directly affected by this policy.

Our analyses yielded three key observations. First, Medicaid coverage was strongly associated with a lower likelihood of receiving ASCT, with patients younger than 65 years substantially less likely to undergo transplantation than those with private insurance. Second, Black patients were more likely to have Medicaid coverage at diagnosis and less likely to undergo ASCT, suggesting overlapping structural factors that may contribute to differences in treatment access. After accounting for ASCT and insurance, the observed survival difference between Black and White patients was attenuated, supporting the role of access to care in observed disparities. Third, among patients younger than 65 years who reached oncology care, Medicaid expansion was not associated with receipt of ASCT or rwOS but was associated with shifts in insurance coverage, including reduced Medicare and a nonsignificant increase in Medicaid enrollment. A possible explanation is that expanded Medicaid eligibility based on income alone may have disincentivized pursuit of Social Security Disability Insurance–linked Medicare, which requires stringent disability criteria, has low approval rates, and involves a long waiting period before coverage begins. 22 , 23 Together, these findings suggest that Medicaid coverage is an important barrier to ASCT and that Medicaid expansion alone may be insufficient to improve access to complex therapies or eliminate disparities in outcomes.

Our findings highlight the central role of Medicaid coverage in shaping access to transplantation. Patients with Medicaid were substantially less likely to receive ASCT than those with private insurance, consistent with prior work. 11 , 19 , 21 At the same time, Black patients were more likely to have Medicaid coverage at diagnosis, suggesting that differences in insurance coverage may compound racial disparities in access to transplantation. These associations likely reflect structural and health care system factors influencing access to ASCT rather than intrinsic biologic differences.

Medicaid coverage varies across states, which may not align with national transplantation guidelines. Prior audits have identified inconsistent eligibility criteria, unclear transplantation coverage, exclusions based on behavioral or comorbid conditions, 24 , 25 , 26 and limited support for travel, lodging, and caregiver expenses, all of which are critical for successful ASCT delivery. Administrative complexity, financial constraints, and limited flexibility for time away from work may further hinder access. Together, these factors suggest that Medicaid‐related barriers extend beyond insurance status alone and may limit access to resource‐intensive therapies such as ASCT.

Medicaid expansion has been associated with reduced rates of uninsurance, earlier diagnosis, improved outcomes in several solid tumors, 27 , 28 , 29 , 30 , 31 , 32 , 33 , 34 and narrowed racial disparities in some studies. 29 , 35 , 36 , 37 However, among patients with MM younger than 65 years who had already reached oncology care in our study population, Medicaid expansion was not associated with receipt of ASCT or survival. These findings may reflect the nature of the Flatiron Health population, which includes patients already engaged in oncology care and thus may be less sensitive to policy changes occurring earlier in the care continuum. In addition, unlike chemotherapy or surgery, which may be initiated within community oncology practices, ASCT requires referral to specialized centers, multiprovider coordination, and substantial caregiver and logistic support. Although Medicaid expansion increases insurance coverage, limited transplantation‐related benefits and persistent structural barriers associated with Medicaid may continue to impede access to ASCT and sustain disparities. These findings suggest that Medicaid expansion alone may be insufficient to address disparities in access to highly complex cancer therapies such as ASCT.

Whereas Medicaid coverage appears to represent an important barrier to ASCT, additional patient‐level and provider‐level factors may also contribute, as indicated by the lower likelihood of Black patients undergoing ASCT. Patient‐level barriers include financial strain beyond medical costs, limited caregiving support, perceived barriers to the health care system, and variations in counseling and access to information regarding ASCT benefits relative to induction therapy. 38 Provider‐level barriers include implicit bias, reluctance to refer patients perceived as socially or financially vulnerable, and unfamiliarity with Medicaid authorization processes. 38 Addressing these barriers will likely require coordinated strategies beyond coverage expansion, including culturally tailored education, navigation support for logistics and caregiving, and provider training or incentives to promote equitable referrals.

Interpretation of our findings should consider several limitations. Comorbidities, as well as educational attainment, socioeconomic status, and distance to treatment centers—factors that disproportionately affect Black populations 39 , 40 —were not captured and may influence ASCT eligibility and outcomes. Nevertheless, prior studies indicated persistent disparities even after accounting for comorbid conditions. 19 , 41 The Flatiron Health database does not capture cause‐specific mortality, limiting our ability to distinguish myeloma‐related from nonmyeloma‐related deaths and to interpret whether observed survival differences reflect disease progression potentially influenced by ASCT access or competing causes. This cohort was treated largely before the routine use of anti‐CD38 antibodies and quadruplet induction, although randomized trials continue to support a progression‐free survival benefit with upfront ASCT. 42 , 43 Black patients with access to academic oncology centers may have better outcomes. It is important to note that, because the Flatiron Health data set captures patients who reached oncology care, our analyses of Medicaid expansion reflect insurance patterns among treated patients rather than effects on earlier stages of access, such as diagnosis or referral. State‐level variations in Medicaid policies and patient mix may also limit generalizability.

Despite these limitations, the current study integrates clinical, insurance, and policy factors within a single analytic framework in a large, contemporary cohort. Our findings suggest that Medicaid coverage represents a key barrier to the receipt ASCT within this treated population and that Medicaid expansion alone may be insufficient to close these gaps. As resource‐intensive therapies, such as chimeric antigen receptor T‐cell therapy, move earlier in the MM treatment paradigm, disparities observed in ASCT access may foreshadow similar challenges. Addressing these inequities will likely require coordinated strategies beyond coverage expansion, including more consistent transplantation policies, supportive services, equitable referral practices, and patient‐centered navigation to ensure that advances in MM therapy benefit all populations.

AUTHOR CONTRIBUTIONS

F. Lennie Wong: Conceptualization; methodology; software; data curation; investigation; validation; formal analysis; writing—original draft; writing—review and editing; funding acquisition. Scott R. Goldsmith: Investigation; writing—review and editing. Kimlin Ashing: Writing—review and editing. Amrita Krishnan: Writing—review and editing. Michael A. Rosenzweig: Writing—review and editing. Saro H. Armenian: Methodology; investigation; writing—review and editing.

CONFLICT OF INTEREST STATEMENT

Scott R. Goldsmith reports fees for advisory board activities from Bioline, Bristol Myers Squibb Company, Janssen Biotech, Legend Biotech, and Pfizer outside the submitted work; speaking fees from Bristol Myers Squibb Company and Johnson & Johnson. Amrita Krishnan reports personal/consulting fees from AbbVie, AstraZeneca, Bristol Myers Squibb Company, GlaxoSmithKline LLC, Johnson & Johnson, Legend Biotech, Pfizer Inc., Roche, and Sanofi Pasteur Biologics LLC; service on independent review committees for Bristol Myers Squibb Company and GlaxoSmithKline; and stock ownership in Arcellx and Bristol Myers Squibb Company outside the submitted work. Michael A. Rosenzweig reports personal/consulting fees from AbbVie Biotherapeutics and Janssen Biotech; and support for other professional activities from Akcea Therapeutics, Bristol Myers Squibb Company, Celgene Corporation, and Takeda Pharmaceutical Company outside the submitted work. The remaining authors disclosed no conflicts of interest.

Supporting information

Supporting Information S1

ACKNOWLEDGMENT

This work was supported by Blood Cancer United, formerly The Leukemia & Lymphoma Society (Equity in Access grant HSR9016‐23; F. Lennie Wong, principal investigator). The funder did not play a role in the design of the study; the collection, analysis, or interpretation of the data; the writings of the article; or the decision to submit the article for publication.

DATA AVAILABILITY STATEMENT

The data that support the findings of this study were originated by and are the property of Flatiron Health, Inc. Requests for data sharing by license or by permission for the specific purpose of replicating results in this article can be submitted to publicationsdataaccess@flatiron.com .

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