Health Care Costs in Clinical Trial Participants With Advanced Lung Cancer

ABSTRACT

Objectives: To evaluate the impact of clinical trial participation (CTP) on health care costs among patients with advanced lung cancer.

Study Design: Retrospective cohort study

Methods: Using deidentified administrative claims data from commercial and Medicare Advantage (MA) enrollees in the Optum Labs Data Warehouse, we selected patients with evidence of advanced lung cancer, no other primary cancers, systemic anticancer therapy, and continuous identification from January 1, 2018, to February 28, 2022. Patients were categorized as “with CTP” (International Classification of Diseases, Tenth Revision, Clinical Modification code Z00.6 and ≥ 1 Q modifier [signifying Medicare clinical trial routine or investigational services] on or within 90 days after index claim) or “without CTP.” Total health care costs (2022 US$) per patient per month were measured during the follow-up period and adjusted for baseline characteristics using generalized linear models.

Results: The study included 274 patients with CTP (20.8% commercially insured and 79.2% MA) and 8500 without CTP (15.3% commercially insured and 84.7% MA). For patients with commercial insurance, total health care costs were lower with CTP than without CTP, both unadjusted ($19,774 vs $25,653; P = .011) and adjusted ($18,792 vs $27,040; cost ratio, 0.70; 95% CI, 0.51-0.94; P = .018). In MA patients, total health care costs were lower with CTP than without CTP before adjustment ($9869 vs $11,668; P = .014) but were not significantly different after adjustment ($14,074 vs $12,539; cost ratio, 1.12; 95% CI, 0.98-1.29; P = .102).

Conclusions: In this insured population with advanced lung cancer, patients with CTP had lower or similar total adjusted health care costs compared with patients without CTP, and CTP did not appear to increase costs paid by the patients or health plans.

Am J Manag Care. 2026;33(2):In Press

doi:10.37765/ajmc.2026.90052

Takeaway Points

Among commercially insured and Medicare Advantage patients with advanced lung cancer, concerns about the cost impact of clinical trial participation (CTP) may discourage broader testing and enrollment.

• This study examined total health care costs among patients with advanced lung cancer, with and without CTP.
• CTP did not appear to increase costs paid by the patient or health plan among this population.
• Results may alleviate concerns about the impact of CTP on health care costs.

Lung cancer is a leading cause of cancer-related deaths in the US.¹ In 2025, approximately 226,650 new cases of lung cancer were diagnosed.¹ Advances in molecular profiling have revealed that lung cancer harbors numerous actionable tumor DNA mutations and activating fusions.² According to practice guidelines, somatic biomarker testing for 19 different biomarker mutations is recommended for patients with newly diagnosed stage IV lung cancer.³ Guidelines advise broader molecular profiling to appropriately counsel patients regarding the availability of clinical trials.⁴ A 2016 study evaluated pharmacogenomic-based inclusion criteria for clinical trials and found that 68% of clinical trials involving oncology-targeted therapies required documentation of a biomarker.⁵

Guidelines encourage clinical trial participation (CTP) for all patients with lung cancer.⁴ Although Medicare covers costs in clinical trials, it is not required to cover the cost of biomarker testing to determine trial eligibility.⁶ Addressing payer concerns about perceived higher costs associated with CTP may allow broader coverage of testing to determine trial eligibility.

In a previous study evaluating health care costs associated with CTP, Merkhofer et al assessed costs for Medicare and commercial payers among 22 patients with CTP and 48 without CTP who had metastatic non–small cell lung cancer (NSCLC) and were receiving second-line systemic therapy at a single institution between January 2007 and December 2015.⁷ CTP was associated with a savings of $6663 per month throughout the trial.⁷ Building on this single-institution finding, Wiedower et al conducted a retrospective cohort study using a clinical genomic database to examine the costs of care for patients with advanced NSCLC following liquid biopsy between June 2014 and March 2022 in 323 patients with CTP compared with matched controls without CTP.⁸ Results suggested that patients with CTP had similar health care costs to those without CTP and better real-world overall survival.⁸ To expand research in this area, we compared health care costs by CTP status among commercially insured and Medicare Advantage (MA) patients with advanced lung cancer.

METHODS

Design

This retrospective cohort analysis examined commercial and MA health plan members with advanced lung cancer. The data source was deidentified administrative pharmacy and medical claims, enrollment records, and death information for enrollees from the Optum Labs Data Warehouse (OLDW) from January 1, 2017, to February 28, 2023 (study period). The OLDW contains longitudinal health information for enrollees and patients across the US. eAppendix A (eAppendix available at ajmc.com) presents an overview of the methods for assigning the index date for patients without claims evidence of CTP.

Institutional review board approval or waiver of approval was not required for this study because the study data were secondary and deidentified in accordance with the Health Insurance Portability and Accountability Act Privacy Rule’s requirements for deidentification, codified at 45 CFR §164.514(b).

Study Population

Included patients were required to have 2 or more medical claims for nondiagnostic services 30 or more days apart with a diagnosis code for lung cancer (International Classification of Diseases, Tenth Revision, Clinical Modification [ICD-10-CM] diagnosis code C34*) in any position and at least 1 medical claim for a nondiagnostic service with a diagnosis code for advanced cancer (ICD-10-CM diagnosis codes C77*, C78*, C79*, C7B*, C80.0) in the identification period (January 1, 2018-February 28, 2022). Patients were also required to have at least 1 claim with a National Drug Code or Healthcare Common Procedure Coding System code for systemic anticancer treatment in the identification period. For patients with CTP, the index date was the date of their first claim with a diagnosis code for CTP (ICD-10-CM diagnosis code Z00.6) on or after the date of the first claim with a diagnosis code for advanced cancer in the identification period.

Patients without CTP received a randomly selected index date based on the distribution of the number of days from the first observed advanced cancer diagnosis to the index date among patients with CTP.

Patients were excluded if they had fewer than 360 days of continuous enrollment prior to the index date (baseline period) or after the index date (follow-up period), unless due to death; were younger than 18 years; had missing demographic data; had at least 1 claim with a CTP diagnosis code at baseline; had at least 1 medical claim with a Q0 or Q1 modifier code (signifying Medicare clinical trial investigational or routine services, respectively) but no medical claims with a diagnosis code for CTP (ICD-10-CM diagnosis code Z00.6) during the study period; had at least 2 nondiagnostic medical claims at least 30 days apart for 2 or more primary cancers in any position on the claim during baseline or follow-up; had claims evidence of CTP but no claims with a Q0 or Q1 modifier on the date of or within 90 days after the index date; or died on the index date.

Cohort Assignment

Patients with claims evidence of CTP were included in the CTP cohort. Patients were assigned to the non-CTP cohort if there were no medical claims with a diagnosis code for CTP (ICD-10-CM diagnosis code Z00.6) during the study period. Patients without CTP were excluded from the study sample if they did not have a medical claim within the range of days defined by their randomly assigned quartile, measured from their first claim with an advanced cancer diagnosis code.

Study Variables

The primary outcome variable was health care costs in the follow-up period. All-cause health care costs were assessed in the follow-up period and reported in per patient per month (PPPM) US$.Subcategories of health care costs were also reported, including pharmacy costs (systemic anticancer treatment and other costs) and medical costs (systemic anticancer treatment, biomarker testing, ambulatory visits, inpatient hospitalizations, emergency department [ED] visits, and other costs). Health care resource utilization (HCRU) PPPM was also assessed. To account for the variable follow-up time among patients who died during follow-up, PPPM values were calculated as:

(total costs or HCRU during follow-up ÷ number of follow-up days) × 30.

Health care costs were further categorized as health-plan paid vs patient paid. Health care costs were adjusted for inflation using the Consumer Price Index for 2022.⁹

We collected baseline demographics and clinical characteristics, including index year, age at index year, sex, and geographic region.¹⁰ The time from the first observed advanced cancer diagnosis to the index date was recorded for each patient. The length of patient follow-up was also recorded. Treatment center type was categorized as a comprehensive cancer center (CCC) for patients with 1 or more medical claims from a National Cancer Institute–designated CCC facility provider during the baseline period or on the index date, using previously published methodology.¹¹ Baseline comorbidities were collected, and the Quan-Charlson Comorbidity Index (Quan-CCI)¹² was calculated. Baseline biomarker testing was identified by at least 1 claim with a biomarker test procedure code during the baseline period and was categorized as comprehensive genomic profiling (CGP), non-CGP, or unknown type. Baseline use of systemic anticancer treatment was identified and categorized as recent use (≥ 1 claim for systemic anticancer treatment in the 60-day period prior to index), nonrecent use (without recent use and with ≥ 1 claim for systemic anticancer treatment during baseline), or no claims for systemic anticancer treatment during baseline. Baseline use of radiation therapy was identified by at least 1 claim with a procedure code for radiation therapy in the baseline period. Additional baseline measures included HCRU and all-cause health care costs.

Analyses

Analyses were performed using SAS 9.4 (SAS Institute Inc), and results were stratified by insurance type. Bivariate comparison between patients with CTP and patients without CTP were assessed with t tests for means and χ²tests for proportions, and P values were reported. Kaplan-Meier analyses were used to assess survival during the follow-up period. Multivariable analyses were performed to assess health care costs after adjusting for baseline characteristics. Due to the right-skewed distribution of health care cost data, we used generalized linear models with a gamma distribution and a log link for these analyses.^13-15 Modified Park tests were used to assess the relationship between the variance and the mean and to select the gamma distribution. Covariates included in the models were age, sex, year of index date, geographic region (Midwest, Northeast, South, West), baseline Quan-CCI, treatment center type (CCC or other), days from first observed advanced cancer diagnosis in the baseline period to the index date, medical costs PPPM from the first claim with an advanced cancer diagnosis in the baseline period to the index date, pharmacy costs PPPM from the first claim with an advanced cancer diagnosis in the baseline period to the index date, baseline timing of systemic anticancer treatment, baseline use of biomarker testing, and baseline use of radiation therapy.

RESULTS

The CTP cohort included 274 patients; 20.8% had commercial insurance, and 79.2% had MA (Figure 1). The cohort without CTP included 8500 patients; 15.3% had commercial insurance, and 84.7% had MA (Figure 2).

Baseline Characteristics

Patients with CTP were more likely than patients without CTP to be treated at a CCC (commercial insurance: 40.4% vs 27.0% [P = .028]; MA: 33.2% vs 14.5% [P < .001]) and have baseline CGP or other biomarker testing (commercial: 54.4% vs 34.6% [P = .002]; MA: 46.1% vs 34.0% [P < .001]) (Table 1).

Among both commercially insured and MA populations, patients with CTP had lower recent baseline use (within 60 days of index date) of a systemic anticancer treatment than patients without CTP (commercial: 47.4% vs 62.2% [P = .025]; MA: 47.5% vs 57.1% [P = .005]) and lower baseline medical costs (commercial: $29,746 vs $47,065 [P = .005]; MA: $11,168 vs $20,840 [P < .001]) (Table 1).

Follow-Up Measures

For patients with commercial insurance, the mean (SD) follow-up time was 277.6 (116.6) days and 282.6 (121.8) days for the with-CTP and without-CTP cohorts, respectively (P = .759). For those with MA, the mean (SD) follow-up time was 278.1 (111.0) days for the with-CTP cohort and 257.5 (128.4) days for the without-CTP cohort (P = .008).

Among patients with commercial insurance, total unadjusted health care costs PPPM in the follow-up period were lower for patients with CTP than for those without CTP (mean: $19,774 vs $25,653; P = .011) (Table 2). After adjusting for differences in baseline characteristics, including baseline medical and pharmacy costs, total health care costs PPPM among commercially insured patients in the follow-up period were significantly lower for those with CTP than for those without CTP ($18,792 vs $27,040; cost ratio, 0.70; 95% CI, 0.51-0.94; P = .018). Most costs (97%-98%) were plan paid, with only 2% to 3% patient paid (Table 2).

For patients with MA insurance, the mean unadjusted total health care costs during follow-up were $9869 for those with CTP vs $11,668 for those without CTP (P = .014). After adjusting for differences in baseline characteristics, including baseline medical and pharmacy costs, total health care costs PPPM in the follow-up period were not significantly different for patients with CTP vs patients without CTP ($14,074 vs $12,539; cost ratio, 1.12; 95% CI, 0.98-1.29; P = .102). Most costs (92%-93%) were plan paid, with 5% to 6% patient paid (Table 2).

HCRU visit counts in the follow-up period are shown in Table 3. For both the commercially insured and MA populations, patients with CTP had a similar number of hospital and ED visits in the follow-up period as patients without CTP but had more frequent ambulatory visits (commercial mean: 8.1 vs 6.5 [P = .015]; MA mean: 7.7 vs 6.8 [P = .003]). Kaplan-Meier analyses found similar overall survival for patients with CTP vs those without in both the commercial population (log-rank P = .583 [eAppendix B]) and the MA population (log-rank P = .227 [eAppendix C]).
DISCUSSION

In this study of commercially insured and MA patients with advanced lung cancer, those with CTP had lower or similar total adjusted health care costs similar to patients without CTP. Hospital and ED visits during the follow-up period were similar between patients with and without CTP, but ambulatory visits were higher among patients with CTP. Survival analyses demonstrated no significant differences between those with CTP and those without. This finding is central to interpreting cost outcomes, as it suggests that cost comparisons are not confounded by differential mortality or truncated follow-up.

In a previously published study using the OLDW over a similar time frame, patients with NSCLC had first-line systemic therapy costs ranging from $14,269 to $21,045 PPPM for those with commercial insurance and $8209 to $13,149 PPPM for those with MA.¹⁶ By comparison, systemic therapy costs for patients with advanced lung cancer and without CTP in the present study—closer in composition to the previous study’s NSCLC cohort—were lower, averaging $11,148 PPPM for commercial patients and $5353 PPPM for MA patients. However, the previous study examined patients with NSCLC and measured costs during first-line systemic therapy, whereas the present study included patients with a broader diagnosis of lung cancer and measured costs over the entire follow-up period, which may account for differences between the 2 studies.

This study expands on the work of Merkhofer et al⁷ and Wiedower et al⁸ by examining the costs associated with CTP among patients with advanced lung cancer using recent data from a nationwide database. Results of this present study align with these previously published studies,^7,8 demonstrating that CTP is not associated with greater total health care costs to payers among commercially insured and MA patients. Patients with CTP had different baseline characteristics than patients without CTP, which was not unexpected given that prior studies have shown age, sex, and racial disparities in cancer CTP.^17,18 To control for differences between the with-CTP and without-CTP cohorts, we adjusted health care costs for baseline characteristics. Patients with CTP exhibited significantly higher ambulatory visit utilization but similar inpatient and ED use compared with those without CTP. This pattern likely reflects protocol monitoring rather than increased morbidity, although adverse event–related visits cannot be ruled out.

One notable baseline difference was a higher percentage of patients with CTP received care at a CCC than did patients without CTP (commercial: 40.4% vs 27.0% [P = .028]; MA: 33.2% vs 14.5% [P < .001]). Multiple previously published studies have shown that cancer treatment costs at CCCs are substantially higher than in the community setting.^19-21 In the present study, unadjusted and adjusted health care costs for patients with CTP were found to be lower or similar to those of patients without CTP, despite the higher percentage of patients with CTP receiving treatment at a CCC.

Another notable difference in baseline treatment characteristics for patients with CTP vs patients without CTP was the use of molecular biomarker testing. When compared with patients without CTP, more patients with CTP had CGP or other biomarker testing (commercial: 54.4% vs 34.6% [P = .002]; MA: 46.1% vs 34.0% [P < .001]). This finding aligns with previous research that showed CTP was facilitated using CGP.⁸

Despite concerted efforts to improve CTP in patients with cancer, enrollment remains low (2%-8%), which has been attributed to a variety of barriers.^22-24 A systematic literature review assessing barriers to CTP found that one potential barrier is patient concerns about costs.²⁴ The present study’s findings may help alleviate some of these concerns, as CTP did not appear to increase costs paid by patients or health plans.

The selection of the index date for patients without CTP relied on the assumption of a temporal relationship between first observed advanced cancer diagnosis and disease phase and treatment trajectory on the index date. Accordingly, we used the distribution of the number of days from the first observed advanced cancer diagnosis to the index date for patients with CTP to randomly assign a claim for the index date for patients without CTP. Multivariable analysis was used to further control for baseline differences. Further research is warranted to confirm whether the temporal alignment of advanced cancer diagnosis to index date reflects comparable points in the advanced cancer care continuum.

Limitations

This study has limitations related to the use of claims data. Because investigational treatments and procedures are usually not reimbursed by health insurers, CTP coding information (ICD-10-CM code Z00.6) may not always be submitted through administrative claims. CTP was identified using diagnosis codes and Q modifiers, which may incompletely capture CTP because sponsor-funded services are often excluded from claims. The potential for nondifferential misclassification of a CTP patient as a non-CTP patient would favor the null hypothesis that there is no difference in costs between the 2 groups. In addition, claims data do not contain information on the specific start and end date for patients with CTP. The lower baseline costs and recent baseline use of systemic therapies in patients with CTP suggest nonrandom selection of clinically healthier patients in the with-CTP group, and the longer time from first observed cancer diagnosis suggests a longer duration of advanced cancer in the with-CTP group vs the without-CTP group. Although the analysis of health care costs adjusted for baseline characteristics, key clinical determinants of both CTP and health care costs, such as performance status, tumor burden, and molecular subtype, were not available in claims data, creating potential for residual confounding by unmeasured disease severity that could impact cost estimates. In this data set, most standard deviations exceed means, indicating that data are right-skewed, driven by outliers. Lastly, this study was limited to commercially insured and MA patients, so the results may not be generalizable to other populations. Despite these limitations, claims data remain a robust source for the real-world examination of HCRU and costs.

CONCLUSIONS

Among commercially insured and MA patients with advanced lung cancer, those with CTP had lower or similar total adjusted health care costs compared with those without CTP, and CTP did not appear to increase costs paid by the patient or health plan. These findings may help alleviate cost-related concerns that have been cited as a barrier to CTP, supporting continued efforts to expand trial access in this population.

Acknowledgments

The authors would like to acknowledge Gretchen Hultman, MPH, of Optum for medical writing support.

Author Affiliations: Illumina, Inc (SS, DH, JLF), San Diego, CA; Optum (KS, PM, JC, JT), Eden Prairie, MN.

Source of Funding: This work was funded by Illumina.

Author Disclosures: Dr Spencer, Mr Hostin, and Dr Fox report employment at Illumina. Dr Stockl, Ms Morin, Ms Certa, and Ms Tucker report employment at Optum and are shareholders. Dr Spencer reports that his employer operates in the next-generation sequencing space and builds sequencers. Dr Stockl and Ms Certa report receipt of funding from Illumina to conduct this study. Dr Stockl, Ms Morin, Ms Certa, and Ms Tucker report stock ownership in UnitedHealth Group. Dr Fox and Mr Hostin report stock ownership in Illumina, Inc.

Authorship Information: Concept and design (SS, KS, DH, JC, JLF); acquisition of data (KS, PM, JT); analysis and interpretation of data (SS, KS, PM, JC, JT, JLF); drafting of the manuscript (SS, PM, JC, JT, JLF); critical revision of the manuscript for important intellectual content (SS, KS, JC, JLF); statistical analysis (SS, PM, JT); provision of patients or study materials (SS); obtaining funding (SS, DH, JLF); administrative, technical, or logistic support (SS, DH, JC); and supervision (SS, DH).

Address Correspondence to: John L. Fox, MD, MHA, Illumina, 5200 Illumina Way, San Diego, CA 92122. Email: jfox1@illumina.com.

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