Pharmacogenomics (PGx), the study of inherited genomic variation and drug response or safety, is a vital tool in precision medicine. In oncology, testing to identify PGx variants offers patients the opportunity for customized treatments that can minimize adverse effects and maximize the therapeutic benefits of drugs used for cancer treatment and supportive care. Because individuals of shared ancestry share specific genetic variants, PGx factors may contribute to outcome disparities across racial and ethnic categories when genetic ancestry is not taken into account or mischaracterized in PGx research, discovery, and application. Here, we examine how the current scientific understanding of the role of PGx in differential oncology safety and outcomes may be biased toward a greater understanding and more complete clinical implementation of PGx for individuals of European descent compared with other genetic ancestry groups. We discuss the implications of this bias for PGx discovery, access to care, drug labeling, and patient and provider understanding and use of PGx approaches. Testing for somatic genetic variants is now the standard of care in treatment of many solid tumors, but the integration of PGx into oncology care is still lacking despite demonstrated actionable findings from PGx testing, reduction in avoidable toxicity and death, and return on investment from testing. As the field of oncology is poised to expand and integrate germline genetic variant testing, it is vital that PGx discovery and application are equitable for all populations. Recommendations are introduced to address barriers to facilitate effective and equitable PGx application in cancer care.

Aim: Commercial plan coverage policies for multigene panel tests may vary and could result in geographic variation in coverage due to the fragmented nature of the commercial insurance market. This study aimed to characterize the alignment of multigene panel tests coverage policies to that of clinical guidelines, overall and by state. Materials & methods: We reviewed NCCN Guidelines® for four tumors. Public coverage policies were identified via web search. Payer policies included those with the largest or second largest number of commercial lives in each state. Policies were classified as 'more restrictive' or 'consistent' with the guidelines. Results: Of 38 plans/policies reviewed, 71% were classified as 'more restrictive' than the guidelines, with variation in the number of commercial lives by state. Among these, 52% restricted on panel size and 63% restricted in all or select tumors. Conclusion: Most coverage policies were more restrictive. Clinical guideline clarity and state policies may improve alignment to guidelines and geographic variations.

Importance Logistical challenges such as travel time and distance to a clinical trial site can be a barrier to patient participation. The association of remote technology use and other decentralization tools that can reduce these barriers with likelihood to enroll in cancer trials is not well understood. Objective To assess the association of remote technology and other decentralization tools used to reduce participation-related time and travel with the likelihood to enroll in cancer clinical trials. Design, Setting, and Participants Between July 6 and September 8, 2021, a 41-question, cross-sectional, internet-based survey was administered to patients with cancer and survivors of cancer in the US who had been diagnosed with or treated for cancer in the past 7 years. Main Outcomes and Measures Increase in self-reported likelihood to enroll in cancer clinical trials that use remote technology and other decentralization tools to decrease the need for travel to the trial site. Results There were 1183 survey respondents, with a mean (SD) age of 58.2 (12.5) years. Respondents self-reported their gender, race and ethnicity, cancer type, and treatment status. Of the 1183 respondents, 848 (72%) were female, 296 (25%) were male, 8 (1%) were other/nonbinary, and 31 (3%) declined to answer. With regard to race, 28 respondents (3%) were American Indian or Alaska Native, 25 (2%) were Asian, 234 (20%) were Black or African American, 20 (2%) were Native Hawaiian or Other Pacific Islander, 825 (70%) were White, and 51 (4%) declined to answer. With regard to ethnicity, 115 respondents (10%) were Hispanic, Latino/Latina, or of Spanish origin, whereas 1017 (86%) were not and 51 (4%) declined to answer. Regarding cancer type and treatment status, 483 respondents (41%) either had or had survived breast cancer and 325 (28%) were being treated for cancer during the survey period. Individuals older than 55 years were more likely to say that they would only participate in trials no farther from their home than their regular care health care practitioner compared with younger respondents (26% vs 16%, respectively;P = .02). Higher-income earners (ie, those in households earning >$125 000/y) were significantly more likely than lower-income earners (ie, those in households earning <$70 000/y) to say they would participate in trials requiring additional effort (62% vs 41%, respectively;P = .03). If given the opportunity to enroll in a cancer clinical trial that required travel farther than their regular care, a majority of respondents (range, 60%-85%) indicated that they would be more likely to participate if the trial used remote technology and other tools to decrease the need for travel to a trial site. Conclusions and Relevance In this cross-sectional study, the survey findings suggest that cancer clinical trials leveraging remote technology and decentralization tools to reduce patient time and travel burden associated with participation may increase the patient consent rate.

Comprehensive biomarker testing has become the standard of care for informing the choice of the most appropriate targeted therapy for many patients with advanced cancer. Despite evidence demonstrating the need for comprehensive biomarker testing to enable the selection of appropriate targeted therapies and immunotherapy, the incorporation of biomarker testing into clinical practice lags behind recommendations in National Comprehensive Cancer Network guidelines. Coverage policy differences across insurance health plans have limited the accessibility of comprehensive biomarker testing largely to patients whose insurance covers the recommended testing or those who can pay for the testing, and this has contributed to health disparities. Furthermore, even when insurance coverage exists for recommended biomarker testing, patients may incur burdensome out-of-pocket costs depending on their insurance plan benefits, which may also create barriers to testing. Prior authorization for biomarker testing for some patients can add an administrative burden and may delay testing and thus treatment if it is not done in a timely manner. Recently, three states (Illinois, Louisiana, and California) passed laws designed to improve access to biomarker testing at the state level. However, there is variability among these laws in terms of the population affected, the stage of cancer, and whether the coverage of testing is mandated, or the legislation addresses only prior authorization. Advocacy efforts by patient advocates, health care professionals, and professional societies are imperative at the state level to further improve coverage for and access to appropriate biomarker testing.

IMPORTANCE In March 2018, Medicare issued a national coverage determination (NCD) for nextgeneration sequencing (NGS) to facilitate access to NGS testing among Medicare beneficiaries. It is unknown whether the NCD affected health equity issues for Medicare beneficiaries and the overall population. OBJECTIVE To examine the association between the Medicare NCD and NGS use by insurance types and race and ethnicity. DESIGN, SETTING, AND PARTICIPANTS A retrospective cohort analysis was conducted using electronic health record data derived from a real-world database. Data originated from approximately 280 cancer clinics (approximately 800 sites of care) in the US. Patients with advanced non-small cell lung cancer (aNSCLC), metastatic colorectal cancer (mCRC), metastatic breast cancer (mBC), or advanced melanoma diagnosed from January 1, 2011, through March 31, 2020, were included. EXPOSURE Pre- vs post-NCD period. MAIN OUTCOMES AND MEASURES Patients were classified by insurance type and race and ethnicity to examine patterns in NGS testing less than or equal to 60 days after diagnosis. Differencein-differences models examined changes in average NGS testing in the pre- and post-NCD periods by race and ethnicity, and interrupted time-series analysis examined whether trends over time varied by insurance type and race and ethnicity. RESULTS Among 92 687 patients with aNSCLC, mCRC, mBC, or advanced melanoma, mean (SD) age was 66.6 (11.2) years, 51 582 (55.7%) were women, and 63 864 (68.9%) were Medicare beneficiaries. The largest racial and ethnic categories according to the database used and further classification were Black or African American (8605 [9.3%]) and non-Hispanic White (59 806 [64.5%]). Compared with Medicare beneficiaries, changes in pre- to post-NCD NGS testing trends were similar in commercially insured patients (odds ratio [OR], 1.03; 95% CI, 0.98-1.08; P =.25). Pre- to post-NCD NGS testing trends increased at a slower rate among patients in assistance programs (OR, 0.93; 95% CI, 0.87-0.99; P =.03) compared with Medicare beneficiaries. The rate of increase for patients receiving Medicaid was not statistically significantly different compared with those receiving Medicare (OR, 0.92; 95% CI, 0.84-1.01; P =.07). The NCD was not associated with statistically significant changes in NGS use trends by racial and ethnic groups within Medicare beneficiaries alone or across all insurance types. Compared with non-Hispanic White individuals, increases in average NGS use from the pre-NCD to post-NCD period were 14% lower (OR, 0.86; 95% CI, 0.74-0.99; P =.04) among African American and 23% lower (OR, 0.77; 95% CI, 0.62-0.96; P =.02) among Hispanic/Latino individuals; increases among Asian individuals and those with other races and ethnicities were similar. CONCLUSIONS AND RELEVANCE The findings of this study suggest that expansion of Medicarecovered benefits may not occur equally across insurance types, thereby further widening or maintaining disparities in NGS testing. Additional efforts beyond coverage policies are needed to ensure equitable access to the benefits of precision medicine.