Cost-Effectiveness of Remote Tailored Risk Communication and Navigation for Hereditary Genetic Risk Assessment Uptake: Economic Evaluation From the Genetic Risk Assessment for Cancer Education and Empowerment Trial.

Cost-effectiveness of remote tailored risk communication and navigation for hereditary genetic risk assessment uptake: economic evaluation from the GRACE trial - PMC Skip to main content An official website of the United States government Here's how you know Here's how you know Search Log in Primary site navigation Search Log in Search PMC Full-Text Archive Search in PMC Journal List User Guide As a library, NLM provides access to scientific literature. Inclusion in an NLM database does not imply endorsement of, or agreement with, the contents by NLM or the National Institutes of Health. Learn more: PMC Disclaimer | PMC Copyright Notice JCO Oncol Pract . Author manuscript; available in PMC: 2026 Jun 1. Published in final edited form as: JCO Oncol Pract. 2024 Dec 11;21(6):824–831. doi: 10.1200/OP-24-00617 Cost-effectiveness of remote tailored risk communication and navigation for hereditary genetic risk assessment uptake: economic evaluation from the GRACE trial Elizabeth A Handorf 1, 2 , Jean A McDougall 3 , Emily Heidt 2 , Jinghua An 2 , Scott T Walters 4 , Deborah L Toppmeyer 2 , Anita Y Kinney 1, 2 Author information Article notes Copyright and License information 1. Rutgers University School of Public Health, Rutgers University, The State University of New Jersey, Newark, NJ 2. Rutgers Cancer Institute, New Brunswick, NJ 3. Fred Hutchison Cancer Center, Seattle, WA 4. University of North Texas Health Science Center, Fort Worth, TX ✉ Corresponding author address: Rutgers Cancer Institute, 120 Albany Street, room 5007, Tower II, New Brunswick, NJ 08901, ehandorf@cinj.rutgers.edu Issue date 2025 Jun. PMC Copyright notice PMCID: PMC12152208  NIHMSID: NIHMS2035516  PMID: 39661922 The publisher's version of this article is available at JCO Oncol Pract Abstract Purpose The Genetic Risk Assessment for Cancer Education and Empowerment (GRACE) Project demonstrated that Tailored Counseling and Navigation (TCN) substantially increased the rate of genetic evaluation (GE) in women with high-risk breast or ovarian cancer (OR 8.9, 95% CI 3.4–23.5 for TCN vs Usual Care). This study sought to estimate the cost and cost-effectiveness of TCN in a clinic setting, from a societal perspective. Methods We identified the components of the intervention and downstream outcomes which would result in resource use. We assessed time spent by staff, cost of mailings, cost of patient time, and cost of testing and counseling through 6 months. Incremental cost-effectiveness ratios were calculated for outcomes of interest. We assessed the sensitivity of our results to assumptions via one-way sensitivity analyses. Also, we assessed how results would change if a higher volume of patients were given TCN, with a health coach working full-time. Results TCN cost $68,924 to deliver tor 212 patients, or $325 per patient. The intervention cost was $2,154 per record-verified GE. Much of this was attributed to training costs for health coaches ($50,223). When including testing and counseling, the incremental cost effectiveness ratio (ICER) of TCN versus usual care was $3,250 per additional GE. This was most sensitive to TCN effectiveness (i.e GE rate in TCN patients), and cost of testing. Cost-effectiveness would be more favorable with higher coaching volume (ICER of $1,730/GE). Conclusions Implementing TCN in a clinic setting would come with notable costs, and current reimbursement policies for telemedicine may not be sufficient. Cost-effectiveness of TCN can be improved if subsequent interventions are more efficacious or are delivered to greater patient volumes. Keywords: Genetic counseling, hereditary cancer risk, cost-effectiveness, microcosting 1. Background According to national guidelines, women who are diagnosed with high-risk breast or ovarian cancer should receive a hereditary cancer risk assessment. 1 Genetic Evaluation (GE) through genetic counseling and/or testing may result in the identification of inherited pathogenic variants. This could inform the patient’s cancer treatment and trigger GE for at-risk biological relatives. 2 – 7 Despite these benefits, GE rates in high-risk cancer survivors in the US remain low, as over half of breast and ovarian cancer survivors who meet national criteria have not had genetic counseling and/or testing. 8 , 9 This motivates interventions to increase the uptake of GE. The Genetic Risk Assessment for Cancer Education and Empowerment (GRACE) Project was designed to assess the efficacy of a telephone-based psychoeducation and navigation intervention to increase uptake of GE in high-risk breast and ovarian cancer survivors. 10 In this 3-arm randomized controlled trial participants were assigned to Usual Care (UC), Targeted Print (TP), or Tailored Counseling and Navigation (TCN). TP participants received an educational brochure that aimed to increase awareness about hereditary cancer risk, address the benefits of GE, and enhance patients’ self-efficacy to obtain GE. TCN patients received the same mailed brochure, followed by a health coaching telephone call that provided personalized counseling and navigation. Health coaches received training to deploy evidence-based health communication and behavior change theories and motivational interviewing techniques. 11 – 14 UC participants received no intervention by 6-month assessment. The protocol for this study has been described in detail elsewhere. 10 A total of 641 participants (1:1:1 randomized) were included in the final analysis. The TCN intervention substantially increased the rate of GE compared to UC (OR 8.9, 95% CI 3.4–23.5) and TP (OR 7.4, 95% CI 3.0–18.3). Nevertheless, the rate of GE in the TCN arm was still modest (19% when outcome known, 15% with negative outcome imputation), indicating the need for further strategies to reduce barriers to testing. During the GRACE study (between November 2017 and July 2020), consensus guidelines for GE of hereditary breast and ovarian cancer survivors changed. (18) At the start, guidelines recommended that patients be referred for genetic counseling, after which the patient could make an informed decision about testing (prior papers termed this process “Cancer Genetic Risk Assessment”). 15 In November 2019, the American Society of Breast Surgeons released consensus guidelines stating that referral to a genetic counselor before testing is no longer required. Thus, we define a “Genetic Evaluation (GE)” as genetic counseling and/or testing. In high-risk breast and ovarian cancer patients, germline genetic testing is usually cost-effective. 16 – 18 Nevertheless, the cost of interventions to motivate and guide patients to access genetic counseling and/or testing is under-studied, which inspires our current work. Although the TCN intervention was shown to effective, cost is an important consideration for dissemination. We therefore conducted an economic evaluation alongside the GRACE randomized controlled trial, similar to what has been done for prior studies 15 , 19 Using a microcosting approach, 20 we estimated the costs of each of the three intervention arms: TCN, TP, UC. We then calculated the difference in costs and outcomes compared to UC, and estimated the cost per additional GE. 2. Methods This analysis includes costs that would be incurred if implementing this intervention in a clinical practice for 212 patients (the number of patients on the TCN arm). Costs of intervention development and study-specific costs were excluded; we excluded costs of participant ascertainment and recruitment, participants’ compensation, and survey administration. The costs include the following sources: 1) training health coaches, 2) brochure printing and mailing, 3) staff costs consisting of salaries and overhead for administrative staff and health coaches, 4) participant time, and 5) downstream genetic counseling and testing and related costs. Costs were calculated in 2022 dollars, from a societal perspective. The Consumer Price Index (CPI) was used to convert costs measured in earlier years. 21 Key model inputs are summarized in Table 1 , with additional details in the Supplementary Table . Table 1: Key model inputs Tailored Counseling and Navigation (TCN) Tarted Print (TP) Usual Care (UC) Est Range Est Range Est Range Training ($) 50223.2 39550.4 60267.9 0 - - 0 - - Overhead ($) 388.1 - - 7.6 - - 0 - - Mailings ($) 1441.6 - - 705.9 - - 0 - - HC hours per pt 1.3 1.1 2.1 0 - - 0 - - Staff hours per pt 0.2 - - 0.03 - - 0 - - HC Wages+benefits/hr 40.9 35.4 46.3 40.9 35.4 46.3 40.9 35.4 46.3 Staff Wages+benefits/hr 29.1 - - 29.1 - - 29.1 - - Participant time $/hr 24.0 20.7 27.1 24.0 20.7 27.1 24.0 20.7 27.1 Participant time (hr per person coached) 0.8 0.8 0.8 0 - - 0 - - Participant time (hrs per person tested) 2.0 1.4 2.6 2.0 1.4 2.6 2.0 1.4 2.6 Participant time (hrs per person counseled) 1.4 0.9 2.6 1.4 0.9 2.6 1.4 0.9 2.6 Participant travel cost ($ per person tested) 6.3 - - 6.3 - - 6.3 - - Cost ($) per test 679.1 486.0 1824.9 679.1 486.0 1824.9 679.1 486.0 1824.9 Cost ($) per genetic counseling session 118.0 58.0 211.0 118.0 58.0 211.0 118.0 58.0 211.0 Number of genetic tests 27.0 18.2 38.1 5.0 1.6 11.5 5.0 1.6 11.5 Number of genetic counseling sessions 23.0 14.8 33.6 5.0 1.6 11.5 5.0 1.6 11.5 Number of GEs (genetic counseling and/or testing) 32.0 22.4 43.7 6.0 2.2 12.8 5.0 1.6 11.5 Open in a new tab Most costs were assumed to be variable (i.e., costs rise with an increased number of participants), while training costs were considered fixed. Our base case analysis uses the number of patients from the study to assess variable costs. In an additional scenario analysis, we increased the number of patients. The population of interest is women with a personal history of high-risk cancer, as defined by National Comprehensive Cancer Network guidelines. 15 This includes women diagnosed with breast cancer (any type at age ≤50, triple-negative breast cancer diagnosed at age ≤60, or ≥2 primary breast cancers), or with epithelial ovarian, peritoneal, or fallopian tube cancer. This study was approved by all participating sites’ Institutional Review Boards. All patients gave informed consent. 2.1.1. Costs of intervention delivery The costs to train interventionists were assumed to be fixed and include instructor fees for training sessions, and follow-up motivational interviewing coding and supervision. Initial training took 28 hours (3.5 days), and follow-up coding and supervision took 133 hours. One additional training session was required due to staff turnover. In sensitivity analysis, we assume that the cost of initial in-person training could be conducted remotely, for a savings of 50%. The cost of materials included brochures, printouts, and postage. 21 – 26 Staff costs included wages and benefits, using the national averages reported by the Bureau of Labor Statistics. 27 For health coaches we used the average wages reported for “health education specialists” ($28.84/hour), 28 and for administrative staff we used the “Office and Administrative” subsection of the “health care and social assistance industry” ($20.58 /hour). 29 . Upper and lower bounds for sensitivity analyses were based on area-level variability in mean wages. 30 Based on study invoices in the TCN arm, we estimated that the time spent per patient by the health coach was 1.32 hours. Time used by administrative staff included scheduling calls and preparing mailings; we estimated that each patient required 0.22 hours in the TCN condition and 0.03 hours in the TP condition. Mailing costs were based on US postage rates, invoices for envelopes, and industry-reported prices for printing. Overhead costs included the cost of office space (50 square feet per staff member, $38 per square foot) 31 , and telecom costs ($39 per line per month). These overhead costs were adjusted to the proportion of hours for a full-time worker that would be spent on TCN-related tasks. The costs of participant time for the counseling session were $23.95/hour, the median female wage in the US. 32 Time spent in counseling sessions was recorded as part of the study procedures. 2.1.2. Outcomes and related costs In this study, GE uptake is defined as receipt of genetic counselling and/or genetic testing, confirmed by medical record verification. In our prior study, GE rates were calculated in various ways to account for missing data. Here we conservatively chose the “medically verified, negative outcome imputation” rates of GE (i.e., patients with unknown testing/counseling considered not receiving GE), as opposed to imputed or complete case rates. When calculating costs, genetic counseling and testing were considered separately. These costs were obtained from Centers for Medicare and Medicaid Services or relevant literature. 33 , 34 We also considered participant time and travel costs for genetic counseling (minimal travel distances were reported for testing). 35 These values were obtained via a follow-up self-administered survey at 6 months after the intervention (for TCN and TP arms) or baseline assessment (for UC arm). Upper and lower bounds for sensitivity analyses were informed using relevant 95% confidence intervals (exact binomial or normal approximation). We only considered genetic counseling or testing within 6 months of the initial intervention. The study had a secondary component whereby patients who were not able to obtain GE within the first 6 months due to cost barriers had their tests paid for by the study; therefore, we do not have accurate rates GE uptake after 6 months if patients or insurance providers paid costs of GE. The number of GEs may therefore be slightly underestimated. In sensitivity analysis, we examined the impact of an increased rate of GE testing to account for this. We did not include costs of follow-up medical care if pathogenic mutations were identified by GE (MRIs, prophylactic surgery), as these would mainly occur after the 6-month window, and the number of observed patients with deleterious mutations was small. No participants reported childcare costs associated with counseling or testing. 2.2. Analytic methods We calculated the total cost for each arm, based on the cost components described above, and the difference between TCN/TP vs UC. We also calculated the difference in the number of patients receiving GE, and then the ratio of those differences (i.e. number of additional dollars spent per additional GE received). We conducted a series of one-way sensitivity analyses, using upper and lower limits of important cost components, to assess how the cost-effectiveness would change if cost components were over- or under-estimated. Additionally, we conducted a scenario analysis where a higher volume of patients were given the TCN intervention, up to a full-time workload for one genetic counselor. 3. Results This study included 641 participants with breast and/or ovarian cancer randomized to 1 of 3 arms. Patient characteristics were similar across arms. The study sample had a mean age of 61.1 years (SD=10.2), time since diagnosis of 11.2 years (SD=7.7), and 85.3% of the sample had breast cancer. The sample was diverse, with 25.5% were Hispanic, 60.3% Non-Hispanic white, 5.9% Non-Hispanic Black, and 8.4% other race/ethnicity. 17.5% lived in rural areas. 2.9% reported Ashkenazi Jewish ancestry. 94.5% reported having health insurance, and 24.8% reported an annual household income of <$30,000. 45.7% had a bachelor’s degree or higher. 15 See Figure 1 for the study CONSORT diagram. Figure 1. Open in a new tab GRACE Study CONSORT Diagram In the TCN arm, 32 of 212 participants (15%) received GE (negative outcome imputation methods). Of these, 5 received counseling only, 9 received testing only, and 18 received both. In the TP arm of the 216 participants, 6 received GE, with 1 receiving only counseling, 1 receiving only testing, and 4 receiving both. In the UC arm, of the 213 participants, 5 received GE, all of whom received both counseling and testing. We found that the TCN intervention delivery cost $68,924 for 212 patients ($325 per patient, $2,154 per GE). A large proportion of this cost was the initial and booster trainings for health coaches ($50,223). Other notable components of the intervention delivery cost were salary and fringe costs of health coaches ($11,437) and participant time cost for health coaching ($4,075). In the TP arm, the total costs of intervention delivery were $902 or $4 per patient, while the UC arm had no intervention delivery costs. (See Table 2 ) Table 2: Results of microcosting analysis TCN TP UC Components of costs ($, % of total) Training 50,223 (54%) 0 (0) 0 (0) Health coach salary 11,437 (12%) 0 (0) 0 (0) Staff salary 1,359 (1%) 189 (4%) 0 (0) Overhead 388 (0%) 8 (0) 0 (0) Mailings 1,442 (2%) 706 (13%) 0 (0) Participant time for health coaching 4,075 (4%) 0 (0%) 0 (0) Cost of testing 19,628 (21%) 3,635 (68%) 3,635 (82%) Cost of counseling 3,626 (4%) 788 (15%) 788 (18%) Intervention total cost $68,924 $902 $0 Total costs (intervention, testing, counseling) $92,178 $5,325 $4,423 Costs per unit/outcome Intervention cost per patient (excl. testing/counseling) $325 $4 $0 Cost per GE (test or GC) $2,881 $888 $885 Cost per test $3,414 $1,065 $885 Cost per GC $4,008 $1,065 $885 Cost per test and GC $5,121 $1,331 $885 Incremental Cost per additional GE (vs UC) $3,250 $902 Open in a new tab When including the costs of testing and counseling, the total costs for TCN were $92,178. As 32 patients received GE (testing and/or counseling), the total costs were $2,881 per GE. In the TP arm, total costs were $5,325, or $888 per GE. In the UC arm, 5 patients received GE, and the only costs accrued were testing and counseling ($4,423 total), or $885 per GE. Compared to UC, the incremental cost of TP was $902 per GE, and the incremental cost of TCN was $3,250 per GE. We conducted a series of one-way sensitivity analyses for the ICER of TCN vs UC; results are presented in Figure 2 . The results were most sensitive to the intervention’s effectiveness. If the intervention was more effective than the base case (21% instead of 15% receiving GE), the ICER falls to $2,520 per additional GE. If the intervention was less effective (11%), the ICER increases to $4,600 per additional GE. The ICER was also sensitive to the cost per test, the rate of GE in UC, and the cost of training, with lower bounds resulting in more favorable ICERs. In the future, costs of print materials could be reduced or eliminated by using web-based materials, however, when the cost of mailings was set to $0, the ICER was $3197, a modest decrease. Figure 2: Open in a new tab One-way Sensitivity analysis results for the Incremental Cost Effectiveness Ratio (ICER) of Tailored Counseling and Navigation (TCN) vs Usual Care (UC). This demonstrates how the ICER changes based on varying the assumptions for the parameters listed in Table 1 , by re-estimating the ICER at the upper and lower end of the range for each parameter. In our scenario analysis, we assume that the training costs would remain constant if the staff headcount did not change. For 212 participants, we estimate that the time required is 14.6% of a full-time health coach’s yearly work hours. We assume this can be increased to 80%, so a health coach could counsel approximately 1160 patients per year. Under this scenario, the ICER is $1,730 per additional GE. 4. Discussion This study provides important data on the costs of a novel multi-component behavioral intervention that aimed to motivate cancer survivors at increased risk for hereditary breast and ovarian to have genetic counseling and testing. We found that the TCN intervention cost $3,250 per additional GE compared to usual care. In sensitivity analyses, the ICER was highly sensitive to the rate of testing. Note that the upper limit (21%) of TCN efficacy used in sensitivity analyses is in line with other estimates of intervention efficacy from the GRACE Study (19% known outcome, 24% multiple imputation). 15 Thus, the ICER of $2,520 per additional GE is also applicable to the main study findings and may be closer to the value of TCN in practice. Nevertheless, we conservatively used the negative outcome imputation results for our primary analysis, as those with unknown outcomes still accrued costs. The GRACE study ascertained patients from cancer registries, but TCN could be readily implemented as part of care/survivorship pathways by individual cancer clinics. This is the perspective which we took for this cost-effectiveness analysis. Our findings demonstrate that it would be important for payors to provide appropriate reimbursement for health coaching and related activities, so that this cost would not be borne by the clinics themselves In 2024, CPT codes for health and wellness coaching was added to the Medicare telehealth list. 36 , 37 As Medicare policies often influence private market coverage, other payors may add similar reimbursements. 38 This is an important step in making health coaching accessible. Without appropriate reimbursement strategies, provider incentives to roll out evidence-based coaching-based prevention activities may be lacking. 39 , 40 A large proportion of the intervention delivery cost was due to training health coaches. TCN used Motivational Interviewing (MI), an evidence-based strategy for increasing motivation and commitment. 12 MI was chosen due to its demonstrated success in improving patient health behaviors. Nevertheless, ensuring that the coaches delivered MI with sufficient fidelity required substantial initial training and follow-up practice scenarios which were scored by a MI expert who provided feedback to coaches. 14 Decreasing training costs by improving efficiency at scale would provide an opportunity to reduce costs in a wider roll-out, although any such efficiency gains would be limited to larger institutions. Outside of a research setting, it should be possible to decrease costs of training and fidelity monitoring. Intervention refinement could also improve cost-effectiveness. For example, adaption to a web-based digital health tool could decrease costs and reach more survivors. For future implementation studies of TCN, ascertaining patients and collecting data through the EHR could help us understand long-term effects and costs. This is, to our knowledge, the first economic evaluation of remote targeted print and health coach interventions aiming to promote GE utilization among high-risk cancer survivors. Past studies investigating the cost-effectiveness of interventions to increase uptake of cancer-prevention services often conclude that such interventions are of high-value. 41 , 42 Spencer et al. evaluated the cost-effectiveness of interventions to increase HPV vaccination rates. They concluded that an intervention that costs $282 per additional person vaccinated was cost-effective (in terms of dollars per quality-adjusted life year) from a state government perspective. 42 Spees et al. examined an uptake intervention to increase HPV screening and determined that the intervention which cost $298 per additional person screened was cost-effective, compared to a willingness-to-pay threshold of $300. 41 The intervention we describe here was substantially more costly, as TCN intervention costs (excluding testing and counseling) were $2,553 per additional patient receiving GE. Nevertheless, there is no accepted cost-effectiveness threshold in the US, and there is no consensus on how much should be spent to increase utilization of cancer-prevention services. The purpose of this study was not to determine whether TCN is cost-effective in terms of quality-adjusted life-years gained, but to give decision makers information about the cost and cost drivers of this effective evidence-based intervention. This analysis has several important limitations. First, this analysis was limited to costs accrued in the 6 months following intervention. We did not consider any of the follow-up costs of positive test results, (e.g. prophylactic surgery) as due to the small number of tested individuals, this could not be estimated reliably. We also did not account for future testing of family members (cascade testing). Costs of care outside of the scope of this study (i.e., patients’ discussions about GE with their primary care clinician or oncologist) were not captured and were therefore excluded from the analysis. This is an area that warrants future research. We calculated outcomes as the study-specific measure of the number of GEs, not a general measure like Quality Adjusted Life-Years; such an analysis is of interest but beyond the scope of this microcosting analysis. Wherever possible, we used study data to estimate costs. As this was not always possible, we augmented study data with external information in the relevant literature. The generalizability of our study findings is limited based on the trial population; although our sample was registry-based and diverse, it was limited geographically. Future adaptions of the intervention using community, patient, provider, and system engagement should be considered to optimize the intervention’s impact. An additional limitation is that in the GRACE trial, we did not calculate individuals’ pre-test probability of mutations. Patients with a higher likelihood of mutations may have response rates to TCN, which would change cost-effectiveness. Another limitation is the higher rate of dropout in the TCN arm, likely due to the larger patient time commitment. Despite these limitations, this paper provides a comprehensive evaluation of the cost of implementing TCN in a cancer clinic. Further refinements to increase efficacy and reduce the cost of delivery would make the cost-effectiveness of TCN more favorable. Reimbursement strategies for interventions like TCN should be considered in the larger context of payment for preventative health interventions. 36 Supplementary Material PV Protocol NIHMS2035516-supplement-PV_Protocol.pdf (663.8KB, pdf) PV Appendix Table NIHMS2035516-supplement-PV_Appendix_Table.docx (27KB, docx) Context Summary: Key Points Key objective: To estimate the cost and cost-effectiveness of Tailored Counseling and Navigation (TCN), an evidence-based intervention shown to increase the rate of genetic evaluation in high-risk breast or ovarian cancer survivors. Knowledge generated: Delivery of TCN cost $325 per patient, and the incremental cost-effectiveness ratio was $3,250 per additional genetic evaluation. Cost-effectiveness would be more favorable at higher patient volumes, if rates of genetic evaluation could be further increased, or if training costs could be reduced. Relevance: Appropriate reimbursements for telehealth interventions like TCN are necessary to make health coaching accessible. Support: Supported by the National Cancer Institute of the National Institutes of Health (R01CA211625 to A.Y.K.), the Rutgers Cancer Institute Comprehensive Cancer Center core grant from the National Cancer Institute (NIH/NCI, 3P30CA072720) including the use of the Biostatistics Shared Resource and the University of New Mexico Comprehensive Cancer Center core grant from the National Cancer Institute (NIH/NCI P30CA118100) including use of the services provided by the Behavioral Measurement and Population Sciences (BMPS) and Biostatistics Shared Resources. Support is also provided by the New Jersey Cancer Registry, Cancer Epidemiology Services, New Jersey Department of Health, cooperative agreement NU58DP006279-04-00, from the National Cancer Institute, National Program of Cancer Registries (NPCR), US Centers for Disease Control and Prevention (CDC), the State of New Jersey, and the Rutgers Cancer Institute of New Jersey; New Mexico Tumor Registry, contract number HHSN261201800014I, Task Order HHSN26100001 from the National Cancer Institute; and the Colorado Cancer Registry, cooperative agreement NU58DP006347-02 from the CDC, with data collected and provided, in part, by the Colorado Central Cancer Registry (CCCR), a participating registry in the National Program of Cancer Registries (NPCR), CDC, cooperative agreement number 5 NU58DP006347. Study data were collected and managed using REDCap electronic data capture tools hosted at the University of New Mexico and the Rutgers Cancer Institute. References 1. 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