4-Year Employer Trends and Value-Based Oncology Coverage–Related Findings from a National Employer Survey
FR Vogenberg,1 C Larson,2 M Rehayem,2 L Boress2 1Institute for Integrated Healthcare, Greenville, SC; and University of Illinois-Chicago, Department of Pharmacy Systems, Outcomes and Policy; 2Midwest Business Group on Health, Chicago, IL
Background Healthcare costs are a continued concern among employers and other purchasers and extend especially to biologics or oncolytics that are being increasingly scrutinized to demonstrate value over time. A significant cost challenge to employers, these drugs create logistical issues for patients, physicians, pharmacies, and manufacturers because of their unique approval requirements, dosing, side effects, and distribution methods. Costs and outcomes of biologics and oncolytics are also hard to track, because they show up in both medical and pharmacy benefit claims.
Objectives The National Employer Initiative on Biologic & Specialty Drugs survey objectives are to assess the change in level of knowledge and benefit design gaps of employer plan sponsors in the area of specialty pharmacy and biologic products for conditions such as cancer and immune disorders, and to identify opportunities for future benefit coverage innovation.
Methods An online survey instrument was developed through an advisory council comprising self-funded employers for distribution in late (fall) 2014 to early 2015. The survey was disseminated to employers and through 15 business coalitions across the United States, and was completed in March 2015. Results were then analyzed by the Midwest Business Group on Health and the Institute for Integrated Healthcare.
Results The 2014 survey had a total of 81 employers of varying sizes and representative Standard Industrial Classification types that completed the survey and represented more than 1.5 million employee lives, with an average employer size of 19,600. The key findings in 2014 indicate that the majority of employers (77%) reported having an above average to average level of understanding of specialty drugs, with 17% having a high level of understanding. This is a slight decrease from 2013, when the survey had a higher proportion of large employer respondents. Although most employers continue to use traditional drug benefit tactics for management of specialty drugs, they understand the need for oncology-based plan design strategies, with 37% of respondents using an integrated pharmacy benefit management (PBM), 25% requiring the use of specialty pharmacies, and 21% using a physician-based model using prior authorization from a select list. None of the respondents reported offering an oncology carve-out or a narrow formulary to include preferred oncology drugs, but that may change in the future. Nearly 80% of respondents indicate they are concerned about the new drug pipeline, and many support drug innovation for chronic or life-threatening diseases. In addition, most are concerned about quality and cost outcomes management, as well as incorporating wellness strategies across the continuum of patient care. The survey results over a 4-year period indicate that larger-sized companies have a higher knowledge base versus the 2011 findings, which indicated that 78% of small- to midsized employers had little to moderate understanding of specialty drugs or biologics. Similar to 2011, the 2012-2014 results showed that many employers did not know whether their company’s claim costs for specialty drugs had increased over the past several years. In previous years, as well as in 2014, most employers have been using traditional benefit plan design (eg, tiered formularies, copayments, and coinsurance) instead of innovative benefit designs (ie, value-based) that may be more appropriate for biologic or specialty/oncology drugs. In addition, there continues to be an increasing use of high-deductible plans, which will continue to result in more cost-shifting to the consumer. Vendor performance is consistently highly valued, yet the majority of employers only agree or somewhat agree that their PBM does a good job in managing costs. In addition, the majority of benefit designs continue to omit an incentive to ensure the proper compliance to drug therapy or adherence to treatment.
Conclusions There remains a knowledge gap among commercial plan sponsors, especially in clinical outcomes, that is important to those who manage oncology services or risk, among other specialty drug categories. The survey findings demonstrate employers’ relatively low knowledge of biologic drugs, appropriate support technologies or incentives, and vendor contracting options available to their plan for effective management of oncology/specialty drugs. The employers who can improve their understanding of the many challenges in managing this area will be able to more effectively manage total costs and improve related patient outcomes.
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Willingness to Pay for Treatment Among Women with Metastatic Breast Cancer
Jacqueline Hall, MSPH1; Marco daCosta DiBonaventura, PhD2; Ronda Copher, PhD1; Shu Huang, BA2; Enrique Basurto, MSc2; Safiya Abouzaid, PharmD, MPH1 1Eisai Inc.; 2Kantar Health
Objectives Treatment for metastatic breast cancer (mBC) focuses on extending survival, promoting quality of life, and ensuring adequate symptom management. Although many of the available treatment options can be quite costly, few studies have examined the point at which out-of-pocket costs become so high as to not be worth the expense from the patient’s perspective. The present study addressed this gap.
Methods Data were collected through a cross-sectional Internet survey of 175 adult women diagnosed with mBC who had been treated with at least 2 hormone and/or chemotherapy agents. Respondents provided demographic and health history information. Respondents were also presented with an mBC treatment profile and asked their willingness to take the medication with varying levels of per-cycle out-of-pocket costs (ranging from $0 to $3000). A hierarchical Bayesian logistic regression was then conducted to predict willingness to take the treatment (willing vs unwilling) from levels of per-cycle out-of-pocket costs.
Results The mean age was 53.5 years (standard deviation, 10.1), and women were predominantly non-Hispanic white (90.9%). The adjusted probability of being willing to pay decreased consistently from 0.94 (at $0 per cycle) to 0.05 (at $3000 per cycle). Once the per-cycle costs exceeded $100 (0.79 adjusted probability of being willing to pay), the willingness disproportionately decreased. The probability of being willing to pay dropped from 0.79 at $100 to 0.59 at $200, the largest decrease observed after a $100 change in costs (eg, the probability of being willing to pay dropped from only 0.59 at $200 to 0.49 at $300). Post-hoc analyses of willingness to pay by different demographic strata revealed a consistency in results. Although low sample sizes precluded meaningful comparisons in some cases, willingness to pay did not vary by age, household income, or education group, among other variables.
Discussion Despite the treatment advancements in mBC, affordability remains an important factor in patients’ decision to use a medication. The results suggest that the sharpest decline in willingness to pay occurs after $100 per cycle, a potential “walking away” point for women. Willingness to pay was generally consistent across demographic (eg, age, income) and health history strata. Healthcare decision makers should be aware of the influence that out-of-pocket costs can have on patient’s willingness and ability to pursue treatment options.
Current Practices in the Use of Next-Generation Sequencing: A Steep Learning Curve?
Manjari Pandey,1 Matthew K Stein,2 Jason C Chandler,1 Bradley G Somer1 1West Cancer Center; 2Department of Internal Medicine, University of Tennessee Health Science Center
Background Next-generation sequencing (NGS) is a relatively recent technology that performs the processes of DNA fragmentation and resynthesis in a parallel fashion, thus amplifying the output and enabling the sequencing of large fragments of DNA in a single run. NGS was rapidly accepted by the field of oncology and has been used to identify hereditary susceptibility to cancers, to understand tumor biology, and to identify “targetable” mutations or predict responses to therapy. Currently, there are no clear guidelines or standards for NGS and the clinician’s abilities to interpret and use the information effectively remain questionable. As the popularity of “personalized” or “precision” medicine grows, we describe the patterns of use of NGS in patient care at the West Cancer Center at Memphis, TN.
Methods We performed a retrospective chart review using the electronic medical records at the West Cancer Center and identified all patients for whom NGS testing through a particular vendor was ordered from October 2009 through August 2014. We collected data on demographics, diagnosis, previous treatments, and reasons cited for ordering NGS. We then determined whether the results led to any change in the management (ie, choice of therapy or enrollment in a trial).
Results A total of 179 patients had NGS testing performed on their tumor samples; 70% were white, and 72% were women. In all, 68% of the patients had private insurance, whereas 26% had Medicare as their primary insurance. All the testing was in the setting of metastatic disease, there were more than 20 different cancer types, of which 34% were gynecologic malignancies; among them, the most common diagnosis was ovarian cancer (79%). The other most common tumors were lung (14.5%), breast (13.4%), and colorectal (8.9%). The indication for testing was documented for 65.9% of cases; the most common reason cited for testing was to “guide therapy” (43.2%), followed by “molecular profiling” (32.2%) and to “evaluate for clinical trials” (24.6%). Of the 38 patients who had NGS for molecular profiling, 12 had the testing done to look for specific targetable mutations with approved therapies available. The results led to a change in management for 47 (26.3%) patients; 18 patients enrolled in trials, 22 received on-label therapy, and 5 patients received off-label therapy.
Conclusions The availability of NGS led to testing in a wide variety of cancers and led to a change in management in a number of patients, including enrollment in clinical trials. However, the patterns of NGS use and documentation differed widely between physicians and reflect a need for standardization.
Using Data to Improve Quality of Care and Process
Sheryl Riley Director of Clinical Programs, SAI Systems International, Inc Contact: Sheryl Riley at This email address is being protected from spambots. You need JavaScript enabled to view it. or 908-397-1706
Background Using data to improve quality of care, patient adherence, quality of life, and process of care, comprehensive data analysis should lead to identifying barriers to patient care and to improving patient adherence.
Objectives To understand the key data components that are needed to identify barriers and adherence concerns of patients, to identify the substance behind utilizing an algorithm to stratify and calculate member risk, and to delineate what can be done with the data that are collected to improve adherence and patient quality of care.
Discussion Nonadherence can have profound clinical consequences, and medication nonadherence in patients with cancer is a growing concern today because of the increasing availability of new oral medications. There are many factors contributing to patient nonadherence to treatment regimens, but many times these factors are not identified until it is too late. Understanding the potential barriers and factors that affect patient adherence will help providers develop strategies to promote patient adherence to cancer treatments, especially oral regimens. Optimal patient outcomes require adherence, education, communication, ongoing monitoring, and follow-up. Many of these potential problems need to be identified and discussed with the patient before they start a cancer treatment program. For oncology, published studies reflect highly variable adherence rates of 17% to 27% for hematologic malignancies, 53% to 98% for breast cancer, and 97% for ovarian cancer. When looking at data, we can calculate the “member risk” and delineate which data elements can improve quality and the process of care. We can also begin to understand the barriers that prevent patients from adhering to treatment plans and care, while utilizing the data to create a cohesive plan of care that can guide patients and their families to wellness and self-management. Also, this process will reduce costs to hospitals and doctors through decreasing the gaps in care and ultimately improving quality of life.
Conclusion There are many barriers regarding adherence; hence, we should utilize the data to jump-start the process and also create strong, trusting patient relationships to get us the rest of the way. Comprehensive care management programs utilize data to improve patient adherence and to decrease barriers, but this information is also vital to hospitals, doctors, and other healthcare professionals working with patients to improve care and cost.
Treatment-Sequencing Patterns of Novel Agents in Patients with Prostate Cancer
Elisabetta Malangone-Monaco,1 Kathy Foley,1 Kathleen Wilson,1 Helen Varker,1 Alison Binder,1 Scott McKenzie,2 Lorie Ellis2 1Truven Health Analytics, Ann Arbor, MI; 2Janssen Pharmaceuticals, LLC, Horsham, PA
Objective Guidelines from the National Comprehensive Cancer Network recommend chemotherapy, immunotherapy, or antiandrogen therapy for the treatment of advanced castration-resistant prostate cancer (CRPC). This study evaluated treatment sequencing of recently approved agents for CRPC (abiraterone [ABI], enzalutamide [ENZ], docetaxel [DOC], cabazitaxel [CAB], or sipuleucel-T [SIP]) among men with prostate cancer.
Methods This retrospective, observational study evaluated adult men with prostate cancer in the MarketScan Oncology EMR Database, which includes data from more than 900 contributing oncologists from greater than 100 community practices. Inclusion required a diagnosis of prostate cancer (International Classification of Diseases, Ninth Edition, Clinical Modification diagnosis code 185) from July 1, 2011, to March 31, 2014, no treatment with ABI, ENZ, DOC, CAB, or SIP before September 1, 2012, no other primary cancers, and 6 months of medical record history before the index date. The index date was the date of first prescription of ABI, ENZ, DOC, CAB, or SIP between September 1, 2012, and March 31, 2014. First-, second-, and subsequent-line treatments were evaluated before the end of the data availability or the end of the study.
Results In total, 812 patients with prostate cancer were identified; the mean patient age was 75 years, and 68% of the patients had recorded metastasis. A single line of therapy was observed for 544 (67%) patients. ABI was the most common first-line treatment (N = 443 [55%]), followed by DOC (N = 167 [21%]), ENZ (N = 113 [14%]), SIP (N = 82 [10%]), and CAB (N = 7 [1%]). A second line of therapy occurred in 268 (33%) patients and third line in 8% of patients. The Table describes the first-line therapy and the 2 most common second-line therapies for the men who moved to second-line therapy.
Conclusion Of the 5 agents of interest, ABI was the most frequently prescribed first-line medication for advanced prostate cancer in this patient cohort. First-line treatment with DOC was more common than first-line treatment with CAB or SIP. Further studies with longer follow-up and other treatments are warranted.
Prostate Cancer Assay Improves Treatment Decisions for Patients with Early-Stage Disease
John W. Peabody,1-3 Diana Tamondong-Lachica,3 Trever Burgon,3 Megan Chen,3 Lisa M. DeMaria3 1University of California, San Francisco; 2University of California, Los Angeles; 3QURE Healthcare, San Rafael, CA
Background Of the 240,000 men in the United States diagnosed annually with prostate cancer, the majority have indolent tumors. Distinguishing between aggressive and indolent cancers is an important clinical challenge. The current approaches for assessing tumor aggressiveness are insufficient. ProMark is a novel protein-based assay with a demonstrated ability to predict tumor aggressiveness at biopsy.
Objective To measure the clinical utility of ProMark in the management of early-stage prostate cancer.
Methods A total of 86 board-certified urologists were enrolled in a randomized, 2-arm experiment that collected data using Clinical Performance and Value (CPV) vignettes, which are simulated cases wherein doctors are provided with results to any tests or procedures they choose to order and are asked to make a treatment plan based on their investigations. To measure changes in practice, the participants completed 3 CPVs at baseline (R1) and 3 CPVs at round 2 (R2). After the baseline data were collected, the urologists randomized to the intervention arm received a 15-minute webinar on ProMark and then, for their R2 cases, were given the results from the ProMark assay. The cases were all newly diagnosed patients with Gleason 3+3 and 3+4 prostate cancer. Each case had a treatment course of either active surveillance (AS) or active treatment (AT), which was determined from the literature and the guidelines from the National Comprehensive Cancer Network.
We measured clinical utility for 3 archetypes: (1) cases for whom ProMark scores confirm the evidence-based treatment indicated by the patient’s clinical presentation, (2) cases where ProMark would indicate the need to switch therapeutic approach from AS to AT or from AT to AS, and (3) cases where the treatment course was indeterminate by the current guidelines. The outcome measure was the appropriate treatment, which was defined as urologists who ordered a biopsy and correctly indicated AS or AT according to the individual case. The analyses were done using difference-in-difference estimations.
Results The introduction of ProMark resulted in a marked increase in the number of urologists instituting the correct treatment. Although the control group scores for appropriate treatment stayed virtually the same across the rounds (P >.1), the appropriate treatment in the intervention group increased from 12% in R1 to 28% in R2. This change was most marked in the confirmatory (23%; P <.01) and switch cases (21%; P <.01), but was not statistically significant for the clinically indeterminate cases.
Conclusions In a randomized, experimental study, a novel protein-based assay significantly increased the number of patients who were given the appropriate treatment and suggests that this type of testing has demonstrable clinical utility and may generate significant savings.
Defining Value in Oncology: Perspectives from Patients with Metastatic Breast Cancer
Longacre ML,1 Charap ES,2 Buzaglo JS,1 Kennedy V,1 House L1 1Cancer Support Community; 2inVentiv Health, Adheris Behavioral Insights Group
Objectives Value, as defined by the Institute of Medicine, is the “best care at lower cost.” Yet value may be differently interpreted among healthcare stakeholders (Porter, 2010). We explored the understandings of value among patients with metastatic breast cancer (mBC). By understanding how patients define value when considering their cancer experience, we can identify ways to bridge gaps between healthcare theory and practice.
Methods Using the Cancer Support Community’s Cancer Experience Registry, an online initiative to capture the experiences of those impacted by cancer, we asked patients the following question: “When considering your cancer experience, how would you define value?” We focused on patients with mBC (n = 769), because of these patients’ likely high number of health interactions and consistency of cancer stage. Two researchers coded open-ended responses in vivo by thematic category. The interrater reliability was 85%.
Results The average patient age was 56 years (standard deviation, 9.91; range, 24-93 years). All percents refer to the total sample; 45.9% did not respond, 8.97% did not understand the question, 2.34% were unclear, and 2.73% reported “no value.” The remaining responses were categorized broadly as personal value (38.4%) or exchange value (7.41%). Personal value responses fit into the following subcategories: relational, practical, or existential benefit (“I learned to cherish every day and know who my friends are,” 25.4%); preference (“quality of life,” 8.06%); and guiding principle (“live with no limitations,” 4.94%). Exchange value responses were general (“value should always exceed price paid,” 1.95%) and health-specific (“the cost/benefit of treatment,” 5.46%). Of those with a health-specific response (n = 42), most (76.2%; n = 32) described treatment benefit as being engaged by or feeling close to their healthcare provider (HCP), while financial cost relative to benefit was mentioned rarely (n = 7).
Conclusion “Value” is multivalent; only 5.46% of patients with mBC in our sample conceived value as having any exchange-based meaning. When defining value relative to healthcare, patients emphasized the importance of their relationship with HCPs rather than the benefit of cost-effective treatment. Although quality, efficiency, and cost transparency in value-based care are essential, patients may be more focused on quality care as it relates to the HCP–patient relationship than on value relative to efficiency/cost. Patient engagement can help build on patients’ focus on value as relationship, while promoting the principles of the Value Initiative.
This work is supported through contributions to the Cancer Support Community’s Cancer Policy Institute.
Examining Experiences of Patients Currently Being Treated with Abiraterone Acetate for Metastatic Castrate-Resistant Prostate Cancer
Ahmad B. Naim,1 Barbara Roland,2 Susan Wyant,2 Lorie A. Ellis1 1Janssen Scientific Affairs LLC, Horsham, PA; 2The Dominion Group, Reston, VA Contact: Lorie A. Ellis, at This email address is being protected from spambots. You need JavaScript enabled to view it. or 443-640-4744
Objective Targeted treatments for advanced prostate cancer have been available for 2 to 3 years. Abiraterone acetate (AA) is a prodrug of abiraterone, which is a novel oral androgen biosynthesis inhibitor that is approved for metastatic castration-resistant prostate cancer (mCRPC). This study examines the overall experiences of patients currently being treated with AA therapy for mCRPC.
Methods A total of 100 patients with mCRPC who were being treated with AA completed a 30-minute survey in the fourth quarter of 2013. In all, 48 patients were receiving AA for >6 months. The majority (n = 62) of patients were aged ?62 years; 55 patients were employed full time. A total of 57 patients had received chemotherapy before starting AA, whereas 43 patients had not received chemotherapy in the past.
Results When asked about their experiences with AA therapy, 76% of the patients reported that they feel more positive about their disease condition, and 91% reported that friends and family have a more positive view of their disease. Furthermore, 86% of the patients said they are less reliant or less dependent on others, 78% said they have greater control over their life and treatment, 78% reported they are better able to continue working and/or doing their daily activities, 76% said they are less restricted in being able to plan and participate in social activities, and 72% said they are better able to do the things they want to do. The vast majority of patients (86%) reported that their fatigue has not worsened since they started receiving AA. A total of 35% of patients reported that their fatigue has improved. In all, 49% of patients reported that their pain has not worsened since they started receiving AA.
Conclusions The results from this self-reported patient survey show that the majority of patients view their treatment experiences with AA therapy to be mostly positive. After receiving AA, the patients felt that their fatigue was stable or did not worsen. Furthermore, they had favorable perceptions of well-being, and felt that they had more control over their disease and life. More research is needed to further understand the patient-centered benefits of treatment with AA.
Myeloid Growth Factor Utilization in a Commercial and Medicare Population: Phase 1 of a Quality Improvement Initiative
Edward Li, PharmD, BCOP1; Barry Peterson2; Cecilia Tran2; Michael Sturgill2; Dudley Gill2; Stanley Forston2; Romano Bastianpillai2 1University of New England College of Pharmacy; 2New Century Health Contact: Edward Li, PharmD, BCOP, at This email address is being protected from spambots. You need JavaScript enabled to view it. or 207-221-4120
Background Some clinical practice guidelines encourage the judicial use of myeloid growth factors (MGFs) in the prevention of chemotherapy-induced febrile neutropenia (FN) because of efficacy and safety concerns. For example, the American Society of Clinical Oncology (ASCO) guidelines state that a dose reduction of myelosuppressive chemotherapy in patients with incurable disease rather than prescribing an MGF for secondary prophylaxis is a reasonable alternative. Because there is wide variation in MGF prescribing, New Century Health (NCH) conducted a quality improvement analysis of MGF requests in a commercial and Medicare population.
Objectives To describe the cohort demographics, identify areas of improvement to promote cost-effective use, and measure the economic impact of interventions.
Methods The MGF authorization requests for oncology indications to NCH in 2013 were analyzed for cohort demographics, such as age, weight, tumor diagnosis, and treatment intention (eg, metastatic/palliative, curative, etc). The requests were analyzed for concurrent use with chemotherapy, approval status of the request (including reason for withdrawal), and cost-savings associated with the interventions.
Results There were 7958 requests for an MGF; 81% were for pegfilgrastim and 19% for filgrastim. The average age of the cohort was 66 years; weight-based dosing (>70 kg) was appropriate in 43% of patients receiving 300 mcg, and 72% of patients receiving 480 mcg. MGFs were most frequently requested in: breast (18%), lung (17%), lymphoma (14%), and gynecologic (8%) tumors. A total of 40% of the requests were for metastatic or recurrent disease, and 38% were for curative intent. In all, 6724 (84%) of the requests were authorized based on established-use criteria. The main reason for not authorizing was the lack of compendia support for primary and secondary prophylaxis; this resulted in approximately $3.5 million in cost-savings.
Conclusions There is an opportunity to improve the efficiency of MGF use in this population through a dose-rounding protocol and by promoting chemotherapy dose reductions, as advocated by the ASCO guidelines. Further analysis will assess the concordance of MGF use with the guidelines, specifically in regard to chemotherapy regimens and their risk for FN.
Improving the Awareness, Identification, and Management of Sarcopenic Obesity: An Evidence-Based Toolbox
Sarah Lindsey, MSN, APN, ACNS-BC, AOCNS; Kim Astroth, RN, PhD Mennonite College of Nursing, Illinois State University
Background Sarcopenic obesity, a loss of muscle mass coupled with an increase in fat mass, places the more than 14 million cancer survivors at greater risk for recurrence, new cancers, and long-term morbidity. Body mass index alone is not accurate enough to identify either muscle wasting or obesity. Sarcopenic obesity can be found in average-weight individuals.
Research Questions Will the use of an educational toolbox increase the advanced practice nurses’ perceived ability to identify and manage patients who are at risk for sarcopenic obesity? Will the introduction of the educational toolbox increase the documentation of patients’ baseline risk factors, education provided, and referrals made for the management of risk factors related to sarcopenic obesity?
Participants The convenience sample of participants included a group of advanced practice nurses (N = 15) from a large Midwest oncology practice.
Method One-group pretest/posttest using a controlled intervention “toolbox.”
Instrument Survey to assess awareness, identification, and monitoring of sarcopenic obesity.
Intervention An educational presentation that defines the problem and explains the implications for cancer survivors; educational resources that detail expert recommendations for nutrition, weight management, and physical activity; evidence-based practice guidelines adapted from the National Comprehensive Cancer Network Guidelines for Survivorship on healthy lifestyles, SARC-F rapid-scoring tool to assess the risk for sarcopenic obesity; a list of local referral resources for the expert management of functional impairment, physical disability, and nutritional counseling; a documentation template for practitioners to consider after providing an assessment or intervention; and a patient education handout. Framework used was the ACE Star Model of Knowledge Transformation.
Preliminary Results An educational toolbox provides an opportunity for advanced practice nurses to improve the awareness, identification, and monitoring of adult cancer survivors who are at risk for sarcopenic obesity. This opportunity could potentially improve the quality of life of cancer survivors.
Measuring the Value of Telephone Distress Screening and Referral on Resource Utilization and Distress in Patients with Multiple Myeloma
Kennedy V, Buzaglo JS, Goldberger S Cancer Support Community, Washington, DC Contact: Vicki Kennedy at This email address is being protected from spambots. You need JavaScript enabled to view it. or 202-650-5379
Objectives Although distress screening is known to reduce distress, little is known about its impact on service utilization. The Cancer Support Community (CSC), in collaboration with Onyx Pharmaceuticals, Inc, has established an integrated patient assistance program to screen and refer patients and caregivers facing advanced multiple myeloma for psychosocial services. We sought to measure the impact of distress screening on the utilization of resources and the effect on patient distress.
Methods Patients were asked 4 distress screening questions by an Onyx 360 Nurse Advocate during an initial phone call. For each question, patients self-reported a level of distress on a scale from 0 to 10 (0-lowest, 10-highest). Patients were then offered enrollment in Onyx 360 services, which include reimbursement and clinical support, transportation assistance, and real-time referrals to key resources. Consenting callers were transferred to the CSC, whose licensed mental health professionals conducted further assessment and offered free counseling, resource referral, and treatment decision counseling. Patients were rescreened 30 days after the initial call.
Results A total of 227 patients were screened for baseline distress. For each question, 70%-80% of patients expressed some level of distress (ie, ?1). A total of 172 (76%) patients responded with a distress level of ?4 for ?1 of the screening questions; of the patients who were also new to the program, 86% subsequently enrolled in ?1 Onyx 360 service, including 72% enrolling in transportation services and 27% enrolling in copay assistance. Referral rates to the CSC increased when screening was performed compared with when it was not. A total of 145 (64%) patients completed a follow-up call; 74% reported lower levels of distress for ?1 question since the initial call. Among patients who initially reported a distress level of ?4 on ?1 of the screening questions, 79% reported lower levels of distress for ?1 question since the initial call.
Conclusion The inclusion of distress screening into a pharmaceutical patient assistance program made a significant difference in identifying patients with distress and linking them to resources. Patients utilized these free professional resources at a higher rate when distress screening was implemented compared with when it was not. Distress levels, especially for those with the highest levels, decreased after patients engaged with these resources and services. Patient satisfaction with the services provided was extremely high. These results demonstrate that a simple distress screening, referral, and follow-up program can improve psychosocial outcomes in patients with advanced multiple myeloma in a unique telephonic setting. Further research is needed to determine whether reduced levels of distress will translate into increased duration of therapy and increase in value to the patient and healthcare system.
This work is supported through an unrestricted grant by Onyx Pharmaceuticals, Inc, an Amgen subsidiary.
Demonstrating Return on Investment for Stakeholders in a Care Coordination Program
Background Too many patients are being hospitalized for side effects and adverse drug reactions that can and should be managed by their doctors and nurses. When looking at the reasons for readmission, 33% of these result from potentially preventable problems, such as nausea, vomiting, dehydration, and postoperative pain.
Objectives To show that stratifying and assigning acuity to patients based not only on cost but also on disability, functional, and cognitive weights and measures can assist in creating a better plan of care for patients, which improves symptom management and decreases the use of emergency department and hospital admissions; and that by utilizing data analysis, you place tools into the hands of the treating physicians that can improve care and cost-effectiveness.
Discussion The early identification of members who may benefit from care coordination is critical to ensure quality outcomes and to have a positive impact on healthcare costs. Our proprietary algorithm synthesizes demographics; laboratory, medical, behavioral, and pharmaceutical claims; as well as health risk assessment responses to stratify patients into risk categories, which allows proper placement in the best level of care to achieve the best patient and cost outcomes.
Through comprehensive care coordination, we are able to drill down further on each patient to identify those who are at a greater risk for complications (eg, patients aged >65 years; patients who have comorbidities; those with gastrointestinal cancer; and those with late-stage cancers who have a greater risk of rehospitalization after cancer surgery). Once these risks are identified, the care coordinators will develop a plan of care that includes building a relationship with the patient and the family, following the patient at home, and frequent, consistent communication to focus on proactive education regarding treatment and side effects, all the time working as a physician extender to assist the oncologist and the rest of the healthcare team.
Conclusion By working directly with patients and their families to keep them informed, educated, and out of the hospital, comprehensive, well-managed care coordination programs can aid patients, physicians, and health plans regarding symptom management and care support, which are clinical and financial wins for stakeholders.
Budget Impact Analysis of Abiraterone Acetate plus Prednisone versus Enzalutamide for the Treatment of Patients with Metastatic Castration-Resistant Prostate Cancer
Lorie A. Ellis, PhD1; Dominic Pilon, MA, MD2; Patrick Lefebvre, MA2 1Janssen Scientific Affairs, LLC, Horsham, PA; 2Groupe D’Analyse, Ltée, Montreal, QC, Canada Contact: Lorie A. Ellis at This email address is being protected from spambots. You need JavaScript enabled to view it. or 443-640-4744
Objective Previous studies have shown that abiraterone acetate plus prednisone (AA+P) is the most frequently prescribed first-line therapy for advanced prostate cancer among therapies that offer a survival benefit (ie, AA+P, enzalutamide [ENZ], docetaxel, cabazitaxel, and sipuleucel-T). The objective of this study was to model the financial impact of an oral treatment mix for antineoplastic metastatic castration-resistant prostate cancer (mCRPC) in the pharmacy budget from a commercial health plan perspective.
Methods An analytic model was developed for a hypothetical million-member commercial health plan to estimate the costs incurred by different treatment mixes of AA+P and ENZ for patients with mCRPC. The prevalence and incidence rates of prostate cancer were derived from US surveillance data, and mCRPC progression data were obtained from published trials to estimate the number of patients with mCRPC. The base-case treatment mix was obtained from studies of physician prescribing patterns observed from retrospective health claims studies. The pharmacy costs were calculated from the wholesale acquisition costs (wholesale acquisition price effective on August 7, 2014) of a 30-day supply of AA ($7376.68) plus prednisone ($10.85) or ENZ ($8355.03). The budgetary impact of increasing the proportion of patients receiving first-line AA versus increasing the number of patients receiving first-line ENZ was evaluated.
Results A total of 256 patients with mCRPC per million members was estimated; 65% of these patients were assumed to be treated with an oral agent in the first-line setting. The 30-day treatment costs per patient were higher for ENZ ($8355.03) than for AA+P ($7387.53). Assuming 50% of patients were treated with first-line AA+P and 15% were treated with first-line ENZ, the total pharmacy costs were $10,171,600 and $15,257,400 for 8 months and 12 months of therapy, respectively. Decreasing first-line therapy with AA+P by 10%, 20%, or 30% with a corresponding increase in first-line ENZ resulted in $193,500, $394,740, and $588,240 of additional spending over an 8-month period. Likewise, decreasing first-line therapy with AA+P by 10%, 20%, or 30% with a corresponding increase in first-line ENZ resulted in $290,250, $592,110, and $882,360, respectively, of incremental pharmacy expenditures over a 12-month period.
Conclusion The model demonstrates the financial impact of a treatment mix of oral antineoplastic therapies for mCRPC. For each 10% of first-line AA+P replaced by ENZ, pharmacy spending increased by approximately $200,000 over an 8-month period and by approximately $300,000 over a 12-month period. These results have important implications for population health decision makers who are evaluating the relative value of therapies for this patient population.
This study was funded by Janssen Scientific Affairs, LLC.
Budget Impact Analysis of Ibrutinib for Patients with Previously Treated Mantle-Cell Lymphoma
Schenkel B,1 Dandappanavar A,2 O’Day K,2 Queener M1 1Janssen Scientific Affairs, LLC, Horsham, PA; 2Xcenda, Palm Harbor, FL Contact: Brad Schenkel at This email address is being protected from spambots. You need JavaScript enabled to view it. or 215-325-3614
Objective In the United States, approximately 4000 cases of mantle-cell lymphoma (MCL) and 1000 attributed deaths occur annually. The management of previously treated MCL is challenging, because responses to second- and third-line chemotherapies are often incomplete and are not durable as a result of the highly toxic regimens. Ibrutinib is approved by the US Food and Drug Administration (FDA) for the treatment of MCL in patients who have received at least 1 previous therapy. Because of the increased healthcare costs, health plans are interested in the budget impact of new treatments. The objective of this analysis was to estimate the budget impact of adding ibrutinib to a US health plan formulary over a 1-year time horizon.
Methods An Excel-based budget impact model was developed to evaluate the budget impact of ibrutinib in a hypothetical 1-million-member US health plan. The comparators included FDA-approved and category 2A National Comprehensive Cancer Network–recommended regimens for patients with previously treated MCL. The dosing, administration, mean duration of therapy (DOT), and adverse event (AE) rates were based on package inserts for the approved drugs and on published literature for NCCN-recommended regimens. The drug and administration costs were based on Red Book and on the Centers for Medicare & Medicaid Services Physician Fee Schedule, respectively. The AE costs were based on the Agency for Healthcare Research and Quality’s Healthcare Cost and Utilization Project data and on published literature. The estimated treatment-eligible population was estimated from epidemiologic data and a large claims database analysis. The market share was estimated for each treatment with and without ibrutinib. The incremental per-treated-member per-month (PTMPM) cost and incremental per-member per-month (PMPM) cost were calculated. A one-way sensitivity analysis was also performed.
Results The model estimated a treatment-eligible population of 17 previously treated patients with MCL for a 1-million-member health plan. The 1-year incremental budget impact of adopting ibrutinib for previously treated patients with MCL was $838 PTMPM, or $0.014 PMPM. The model results were most sensitive to ibrutinib DOT, followed by ibrutinib market share, and proportion of treated population aged ?65 years.
Conclusions The model estimates a small treated population and indicates that the budget impact of ibrutinib is estimated to be modest from a US health plan perspective. This is important for healthcare decision-making, considering the efficacy and safety benefits for ibrutinib in this orphan disease with a high unmet need.
Cost-Effectiveness of Octreotide LAR versus Lanreotide Depot in the Treatment of Metastatic Gastrointestinal Neuroendocrine Tumors
Rajeev Ayyagari, PhD1; Maureen Neary, PhD, MS2; Shang Li, MS3; Chen Zhao, PhD3; Keiko Higuchi, MPH2; Jipan Xie, MD, PhD3; Al B. Benson III, MD, FACP, FASCO4 1Analysis Group Inc., Boston, MA; 2Novartis Pharmaceuticals, East Hanover, NJ; 3Analysis Group Inc., New York, NY; 4Northwestern University, Chicago, IL
Background The long-acting somatostatin analogs octreotide LAR and lanreotide depot are recommended in guidelines by the National Comprehensive Cancer Network (NCCN) for the treatment of functional and nonfunctional metastatic gastrointestinal neuroendocrine tumors (GI-NETs). This study estimated the cost and effectiveness of treating metastatic GI-NETs with long-acting octreotide versus lanreotide from a US payer perspective.
Methods An economic model was constructed to compare octreotide versus lanreotide on effectiveness and costs among functional and nonfunctional patients with GI-NETs over 3-year and lifetime horizons. The model estimated costs, life-years, and quality-adjusted life-years (QALYs) using an annual discount of 3%. A partitioned survival structure was used. Patients were distributed among stable disease, progressive disease, and death with breakthrough symptoms possible for functionally active patients. The efficacy inputs for octreotide were obtained from the PROMID trial. The efficacy for lanreotide was assumed to be the same as that of octreotide because of lack of data comparing these drugs. The equal efficacy assumption is supported by the fact that the NCCN guidelines do not differentiate between these drugs and treat them as interchangeable. Utilities for stable and progressive disease, which are used for estimating QALYs, were obtained from a published study estimating the utilities for NET. The costs for treatments, hospitalizations, physician visits, procedures, and end-of-life treatment were considered and were obtained from standard sources and the literature.
Results The total life-years and QALYs were identical for the 2 drugs because of equal efficacy assumptions. Over the 3-year horizon, on average, patients lived 1.8 years with stable disease and 0.8 years with progressive disease, and spent 0.2 years with breakthrough symptoms requiring additional treatment. The estimated QALY was 1.8 years. Over 3 years, the overall cost was $250,547 for patients receiving lanreotide and $223,437 for patients receiving octreotide. Patients lived 7.9 years on average, with patients receiving octreotide incurring $84,875 less in lifetime costs than patients receiving lanreotide.
Conclusions For patients with metastatic GI-NETs, the cost of treatment with octreotide LAR was considerably lower than the corresponding cost for treatment with lanreotide depot over the 3-year and lifetime horizons.
Patterns of Utilization of Bortezomib Retreatment in Patients with Relapsed and/or Refractory Multiple Myeloma Who Received ?3 Lines of Therapy: Analysis of Physician Chart Data from US Community Oncology Practices
S. Jagannath,1 A. Roy,2 J. Kish,3 D. Globe,2 E. Kuriakose,2 D. Siegel4 1Mount Sinai Hospital, New York, NY; 2Novartis Pharmaceuticals Corporation, East Hanover, NJ; 3Xcenda, Palm Harbor, FL; 4John Theurer Cancer Center, Hackensack, NJ
Background The introduction of “novel” agents, including bortezomib (BTZ) and the immunomodulatory drugs (IMiDs) lenalidomide, thalidomide, or pomalidomide, as treatments for multiple myeloma (MM) has significantly prolonged patient survival. Physicians can choose from older agents or novel agent–based induction therapies as well as carfilzomib and pomalidomide, in later lines. Retreatment with BTZ or an IMiD after their initial use is common in patients who have had a durable response before relapse. Guidelines offer many options for induction therapy and in patients with relapsed and/or refractory MM (RRMM), leading to widely varying anticancer regimens and sequencing patterns in real-world settings.
Objective To describe baseline treatment patterns and real-world utilization of BTZ and IMiDs through multiple regimens of therapy in RRMM, and to better understand which retreatment and sequencing scenarios are preferred in clinical practice.
Methodology A retrospective chart review was conducted among patients treated for MM in 30 large US community oncology practices, between January 1, 2007, and the data cutoff on March 31, 2014. From an original patient sample of 4729 patients with an International Classification of Diseases, Ninth Edition–coded diagnosis for MM, the final RRMM study population was a cross-section of 589 patients at various treatment stages who had received ?3 treatment regimens in a community setting by the cutoff date.
Results Of the 589 patients with RRMM who were studied, 261 (44%) had at least 4 regimens and 116 (20%) had at least 5 regimens. From this sample, the first recorded therapy was BTZ with various treatment partners in 55% (324/589) of patients. Of these patients, 58% (187/324) were retreated with BTZ in the next line, whereas 47% (153/324) received BTZ 2 lines later. A total of 28% (92/324) of patients started on BTZ were retreated with BTZ on the next 2 lines, often with companion IMiDs. In addition, a large majority of patients started on IMiDs were switched to BTZ.
Conclusion This chart review shows that a significant fraction of patients with RRMM are being treated with >3 lines of therapy after starting on BTZ or IMiDs. Retreatment with BTZ was common, even before its formal August 2014 approval for reuse. Physicians often start therapy with BTZ to reuse it following early relapses in patients where the tumor is not refractory to BTZ. In this chart review, retreatment with BTZ was more common than switching to IMiDs. The addition of an efficacy-enhancing companion agent to BTZ for retreatment on later lines may further increase the value and efficacy of care delivered.
Utilization Beyond Traditional Oncology Care Management: Utilizing Multiple Data Sets and Clinical Tools to Improve the Care and Cost-Effectiveness in the Management of Oncology Patients
Sheryl Riley Director of Clinical Programs, SAI Systems International, Inc. Contact: Sheryl Riley at This email address is being protected from spambots. You need JavaScript enabled to view it. or 908-397-1706
Utilization management evaluates the appropriateness and medical need of healthcare services while applying evidence-based criteria or guidelines. Plans utilize this information to proactively manage the costs relative to high-dollar drugs and/or procedures. This process is not always provider- and patient-friendly, so utilizing retrospective data analysis to view treatment cost and patterns of care can and should be beneficial in controlling cost.
The presentation will outline the type of data needed, as well as the role that data elements play in the process; describe in detail how each element of clinical, operational, and financial data can play into the administration of oncology management; and ascertain how each of these elements works to identify, stratify, and engage the right members for the program. We will also outline how comprehensive and proprietary algorithms utilizing the current patient data can be used to engage physicians and health plans to improve overall patient care.
The hope is that with this information we can empower oncologists and health plans to better understand where oncology dollars are being spent, who is spending them, and what they are being spent on. In turn, this information can and should be utilized to change and/or improve current practice patterns in the areas of utilization, symptom management, hospital admissions, and emergency department visits, and the use of palliative and hospice care, therefore supporting the link between data and improving patients’ clinical and financial outcomes.
Objectives To outline the data items needed to create the best clinical, operational, and financial analysis; to define how different types of data are utilized to find the right patients for the program; to identify where dollars are being spent, on what services, and by which physicians; and to describe how utilizing assessment data and additional information collected will improve patient outcomes through reducing hospital admissions and emergency department visits.
Utilization of the New Agents Carfilzomib and Pomalidomide in Relapsed and/or Refractory Multiple Myeloma: Analysis from 30 Large US Community Oncology Practices
S Jagannath,1 A Roy,2 J Kish,3 D Globe,2 E Kuriakose,2 D Siegel4 1Mount Sinai Hospital, New York, NY; 2Novartis Pharmaceuticals Corporation, East Hanover, NJ; 3Xcenda, Palm Harbor, FL; 4John Theurer Cancer Center, Hackensack, NJ
Background The introduction of bortezomib (BTZ) and lenalidomide (LEN) as induction therapies in multiple myeloma (MM) has lengthened progression-free survival in early stages of disease and has increased overall survival. However, for patients previously exposed to both therapies, there are few other available therapeutic options. The recent approval of the proteasome inhibitor carfilzomib (CFZ) and the immunomodulator pomalidomide (POM) adds 2 relatively novel options for patients with relapsed and/or refractory MM (RRMM) to the treatment algorithm.
Objective To evaluate US community oncologists’ prescribing behavior with recently introduced CFZ and POM for RRMM.
Methodology A retrospective chart review was conducted for patients treated for MM in 30 large US oncology practices between January 1, 2007, and the data cutoff on March 31, 2014. From an original sample of 4729 patients with an International Classification of Diseases, Ninth Edition–coded diagnosis for MM, the final RRMM study population was a cross-section, with 589 patients at various treatment stages who had received ?3 treatment regimens in a community setting by the cutoff date.
Results In 589 patients with RRMM who received ?3 previous treatment regimens, the use of CFZ and POM had increased with each successive treatment: 1 previous treatment, 2%; 2 treatments, 11%; 3 treatments, 27%; 4 treatments, 33%; and 5 previous treatments, 22%. The chart data revealed that patients who received frontline therapy with bortezomib/lenalidomide/dexamethasone (RVD) were started on new therapies after earlier relapses than patients who received doublet induction with bortezomib/dexamethasone (VD) or lenalidomide/dexamethasone (RD). Patients who received VD induction were prescribed CFZ and/or POM less often in later treatment lines than patients who received RD or RVD induction. Of patients receiving induction with VD, RD, and RVD, 19%, 33%, and 44%, respectively, were prescribed new agents after relapse.
Conclusion An analysis of prescribing patterns for new agents for the treatment of RRMM showed that within 1 year to 1.5 years of the launch of CFZ and POM, they were frequently prescribed by community oncologists after 3 previous treatments. Most community oncologists initiated treatment of MM with a doublet, and often retreated once or twice with BTZ and/or LEN/thalidomide before using the new drugs (up to 33% of patients with 3 previous treatments). In contrast, when patients were started on RVD, almost 50% with 3 previous treatments received the new agents. The lower utilization of new therapies after induction with VD, relative to RD and RVD, may reflect physicians’ preferences for early retreatment with BTZ.
Economic Impact of a Novel Circulating Tumor DNA Test for Third-Generation EGFR TKI Biomarker Testing in NSCLC
Gary Gustavsen,1 Patrick Kennedy,1 Martha Boylston,1 Maxwell Mean,1 Oanh Dang,2 Vlada Melnikova,2 Mark Erlander2 1Health Advances, LLC, Weston, MA; 2Trovagene, Inc., San Diego, CA
Background The explosion of targeted therapies in oncology has placed significant pressure on tissue acquisition for companion diagnostic testing. Non–small-cell lung cancer (NSCLC) is a particularly important indication with high demand for molecular testing yet suboptimal tissue access. Third-generation epidermal growth factor receptor (EGFR) tyrosine kinase inhibitors (TKIs) are approaching launch, placing even greater demands on tissue. Eligibility for these therapeutics will be determined by the presence of a T790M resistance mutation, as identified by a repeat biopsy. Given the high expense of a repeat biopsy, the use of a novel circulating tumor DNA (ctDNA) test from Trovagene, based on either blood or urine samples, may provide clinical and economic benefits to the healthcare system.
Objective The purpose of this study was to quantify the economic impact of the ctDNA test for US commercial health plans.
Methods A fact-based economic model was developed for a hypothetical cohort of patients who had progressed on first-line EGFR TKIs and were considering third-generation EGFR TKI therapy (once approved). Costs were assigned to each unit of care based on 2014 Medicare fee-for-service rates and other published costs of care. Patients were followed for 5 years, with management assumptions based on patterns of care and progression data. Costs were calculated for 2 scenarios: a “reference scenario” representing standard practice with a tissue-based repeat biopsy and a “test scenario” utilizing the ctDNA test. The total cost of care was compared between the 2 scenarios. Sensitivity analyses were performed around key inputs to test model robustness.
Results The ctDNA test reduces costs by $12,938 per patient tested. For a health plan with 10 million members, this would translate to more than $26 million. The vast majority of savings is generated by the avoidance of invasive biopsies, which often lead to very expensive complications. In sensitivity analyses, no single input, when altered within a reasonable range, caused the model to show the test was no longer cost-saving.
Limitations Patient care was modeled based on clinical guidelines, published literature, and physician expert opinion. Real-world practice may differ from the modeled care pattern. The costs were based on national Medicare rates, and may vary by individual health plans.
Conclusion Beyond the clinical and logistical improvements seen with a highly accurate liquid biopsy test, the ctDNA test would likely reduce costs for health plans that choose to cover it.
