Oral Oncolytics Research Articles

Pharmacist-facilitated Patient Reported Outcome Measure (PROM) monitoring: developing an EHR SmartForm© to monitor side effects of oral oncolytics during routine telehealth encounters.

Patient reported outcome measures (PROMs) are increasingly used in oncology care, but pharmacists providing direct patient care have been overlooked. We engaged pharmacists and adults receiving oral oncolytics (chemotherapy medication taken by mouth) to develop a SmartForm© in the electronic health record (EHR) for PROM monitoring. Pharmacists verbally ask the patient side effect questions during routine telehealth encounters and enter responses in real time. Our development process was guided by the Knowledge to Action Framework. In phase 1 (Knowledge Inquiry), we prioritized side effects to assess in the EHR SmartForm© via interviews with patients and a Delphi panel with pharmacists. Adults receiving oral oncolytics for breast (n = 12), thoracic (n = 12), or hematological (n = 12) cancer were interviewed, with purposeful sampling for adults who were aged 65 + years or Black. Interviews were coded with content analysis. We conducted three Delphi rounds, with 11/19, 13/19, and 19/19 pharmacists, respectively. In phase 2 (Knowledge Synthesis), PROM items were selected and the EHR SmartForm© programmed. In phase 3 (Knowledge Tailoring), we conducted usability testing with pharmacists. Pharmacists and patients were consistent in prioritizing side effects of oral oncolytics and 10 were retained. Patients advocated asking whether they can do their usual activities, while pharmacists added medication adherence. Usability testing yielded suggestions to simplify the SmartForm©. By presenting screenshots of our SmartForm©, our findings are useful to other healthcare systems looking for a PROM solution integrated in the EHR, with a reasonable pharmacist/clinician workload, and no requirement for patients to have internet access/comfort.

The impact of oral oncology drugs in the era of value-based care.

15 Background: Oncology drug expenditures are a significant contributor to increasing total cost of care (TCOC). Oral oncolytics (OO), such as small molecule inhibitors (CDK 4/6 inhibitors, tyrosine kinase inhibitors, etc.), and immunomodulators, have revolutionized the treatment landscape for many cancers. We evaluated the patterns of OO use and spend for Medicare patients over time at a large community oncology practice participating in the Center for Medicare and Medicaid Innovation (CMMI)’s Value-based care (VBC) Program, the Oncology Care Model (OCM), with a focus on the seven cancers that are part of a successor model, the Enhancing Oncology Model. Methods: Using CMMI claims for attributed 6-month OCM episodes, we evaluated drug use and expenditures by performance period (PP) from July 2016 – June 2022 (11 PPs), with an emphasis on OO drugs. We used Part D expenditures as a proxy for OO. Results: From 2016-22, average TCOC per PP increased by 15.5% in the 7 EOM diagnoses (breast, lung, colon, prostate cancer, myeloma, lymphoma, and chronic leukemia). Average drug expenditures per PP grew 33% percent and represented 71% of total cost by PP11, up from 61% in PP1. Average expenditures per episode increased by 11.7% for Part B and 82.6% for Part D drugs (p<0.01). Increase in Part D drug expenditures was partly due to an increase in the number of unique oral drugs which grew by 32% over the evaluation period. The greatest increases in Part D drug expenditures occurred in breast cancer (87%) and lymphoma (153.7%). Table reports average OO expenditures per PP, percent change from PP1 to PP11, and the change in the % Part D drugs contributed to TCOC. Conclusions: Increases in drug expenditures represent the greatest impact on TCOC for cancer patients. OO medicines have an increasing role in the treatment landscape and represent a growing focus in VBC models. Utilization and cost of OO medication have a significant bearing on VBC performance. Diagnosis Avg. OO Expenditures PP1 Avg. OO Expenditures PP11 Avg. OO Expenditures Change Contribution of OO to TCOC Change from PP1 - 11 Breast $4,208 $7,869 87.0% 9.9% Leukemia $25,334 $41,128 62.3% 19.9% CRC $1,206 $2,158 78.9% 3.1% Lung $3,650 $3,625 -0.7% -2.5% Lymphoma $4,193 $10,637 153.7% 13.0% Myeloma $25,109 $39,298 56.5% 6.7% Prostate $18,815 $20,114 6.9% 3.2% Total $8,291 $15,140 82.6% 10.8%

Characterizing access for oral oncolytics used to treat breast cancer at an academic medical center.

116 Background: Everolimus, CDK 4/6, PIK3CA, Her2 tyrosine kinase, and PARP inhibitors are commonly used oral oncolytic agents for breast cancer patients. However, oral oncolytics are tiered differently for insurance cost coverage than IV therapies. We characterized the financial toxicity associated with breast cancer oral oncolytics, investigated the prevalence of financial assistance mechanisms utilized, and explored the association of these mechanisms with timing of treatment initiation in adult breast cancer patients. Methods: Patients 18 years or older with a primary breast cancer diagnosis who received care at the outpatient breast cancer clinic and were prescribed an oral oncolytic by a Michigan Medicine provider were included. Using the electronic medical record, we identified initial prescriptions for everolimus, CDK 4/6 inhibitors (palbociclib, ribociclib, abemaciclib), PIK3CA inhibitor (alpelisib), HER2 tyrosine kinase inhibitors (lapatinib, neratinib, tucatinib), and PARP inhibitors (olaparib, talazoparib) dated between January 1, 2014 and November 30, 2022. Patient demographics, adjuvant versus metastatic status, insurance coverage, monthly out-of-pocket costs, financial assistance obtained, prescribed date, planned medication start date, pill-to-mouth date, duration of treatment and reason for treatment discontinuation were collected. Results: There were 418 unique patients in our final cohort. Almost one third of all prescriptions were filled with financial assistance (n=126, 31.2%). The three most common assistance mechanisms were copay cards (n=55, 43.6%), grants (n=34, 26.9%) and patient assistance programs (n=31, 24.6%). For monthly out-of-pocket costs before any financial assistance was obtained, the three most common cost groups were $0-$15 (n=155, 36%), $15-$100 (n=101, 23.7%) and >$500 (n=91, 21%). Among the 48 prescriptions that were never filled, almost one third were due to prohibitive cost (n=15, 28.3%). For insurance coverage, the three most common types were commercial (n=224, 54%), Medicare Part D (n=108, 26%), and Medicaid (n=57, 14%). The median number of days treatment was delayed was 10 days (range 0-495 days). Insurance approval/denial delays accounted for 33.9% of delays (n=120). Conclusions: One third of breast cancer oral oncolytic prescriptions were filled with financial assistance. In the instances in which patients were not able to receive timely treatment for their cancer, one out of three times it was due to insurance delay.

Financial toxicity (FT), quality of life (QoL), and medication adherence patient-reported outcomes (PROs) in CLL on first-line (1L) oral oncolytics.

e23157 Background: While oral oncolytics have transformed CLL treatment, high costs may cause significant FT adversely impacting patients beyond direct out-of-pocket (OOP) costs. The association of FT with QoL and medication adherence has not been characterized with oral oncolytics in CLL. Methods: Electronic PRO surveys were longitudinally administered to patients initiating any 1L oral oncolytic therapy for CLL within the last 6 months at two academic centers. PROs included FACIT-COST (significant FT: score < 26), FACT-LEU QoL, MARS-5 (suboptimal adherence: score < 25) and PROMIS PMAS to assess medication adherence. PROs were administered at baseline, 3 months, and 6 months after enrollment. Pearson’s correlation ( r) was calculated between PRO domains. Semi-structured, qualitative interviews were conducted after 3-month timepoints and analyzed. Results: 34 patients were enrolled: median age 65 yrs (range 33-80), 59% male, 6% Black, 9% Hispanic. Majority received BTK inhibitors (56%, acalabrutinib/zanubrutinib) followed by venetoclax (44%); 50% received concurrent obinutuzumab. Most had private insurance (50%) followed by Medicare (44%). Median time from 1L initiation to study enrollment: 1.5 months. PRO completion rates: 100% (baseline), 85% (3 mo) and 74% (6 mo). Summarized PRO and interview outcomes are displayed below. Conclusions: Patients with CLL on 1L oral oncolytics experienced worsening FT associated with poor medication adherence and worse QoL over time. PROs were discordant with qualitative interviews and suggested that FT may be driven by factors other than OOP costs. Although funding and patient assistance programs were beneficial, uncertainty over losing funding may be a long-term driver of FT and merits further study. [Table: see text]

Oral oncolytics medically integrated dispensing: Impact on medical spending compared to non-integrated dispensing.

e23098 Background: Medically integrated dispensing, consisting of multidisciplinary care teams dispensing drugs within clinics, has been associated with reduced medical spending for members receiving oral oncolytics (OO). However, there is little understanding of how medical spending differs across sites of care by dispensing channel. Objective: To compare 6-month pre/post all-cause medical spending by site of care between integrated and non-integrated dispensing channels among commercially insured members initiating OO therapy. Methods: Prime Therapeutics’ integrated pharmacy and medical claims database was used to identify members newly initiating an OO of interest between 1/1/2019 and 12/1/2022. Members were required to be continuously enrolled 6 months before and after index, had a cancer diagnosis, and had > $0 medical spending. Dispensing channel Integrated Health System Specialty Pharmacy (Int-HSSP), Integrated Physician Office (Int-Phys), Non-Integrated (Non-Int) was assigned using index OO fill. The primary outcomes were change in all-cause medical spending, medical drug spending, and non-drug medical spending divided into five site of care categories: inpatient, outpatient facility, emergency department, provider office visits, and other. Regression analysis was used to compare change in spending across channels, adjusting for demographics, health status, and cancer type. Results: A total of 30,928 (Int-HSSP: N = 5,500; Int-Phys: N = 2,550; Non-Int: N = 22,878) commercially insured members met all study criteria. Mean age ranged from 53.9 (Int-HSSP) to 56.1 years (Int-Phys). Compared to Non-Int (Unadjusted All Medical Pre: $56,214, Post: $67,050), significant cost savings were observed in the Int-Phys (Unadjusted All Medical Pre: $64,794 Post: $64,670; adj. diff -$5,672 [-9,384 to -1,960; p = 0.003]). Across categories of medical spending, the largest decreases were observed for inpatient medical spending (adj. diff -$2,663 [-5,000 to -326; p = 0.026]) and medical drug spending (adj. diff -$2,082 [-$4,248 to 84; p = 0.060]) with the remaining $927 in savings coming from differences across all other sites of care combined. No significant differences were observed for other medical spending categories or for Int-HSSP compared to Non-Int. Conclusions: Int-Phys dispensing channel for OO drugs was associated with a $5,672 reduction in medical spending compared to Non-Int, nearly half of which was driven by changes in inpatient non-drug medical spending alone. These findings support managed care models which include integrated oncology dispensing as a potential opportunity to reduce medical spending. Future work should assess the impact of dispensing channel on total cost of care and differences in healthcare utilization and in patient care experiences by dispensing channel.

Evaluation of clinical adherence measures for oral oncolytics: A systematic review.

e23130 Background: Despite the critical importance of adherence monitoring for oral oncolytics, there are no standard measures for clinical practice. Methods: We conducted a systematic review using 4 databases aiming to characterize validated adherence monitoring tools utilized in either pre-implementation or evaluation of clinical programs. Various Medical Subject Headings (MeSH) and other search terms related to cancer, oral oncolytics, adherence, metrics, and outcomes were included. Measures used only for research (outside of clinical use) were excluded. Two independent reviewers screened articles with a third reviewer resolving discrepancies. Data extraction and quality assessments concluded the review. Results: Out of 751 screened articles, 73 proceeded to full-text review, with 6 selected for data extraction and quality assessment (Table 1). Two studies focused on the Morisky Medication Adherence Scale-8 (MMAS-8) tool, while others examined Michigan Oncology Quality Consortium Patient Reported Outcome Measure (MOQC PROM), 6-Item Girerd Scale, Medication Adherence Self-Efficacy Scale (MASES), and EXPeriencia con y ADherencia a AntiNEoplasicos Orales (EXPAD-ANEO). Among the five tools, MASES featured the most questions (24). All tools were implemented by healthcare professionals. Girerd and MASES were used specifically in hematologic and solid tumor populations respectively, whereas the remaining tools were applied in both cancer types. MMAS-8 and MASES were employed to evaluate current clinical programs, while MOQC PROM, Girerd, and EXPAD-ANEO were used during pre-implementation for future programs. Common biases from studies included limited generalizability, patient self-reported adherence credibility, and variability in patient baseline characteristics. Conclusions: Our findings highlight the paucity of validated adherence monitoring tools in clinical practice. The five tools discussed above exhibit potential in measuring adherence in a clinical setting; however, small sample size and short duration limit generalizability. Further investigation of new and existing tools in broader settings is needed. [Table: see text]

Impact of a pharmacist-led oral chemotherapy monitoring clinic at the South Texas Veterans Health Care System.

As cancer treatments shift from traditional intravenous chemotherapy to inclusion of oral oncolytics, there is a critical need for structured oral chemotherapy monitoring and follow-up programs. To provide continuous care and minimize clinical gaps to Veterans receiving oral chemotherapy, the hematology/oncology clinical pharmacy practitioners designed and initiated a pilot, pharmacist-driven, Oral Chemotherapy Monitoring Clinic at the South Texas Veterans Health Care System supported by an oral chemotherapy certified pharmacy technician. A retrospective evaluation of patients receiving oral chemotherapy at the South Texas Veterans Health Care System was performed before (Phase I) and after (Phase II) pilot implementation to assess the impact of an Oral Chemotherapy Monitoring Clinic on compliance with drug-specific lab and symptom monitoring. Complete monitoring was defined as 100% of recommended labs and symptoms assessed per cycle, partial monitoring was <100%, but >0%, and incomplete monitoring was defined as 0%. The primary outcome assessed the proportion of patients receiving complete monitoring in Phase II compared to Phase I. Most patients were male (94%), with a median age of 72 years. The most common oncolytic was abiraterone acetate. Overall, drug-specific baseline and follow-up laboratory and symptom monitoring was complete at a statistically significantly higher rate in Phase II compared with Phase I (p-value < 0.01). A significantly higher portion of patients in the Phase II cohort had a clinical pharmacy practitioner intervention (44% vs. 90%; p < 0.01). Monitoring for Veterans receiving oral chemotherapy was optimized with clinical pharmacy practitioner and certified pharmacy technician involvement while simultaneously alleviating Oncologist and nurse oral chemotherapy workload.

Abstract PO5-05-04: Advancing Treatment and Management of Patients with HR+/HER2- Breast Cancer: Findings from a Quality Improvement Initiative

Abstract Background: With the advent of novel oral oncolytics, the cancer care delivery model for HR+/HER2- breast cancer (BC) is evolving, shifting the responsibility for medication adherence and monitoring and managing of side effects to patients and their caregivers. In this quality improvement (QI) initiative, we aimed to uncover and address gaps in patient and provider education, risk reduction, adverse event management, and shared decision-making in order to improve outcomes for HR+/HER2+ patients on oral oncolytics. Methods: From 9/2022 to 12/2022, 54 HCPs who treat breast cancer and 111 HR+/HER2- BC patients from 4 US community oncology clinics completed surveys assessing attitudes, values, and challenges related to practice patterns, education, and therapy adherence in HR+/HER2- BC. HCPs participated in audit-feedback sessions to reflect on survey results and their own practice, and developed action plans to improve care, which were implemented in subsequent collaborative patient-provider learning sessions. Results: Top reported HCP challenges in HR+/HER2- BC care include providing patient-centered supportive care measures (32%), patient adherence/lack of follow up (22%), and individualizing treatment plans (17%). Additionally, 43% of providers reported that improved collaboration across interprofessional teams would most improve care. Top reported patient challenges include worry about and/or difficulty managing side effects from treatment (26%), difficulty scheduling visits with many different HCPs/following up (24%), and difficulty communicating with healthcare teams (16%). In surveys, 28% of patients reported frequently or very frequently missing/skipping doses of oral breast cancer medication. Top reasons for missing/skipping doses included forgetting or not having it nearby (36%), cost (21%), and side effects (20%). To address the top challenges identified in baseline surveys, HCPs developed and implemented action plans, such as improving the identification of patients at high risk of recurrence, establishing patient-provider educational sessions, increasing the use of patient navigators, incorporating oral adherence toolkits, and educating patients and staff about available supportive care resources. After implementation of patient-provider collaborative education sessions at community clinics, patients reporting high levels of knowledge about BC treatment options and communicating side effects/symptoms increased from 27% to 57%, and 37% to 77%, respectively. At 60-day follow-up, 58% of patients reported taking a more active role in treatment decision-making, and 52% reported setting reminders/alarms/using apps to remember to take medication on time. Conclusions: Patient adherence to oral oncolytic medications remains a challenge in BC treatment. This quality improvement initiative uncovered underlying barriers to effective treatment management of HR+/HER2- breast cancer patients on oral oncolytics. Action plans and educational resources were developed and implemented to address identified barriers and optimize treatment management for HR+/HER2- BC. These methods and findings represent key opportunities for improvement that can be implemented in community oncology practices to improve adherence to oral oncolytics and overall HR+/HER2- breast cancer care. Citation Format: Jane Meisel, Chelsie Anderson, Ilona Dewald, Jeffrey Carter, Cherilyn Heggen, Kelly McKinnon. Advancing Treatment and Management of Patients with HR+/HER2- Breast Cancer: Findings from a Quality Improvement Initiative [abstract]. In: Proceedings of the 2023 San Antonio Breast Cancer Symposium; 2023 Dec 5-9; San Antonio, TX. Philadelphia (PA): AACR; Cancer Res 2024;84(9 Suppl):Abstract nr PO5-05-04.

Real-world data of cardio-oncologic interventions for cardiovascular adverse events with oral oncolytics

BackgroundOral cancer therapy-related cardiovascular (CV) toxicity has a wide variety of presentations including arrhythmia, cardiomyopathy, and myocardial infarction, but clinical evidence related to its management is limited. The purpose of this IRB-approved, single-center, retrospective, cohort study was to characterize cardio-oncologic interventions for CV adverse events related to oral oncolytics.MethodsThe cohort included 67 patients who were admitted to a multi-hospital health system between June 1, 2016 and July 31, 2021, had at least one medical record order of oral oncolytics considered to have cardiotoxic potential, and had an ICD10 code for a cardiotoxic event added to their electronic medical records after initiation of oral oncolytics.ResultsThe majority (97%) had pre-existing cardiovascular disease (CVD) or a CV risk factor. The three most common classes of oral oncolytics were aromatase inhibitors (36%), BCR-ABL inhibitors (16%), and VEGFR inhibitors (13%). New-onset or worsening heart failure (HF) (n = 31), which occurred after a median of 148 days (Interquartile range (IQR) 43–476 days) was the most common cardiotoxic event. The most frequent interventions were pharmacological treatment of the CV adverse event (n = 44) and treatment interruption (n = 18), but guideline-directed medication therapy for HF could be further optimized.ConclusionPre-existing CVD or CV risk factors predispose oncology patients to CV adverse events. Real-world practice reveals that CV adverse events require temporary interruption of treatment and initiation of pharmacologic treatment. A multidisciplinary, patient-centered approach that includes discussion of risks/benefits of treatment continuation, and initiation of guideline-directed treatment is recommended until high-quality, drug-specific data for monitoring and treatment become available.

Oral Oncolytics and Cardiovascular Risk Management and Monitoring: Erratum.

Oral Oncolytics and Cardiovascular Risk Management and Monitoring: Erratum.

SIOG2023-4-P-283 - A 1-Year Prospective Study Evaluating Adherence to Oral Oncolytics in Older Adults with Lymphoma

SIOG2023-4-P-283 - A 1-Year Prospective Study Evaluating Adherence to Oral Oncolytics in Older Adults with Lymphoma

Are novel oral oncolytics underdosed in obese patients?

PurposeData on the effects of obesity on drug exposure of oral targeted oncolytics is scarce. Therefore, the aim of this study was to investigate the influence of body weight and body mass index (BMI) on trough levels of oral oncolytics with an exposure–response relationship. The oral oncolytics of interest were abiraterone, alectinib, cabozantinib, crizotinib, imatinib, pazopanib, sunitinib and trametinib.MethodsThis retrospective cohort study included patients treated with the selected oral oncolytics at the standard dose, with a measured trough level at steady state and with available body weight. The Spearman’s correlation test was used to determine the correlation between body weight and trough levels. The Fisher’s exact text was used to compare the frequency of inadequate trough levels between BMI categories.Results1265 patients were included across the different oral oncolytics. A negative correlation coefficient was observed between weight and trough levels for crizotinib (n = 75), imatinib (n = 201) and trametinib (n = 310), respectively, ρ = − 0.41, ρ = − 0.24 and ρ = − 0.23, all with a p-value < 0.001. For crizotinib, a higher percentage of patients with a body weight > 100 kg had inadequate trough levels. No statistically significant differences were observed in the frequency of inadequate trough levels between BMI categories.ConclusionHigher body weight was only correlated with lower plasma trough levels for crizotinib, imatinib, and trametinib. Therefore, patients with a high body weight may require dose escalation to obtain adequate target levels when treated with these oral oncolytics.

Development of oral oncolytic nonadherence estimator (ORACLE): A pretreatment nonadherence risk assessment for oral oncolytics.

To date, there is no adherence estimator to identify risk of nonadherence prior to initiating oral oncolytics. A workgroup was assembled through the National Community Oncology Dispensing Association and tasked with creating a tool to meet this need. Tool constructs were defined after a review of the literature identifying top barriers to adherence. A second literature search was conducted to identify questions targeting specific barriers from validated adherence questionnaires. Once a finalized draft was complete, the risk assessment tool was built into an electronic survey where a risk category can be automatically calculated for the patient. The six most impactful factors affecting compliance to oral oncolytics were identified as patient's confidence, health literacy, perception of treatment, quality of life, social support, and complexity of chemotherapy regimen. A six-item questionnaire was created with five patient-directed questions and one clinician-directed question. Examples and descriptions were provided for clinicians to consider when categorizing complexity of a regimen. The tool was designed for responses to each question to be indexed into categories through a 10-point system. Results will be stratified into low, moderate, or high risk for nonadherence. The creation of a tool to predict nonadherence prior to starting therapy is an unmet need for patients initiating oral oncolytics. The aim of this tool is to meet those needs and better guide clinicians to provide patients with strategies to better manage nonadherence. Next steps include tool validation and piloting in clinical practice.

Results of the first international quality control programme for oral targeted oncolytics.

With the rising number of oral targeted oncolytics and growing awareness of the benefits of therapeutic drug monitoring (TDM) within the field of oncology, it is expected that the requests for quantifying concentrations of these drugs will increase. It is important to (cross-)validate available assays and ensure its quality, as results may lead to altered dosing recommendations. Therefore, we aimed to evaluate the performance of laboratories measuring concentrations of targeted oral oncolytics in a one-time international quality control (QC) programme. Participating laboratories received a set of plasma samples containing low, medium and high concentrations of imatinib, sunitinib, desethylsunitinib, pazopanib, cabozantinib, olaparib, enzalutamide, desmethylenzalutamide and abiraterone, with the request to report their results back within five weeks after shipment. Accuracy was defined acceptable if measurements where within 85%-115% from the weighed-in reference concentrations. Besides descriptive statistics, an exploratory ANOVA was performed. Seventeen laboratories from six countries reported 243 results. Overall, 80.7% of all measurements were within the predefined range of acceptable accuracy. Laboratories performed best in quantifying imatinib and poorest in quantifying desethylsunitinib (median absolute inaccuracy respectively 4.0% (interquartile range (IQR) 1.8%-6.5%) and 15.5% (IQR 8.8%-34.9%)). The poorest performance of desethylsunitinib might be caused by using the stable-isotope-labelled sunitinib instead of desethylsunitinib as an internal standard, or due to the light-induced cis(Z)/trans(E) isomerization of (desethyl)sunitinib. Overall, drug substance and performing laboratory seemed to influence the absolute inaccuracy (F = 16.4; p < 0.001 and F = 35.5; p < 0.001, respectively). Considering this is the first evaluation of an international QC programme for oral targeted oncolytics, an impressive high percentage of measurements were within the predefined range of accuracy. Cross-validation of assays that are used for dose optimization of oncolytics will secure the performance and will protect patients from incorrect advices.

Impact of health system specialty pharmacies on total cost of care in cancer treatment, a multisite review.

Integrated delivery networks can use medically integrated dispensing of oral oncolytics on site through health system specialty pharmacies. There is little published research examining cost savings. Our objective was to demonstrate the financial value of health system specialty pharmacies among patients receiving oral oncolytics dispensed through fully, partially, and non-integrated dispensing strategies. This was a retrospective cohort study of adult patients from Symphony Health's Integrated Dataverse® repository who filled a prescription for an agent of interest from 7/1/16-6/30/20 that was written within 25 US health systems. Outcomes included costs, healthcare resource utilization, and duration of therapy. In total, 36,816 patients were included; 986 patients (2.7%) integrated, 1,822 (4.9%) partially integrated, and 34,008 (92.4%) non-integrated. Mean 6-month medical charge and oncolytic prescription costs were lower for the integrated group ($36,831; $55,786) than the partially integrated ($46,304, p = 0.053; $63,295, p = 0.071) and non-integrated groups ($54,261, p < 0.001; $65,005, p = 0.004). In most healthcare resource utilization categories, the integrated group had the lowest patient percentage utilizing medical care. Duration of therapy was lower on average by ∼3 months in the integrated vs non-integrated group, which may represent closer monitoring of patient medical records and need for fills vs autoship practices. Patients receiving oral oncolytics through medically integrated dispensing at health system specialty pharmacies may have lower medical and pharmacy costs and decreased healthcare resource utilization. This study adds to the growing body of literature supporting integrated delivery networks and integrated dispensing. Further research is needed to demonstrate the value of medically integrated dispensing through health system specialty pharmacies in the delivery of treatment to patients with cancer and other high-cost diseases.

Oral Oncolytics and Cardiovascular Risk Management and Monitoring.

Oral oncolytic treatment options have expanded over the last decade and have brought to light the need to monitor and manage cardiovascular (CV) disease in patients being treated with these therapies. There is a need to assess CV risk before patients receive oral oncolytic therapy with known potential to cause negative CV sequelae such as left ventricular dysfunction, hypercholesterolemia, hypertension, and arrhythmias. The review highlights the need to evaluate traditional CV risk factors and their association with the development and progression of cancer. Additionally, this review suggests approaches to monitor for CV adverse events and manage CV disease during and after treatment with oral oncolytic therapy. Key guideline recommendations are reviewed and highlight specific approaches to minimize CV harm for patients exposed to oral oncolytic therapy. Careful monitoring and patient-centered decision making is key in choosing appropriate therapies. A multidisciplinary approach between oncologists, cardio-oncologists, pharmacists, and other members of the healthcare team is essential in navigating cardiac toxicities.

Quality care of patients with HR+/HER2- breast cancer: Insights from an implementation science program.

e18756 Background: Oral oncolytics have transformed the treatment landscape of HR+/HER2- breast cancer, shifting the responsibility for medication adherence and side effect management to patients. To optimize patient outcomes, collaborative patient-provider education on treatment expectations, adverse event management, and shared decision-making is imperative. Methods: From 11/2021 to 2/2022, HR+/HER2- breast cancer patients (N = 55) and health care professionals (HCPs) (N = 69) who treat breast cancer from 5 community practices were surveyed on attitudes, values, and challenges related to treatment, adherence, and adverse event management on oral therapies. HCPs (N = 59) participated in audit-feedback (AF) sessions to reflect on their own practice and develop action plans to improve care, which were implemented in subsequent collaborative patient-provider learning sessions. Informed by survey findings and insights from patient focus groups a, a point-of-care oral oncolytic toolkit was disseminated to support patients and providers in effective communication, treatment adherence, and side effect management. Results: In surveys, HCPs and patients reported side effects of medication as the top challenge impacting treatment adherence, with fatigue (33%), nausea/vomiting (28%), and hair loss (28%) the most challenging side effects. Notably, 46% of HCPs reported inadequate time to discuss patient goals, preferences and concerns as the biggest barrier for shared decision-making, and 15% of patients reported their doctor does not always ask about goals, preferences, and concerns. Reflection on survey and focus group insights in AF sessions enabled providers to develop and implement action plans including the provision of patient education resources on medication adherence and side effect recognition and management, scheduling adequate follow-up appointments to ensure side effect management and medication compliance, and engaging in shared decision-making. In patient-provider collaborative sessions, patients demonstrated substantial knowledge gains in how to communicate, recognize, and manage side effects associated with treatment, and providers committed to continuing patient education. Conclusions: Through a combination of a patient and provider survey study, patient focus groups, HCP AF sessions, and collaborative patient-provider learning sessions, action plans and education resources were developed and implemented to support the provision of effective treatment management for HR+/HER2- breast cancer. The methods and findings of this study represent key opportunities for improvement in caring for patients with HR+/HER2- breast cancer. Study Sponsor Statement: This activity is supported by educational grants from Lilly and Novartis Pharmaceuticals Corporation, who had no role in the study design, execution, analysis, or reporting.

RWD124 Understanding the Value of Chart Abstraction for Assessing Oral Treatment History in the Oncology Outpatient Setting

The use of oral oncolytics continues to expand within the oncology landscape. Electronic medical records (EMR) can capture prescribing information such as initial dose and prescription dates, which can be readily extracted through databases. However, these structured data often lack accurate treatment histories on actual fulfilment and how patients are taking oral therapies at home. The latter information often requires assessment of unstructured data, which includes progress notes, phone notes and email communications within the EMR. We aimed to assess the rate of completeness of data describing oral oncolytics from charts.

Copay assistance use and prescription abandonment across race, ethnicity, or household income levels for select rheumatoid arthritis and oral oncolytic medicines.

BACKGROUND: Disparities in prescription abandonment may exacerbate health inequities. Whether copay assistance is associated with changes in prescription abandonment across different patient groups is unknown. OBJECTIVE: To assess disparities in copay assistance use; prescription abandonment across race, ethnicity, or income; and association of copay use with prescription abandonment and whether it differs across race, ethnicity, or household income. METHODS: This pooled, cross-sectional study assessed claims-level prescription data linked to a consumer database containing information on race, ethnicity, and household income for commercially insured patients. The first prescription for rheumatoid arthritis (RA) or oral oncolytic medicines from 2016 to 2020 was included. Logistic regression models measured odds of copay assistance use (copay/discount cards or free-trial voucher) and prescription abandonment (prescription not filled within 30 days of health plan approval). Interaction terms for copay assistance use by race, ethnicity, and income were tested. RESULTS: The sample included 67,674 patients prescribed RA medications and 9,560 prescribed oral oncolytic medications. Copay assistance use across race, ethnicity, and income ranged from 28.2% to 31.1% (RA medicines) and 27.2% to 36.7% (oral oncolytic medicines). Among those prescribed RA medicines and not using copay assistance, Black/African American, Hispanic patients, and those with household incomes less than $50,000 were more likely to abandon prescriptions than White patients and patients with household incomes more than $200,000 (odds ratio [OR] [95% CI], P value: Black/African American: 1.17 [1.06-1.29], P < 0.01; Hispanic: 1.11 [1.01-1.22], P = 0.03; income <$50,000: 1.24 [1.11-1.37], P < 0.01). Among patients using oral oncolytic medicines and not using copay assistance, there was no racial or ethnic difference in prescription abandonment. Patients using oral oncolytics with household incomes less than $50,000 were more likely to use copay assistance (1.34 [1.12-1.61], P < 0.01), but also more likely to abandon their prescriptions if not using copay assistance (1.44 [1.12-1.85], P < 0.01). Copay assistance was associated with a 79% (RA) and 71% (oral oncolytics) lower odds of prescription abandonment (0.21 [0.19-0.24], P < 0.01; 0.29 [0.24-0.36], P < 0.01), which did not differ across race, ethnicity, or income levels (P > 0.05). CONCLUSIONS: Copay assistance has potential to narrow disparities in prescription abandonment for commercially insured Black/African American or Hispanic patients taking RA medicines and patients with household incomes less than $50,000; however, efforts to improve access to copay assistance are needed. Copay assistance, as a factor facilitating equal access to medicines, is an important consideration when evaluating policies that impact access to copay assistance programs. DISCLOSURES: Genentech, Inc., provided funding and support for this study. Dr Wong is an employee of Genentech, Inc., and shareholder of Roche, Inc. Ms Donahue, Mr Thiesen, and Mr Yeaw are employees of IQVIA.

Cancer patients' experience with a pharmacist‐led oral chemotherapy clinic: A qualitative descriptive study

AbstractIntroductionGeisinger in Danville, Pennsylvania, has pharmacist‐managed oral chemotherapy clinics that manage approximately 100 patients per day. Through a collaborative practice agreement with the provider, the pharmacist serves as a clinical extender to manage patients' oral oncolytics between provider visits. Previous studies have described the clinical and financial impact of a pharmacist‐driven oral chemotherapy clinic, yet there is a paucity of data regarding patients' perceptions of the care received in such clinics.ObjectivesWe aimed to conduct a qualitative, semi‐structured, and descriptive study to better understand the patients' perceived role of the pharmacist in their care, perceived benefits, and opportunities for optimization.MethodsPatients were prospectively sampled from clinic records in this single clinic study. Eligible patients must have a clinic visit between November 2020 and March 2021, be at least 18 years of age, and have at least six documented encounters with the clinic pharmacist within the last 6 months. Patients were excluded if they were residents of a nursing home or rehab if they required a professional caregiver, or if they had not personally talked with the pharmacist during at least four encounters within the previous 6 months.ResultsOut of 110 screened patients, 36 met the inclusion criteria, and 21 completed the interview. Overall, patients described the oral chemotherapy pharmacist as knowledgeable, helpful, and considerate of their situation. When comparing the oral chemotherapy pharmacist to a community pharmacist, some patients felt the oral chemotherapy pharmacist provided more personalized care. One area of improvement identified by patients included improving the clarity and consistency of clinic phone calls.ConclusionsBased on the results of our thematic analysis, patients value the services provided in our pharmacist‐managed oral chemotherapy clinic; however, areas of improvement included how pharmacists communicate with patients regarding their care and the pharmacist's role within the care team.