Golbach, Allison P.

Abstract Background: Cyclin dependent kinase (CDK) 4/6 inhibitors (CDK 4/6i) can improve outcomes in ER-positive/HER2-negative (ER+/HER2-) breast cancer. The choice of CDK 4/6i selection and dose depends on clinical context and/or potential side effect of profile of each unique CDK 4/6i. The objective of this study was to evaluate practice patterns in patients initiated on CDK 4/6i and assess adherence to recommended laboratory monitoring in breast cancer patients in both an institutional and national dataset. Methods: The institutional cohort (IC) involved a retrospective chart review of patients newly initiated on palbociclib between May 8, 2018 - June 4, 2019 at Mayo Clinic, Rochester. The national cohort (NC) reviewed medical and pharmacy claims data from the OptumLabs Data Warehouse (OLDW) and included patients who were initiated on palbociclib (P), ribociclib (R) or abemaciclib (A) between February 6, 2015 - September 30, 2019. NC patients were required to have a minimum of 6 months baseline coverage, 6 months coverage after first prescription and Day 1 labs drawn. For both cohorts, patients were ≥18 years old with metastatic ER+/HER2- breast cancer. Data was collected for up to 6 cycles of treatment and included cycle start dates, doses, dates of lab draws and dose changes. Laboratory adherence was defined as a complete blood count being drawn +/- 3 days of the defined timepoint for the IC and +/- 5 days for the NC with a l4-day window for Cycle 1, Day 1 labs. Results: The IC included 81 patients and the NC 2600. In the NC, the most prescribed CDK 4/6i was P (90%), followed by A (6%) and R (4%). Prescription breakdown by geographic region was Midwest (26%), Northeast (14%), South (47%), West (13%). Ethnic breakdown of the group was White (68%), Black (15%), Hispanic (8%), Asian (3%) and unknown (6%). P practice pattern data were available for both the IC and NC, but R and A data in the NC only. In the IC, the initial P dose was 125 mg (95%), 100 mg (1%) and 75 mg (4%). In the NC, P (n=2329) dose was 125 mg (81%), 100 mg (15%) and 75 mg (4%). Dose reductions were common with 25% and 28% of patients requiring one dose reduction and 16% and 9% of patients requiring two dose reductions in the IC and NC, respectively. In NC patients initially treated with P, 5% were subsequently treated with A and 2% with R. In the NC, A (n=163) was initiated at 200 mg (7%), 150 mg (79%), 100 mg (10%) and 50 mg (4%). One dose reduction was required in 25% of patients and 6% required two dose reductions. Of those initially treated with A, 16% were subsequently treated with P and 1% with R. In the NC, R (n=108) was initiated at 600 mg (81%), 400 mg (8%) and 200 mg (11%). One dose reduction was required in 17% of patients and 2% required two dose reductions. Of those initially treated with R, 7% each were subsequently treated with P and 10% with A. Laboratory adherence was assessed for P only. For the IC, a total of 81 patients were included (mean age 61±13 years, 98% female and 95% White). The NC included 2329 patients (mean age 66±12 years, 99% female and 69% White). Laboratory adherence is listed in the table below: Conclusions: P was the most commonly prescribed CDK 4/6i. Dose reductions were less common with R. Adherence to laboratory monitoring was higher in our institutional cohort than in a national administrative claims database. Initiatives to ensure that labs are drawn at recommended timepoints during P therapy will be important for safety. ICNCC1D193%100%C1D1589%61%C2D191%71%C2D1558%55%C3D199%62%C4D190%55%C5D184%53%C6D178%50%C = cycle, D = day. Citation Format: Jodi Taraba, Kavya Swarna, Allison Golbach, Lindsey Sangaralingham, Kathryn Ruddy, Kristin Mara, Matthew Smith, Tufia Haddad, Karthik Giridhar. Evaluation of CDK 4/6 inhibitor practice patterns and institutional versus national adherence to palbociclib laboratory monitoring in breast cancer patients [abstract]. In: Proceedings of the 2021 San Antonio Breast Cancer Symposium; 2021 Dec 7-10; San Antonio, TX. Philadelphia (PA): AACR; Cancer Res 2022;82(4 Suppl):Abstract nr P3-23-05.

PURPOSE: To evaluate the prevalence of burnout among hematology-oncology pharmacists and factors associated with an increased risk of high burnout. METHODS: Between October and November 2020, members of the Hematology/Oncology Pharmacy Association were invited to complete an anonymous survey. Questions included the Maslach Burnout Inventory (MBI), Well-Being Index, and sociodemographic and occupational factors linked with burnout. RESULTS: Of 3,024 pharmacists contacted, 614 pharmacists (20.3%) responded to an online survey and 550 (18.2% of overall sample) completed the MBI and were included for analysis. Overall, high levels of burnout were observed in 61.8% of respondents based on the MBI, with 57.9% of respondents scoring high on the emotional exhaustion domain and 31.3% high in the depersonalization domain. Pharmacists with burnout worked on average 48.6 (±9.6) hours per week compared with 44.5 (±9.6) hours per week for those without high burnout and spent more time on administrative tasks per week (7.5 hours v 4.3 hours; all P < .001). Pharmacists reporting high burnout were more likely to report concern they had made a major medication error within the past 3 months (27.6% v 8.1%; P < .001) and greater intent to leave their current job within 2 years (60.3% v 19.0%; P < .001). CONCLUSION: Burnout is prevalent among hematology-oncology pharmacists and may affect both patient safety and the adequacy of the workforce. Risk factors for burnout among hematology-oncology pharmacists in this study may be targets for burnout mitigation and prevention strategies to reduce the impact on pharmacists and improve cancer care for patients.

Abstract Assessment of patient out-of-pocket cost for palbociclib therapy in advanced breast cancerBackground:Palbociclib has demonstrated improved outcomes in patients with advanced hormone receptor positive (HR+)/human epidermal growth factor 2 (HER2) negative breast cancer when used in combination with endocrine therapy 1,2. The current average wholesale price of therapy with this medication class exceeds $190,000 per year (at full dose). Financial toxicity is a major concern in the oncology population and can decrease patient quality of life and may result in non-adherence 3,4. Our objective was to describe the out-of-pocket cost burden for patients treated with palbociclib. Methods:A retrospective review of patients newly initiated on palbociclib therapy between May 5, 2018 and May 30, 2019 was completed at our institution. Patients were included if they were 18 years of age and older, newly starting palbociclib for advanced or metastatic HR+/HER2- breast cancer, had US-based insurance, and received palbociclib from our internal specialty pharmacy. Cost information was collected utilizing dispensing reports and additional patient-specific information was obtained from the EHR. Descriptive statistics were performed on the collected data. Results:A total of 44 patients were included in the cost analysis. Primary sources of coverage for these patients included commercial insurance (n=13), Medicare (n=25), and state/federal insurance (n=6). We first assessed costs with primary insurance coverage alone. The sum of all the initial cycle out-of-pocket copays after primary insurance totaled $49,108. The median individual copay was $291, the range was $0 to $2,943, and 9 of the 44 patients had no copay after the primary insurance was applied. The impact of assistance programs, which include independent grant funding, copay cards, vouchers, and secondary Medicaid plans, was significant. After applying primary insurance and aid from assistance programs, the sum of all initial cycle out-of-pocket copays reduced from $49,108 to $3,172. After assistance, 33 of the 44 patients had an initial copay cost of $0. Over 90% of the out-of-pocket total was from two patients (one each with a copay of $2,467 and $497). Ultimately, Mayo Clinic Specialty Pharmacy helped patients avoid $45,851 in first cycle out-of-pocket copays, of which $41,079 and $4,772 were for Medicare and commercially-insured patients, respectively. Copay cost by type of insurance was assessed. All patients with commercial insurance (n=13) had no actual copay for the first cycle. Medicare patients (n=25) are not eligible for copay cards and had larger pre-assistance copays compared to commercial patients (median $2,454 vs. $45). Vouchers or grants were utilized by 16 out of 25 Medicare covered patients. State/Federal insurance included 2 Tricare and 4 Medicaid patients. While ineligible for copay card assistance, the copays for these patients were low, ranging from $0-$28. Standard Medicare D plans do not have an out of pocket maximum for the year. The catastrophic phase requires an ongoing copay of 5% of the total claim cost, resulting in approximately a $600 per month copay for the remainder of the calendar year during the study period. When combined with the first cycle cost of approximately $2500, the yearly out-of-pocket cost for a patient with a standard Medicare D plan is roughly $10,000. Conclusion:Patients initiating therapy with palbociclib are commonly faced with high out-of-pocket costs. The availability, eligibility, and use of financial assistance programs are imperative in decreasing the financial toxicity. Specialty pharmacies play an important role in obtaining financial assistance which leads to decreased out-of-pocket expenses for patients. Citation Format: Allison P Golbach, Matthew D Smith, Jodi L Taraba, Karthik V Giridhar. Assessment of patient out-of-pocket cost for palbociclib therapy in advanced breast cancer [abstract]. In: Proceedings of the 2020 San Antonio Breast Cancer Virtual Symposium; 2020 Dec 8-11; San Antonio, TX. Philadelphia (PA): AACR; Cancer Res 2021;81(4 Suppl):Abstract nr PS7-49.