HOPA 2020 Abstracts

JHOP - June 2020 Vol 10, No 3 - HOPA
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The following select abstracts were presented during the poster session at the 16th Annual Conference of the Hematology/Oncology Pharmacy Association (HOPA) in Tampa, FL, in April 2020. Additional abstracts will be published in the coming issues of the journal.


Clinical/Transactional Track: Original Research

Abstract #CT01

Extended Stability of Captisol-Enabled Melphalan in Normal Saline in IV Bags and in Glass Vials at Room Temperature and at Refrigeration

Presenter: Jitesh Kawedia, Clinical Pharmacy Specialist, The University of Texas MD Anderson Cancer Center

Coauthors: Sumankalai Ramchandran, Research Scientist; Xiaoqian Liu, Senior Research Assistant; Alison Gulbis, Clinical Pharmacy Specialist; Mark Titus, Associate Professor; Qaiser Bashir, Associate Professor; Muzaffar Qazilbash, Professor; Richard Champlin, Chair, Stem Cell Transplantation; Stefan Ciurea, Associate Professor; all at The University of Texas MD Anderson Cancer Center

Background: Melphalan is an alkylating agent used for intensive treatment of hematological malignancies and solid tumors. The older propylene glycol–based melphalan formulation has limited (<60 minutes) stability, which can significantly affect pharmacy operations and planned patient care. Captisol-enabled (CE) melphalan is a new formulation with increased stability (4 hours [h] at room temperature). In this study, we have determined the stability of 1 mg/mL, 1.5 mg/mL, or 2 mg/mL generic melphalan and 1 mg/mL or 2 mg/mL CE-melphalan admixture solution in intravenous (IV) bags and 5 mg/mL reconstituted solution in glass vials at room temperature (23°C) and under refrigeration (4°C). Extended stability will allow time for pharmacy to prepare and distribute the IV bags for patients receiving melphalan on standard of care, ongoing studies, and for potential new studies that aim to investigate the benefits of prolonged infusion of melphalan.

Objective: The primary objective was to investigate extended stability of CE-melphalan and compare with generic melphalan in normal saline in IV bags. The secondary objective was to determine the extended stability of reconstituted vials.

Methods: Lyophilized CE-melphalan or generic melphalan was reconstituted to 5 mg/mL with normal saline or supplied diluent. Reconstituted vials were diluted to desired concentrations with normal saline, in IV (PVC) bags. They were then stored at room temperature and under refrigeration. Aliquots were removed at 0 h, 1 h, 3 h, 4 h, 6 h, and 8 h for generic melphalan; 0 h, 2 h, 4 h, 6 h, 8 h, 12 h, and 24 h for CE-melphalan. CE-melphalan 5-mg/mL reconstituted vials stability was determined for 0 h, 24 h, 48 h, 72 h, 96 h, and 168 h at room temperature and at refrigeration. The concentration was determined using a validated high-performance liquid chromatography method. Melphalan was considered stable if the concentration, at a given time point, was >90% of the initial concentration at 0 h time.

Results: At room temperature and refrigeration, CE-melphalan 1 mg/mL was stable for 6 h and 8 h, respectively; 2 mg/mL was stable for 24 h in each case; whereas generic melphalan 1 mg/mL was stable for 1 h and 2 h, respectively; 1.5 mg/mL was stable for 2 h and 4 h, respectively; and 2 mg/mL was stable for 2 h and 4 h, respectively. Reconstituted 5 mg/mL CE-melphalan was stable for 24 h and 48 h, respectively, at room temperature and at refrigeration.

Conclusion: CE-melphalan has better stability compared with generic melphalan. CE-melphalan 2 mg/mL IV has 24 h stability and may be used for extended infusion or preparation in advance. Reconstituted CE-melphalan is stable for 48 h under refrigeration, which may allow additional compounding after 24 h.

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Clinical/Transactional Track: Original Research

Abstract #CT02

Ibrutinib for First-Line Treatment of Chronic Lymphocytic Leukemia: 5-Year Follow-Up Results from the RESONATE-2 Study

Presenter: Jan Burger, MD, PhD, The University of Texas MD Anderson Cancer Center

Coauthors: Alessandra Tedeschi, ASST Grande Ospedale Metropolitano Niguarda Paul Barr, Wilmot Cancer Institute; Tadeusz Robak, Medical University of Lodz; Carolyn Owen, Tom Baker Cancer Centre; Paolo Ghia, Università Vita-Salute San Raffaele; Osnat Bairey, Rabin Medical Center; Peter Hillmen, The Leeds Teaching Hospitals, St. James Institute of Oncology; Steven Coutre, Stanford Cancer Center, Stanford University School of Medicine; Stephen Devereux, Kings College Hospital, NHS Foundation Trust; Sebastian Grosicki, Silesian Medical University; Helen McCarthy, Royal Bournemouth General Hospital; Jianyong Li, Jiangsu Province Hospital; David Simpson, North Shore Hospital; Fritz Offner, Universitair Ziekenhuis Gent; Carol Moreno, Hospital de la Santa Creu i Sant Pau; Sandra Dai, Pharmacyclics, an AbbVie Company; Indu Lal, Pharmacyclics, an AbbVie Company; James P. Dean, Pharmacyclics, an AbbVie Company; Thomas Kipps, UCSD Moores Cancer Center

Background: Ibrutinib is the only once-daily inhibitor of Bruton tyrosine kinase (BTK) with significant progression-free survival (PFS) benefit demonstrated in 5 randomized phase 3 clinical trials in patients with chronic lymphocytic leukemia/small lymphocytic lymphoma (CLL/SLL), and overall survival (OS) benefit shown in these 3 studies. Because ibrutinib is given as continuous therapy, evaluating long-term ­efficacy and safety data is critical to inform clinical and pharmacy practice.

Objective: To report long-term data from the RESONATE-2 study over a median of 5 years of follow-up.

Methods: RESONATE-2 is a randomized, phase 3 clinical trial (PCYC-1115/1116; NCT01722487, NCT01724346). Patients aged ≥65 years with previously untreated CLL/SLL and without 17p deletion (N = 269) were randomized 1:1 to ibrutinib 420 mg continuously until disease progression or unacceptable toxicity or to chlorambucil 0.5-0.8 mg/kg for ≤12 cycles. In a long-term follow-up, the efficacy was assessed by the investigator per modified International Workshop on Chronic Lymphocytic Leukemia 2008 criteria.

Results: Baseline characteristics were well-balanced across treatment arms. With a median follow-up of 5 years (range, 0.1-66 months), ibrutinib showed sustained PFS benefit. The median PFS was not reached for ibrutinib versus 15 months for chlorambucil; the 5-year PFS estimates were 70% versus 12%, respectively. Improved OS was also seen with ibrutinib versus chlorambucil (5-year estimates, 83% vs 68%). With ibrutinib, the overall response rate was 92% and complete response rate increased over time, from 11% at a median follow-up of 18 months to 30% at 5 years. The most common grade ≥3 adverse events (AEs) included neutropenia (13%), pneumonia (12%), and hypertension (8%). Rates of most any grade AEs, dose reductions, and discontinuations because of AEs decreased over time. For 27 patients with dose reductions because of AEs, 93% (25/27) had subsequent AE improvement or resolution. In 70 patients, ibrutinib dosing was held (for ≥7 days) for any AE, after which 86% (60/70) of patients had complete AE resolution and were able to continue ibrutinib therapy. After ibrutinib discontinuation, 7 of 9 patients with available data responded to subsequent CLL therapies, including chemoimmunotherapy and alternate kinase inhibitors. More than half (58%) of patients continued using ibrutinib.

Conclusion:Single-agent ibrutinib conferred sustained PFS and OS benefit in patients with CLL/SLL versus chlorambucil in the longest follow-up to date from a phase 3 clinical trial of first-line BTK-directed therapy. No new safety signals emerged. Active dose management (dose holdings and reductions) to address AEs enabled most patients (approximately 90%) to continue ibrutinib therapy. With up to 5.5 years of follow-up, 58% of patients continue to use long-term maintenance ibrutinib treatment.

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Clinical/Transactional Track: Original Research

Abstract #CT03

Safety of Mogamulizumab in Mycosis Fungoides and Sézary Syndrome: Final Results from the Phase 3 MAVORIC Study

Presenter: Rebecca Nelson, PharmD, BCOP, Clinical Pharmacy Supervisor, H. Lee Moffitt Cancer Center & Research Institute, Tampa, FL

Coauthors: Youn Kim, Director, Multidisciplinary Cutaneous Lymphoma Program, Stanford Cancer Center; Mollie Leoni, Kyowa Kirin Pharmaceutical Development; Takahiro Ito, Kyowa Kirin Pharmaceutical Development; Fiona Herr, Kyowa Kirin; Lubomir Sokol, Director, Cutaneous Lymphoma Interdisciplinary Clinic, H. Lee Moffitt Cancer Center & Research Institute

Background: MAVORIC was an open-label, multicenter, randomized phase 3 clinical trial evaluating the safety and efficacy of mogamulizumab compared with vorinostat in patients with mycosis fungoides or Sézary syndrome who had failed at least 1 previous course of systemic therapy (NCT01728805). Primary results have been reported1 and were based on a data cutoff date of December 31, 2016. The primary end point was progression-free survival (PFS); mogamulizumab-treated patients had significantly longer PFS compared with vorinostat-treated patients (median, 7.7 months vs 3.1 months; P <.0001). The most common treatment-emergent adverse events (TEAEs) of any cause or grade in patients randomized to mogamulizumab were infusion-related reaction (33.2%), drug eruption (ie, skin rash attributed to mogamulizumab; 23.9%), diarrhea (23.4%), and fatigue (23.4%).

Objective: To report the final safety results of the MAVORIC study based on a data cutoff date of January 3, 2019.

Methods: Patients were randomized 1:1 to mogamulizumab 1.0 mg/kg administered intravenously on days 1, 8, 15, and 22 of the first cycle and on days 1 and 15 of subsequent cycles or to vorinostat 400 mg administered orally once daily. Patients randomized to vorinostat were allowed to cross over to mogamu­lizumab on disease progression or intolerable toxicity.

Results: In total, 372 patients were randomized to mogamulizumab (N = 186) or to vorinostat (N = 186) and 370 received a study drug (mogamulizumab, 184; vorinostat, 186). For the final safety analysis, the median duration of follow-up was 34.5 months (range, 0.13-70.0) in the randomized part of the study. The median treatment exposure was 170 days (range, 1-1813) for mogamulizumab and 84 days (4-1230) for vorinostat; by comparison, in the primary analysis, the median treatment exposure was 170 days (1-1379) for mogamulizumab and 84 days (4-1058) for vorinostat. The type and frequency of TEAEs (of any cause) in the mogamulizumab and vorinostat treatment groups were similar to those reported in the primary analysis. TEAEs that occurred at higher frequency in the mogamulizumab versus vorinostat arm included infusion-related reaction (33.2% [61/184] vs 0.5% [1/186], respectively) and drug eruption (25.0% [46/184] vs 1.1% [2/186]); the majority (>80%) of these events were grade 1 or 2. Discontinuation rates because of AEs were similar between the treatment arms and in crossover patients (mogamulizumab, 21.7% [40/184]; vorinostat, 23.7% [44/186]; crossover, 25.9% [35/135]).

Conclusion:This final safety analysis from the MAVORIC study in patients with previously treated mycosis fungoides and Sézary syndrome demonstrates that mogamulizumab was generally well-tolerated. Longer follow-up and treatment exposure did not identify any new safety signals.

Reference

  1. Kim YH, Bagot M, Pinter-Brown L, et al; for the MAVORIC investigators. Mogamulizumab versus vorinostat in previously treated cutaneous T-cell lymphoma (MAVORIC): an international, open-label, randomised, controlled phase 3 trial. Lancet Oncol. 2018;19:1192-1204. Erratum in: Lancet Oncol. 2018;19:e581.

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Clinical/Transactional Track: Original Research

Abstract #CT04

Washout Time to Avoid Drug-Drug Interaction Between Metronidazole and Busulfan During Hematopoietic Stem-Cell Transplant Conditioning

Presenter: Jitesh Kawedia, PharmD, PhD, RPh, Clinical Pharmacy Specialist, The University of Texas MD Anderson Cancer Center

Coauthors: Victoria Hand, Clinical Pharmacy Specialist; Anna Jan, Clinical Pharmacy Specialist; Vi Doan, Clinical Pharmacy Specialist; Terry Lynn Shigle, Clinical Pharmacy Specialist; Alison Gulbis, Clinical Pharmacy Specialist; all at The University of Texas MD Anderson Cancer Center

Background: Busulfan is a bi-functional alkylating agent, which, with use of pharmacokinetic therapeutic drug monitoring, has become a mainstay of conditioning regimens used for hematopoietic stem-cell transplant (HSCT). Busulfan has a narrow therapeutic index and a large inter- and intra-patient pharmacokinetic variability attributed to patient’s age, liver function, and concurrent medications. Busulfan undergoes extensive hepatic metabolism via cytochrome (CY) P-dependent pathways and glutathione conjugation. Metronidazole (MTZ) significantly decreases busulfan clearance, increasing serum concentration and treatment-related toxicity, most likely because of MTZ’s metabolism through the CYP-450 system, as well as competition for glutathione.1 Consequently, MTZ should not be administered concomitantly with busulfan; however, if MTZ is given before the start of chemotherapy, it is important to establish a washout period.

Objective: The primary objective was to determine washout time period between last dose of MTZ and first dose of busulfan.

Methods: This is a retrospective case series that evaluated the effects of MTZ on busulfan pharmacokinetics. Because an increase in busulfan clearance can be routinely observed up to 10%, a clinically significant change in busulfan clearance was defined as ≥15%. Patients were included if they had received MTZ within 168 hours (h) of their first dose of busulfan. Baseline characteristics were evaluated, in addition to treatment-related toxicity, such as mucositis, liver function tests after chemotherapy, and development of sinusoidal obstruction syndrome. All-cause mortality was also examined.

Results: In all, 3 patients were identified as having received MTZ within 168 h of busulfan therapy. All 3 patients were males, underwent allogeneic HSCT with busulfan/fludarabine backbone and received 20,000 µg busulfan course of AUC exposure. Patients received their first busulfan dose 8 h, 52 h, and 66 h after the MTZ dose, with a 24%, 16.5%, and 2.5% increase in busulfan clearance, respectively. Of the 3 patients, 2 received follow-up busulfan pharmacokinetics, which demonstrated recovery of busulfan clearance as expected (8 h: repeat at 56 h = 3.9% increase; and 66 h: repeat at 90 h = 0.2% increase).There was no difference in treatment-related toxicity; all 3 patients had grade 3 mucositis, grade 1 hepatotoxicity, and no one had sinusoidal obstruction syndrome. At day 201 and day 705 post-HSCT, 2 patients died, 1 because of disease relapse and 1 from respiratory failure, respectively.

Conclusion: Clinically significant increase in busulfan exposure was observed through 52 h after MTZ administration. Therefore, a washout period of 72 h is a judicious recommendation between administration of MTZ and the start of busulfan. If busulfan needs to be administered within 72 h of MTZ, additional pharmacokinetic monitoring is recommended to adjust the dose based on incremental recovery of busulfan clearance.

Reference

  1. Gulbis AM, Culotta KS, Jones RB, Andersson BS. Busulfan and metronidazole: an often forgotten but significant drug interaction. Ann Pharmacother. 2011;45:1024.

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Practice Management Track: Original Research

Abstract #PM01

Financial Impact of an Automatic Oncology Drug Rounding Initiative: 1-Year Analysis

Presenter: Shannon Hough, PharmD, BCOP, Pharmacy Manager, Oncology Clinical Programs, University of Michigan

Coauthors: Jacqueline Dela Pena, Pharmacy Intern; Katie Eschenberg, Clinical Pharmacist; Vincent LaRocca, Pharmacy Supervisor; Dipale Patel, Assistant Director, Infusion Pharmacies; all at the University of Michigan

Background: Infusion drugs are regarded as one of the highest cost factors in healthcare expenditures. One approach to minimize waste and decrease drug expenditures is by rounding monoclonal antibodies and cytotoxic agents to the nearest vial size. The Hematology/Oncology Pharmacy Association (HOPA) recommends that biologics and cytotoxic agents be rounded to the nearest vial size, as long as it is within 10% of the ordered dose.1

Objective: To determine the impact of an automatic dose rounding policy on drug expenses.

Methods: This prospective study analyzed the impact of 24 infusion medications on drug expenditures from July 2018 to June 2019. Factors that determined drug selection were high frequency of use and cost. A dose rounding protocol was developed and integrated into the electronic ordering system for automatic dose rounding to minimize the impact on current workflow and to reduce medication errors. Ordered doses were automatically rounded to the nearest vial size if the dose was within 10% of the original dose. Physicians reviewed the automatic dose rounding before signing and sending the order to the pharmacy. Physicians could also opt out of the dose rounding process and manually enter the nonrounded dose.

Results: Between July 1, 2018, and June 30, 2019, 10,206 doses of the selected drugs were administered, and 50% of the doses were rounded: 50.4% rounded up and 49.6% rounded down. Using wholesale acquisition cost (WAC) pricing, the drug cost-savings was approximately $3.6 million. The drugs with the highest savings were trastuzumab and ipilimumab, with an annual savings of $756,000 and $494,000, respectively.

Conclusion: The drug rounding initiative has greatly decreased drug costs, with an annual savings of $3.6 million, using WAC pricing. Drug cost-savings will continue to improve with implementation of new agents into the drug-rounding protocol. Automatic dose rounding bypasses the need for a pharmacy-managed protocol and streamlines the process between physician order and pharmacy verification. Further research is needed to determine how dose rounding affects patient outcome.

Reference

  1. Fahrenbruch R, Kintzel P, Bott AM, et al. Dose rounding of biologic and cytotoxic anticancer agents: a position statement of the Hematology/Oncology Pharmacy Association. J Oncol Pract. 2018;14:e130-e136.

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Practice Management Track: Original Research

Abstract #PM02

Evaluation of the Stability of a New IV-NEPA (fosnetupitant-palonosetron) Solution Formulation for Efficient IV Administration of Antiemetic Prophylaxis

Presenter: Valentino J. Stella, PhD, Distinguished Professor Emeritus, Department of Pharmaceutical Chemistry, University of Kansas, Lawrence, KS

Coauthors: Gary Binder, Senior Director, HEOR & Value-Based Medicine, Helsinn Therapeutics; Alessio Venturini, Helsinn Healthcare SA; Timothy Tyler, Director of Pharmacy, Lab & Oncology Supportive Care, Comprehensive Cancer Center, Desert Regional Medical Center

Background: Oral fosnetupitant-palonosetron (NEPA) is a fixed-combination antiemetic comprised of a neurokinin-1 receptor antagonist (netupitant) and a 5-hydroxytryptamine-3 receptor antagonist (palonosetron), which is recommended by the National Comprehensive Cancer Network antiemetic guidelines for oral NEPA and intravenous (IV)-NEPA prophylaxis in patients receiving moderately and highly emetogenic chemotherapy (HEC). IV-NEPA is comprised of 235 mg fosnetupitant, a water-soluble phosphorylated netupitant prodrug (at approximately pH 9), and 0.25 mg palonosetron. Because fosnetupitant is hydrolyzed to netupitant (limited solubility at pH 9), to protect fosnetupitant from water during storage, IV-NEPA was initially developed as a lyophilized powder for reconstitution (IV-NEPA-POW). To increase the efficiency and convenience of administration, a new IV-NEPA solution (IV-NEPA-SOL) has been evaluated.

Objective: To evaluate IV-NEPA-SOL stability in terms of fosnetupitant hydrolysis and precipitation of netupitant.

Methods: The percentage of netupitant hydrolysis drug (Netu%) was determined in IV-NEPA-SOL and IV-NEPA-POW (after reconstitution), stored for 7 days at 2°C to 8°C and 40°C–75% relative humidity. Netu% and netupitant precipitation were analyzed in IV-NEPA-SOL, stored for 30 days at 25°C–60% relative humidity and at 40°C–75% relative humidity, with 5 mg/mL to 26 mg/mL fosnetupitant concentrations, formulated with added EDTA (0%-0.127% w/v). During scale-up, IV-NEPA-SOL was analyzed for Netu% and the presence of precipitates in: (1) pilot batches, in 20-mL and 10-mL vials stored for 3 and 6 months (m) at 5°C, 25°C–60% relative humidity, and 40°C–75% relative humidity; (2) industrial batches, in 20-mL vials stored for 3, 6, 9, and 12 m at 5°C, 25°C–60% relative humidity, and 30°C–65% relative humidity, and stored for 1, 3, and 6 m at 40°C–75% relative humidity.

Results: Netu% released in IV-NEPA-SOL versus IV-NEPA-POW at baseline/7 day (2°C-8°C)/7 day (40°C–75% relative humidity)/7 day was 1.4/1.4/1.6% versus 1.5/1.5/2.9% with per fluorinated film-coated stoppers; and 1.4/1.4/1.6% versus 1.5/1.7/2.5% with rubber stoppers. In IV-NEPA-SOL, EDTA addition showed significantly reduced fosnetupitant hydrolysis (P = .0459). In pilot batches, IV-NEPA-SOL 10-mL vials remained clear for 3 m and 6 m at 25°C–60% relative humidity and 40°C–5% relative humidity but formed precipitates at 5°C; in 20-mL vials no precipitation was observed under all conditions analyzed. In industrial batches, Netu% formed in IV-NEPA–SOL 20-mL vials, stored for 12 m, was 0.4%-0.5% at 5°C and 25°C–60% relative humidity; 0.6%-0.7% at 30°C–65% relative humidity; and 1.0%-1.2%, stored for 6 m at 40°C–75% relative humidity. For IV-NEPA-POW, Netu% release was 0.7%-0.9% at 5°C and 1.4%-1.5% at 25°C–60% relative humidity.

Conclusion: IV-NEPA–SOL showed lower Netu% formation versus IV-NEPA-POW in all storage conditions tested. The final IV-NEPA-SOL formulation, at approximately pH 9, containing 0.13 mg/mL EDTA in 20-mL vials, showed good stability for up to 12 m. An IV-NEPA-SOL formulation would eliminate the effort and reconstitution time of a freeze-dried product. Ultimately, IV-NEPA-SOL could improve antiemetic efficiency, convenience, consistency, and guideline adherence in clinical practice, and meet patients’ and clinicians’ needs for optimal care.

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Practice Management Track: Original Research

Abstract #PM03

Expansion of a Pharmacy Patient Assistance Program

Presenter: Andrea Ledford, PharmD, MBA, BCOP, BCSCP, Oncology Pharmacy Manager, Orlando Health UF Health Cancer Center

Coauthors: Rosemary Lauranzon; Chris Frazier; Jacqueline King; all at Orlando Health UF Health Cancer Center

Background: Chemotherapy financial toxicity is realized by most patients as high out-of-pocket costs, such as high copays or high deductibles, which creates barriers to care. Self-pay patients or underinsured patients struggle with access to care.

Objective: To evaluate if the addition of specialized financial accounting and pharmacy technician personnel to initiate drug manufacturer copay assistance programs and to expand the drug replacement assistance programs at the regional sites increased patient benefit, and to formulate a financial ratio to compare patient benefit at the different cancer center locations.

Methods: The baseline cohort group (October 2015-September 2016) contained drug replacement only at the primary cancer center location (1.6 full time equivalents [ftes]). The copay program with initiated (1 fte added) was initiated (October 2016) and the expansion of on-site personnel (2.0 ftes) at the regional sites (October 2018). Patient financial benefit was tabulated annually, using actual drug cost or copay offset, provided by funding from drug manufacturer programs for eligible patients. This evaluation reviewed only injectable drugs administered in the infusion areas and did not include oral medications taken at home. The centralized copay assistance personnel collaborated with the on-site personnel during the regional expansion. Hospital drug charges were reversed to each location as patient benefit was received.

Results: The baseline primary center location realized $3,037,733 in drug replacement benefit, with no regional site or copay benefit. The study group resulted in $3,465,754, $4,310,177, and $4,233,990 of drug replacement at the primary location and in $349,933, $755,369, and $807,171 in copay assistance. The 2018 three regional locations yielded $781,871, $897,986, and $707,426 in replacement benefit. The 2018 patient benefit, divided by the total drug replacement expense, yielded a financial ratio of 8.1% (primary site), 7.7%, 6.5% and 7.2% (regional sites), respectively, and 1.2% copay savings offset. The added personnel increased the total patient benefit from $3,037,733 to $7,428,445 (P <.0001) and the copay benefit from 0 to $807,171 (P <.0001) using chi-square analyses.

Conclusion: The payer mix and the prescribing trends remained stable during this evaluation. The addition of specialized assistance personnel with on-site services provides patient benefit and reduction of financial toxicity associated with chemotherapy services. The creation of a financial ratio for patient benefit compared with total actual pharmacy expense can be developed to assess program success using a range specific for each location.

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Last modified: July 22, 2020