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HOPA 2020 Abstracts, Part III

JHOP - October 2020 Vol 10, No 5 - HOPA
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These 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. Several abstracts were published in the June and August issues of the journal, and the balance of the 2020 abstracts will be published in the December issue.


CLINICAL/TRANSACTIONAL TRACK: COMPLETED RESEARCH

Abstract #CT09

Correlation of High Body Mass Index with Outcomes in Patients with Chronic Myeloid Leukemia in Chronic Phase Treated with First-Line Dasatinib or Imatinib: Exploratory Analysis of the Phase 3 DASISION Clinical Trial

Presenter: Alexander Brun, PharmD, Bristol Myers Squibb, Princeton, NJ

Coauthors: Massimo Breccia, Department of Translational and Precision Medicine, Policlinico Umberto 1, “Sapienza” University, Rome, Italy; Jorge Cortes, The University of Texas M.D. Anderson Cancer Center, Houston, TX; Neil Shah, Department of Medicine/Hematology-Oncology, UCSF School of Medicine, San Francisco, CA; Giuseppe Saglio, Department of Clinical and Biological Sciences, University of Turin, Italy; Antonio Jiménez-Velasco, Hospital Universitario Carlos Haya, Malaga, Spain; Philipp le Coutre, Charité Universitätsmedizin Berlin, Germany; Alexander Brun, PharmD, Bristol Myers Squibb, Princeton, NJ; Irene DeGutis, Bristol Myers Squibb, Princeton, NJ; Sai Bathena, Bristol Myers Squibb, Princeton, NJ; Oumar Sy, Bristol Myers Squibb, Princeton, NJ; Elias Jabbour, The University of Texas M.D. Anderson Cancer Center, Houston, TX

Background: Early molecular responses to tyrosine kinase inhibitors (TKIs) are associated with improved long-term outcomes, and achievement of a major molecular response at 18 months is an important therapeutic goal for patients with chronic myeloid leukemia in chronic phase (CML-CP). Obesity may be linked to an increased risk for CML,1 and patients with a high body mass index (BMI) at diagnosis who receive treatment with first-line imatinib have been linked to a delayed time to response and reduced rates of major molecular response.2 Extended follow-up of the phase 3 DASISION clinical trial (NCT00481247) demonstrated that dasatinib therapy is associated with rapid, durable, and deeper responses than with imatinib therapy.3

Objective: To investigate the association between patients’ BMI and response to first-line treatment with TKIs.

Methods: DASISION was a multinational, open-label clinical trial that compared dasatinib versus imatinib in patients with newly diagnosed CML-CP. Patients were randomized to 100-mg dasatinib or 400-mg imatinib once daily. For this exploratory analysis, patients were stratified by BMI level, including high BMI (≥25 kg/m2) or normal BMI (<25 kg/m2)

Results: Overall, 259 patients received dasatinib (high BMI, N = 109; normal BMI, N = 147; unknown, N = 3) and 260 patients received imatinib (high BMI, N = 107; normal BMI, N = 147; unknown, N = 6). Baseline characteristics were generally balanced within the BMI subgroups. In patients with high BMI, significant benefits of dasatinib compared with imatinib were seen in median time to complete cytogenetic response (CCyR, 3.1 vs 6.1 months, respectively; P <.0001) and major molecular response (9.2 vs 27.6 months, respectively; P <.0001), and in the proportion of patients achieving major molecular response (79.8% vs 59.8%, respectively; P = .0004) and major response 4.5 (54.1% vs 34.6%, respectively; P = .0013). In the normal BMI subgroup, numerical but nonsignificant benefits were observed with dasatinib versus imatinib in median time to CCyR (5.6 vs 6.0 months, respectively; P = .1055) and in major molecular response (18.0 vs 21.5 months, respectively; P = .4095), and in major molecular response (73.5% vs 67.3%, respectively; P = .3335) and major response 4.5 (36.7% vs 33.3%, respectively; P = .6344) rates. Dasatinib exposure did not differ between the BMI subgroups; data for imatinib exposure were not available. Adverse events were consistent with previous safety profiles for each agent and did not differ by BMI subgroup. Any-cause pleural effusion was more frequent with dasatinib than with imatinib (high BMI, 34.3 vs 0%, respectively; normal BMI, 24.5 vs 2.0%, respectively).

Conclusion: In this exploratory analysis, patients with high BMI had improved outcomes with dasatinib therapy versus imatinib therapy, although this difference was not seen in patients with normal BMI. Further validation of these findings is necessary to delineate the role of BMI as a predictive factor of treatment responses in patients with CML-CP.

This study was funded by Bristol Myers Squibb. Writing support was provided by Andrea Plant, Caudex.

  1. Strom SS, Yamamura Y, Kantarijian HM, Cortes-Franco JE. Obesity, weight gain, and risk of chronic myeloid leukemia. Cancer Epidemiol Biomarkers Prev. 2009;18:1501-1506.
  2. Breccia M, Loglisci G, Salaroli A, et al. Delayed cytogenetic and major molecular responses associated to increased BMI at baseline in chronic myeloid leukemia patients treated with imatinib. Cancer Lett. 2013;333:32-35.
  3. Cortes JE, Saglio G, Kantarjian HM, et al. Final 5-year study results of DASISION: the dasatinib versus imatinib study in treatment-naïve chronic myeloid leukemia patients trial. J Clin Oncol. 2016;34:2333-2340.

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CLINICAL/TRANSACTIONAL TRACK: COMPLETED RESEARCH

Abstract #CT10

The US MM-6 Study in Community Patients with Multiple Myeloma: Efficacy and Safety of an In-Class Transition from Bortezomib- to Ixazomib-Based Induction for Long-Term Proteasome Inhibitor Therapy in the Real-World Setting

Presenter: Stephen J. Noga, MD, PhD, Millennium, a wholly owned subsidiary of Takeda, Cambridge, MA

Coauthors: Sudhir Manda, Arizona Oncology, US Oncology Research, Tucson, AZ; Habte A. Yimer, Texas Oncology–Tyler/US Oncology Research, Tyler, TX; Robert M. Rifkin, Rocky Mountain Cancer Centers, US Oncology Research, Denver, CO; Stephen J. Noga, Millennium, Cambridge, MA, a wholly owned subsidiary of Takeda; Ruemu E. Birhiray, Hematology Oncology of Indiana, PC, Indianapolis, IN; Christopher Yasenchak, Willamette Valley Cancer Institute and Research Center/US Oncology Research, Eugene, OR; Roger M. Lyons, Texas Oncology, US Oncology Research, San Antonio, TX; Presley Whidden, Millennium, a wholly owned subsidiary of Takeda, Cambridge, MA; Robert L. Schlossman, Millennium, a wholly owned subsidiary of Takeda, Cambridge, MA; Bingxia Wang, Millennium, a wholly owned subsidiary of Takeda, Cambridge, MA; Ralph V. Boccia, Center for Cancer and Blood Disorders, Bethesda, MD; Saulius Girnius, Trihealth Cancer Institute, Cincinnati, OH

Background: Long-term proteasome inhibitor–based therapy is challenging in the real world and is associated with risk factors, such as treatment burden and toxicity.

Objective: The US MM-6 community-based study investigates an in-class transition from parenteral bortezomib-based induction to all-oral ixazomib-lenalidomide-dexamethasone (IRd), with the aim of increasing treatment adherence and duration, while maintaining quality of life (QOL). We report the efficacy and safety results for the first 55 patients.

Methods: Transplant-ineligible or transplant-delayed (>24 months) patients with multiple myeloma and stable disease or better after 3 cycles of bortezomib-based induction are receiving IRd (ixazomib 4 mg, days 1, 8, 15; lenalidomide 25 mg, days 1-21; dexamethasone 40 mg [patients aged >75 years, 20 mg], days 1, 8, 15, 22) at 23 planned community sites for up to 26 × 28-day cycles or until disease progression or toxicity. Patients complete electronic patient-reported outcomes (PROs) every cycle to assess QOL or treatment satisfaction. The primary end point is progression-free survival (PFS); key secondary end points include response rates and duration of therapy.

Results: Among 55 patients enrolled at 16 community sites, the median age was 72 years (76% ≥65 years); 40% of patients had International Staging System stage III disease, and 42% had lytic bone disease. Comorbidities or concurrent medical conditions included hypertension (51%), anemia (44%), fatigue (42%), renal and urinary disorders (36%), gastroesophageal reflux disease (31%), cardiac disorders (27%), constipation (27%), nausea (24%), and peripheral neuropathy (16%). At data cut-off, with 40 (73%) patients continuing therapy, the median and mean duration of proteasome inhibitor therapy, including previous bortezomib-based induction, was 6.9 and 8.4 months, respectively. The median and mean duration of IRd treatment was 4.0 and 5.6 months, respectively (maximum, 17.3 months to date). After 3 bortezomib-based induction cycles, the rate of very good partial response (VGPR) or better was 27% (4% complete response [CR] or better); the overall response rate (ORR) was 62%. With IRd, the VGPR or better rate was 40% (22% CR or better); the ORR was 65%. After transition to IRd, 21 (36%) patients had deepened responses (including 18% increase in CR or better). With limited follow-up, and enrollment ongoing, 3 patients had disease progression and 1 patient had died at data cut-off. The preliminary 6-month PFS rate was 91% (95% confidence interval [CI], 74%-97%) or 96% (95% CI, 84%-99%) from the start of IRd and bortezomib-based induction. The average compliance with completing issued electronic PRO questionnaires during IRd treatment was 96% (N = 61; data cut-off July 8, 2019). During IRd treatment to date, 87% of patients had adverse events (including 44% grade 3 or 4 and 29% serious adverse events), including peripheral neuropathy in 25% (4% grade 3).

Conclusion: These preliminary data indicate the feasibility, tolerability, and efficacy of the in-class transition from bortezomib-based induction to IRd treatment, with substantial improvements in response, a promising duration of therapy, and high electronic PRO compliance rates.

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CLINICAL/TRANSACTIONAL TRACK: COMPLETED RESEARCH

Abstract #CT11

The Efficacy and Effectiveness of Ixazomib-Lenalidomide-Dexamethasone: Comparable Outcomes in Patients with Relapsed or Refractory Multiple Myeloma Treated Outside of Clinical Trials and in the Phase 3 TOURMALINE-MM1 Study

Presenter: Dawn Marie Stull, PharmD, BCOP, Millennium, Cambridge, MA, a wholly owned subsidiary of Takeda

Coauthors: Names are posted online with the article, at www.JHOPonline.com

Background: In the phase 3 TOURMALINE-MM1 study, treatment with ixazomib-lenalidomide-dexamethasone (IRd) in patients with relapsed or refractory multiple myeloma with 1 to 3 previous lines of therapy produced an overall response rate (ORR) of 78%, and the median progression-free survival (PFS) was 20.6 months.1 The outcomes and tolerability of therapy in routine clinical practice often differ from data reported in clinical trials.

Objective: We report a pooled analysis of patients treated with IRd in the prospective, observational INSIGHT MM study (NCT02761187) and the Czech Registry of Monoclonal Gammopathies (RMG).

Methods: The INSIGHT MM study has enrolled more than 4200 patients with multiple myeloma from Europe, the United States, Asia, and Latin America. The RMG comprises clinical data for more than 6000 patients with multiple myeloma enrolled at 19 Czech and 4 Slovak centers. Eligible patients had 1 to 3 (INSIGHT MM) or ≥1 (RMG) previous therapies and received an ixazomib-lenalidomide–based regimen. Individual patient-level data were integrated and analyzed. The response and disease progression were determined per investigator assessment (using International Myeloma Working Group criteria). Time-to-event data were estimated using Kaplan–Meier methodology.

Results: A total of 217 patients (83 from INSIGHT MM; 134 from RMG) were included; 89% received treatment in an academic facility. At diagnosis, 32% of the patients had International Staging System stage III disease, 78% had bone lesions, and 46% had anemia. At study start, the median age was 67 years. Previous therapies included bortezomib (90%), stem-cell transplant (60%), thalidomide (47%), lenalidomide (26%), carfilzomib (8%), daratumumab (6%), and pomalidomide (2%). The median time from diagnosis to the start of IRd was 42.1 months; 43%, 35%, and 22% of patients received IRd at the second, third, and fourth or later line of therapy, respectively. The median duration of follow-up was 12.6 months overall. At data cut-off, 117 (54%) patients had discontinued IRd. The median duration of therapy was 11.9 (95% confidence interval [CI], 9.4-15.2) months; at 12 months, 49% (95% CI, 41.3-56.2) of patients were still receiving treatment. In 152 patients with available best-response data, the ORR was 74% (36% very good partial response [VGPR] or better); the ORR at the second, third, fourth or later line of therapy was 82%, 71%, and 59%, respectively (43%, 37%, and 17% VGPR or better). The median PFS was 21.6 (95% CI, 13.6-26.7) months across all lines (30.2, 23.2, 14.1, and 6.7 months at the second, third, and fourth or later line, respectively); 86 (40%) patients had progressed at data cut-off. The median time to next therapy was 31.5 (95% CI, 24.5-35.9) months (12-month rate, 74%). At data cut-off, 53 (24%) patients had died. The median overall survival was 36.7 (95% CI, 24.4-not reached) months (12-month rate, 79%). Ixazomib and lenalidomide dose reductions were required in 16% and 36% of patients, respectively, including in 10% and 21% of patients because of adverse events.

Conclusion: The effectiveness of IRd in this analysis is comparable to the efficacy reported in the TOURMALINE-MM1 study. IRd is well-tolerated, with low rates of ixazomib and lenalidomide dose reductions resulting from adverse events. These outcomes should be interpreted with caution because mature data are limited.

  1. Moreau P, Masszi T, Grzasko N, et al; for the TOURMALINE-MM1 study group. Oral ixazomib, lenalidomide, and dexamethasone for multiple myeloma. N Engl J Med. 2016;374:1621-1634

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CLINICAL/TRANSACTIONAL TRACK: COMPLETED RESEARCH

Abstract #CT12

The Cost of Adverse Events for FDA-Approved or NCCN Category 1 Treatments for Medicare Fee-for-Service Patients with Metastatic Pancreatic Cancer: Focus on Liposomal Irinotecan-Based Regimens

Presenter: Jared Hirsch, Milliman, New York, NY

Coauthors: Gabriela Dieguez, Milliman, New York, NY; Paul Cockrum, Ipsen Biopharmaceuticals

Background: Adverse events related to cancer therapy reduce patients’ quality of life and generate substantial healthcare costs. There is limited real-world evidence regarding adverse event costs for patients with metastatic pancreatic cancer who receive FDA-approved or National Comprehensive Cancer Network (NCCN) Category 1 treatments.

Objective: We analyzed the costs of 3 common adverse events (ie, neutropenia, anemia, and thrombocytopenia) for patients with metastatic pancreatic cancer receiving FDA-approved or NCCN Category 1 lines of therapies, including first-line gemcitabine plus nab-paclitaxel; gemcitabine monotherapy; FOLFIRINOX; and second-line liposomal irinotecan.

Methods: We identified metastatic pancreatic cancer patients and adverse events using ICD-9/ICD10 diagnosis codes in the 2013-2017 Medicare claims. Patients in our study had multiple claims with a pancreatic cancer diagnosis 30+ days apart as well as 1+ claim(s) with a secondary malignancy diagnosis on or after the first pancreatic cancer diagnosis date. Lines of therapies were assigned based on the order of therapies used. A line of therapy ended when a new regimen began, 28 days after the last chemotherapy, or at death. We randomly sampled control patients in the same line of therapy and regimen without an adverse event and assigned them shadow adverse event dates. We calculated 30-day costs after adverse event or shadow adverse event onset, trended to 2017. For lines of therapies and regimens with sufficient volume, we estimated 30-day adverse event incremental costs using log-link generalized linear models and gamma-distributed errors. We predicted mean 30-day adverse event incremental costs relative to controls using recycled projections and bootstrapped 95% confidence intervals to determine statistical significance.

Results: Anemia was the most common adverse event, ranging from 41% of patients who received first-line gemcitabine plus nab-paclitaxel to 32% of patients receiving second-line liposomal irinotecan. The mean 30-day incremental anemia costs ranged from $3080 for first-line gemcitabine monotherapy to $3924 for first-line gemcitabine plus nab-paclitaxel, and was $3257 for second-line liposomal irinotecan. Neutropenia ranged from 32% of those receiving first-line FOLFIRINOX to 16% of those receiving first-line gemcitabine monotherapy. The mean 30-day neutropenia incremental costs ranged from $1284 for second-line liposomal irinotecan to $2503 for first-line gemcitabine plus nab-paclitaxel. Thrombocytopenia ranged from 18% of patients receiving first-line FOLFIRINOX to 8% of those receiving second-line liposomal irinotecan. The mean 30-day incremental thrombocytopenia costs ranged from $2678 for first-line gemcitabine plus nab-paclitaxel to $3721 for first-line FOLFIRINOX.

Conclusion: Adverse events impose substantial costs for Medicare fee-for-service patients with metastatic pancreatic cancer who are receiving FDA-approved or NCCN Category 1 treatments. For first-line regimens, we observed statistically significant incremental costs associated with anemia, neutropenia, and thrombocytopenia. Among patients receiving second-line liposomal irinotecan, only anemia incremental costs were statistically significant; neutropenia incremental costs were not statistically different from zero, and there were insufficient thrombocytopenia cases to estimate the incremental costs.

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PRACTICE MANAGEMENT TRACK: COMPLETED RESEARCH

Abstract #PM07

Oral Chemotherapy and Supportive-Care Prescribing Under a Pharmacist Consult Agreement in a Plasma-Cell Disorders Clinic

Presenter: Joslyn Rudoni, PharmD, BCOP, Hematology/Oncology Pharmacy Clinical Specialist, Cleveland Clinic Taussig Cancer Institute

Coauthors: Tyler Sandahl, PharmD, BCOP, Hematology/Oncology Pharmacy Clinical Specialist, Cleveland Clinic Taussig Cancer Institute; Marc Earl, PharmD, BCOP, Director of Oncology Services, Cleveland Clinic Taussig Cancer Institute; Nathaniel Rosko, PharmD, BCOP, Hematology/Oncology Pharmacy Clinical Specialist, Cleveland Clinic Taussig Cancer Institute

Background: Ohio Board of Pharmacy allows for expanded practice via consult agreements with physicians, which authorizes pharmacists to engage in collaborative drug therapy management, including laboratory orders and assessments. In April 2018, Cleveland Clinic Pharmacists entered into a consult agreement with Taussig Cancer Institute Physicians. The plasma-cell disorder clinic was the first to implement the consult agreement to use clinical pharmacist practitioners for supportive care management. In February 2019, the consult agreement expanded to include management of oral chemotherapy.

Objective: To describe our experience developing an outpatient consult agreement and 9-month outcomes of pharmacist-driven prescribing in a plasma-cell disorder clinic at a large academic medical center.

Methods: A physician-approved supportive care formulary was developed to include medications such as antimicrobials, anticoagulants, antiemetics, and bone strengtheners. To practice under the consult, clinical pharmacist practitioners must complete a PGY2 residency or be board certified with 1 year of oncology practice. With the consult expansion, the scope of practice broadened to include pharmacist authorization to dose adjust, resume, or discontinue formulary-approved oral chemotherapy initiated by the treating physician. To manage chemotherapy, clinical pharmacist practitioners must obtain signed physician sponsorship plus documented content expertise. Periodic quality review was performed by a steering committee. Patient encounters were completed in collaboration with physicians in addition to monthly comprehensive clinical reviews with each refill assessment, which included evaluation of disease response, organ function, toxicity, antimicrobial and thromboprophylaxis, and fulfillment of Risk Evaluation and Mitigation Strategy program requirements. A retrospective chart review of encounters from February to October 2019 was performed to collect and categorize clinical pharmacist practitioner–documented interventions.

Results: Over the 9 months evaluated, 61 new pharmacy consults were ordered (125 overall). Within the 484 patient encounters completed, 682 interventions were identified (84% chemotherapy-related), including 427 issued prescriptions (95% chemotherapy). Medication reconciliation (41) and drug therapy initiation (39) accounted for nearly 75% of the supportive care interventions (109). Chemotherapy interventions (573) were mainly driven by the large number of refills (403), followed by patient education (51), laboratory monitoring (49), and dose adjustments (33). While performing comprehensive clinical reviews (445), clinical pharmacist practitioners recognized omissions in prophylaxis (98% compliance) and identified 15 cases of disease progression, which led to a change in therapy approximately 2 weeks before their next office visit for the majority of cases (8:15) and increased monitoring for the remainder (7:15). Informal polling of participating physicians revealed exceptional satisfaction with the program, resulting in requests for an additional pharmacist full-time equivalent.

Conclusion: Pharmacist-driven prescribing of oral chemotherapy and supportive care in a plasma-cell disorder clinic ensured that patients were responding to treatment, tolerating therapy, and receiving the appropriate prophylaxis, with improved continuity of care. Progressive disease and the need for change in treatments were identified before follow-up visits. Physician workload was decreased, leading to greater satisfaction with pharmacist and physician interactions.

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PRACTICE MANAGEMENT TRACK: COMPLETED RESEARCH

Abstract #PM08

Characterization and Impact of Pharmacy Student Participation on Hematology/Oncology Advanced Pharmacy Practice Experience Rotations in Varied Practice Settings

Presenters: Matthew Yacobucci, PharmD, BCOP, Albany College of Pharmacy and Health Sciences, Albany Medical Center Hospital; Christina L. Lombardi, PharmD, St. Peter’s Health Partners

Coauthors: Laurie Briceland, Albany College of Pharmacy and Health Sciences; Paula Zeszotarski, Albany College of Pharmacy and Health Sciences

Background: During advanced pharmacy practice experiences (APPEs), pharmacy students meaningfully contribute to clinical, economic, and/or humanistic patient care outcomes. With an increasing number of oncology pharmacists, pharmacy students are frequently completing APPEs in oncology settings. While the value of pharmacy students in providing medication reconciliation in cancer centers has been documented, a more comprehensive analysis of the full scope and impact of student contributions in the oncology setting has been sparsely characterized. Furthermore, working as a student in an oncology setting can be intellectually and emotionally challenging, and thus, what is its impact on the students’ professional identity formation?

Objective: To evaluate the impact of APPE student pharmacist contributions to varied oncology practice settings, and to evaluate the impact of the experience on the pharmacy student’s professionalization.

Methods: For 3 APPE cycles spanning 2016 to 2019, students from our affiliated pharmacy college who completed any hematology/oncology APPE were identified. Data extracted from each student’s APPE evaluation in CoreELMS database included student self-reported list of rotation activities, and more than 500-word APPE self-reflection, describing meaningful impact on the student. APPE grades were verified to provide evidence of student aptitude. The impacts of rotation activities were categorized into direct and indirect patient care. For each student, fewer than 3 reflection themes were recorded; thematic analysis was applied to quantify themes of impact.

Results: A total of 171 students completed a hematology/oncology APPE in private or hospital-affiliated ambulatory care (133) and/or inpatient (38) settings; 11 APPEs were at National Cancer Institute–designated comprehensive cancer centers. All but 7 (0.04%) students earned a grade of B+ or higher, with the lowest grade recorded as a C–. A total of 932 self-reported student activities (average, 5.5 per student) were identified. The 5 most common activities were evaluating patient pharmacotherapy (209); in-services to medical staff (132); nonchemotherapy patient counseling (99); answering drug information questions (96); and chemotherapy patient counseling (82). A majority (64.6%) of activities involved direct patient care. Overall, 400 reflection themes (average, 2.3 per student) were extracted and categorized into 7 thematic categories—practice or research skills, curricular immersion (88); self-awareness, such as empathy or metacognition (75); communication skills, teaching, counseling (59); patient interaction or care (50); interprofessional education, team-based collaboration (49); professionalization, such as confidence or motivation, preceptor role modeling, self-directed lifelong learning (40); career development or pharmacists’ roles (39).

Conclusion: Pharmacy students make significant contributions to oncology practice settings and direct patient care in numerous meaningful ways. Participation in oncology APPEs is highly influential to the professional identity formation of students.

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PRACTICE MANAGEMENT TRACK: COMPLETED RESEARCH

Abstract #PM09

Measuring the Impact of Myelodysplastic Syndromes on Health Economic Outcomes Using Real-World Data

Presenter: Kwanza Price, MPH, Jazz Pharmaceuticals

Coauthors: Jason Shafrin, Precision Health Economics & Outcomes Research, New York, NY; Sarah Green, Precision Health Economics & Outcomes Research, New York, NY; Richard Murphy, Precision Health Economics & Outcomes Research, New York, NY; Katie Everson, Precision Health Economics & Outcomes Research, New York, NY; Syvart Dennen, Precision Health Economics & Outcomes Research, New York, NY; Katharine Batt, Wake Forest Baptist Medical Center, Winston-Salem, NC

Background: Myelodysplastic syndromes (MDS) include a diverse group of bone marrow disorders associated with high mortality rate. Mortality associated with MDS is most often caused by transformation to acute myeloid leukemia, infection, or hemorrhage. The health economic impact of MDS is not very well-known; to address this gap, this study measured the economic burden of MDS using real-world data.

Methods: Medicare beneficiaries aged ≥66 years who were diagnosed with MDS between January 1, 2011, and December 31, 2015, were identified in SEER-Medicare data registry linked claims data. A 1-year prediagnosis period was used to identify baseline characteristics. The study window ended December 31, 2016, to allow at least 1 year of follow-up. MDS cases were propensity score–matched to cancer-free controls who were selected from a 5% random sample of Medicare beneficiaries. Using generalized linear models, average 30-day direct costs over the 2-year postdiagnosis period were risk-adjusted for matched patients with MDS versus controls. For healthcare utilization over this period, we used a negative binomial model. The models controlled for patient characteristics, including demographics and comorbidities. Reported P values are nominal.

Results: The 9524 patients with MDS who met the inclusion criteria were matched with 109,075 controls. Among the patients with MDS, 57% were male, with a mean age of 80.1 years (SD = 7.4 years) compared with 57% and 80.6 years (SD = 8.4) among the matched controls. Compared with the controls, patients with MDS had a $4478 per month greater unadjusted cost (risk-adjusted $5394 per month MDS vs $916 for matched controls; P <.001) in the 2 years after diagnosis. Over this period, patients with MDS had 25.6 more outpatient visits (risk-adjusted 18.6; P <.001), 2.2 more inpatient visits (adjusted 1.9; P <.001), and 0.4 more skilled-nursing facility visits (risk-adjusted 0.2; P <.001). In the 6 months postdiagnosis, most patients with MDS received no treatment (26.6%) or supportive care only (30.9%). Among patients receiving disease-modifying treatments, the most common therapies were immunosuppressive therapy (26.8%), chemotherapy (26.3%), and hypomethylating agents (19.1%). Overall therapy use declined in months 7 to 12 and 13 to 24 after diagnosis.

Conclusion: We estimated the adjusted incremental cost burden of MDS at $64,732 per year, with patients with MDS having more hospital and skilled-nursing admissions as well as more outpatient hospital visits compared with matched controls. After diagnosis, most patients with MDS received no treatment or supportive care. Among treated patients, immunosuppressive therapy, chemotherapy, and hypomethylating agents were the most widely used.

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Last modified: November 20, 2020