Home versus outpatient hospital intravenous immunoglobulin infusion and health care resource utilization.

BACKGROUND: Home health care delivery is projected to increase. Intravenous immunoglobulin (IVIG) therapy has high potential to move from the outpatient hospital (OPH) setting to home delivery. OBJECTIVE: This study examined the relationship between home and OPH IVIG infusions and health care utilization. METHODS: We used a retrospective cohort study design and the Humana Research Database to identify patients with 1 or more medical or pharmacy claims for an IVIG infusion agent from January 1, 2017, to December 31, 2018. Eligible patients were enrolled in a Medicare Advantage Prescription Drug (MAPD) or commercial health plan, with at least 12 months of continuous enrollment before and after their first infusion (i.e., index date) received in the home or OPH setting. We measured the odds of experiencing an inpatient (IP) stay or emergency department (ED) visit, adjusted for baseline differences in age, sex, race, region, population density, low-income, and dual eligibility status, MAPD or commercial health plan, plan type, treatment-naïve status, home health use, RxRisk-V comorbidity burden score, and indications for IVIG use. RESULTS: A total of 208 and 1079 patients received IVIG infusions in the home and OPH setting, respectively. The odds for an IP stay (odds ratio [OR] 0.56 [95% CI 0.38-0.82]) and ED visit (OR 0.62 [95% CI 0.41-0.93]) were significantly lower in patients who received IVIG infusion in the home than patients receiving infusion in the OPH setting. CONCLUSIONS: Our findings suggest there may be value to increasing referrals for IVIG home infusion. Decreased health care utilization provides value to the system in cost savings and to patients and families owing to less disruption and improved clinical outcomes. Further study can help inform health policy designed to maximize the benefits of IVIG home infusion while minimizing potential risks.

Treatment utilization patterns of newly initiated oral anticancer agents in a national sample of Medicare beneficiaries.

BACKGROUND: Few studies have examined oral anticancer treatment utilization patterns among Medicare beneficiaries. OBJECTIVE: To assess treatment utilization patterns of newly initiated oral anticancer agents across national samples of Medicare beneficiaries for 5 cancer types: chronic myeloid leukemia (CML), multiple myeloma (MM), metastatic prostate cancer (mPC), metastatic renal cell carcinoma (mRCC), and metastatic breast cancer (mBC). METHODS: This retrospective claims analysis used 100% Medicare Chronic Condition Data Warehouse (CCW) Parts A, B, and D files from 2011 to 2014 (for CML, MM, mPC, and mRCC patients) and a 5% random fee-for-service sample from 2011 to 2013 (for mBC patients). Outcomes of interest were the number of 30-day supply prescriptions, adherence, and discontinuation of newly initiated (ie, index) oral anticancer agents indicated for each of the cancers. Adherence was calculated with both the "traditional" proportion of days covered (PDC) approach, measured over a fixed 1-year period or until hospice/death, and a "modified" PDC approach, measured over the time between the first and last fill of the index oral anticancer agent. Patients with PDC of at least 0.80 were deemed as being adherent. Discontinuation was defined as the presence of a continuous 90-day gap in the availability of days supply of the index oral anticancer agent. RESULTS: Our study included 1,650, 7,461, 6,998, 2,553, and 79 patients for CML, MM, mPC, mRCC, and mBC, respectively. Patients with mRCC had the highest proportion of patients with only 1 fill of their index anticancer agent (28%) followed by mBC (17%), MM (17%), mPC (12%), and CML (12%). Patients with CML had the highest mean (SD) number of 30-day supply equivalent prescriptions (8.3 [4.6]), followed by patients with mPC (6.5 [4.2]), MM (5.7 [4.1]), mBC (4.7 [3.2]), and mRCC (4.5 [3.9]). Using the modified PDC measured between the first and last fills, approximately three-quarters of patients with CML (74%), mRCC (71%), and mBC (70%) were adherent to the index oral anticancer agent. Adherence was highest for patients with mPC (87%) and lowest for patients with MM (58%). The percentage of patients defined as adherent to the index oral anticancer agent decreased for all cancers when using the traditional PDC measure over a fixed 1-year period: CML (54%), MM (35%), mPC (48%), mRCC (37%), and mBC (22%). Rates of discontinuation for patients in our sample were 32% (CML), 38% (mPC), 42% (mRCC), 48% (MM), and 58% (mBC). CONCLUSIONS: Between 13% and 42% of Medicare patients were nonadherent between the first and last fill of their newly initiated oral anticancer therapies across a range of cancers. This study provides a valuable benchmark for stakeholders seeking to measure and improve adherence to oral anticancer agents in Medicare patients. DISCLOSURES: This study was supported by Humana, Inc. (Louisville, KY). The sponsor played a role in the development of the study protocol, interpretation of results, and revisions of the manuscript. The sponsor was not involved in data analysis. Brown is employed by Humana, Inc., and Ward was employed by Humana, Inc., from research inception through initial drafts. Doshi has served as an advisory board member or consultant for Allergan, Ironwood Pharmaceuticals, Janssen, Kite Pharma, Merck, Otsuka, Regeneron, Sarepta, Sage Therapeutics, Sanofi, and Vertex and has received research funding from AbbVie, Biogen, Humana, Janssen, Novartis, PhRMA, Regeneron, Sanofi, and Valeant. Her spouse holds stock in Merck and Pfizer. All other authors have no financial conflicts of interest to report.

Real-World Incidence and Management of Immune-Related Adverse Events from Immune Checkpoint Inhibitors: Retrospective Claims-Based Analysis.

PURPOSE: We assessed real-world spectrum and patterns of irAEs for patients treated with anti-PD(L)1 ICIs. METHODS: irAEs were defined using medical and pharmacy claims for patients enrolled in a Medicare Advantage Prescription Drug plan who initiated treatment with anti-PD(L)-1 and received ≥ 1 dose of therapy between 1 September 2014 and 28 February 2018. RESULTS: Treatment was discontinued for 46.6% of patients, and withheld and subsequently restarted for 10.3%. While toxicity profiles did not differ by age, RiskRx-V co-morbidity index was higher in patients with irAEs. CONCLUSION: These data underscore the needs for tailored irAE diagnostic and management pathways.

Evaluation of the head and neck cancer patient population and the incidence of hospitalization at an academic medical center.

PURPOSE: Patients with head and neck cancer are at risk for disease- and treatment-related toxicities that may be severe enough to require hospitalization. The risk factors associated with hospitalization in these patients are not well defined. METHODS: We conducted a single-center, retrospective observational study of patients with head and neck cancer receiving chemotherapy at an academic medical center infusion clinic in a one-year period. The primary objective was to characterize the head and neck cancer population at an academic medical center. Secondary objectives included describing the clinical and social factors associated with hospitalization. RESULTS: There were 109 patients with head and neck cancer included in the analysis. Of these patients, 38 (35%) were hospitalized. The factors that were significantly associated with hospitalization on univariable logistic regression were former alcohol abuse, being on a nonstandard of care chemotherapy regimen, and having a chemotherapy agent discontinued. On multivariable logistic regression, the factor that was significantly associated with hospitalization was having a chemotherapy agent discontinued. The most common reasons for hospitalization included shortness of breath/respiratory failure, fever/neutropenic fever, and infection. The most common new supportive care medications prescribed at discharge were stool softeners or laxatives and opioids. CONCLUSION: This study identified several factors which may be useful to identify patients as high risk for hospitalization and the next steps will be to determine and study the role of the pharmacist in preventing hospitalization of these patients. Further studies are needed to assess the impact of adding a pharmacist to the head and neck cancer multidisciplinary team.

Factors associated with optimized tacrolimus dosing in hematopoietic stem cell transplantation.

OBJECTIVE: The primary objective was to analyze the initial tacrolimus concentrations achieved in allogeneic hematopoietic stem cell transplantation patients using the institutional dosing strategy of 1 mg IV daily initiated on day +5. The secondary objectives were to ascertain the tacrolimus dose, days of therapy, and dose changes necessary to achieve a therapeutic concentration, and to identify patient-specific factors that influence therapeutic dose. The relationships between the number of pre-therapeutic days and incidence of graft-versus-host disease and graft failure were delineated. METHODS: A retrospective chart review included adult allogeneic hematopoietic stem cell patients who received tacrolimus for graft-versus-host disease prophylaxis in 2012. Descriptive statistics, linear and logistic regression, and graphical analyses were utilized. RESULTS: Ninety-nine patients met the inclusion criteria. The first concentration was subtherapeutic (<10 ng/ml) in 97 patients (98%). The median number of days of tacrolimus needed to achieve a therapeutic trough was 10 with a median of two dose changes. The median therapeutic dose was 1.6 mg IV daily. Approximately 75% of patients became therapeutic on ≤ 2 mg IV tacrolimus daily. No relationship was found between therapeutic dose and any patient-specific factor tested, including weight. No relationship was found between the number of days of therapy required to achieve a therapeutic trough and incidence of graft-versus-host disease or graft failure. CONCLUSION: An initial flat tacrolimus dose of 1 mg IV daily is a suboptimal approach to achieve therapeutic levels at this institution. A dose of 1.6 mg or 2 mg IV daily is a reasonable alternative to the current institutional practice.

Multiple myeloma maintenance therapy: a review of the pharmacologic treatment.

Over the last decade, numerous drug therapies have emerged for the treatment of multiple myeloma including immunomodulating agents namely thalidomide, lenalidomide, and pomalidomide and proteasome inhibitors namely bortezomib and carfilzomib. These agents have transformed the treatment of multiple myeloma and the role of high-dose chemotherapy followed by stem cell transplantation in the treatment of the disease. There are now studies that evaluate the use of drug therapy as maintenance following autologous stem cell transplantation; these studies have shown improvements in surrogate endpoints such as progression-free survival. Studies that have evaluated thalidomide or lenalidomide maintenance therapy have demonstrated an overall survival (OS) benefit in individuals with multiple myeloma who received high-dose chemotherapy followed by stem cell transplantation. A meta-analysis of thalidomide maintenance therapy did show a possible late survival benefit. The use of dexamethasone, thalidomide, lenalidomide, or combination bortezomib with thalidomide in patients who did not undergo transplantation demonstrated progression-free survival benefit; although there was no OS advantage for these agents in this population. There are a number of important considerations when selecting a drug therapy strategy for maintenance therapy which includes practical considerations such as route of administration and frequency of administration. Additionally, patient-specific elements such as potential toxicities, end-organ function, quality of life, cytogenetics, and previous treatment should be considered. Additional studies are needed to elicit the timing for initiation and duration of maintenance therapy, determine the role of cytogenetics, further characterize possible resistance patterns, and determine the combinations necessary to achieve an optimal increase in OS. Until more data are available, the risks and benefits should be evaluated on a patient-specific basis when deciding to initiate maintenance therapy or observation.