Antiemetic use and chemotherapy induced nausea and vomiting related hospitalization costs after highly or moderately emetogenic chemotherapy.

Aim: Despite numerous available antiemetics, chemotherapy induced nausea and vomiting (CINV) still affects many patients, and CINV related hospitalizations and costs often result. Materials & methods: PrecisionQ analyzed its database to evaluate CINV related hospitalizations and costs following antiemetics use including netupitant/fosnetupitant with palonosetron (NEPA), aprepitant/fosaprepitant with ondansetron (APON) or aprepitant/fosaprepitant with palonosetron (APPA) in patients receiving highly emetogenic chemotherapy or moderately emetogenic chemotherapy. Results: Database analysis identified 15,583 patient records (807 NEPA, 2023 APON, 12,753 APPA) and mean CINV related hospitalization costs were lower across all patients receiving NEPA (US$301) compared with patients receiving APON ($1006, p < 0.0001) or APPA ($321, p < 0.0001). Conclusion: NEPA is associated with lower CINV related hospitalization costs compared with APON and APPA among patients receiving highly emetogenic chemotherapy or moderately emetogenic chemotherapy.

Chemotherapy patients often experience nausea and vomiting that not only has a negative impact on the patient's quality of life but can also result in unplanned hospitalizations with high associated costs. Numerous medications and specific guidelines are available to prevent nausea and vomiting in patients with cancer. Specifically, the combination of two classes of medications (serotonin inhibitors + neurokinin type 1 inhibitors) has been shown to provide the greatest benefit. However, hospitalizations due to nausea and vomiting still occur, and providers require further information to determine the best options for their patients. In this study, the combination of netupitant/fosnetupitant with palonosetron resulted in lower hospitalization costs compared with aprepitant/fosaprepitant with ondansetron or aprepitant/fosaprepitant with palonosetron in chemotherapy patients.

Duration of anticoagulant therapy and VTE recurrence in patients with cancer.

PURPOSE: Anticoagulant therapy for at least 3-6 months is currently recommended for treatment of venous thromboembolism (VTE) in patients with cancer, but the optimal duration of treatment is unknown. This study examines the association between the duration of anticoagulation treatment and VTE recurrence in cancer patients. METHODS: The Humana claims database was used to identify newly diagnosed cancer patients who had their first VTE diagnosis between January 1, 2013, and May 31, 2015, and initiated injectable or oral anticoagulant therapy. Follow-up was calculated from the index treatment initiation to the end of eligibility or end of data (June 2015). VTE recurrence was defined as a hospitalization with a primary diagnosis of VTE. Cox proportional hazards models were used to evaluate the risk of VTE recurrence by duration of therapy in patients who discontinued therapy. RESULTS: The study included 1158 patients. Compared to patients treated for 0 to 3 months, VTE recurrences were significantly lower among patients treated for 3 to 6, or over 6 months. After adjustment for baseline characteristics, patients treated for 3 to 6 months (HR [95%CI], 0.53; 0.37-0.76) and more than 6 months (HR [95%CI], 0.48; 0.34-0.68) were still significantly less likely to have VTE recurrences compared to patients treated for 0 to 3 months (both p < 0.01). Findings were similar using a VTE event definition that included outpatient visits. CONCLUSIONS: Among newly diagnosed cancer patients with VTE, anticoagulant therapy lasting more than 3 months was associated with a lower risk of VTE recurrence.

Effectiveness and safety of anticoagulants for the treatment of venous thromboembolism in patients with cancer.

Anticoagulation is used to treat venous thromboembolism (VTE) in cancer patients, but may be associated with an increased risk of bleeding. VTE recurrence and major bleeding were assessed in cancer patients treated for VTE with the most currently prescribed anticoagulants in clinical practice. Newly diagnosed cancer patients (first VTE 1/1/2013-05/31/2015) who initiated rivaroxaban, low-molecular-weight heparin (LMWH), or warfarin were identified from Humana claims data and observed until end of eligibility or end of data availability. VTE recurrence was a hospitalization with a primary diagnosis of VTE ≥7 days after first VTE. Major bleeding events on treatment were identified using validated criteria. Cohorts were compared using Kaplan-Meier rates at 6 and 12 months and Cox proportional hazards models. Cohorts were adjusted for their differences at baseline. A total of 2428 patients (rivaroxaban: 707; LMWH: 660; warfarin: 1061) met inclusion criteria. Patient characteristics were well balanced after weighting. There was a trend for lower VTE recurrence rates in rivaroxaban users compared to LMWH users at 6 months (13.2% vs. 17.1%; P = .060) and significantly lower at 12 months (16.5% vs. 22.2%; P = .030) [HR: 0.72, 95% CI: (0.52-0.95); P = .024]. VTE recurrence rates were also lower for rivaroxaban than warfarin users at 6 months (13.2% vs. 17.5%; P = .014) and 12 months (15.7% vs. 19.9%; P = .017) [HR: 0.74, 95% CI: (0.56-0.96); P = .028]. Major bleeding rates were similar across cohorts. This real-world analysis suggests cancer patients with VTE treated with rivaroxaban had significantly lower risk of recurrent VTE and similar risk of bleeding compared to those treated with LMWH or warfarin.

Effects of Repository Corticotropin Injection on Medication Use in Patients With Rheumatologic Conditions: A Claims Data Study.

Background: Currently, specific studies identifying how repository corticotropin injection (RCI) is used in rheumatologic conditions are lacking. This is a first step to familiarize the trends of demographics using RCI as well as other medication use. Objective: RCI may produce anti-inflammatory as well as immune-modulatory effects. The purpose of this study is to examine the demographics of those who use RCI and the change in medication use, specifically prednisone, after RCI initiation. Method: This study used the Symphony Health Solutions (SHA) Claims database from 2008 to 2015. International Classification of Disease, Ninth Revision, codes were used to identify rheumatologic conditions including rheumatoid arthritis, systemic lupus erythematosus, dermatomyositis, and polymyositis. Information including RCI dose and concomitant medication uses was also obtained. Results: A total of 2749 patients with rheumatologic conditions receiving RCI were investigated for demographic information, and a total of 1048 patients with rheumatologic conditions on RCI were examined for medication use. The use of nonsteroidal anti-inflammatory drugs, disease-modifying anti-rheumatic drugs, and biologics overall decreased significantly in all 3 rheumatologic conditions except biologics in dermatomyositis/polymyositis. In addition, mean prednisone dose before and after RCI use significantly decreased one quarter (12 weeks) after RCI initiation. Conclusion: Claims-based study on RCI use indicates that RCI use might reduce use of prednisone, disease-modifying anti-rheumatic drugs, and other biologics. Further prospective study is needed.

Vitamin K antagonist use: evidence of the difficulty of achieving and maintaining target INR range and subsequent consequences.

Vitamin K antagonists (VKAs) are effective oral anticoagulants that are titrated to a narrow therapeutic international normalized ratio (INR) range. We reviewed published literature assessing the impact of INR stability - getting into and staying in target INR range - on outcomes including thrombotic events, major bleeding, and treatment costs, as well as key factors that impact INR stability. A time in therapeutic range (TTR) of ≥65 % is commonly accepted as the definition of INR stability. In the real-world setting, this is seldom achieved with standard-of-care management, thus increasing the patients' risks of thrombotic or major bleeding events. There are many factors associated with poor INR control. Being treated in community settings, newly initiated on a VKA, younger in age, or nonadherent to therapy, as well as having polymorphisms of CYP2C9 or VKORC1, or multiple physical or mental co-morbid disease states have been associated with lower TTR. Clinical prediction tools are available, though they can only explain <10 % of the variance behind poor INR control. Clinicians caring for patients who require anticoagulation are encouraged to intensify diligence in INR management when using VKAs and to consider appropriate use of newer anticoagulants as a therapeutic option.

Nurses' self-reported time estimation of anticoagulation therapy: a survey of warfarin management in long-term care.

BACKGROUND: A nursing shortage in the United States has resulted in increased workloads, potentially affecting the quality of care. This situation is particularly concerning in long-term care (LTC) facilities, where residents are older, frailer, and may be receiving multiple medications for comorbidities, thus requiring a greater commitment of nurse time. We conducted a survey of LTC nurses to determine how much of their time each week is spent managing newly started and stable warfarin-treated residents. METHODS: Forty LTC nurses validated the questionnaire to determine what protocols/procedures are involved in warfarin management. Twenty LTC nurses completed the survey, quantifying the time they spend on procedures related to warfarin management, and how often they performed each procedure for each resident each week. RESULTS: The nurses reported that 26% of their residents were receiving warfarin; the majority (approximately 75%) of these residents began warfarin after admission to the facility. On average, the nurses spent 4.6 hours per week for treatment procedures and monitoring patients initiating warfarin therapy and 2.35 hours per week for each resident who was stable on warfarin therapy on admission. Overall, to care for an average number of newly initiated and stable warfarin patients in a medium-size LTC facility, staff nurses are estimated to spend 68 hours per week. Study limitations include the potential for bias because of the small sample size, representativeness of the sample, and the possibility of inaccuracies in respondents' self-reported time estimation of warfarin-related procedures. CONCLUSIONS: In the context of a well-documented and expanding nursing shortage in the United States, the substantial use of time and resources necessary to initiate, monitor, and manage warfarin treatment in elderly LTC patients is of concern. Until the problem of understaffing is resolved, implementation of therapies that are simpler and require less nursing time-e.g. the use of new oral anticoagulants in the place of warfarin-may be a way to free up nursing time for other essential care tasks.

Real-World Treatment Outcomes, Healthcare Resource Use, and Costs Associated with Antiemetics Among Cancer Patients on Cisplatin-Based Chemotherapy.

INTRODUCTION: Chemotherapy-induced nausea and vomiting (CINV) is a recognized adverse outcome among patients with cancer. This retrospective study aimed to quantify the treatment outcomes, resource utilization, and costs associated with antiemetic use to prevent CINV in a broad US population who received cisplatin-based chemotherapy. METHODS: Data from the STATinMED RWD Insights Database was collected from January 1, 2015 to December 31, 2020. Cohorts included any patients that had at least one claim for fosnetupitant + palonosetron (NEPA) or fosaprepitant + palonosetron (APPA) and evidence of initiating cisplatin-based chemotherapy. Logistic regression was used to evaluate nausea and vomiting visits within 14 days after chemotherapy, and generalized linear models were used to examine all-cause and CINV-related healthcare resource utilization (HCRU) and costs. RESULTS: NEPA was associated with significantly lower rates of nausea and vomiting visits after chemotherapy (p = 0.0001), including 86% greater odds of nausea and vomiting events for APPA during the second week after chemotherapy (odds ratio [OR] = 1.86; p = 0.0003). The mean numbers of all-cause inpatient visits (p = 0.0195) and CINV-related inpatient and outpatient visits were lower among NEPA patients (p < 0.0001). These differences corresponded to 57% of NEPA patients and 67% of APPA patients having one or more inpatient visits (p = 0.0002). All-cause outpatient costs and CINV-related inpatient costs were also significantly lower for NEPA (p < 0.0001). The mean number of all-cause outpatient visits, all-cause inpatient costs, and CINV-related outpatient costs was not significantly different between groups (p > 0.05). CONCLUSION: In this retrospective study based on claims data, NEPA was associated with lower rates of nausea and vomiting and lower CINV-related HCRU and costs compared to APPA following cisplatin-based chemotherapy. These results complement clinical trial data and published economic models supporting the use of NEPA as a safe, effective, and cost-saving antiemetic for patients undergoing chemotherapy.

Use of warfarin in long-term care: a systematic review.

BACKGROUND: The use of warfarin in older patients requires special consideration because of concerns with comorbidities, interacting medications, and the risk of bleeding. Several studies have suggested that warfarin may be underused or inconsistently prescribed in long-term care (LTC); no published systematic review has evaluated warfarin use for stroke prevention in this setting. This review was conducted to summarize the body of published original research regarding the use of warfarin in the LTC population. METHODS: A systematic literature search of the PubMed, Cumulative Index to Nursing and Allied Health Literature, and Cochrane Library was conducted from January 1985 to August 2010 to identify studies that reported warfarin use in LTC. Studies were grouped by (1) rates of warfarin use and prescribing patterns, (2) association of resident and institutional characteristics with warfarin prescribing, (3) prescriber attitudes and concerns about warfarin use, (4) warfarin management and monitoring, and (5) warfarin-related adverse events. Summaries of study findings and quality assessments of each study were developed. RESULTS: Twenty-two studies met the inclusion criteria for this review. Atrial fibrillation (AF) was the most common indication for warfarin use in LTC and use of warfarin for stroke survivors was common. Rates of warfarin use in AF were low in 5 studies, ranging from 17% to 57%. These usage rates were low even among residents with high stroke risk and low bleeding risk. Scored bleeding risk had no apparent association with warfarin use in AF. In physician surveys, factors associated with not prescribing warfarin included risk of falls, dementia, short life expectancy, and history of bleeding. International normalized ratio was in the target range approximately half of the time. The combined overall rate of warfarin-related adverse events and potential events was 25.5 per 100 resident months on warfarin therapy. CONCLUSIONS: Among residents with AF, use of warfarin and maintenance of INR levels to prevent stroke appear to be suboptimal. Among prescribers, perceived challenges associated with warfarin therapy often outweigh its benefits. Further research is needed to explicitly consider the appropriate balancing of risks and benefits in this frail patient population.

Clinical burden of recurrent Clostridioides difficile infection in the medicare population: A real-world claims analysis.

Objective: To describe 12-month outcomes for beneficiaries in the 100% Medicare Fee-for-Service (FFS) population with primary and recurrent Clostridioides difficile infection (CDI). Design: A retrospective, descriptive, cohort study of CDI claims from the 100% Medicare FFS population, with a first CDI diagnosis between January 1, 2010, and December 31, 2016. Setting: Any US-based provider that submitted inpatient or outpatient CDI diagnosis claims to Medicare FFS. Patients: The study included patients aged ≥65 years with continuous enrollment in Medicare Parts A, B, and D during 12 months before and 12 months after the index period. Methods: The number of CDI and recurrent (rCDI) episodes, healthcare resource utilization, treatments, complications, and procedures were calculated for pre-index and follow-up periods. The data were stratified by number of rCDI episodes (ie, no rCDI, 1 rCDI, 2 rCDI, and ≥3 rCDI). Results: Of 268,762 patients with an index CDI, 34.7% had at least 1 recurrence. Of those who had 1 recurrence, 59.1% had a second recurrence and of those who had 2 recurrences, 58.4% had ≥3 recurrences. Incident psychiatric conditions occurred in 11.3%-18.2% of each rCDI cohort; 6.0% of patients with rCDI underwent subtotal colectomy, and 1.1% of patients underwent diverting loop ileostomy. After each CDI episode, ∼1 in 5 patients had a documented sepsis event. Over the 12-month follow-up, 30% of patients experienced sepsis, and sepsis occurred in 27.0% of the cohort with no rCDI, compared to 35.5% of patients in the rCDI cohorts. Conclusions: Elderly patients with CDI and rCDI experienced a significant clinical burden and complications.

Changes in prescription pain medication and intra-articular corticosteroid utilization after intra-articular bio-fermentation derived hyaluronic acid use in patients undergoing multimodal pain management.

BACKGROUND: Multiple interventions may be used to treat symptomatic knee osteoarthritis (OA), but concerns have been raised about the safety and efficacy of some therapies. Clinical trials have shown that hyaluronic acid (HA) can provide pain relief up to 6 months and possibly to 12 months, while real-world data has shown that pain medication and intra-articular corticosteroid (CS) injection utilization are reduced within 6 months after HA. OBJECTIVE: To examine changes in prescription pain medication and CS utilization during 1 year after multimodal therapy that included high molecular weight, bio-fermentation derived HA (Bio-HA) use for knee OA. METHODS: Commercial and Medicare Supplemental claims data (IBM MarketScan Research Databases) (1 January 2012, through 31 December 2018) was used to identify unilateral Bio-HA patients using multimodal therapy (any combination of CS injection, opioids, and non-opioid pain medication). Monthly therapy utilization was compared in the 12 months after Bio-HA therapy initiation to the 4-month intra-multimodal period. RESULTS: A total of 13,999 patients underwent Bio-HA therapy with concurrent multimodal therapy. The number of filled opioid prescriptions decreased from 2,913.0/month to 2,861.5/month after Bio-HA, with a reduction in mean monthly prescriptions from 0.60 to 0.43 per user (p < 0.001). A number of opioid days supplied also decreased from 48,914/month to 39,730/month, with a decrease from 10.1/month to 6.0/month per user (p < 0.001). Bio-HA patients had prescription pain medication-free days for 71% of the time post-multimodal period compared to 53% during the intra-multimodal period (p < 0.001). The proportion of patients with CS injections after Bio-HA decreased from 53.8% to 29.6% (p < 0.001). Total monthly CS injections decreased from 2,292 to 663. CONCLUSIONS: Our data suggest that high molecular weight Bio-HA, as part of multimodal therapy, may be effective in providing longer-term pain relief with the reduction in pain therapy (CS injections and opioids) and increase in prescription pain medication-free days.

Association Between Bio-Fermentation Derived Hyaluronic Acid and Healthcare Costs Following Knee Arthroplasty.

Background: Limiting access to intra-articular knee injections, including hyaluronic acid (HA), has been advocated as a cost-containment measure in the treatment of knee osteoarthritis. The association between presurgical injections and post-surgical complications such as early periprosthetic joint infection and revision remained to be investigated. This study evaluated pre- and post-surgical costs and rates of post-surgical complications in knee arthroplasty (KA) patients with or without prior HA use. Methods: Commercial and Medicare Supplemental Claims Data (IBM MarketScan Research Databases) from January 1, 2012 to December 31, 2018 were used to identify unilateral KA patients. Those who completed a course of bio-fermentation derived HA (Bio-HA) as the first-line HA therapy comprised of the test group (n = 4091), while the control group did not use HA prior to KA (n = 118,659). Using multivariable regression with propensity score (PS) weighting, overall healthcare costs, readmission rates, and revision rates were assessed at six months following KA. Results: Healthcare costs following KA were significantly lower for the Bio-HA group ($10,021 ± $22,796) than No HA group ($12,724 ± $32,966; PS p < 0.001). Bio-HA patients had lower readmission rates (8.9% vs 14.0%; PS p < 0.001) and inpatient costs per readmitted patient ($43,846 ± $50,648 vs $50,533 ± $66,150; PS p = 0.005). There were no differences in revision rate for any reason (Bio-HA: 0.78% vs No HA: 0.67%; PS p = 0.361) and with PJI (Bio-HA: 0.42% vs No HA: 0.33%; PS p = 0.192). Costs in the six months up to and including the KA were similar for both groups (Bio-HA: $49,759 ± $40,363 vs No HA: $50,532 ± $43,183; PS p = 0.293). Conclusion: Bio-HA use prior to knee arthroplasty did not appear to increase overall healthcare costs in the six months before and after surgery. Allowing access to HA injections provides a non-surgical therapeutic option without increasing cost or risk of post-surgical complications.

Mortality, healthcare resource utilization, and cost among Medicare beneficiaries with Clostridioides difficile infection with and without sepsis.

Objective: To describe mortality, healthcare resource utilization (HRU), and costs among Medicare beneficiaries with primary Clostridioides difficile infection (pCDI) or recurrent CDI (rCDI), with and without sepsis. Methods: We conducted a retrospective observational study of 100% Medicare Fee-for-Service claims from adults aged ⩾ 65 years with ⩾1 CDI episode between 1 January 2009 and 31 December 2017. Patients were continuously enrolled in Medicare Parts A/B/D 12 months before and up to 12 months after pCDI. ICD-9/10 codes defined CDI using ⩾1 inpatient claim, or ⩾1 outpatient claim plus ⩾1 claim for CDI treatment. The pCDI episode ended after 14 days without a CDI claim. rCDI episodes started within 8 weeks from the end of a previous CDI episode. ICD-9/10 codes identified all-cause sepsis over 12 month follow-up. Results: Of 497,489 CDI patients, 41.0% (N = 203,888) had sepsis; 57.7% with sepsis died versus 32.4% without sepsis. Among patients with pCDI only (N = 345,893) or ⩾1 rCDI (N = 151,596), 39.2% and 45.1% suffered sepsis, respectively. All-cause hospitalizations were frequent for all cohorts (range: 81-99%). Among patients who died, those with sepsis versus without had more-frequent intensive care unit (ICU) use (pCDI: 29% versus 15%; rCDI: 65% versus 34%), longer hospital stays (pCDI: 12 versus 10 days; rCDI: 12 versus 9 days), and higher per-patient-per-month costs (pCDI: $34,841 versus $22,753; rCDI: $42,269 versus $25,047). In both cohorts, sepsis patients who survived had higher total costs and all-cause HRU than those without sepsis. All p < 0.001 above. Conclusions: Sepsis was common among Medicare beneficiaries with CDI. CDI patients with sepsis, especially after an rCDI, experienced higher mortality, HRU, and costs compared with those without sepsis.

Mortality, Health Care Use, and Costs of Clostridioides difficile Infections in Older Adults.

OBJECTIVES: Estimate mortality, cost, and health care resource utilization for Medicare beneficiaries aged ≥65 years who suffered a primary Clostridioides difficile infection (CDI) episode only or any recurrent CDI, and understand how outcomes covary with death. DESIGN: Retrospective observational claims analysis. SETTING AND PARTICIPANTS: Patients aged ≥65 years who had an inpatient or outpatient CDI diagnosis claim to Medicare and continuous enrollment in Medicare parts A, B, and D during the 12-month pre- and post-index periods. METHODS: Using 100% Medicare Fee-for-Service claims data for 2009-2017, primary (pCDI, n = 345,893) and recurrent (rCDI: n = 151,596) CDI episodes were identified. Demographic and clinical characteristics, mortality, health care resource utilization, and costs (per patient per month) were summarized for 12 months before and up to 12 months after episode start. Regression models were estimated for hospitalization risk, hospital length of stay (LOS), and cost to adjust for comorbidities. RESULTS: CDI-associated deaths were almost 10 times higher after recurrent CDI (25.4%) than primary CDI (2.7%). Compared with survivors, decedents were older, had higher Charlson Comorbidity Index scores, and were more likely Black. Adjusting for comorbidities, during follow-up, decedents had higher hospitalization rates [pCDI: odds ratio (OR) = 1.83, P < .001; rCDI: OR = 2.58, P < .001], and recurrent CDI decedents had more intensive care unit use (OR = 2.34, P < .001) compared with survivors. Decedents also had a longer length of stay (pCDI: +3.2 days, P < .001; rCDI: +2.6 days, P < .001), and higher total cost (pCDI: +303%, P < .001; rCDI: +297%, P < .001). CONCLUSIONS AND IMPLICATIONS: CDI is an important contributing diagnosis to all-cause mortality, particularly for recurrences. Prior to death, older Medicare beneficiaries who experienced CDI received longer, more intensive, and more costly care compared with survivors. Clinicians should be particularly attentive to prevention, identification, and appropriate treatment of CDI in older adults. Better treatments to reduce primary C difficile infection and recurrences in this vulnerable population can lower both mortality and economic burden.

Maintenance and Concomitant Therapy Use with Chlormethine Gel Among Patients with Stage IA/IB Mycosis Fungoides-Type Cutaneous T-Cell Lymphoma (MF-CTCL): A Real-World Evidence Study.

INTRODUCTION: Chlormethine (CL) gel is a skin-directed therapy approved for treatment of stage IA/IB mycosis fungoides-type cutaneous T-cell lymphoma (MF-CTCL) in the USA. MF-CTCL has a chronic clinical course, requiring long-term maintenance therapy with one or more therapies. This analysis describes real-world patterns of maintenance therapy and use of concomitant therapy with CL gel among patients with stage IA/IB MF-CTCL. METHODS: In a US-based registry, MF-CTCL patients treated with CL gel were enrolled between 3/2015 and 10/2018 across 46 centers and followed for up to 2 years. Patient demographics, clinical characteristics, CL gel treatment patterns, concomitant treatments, clinical response, and adverse events (AEs) were collected from medical records. Descriptive statistics are reported. RESULTS: Of the 206 patients with stage IA/IB MF-CTCL, 58.7% were male, and average age was 60.7 years with 4.6 years since diagnosis. Topical steroids, phototherapy, and topical retinoids were used concomitantly with CL gel in 62.6%, 26.2%, and 6.3% of patients, respectively. Most concomitant therapies (up to 85%) were started before CL gel initiation and, in about half of the cases (up to 57%), were used concurrently for ≥ 12 months. Overall, 158 (76.7%) patients experienced partial response (PR) and 144 continued with maintenance therapy. After achieving PR, most patients (74.3%) kept the same maintenance therapy schedule, most commonly once daily. Of patients who had any skin-related AE (31.6%) or skin-related AEs associated with CL gel (28.2%), nearly half experienced CL gel treatment interruption and ~40% had a dosing reduction. The observed real-world treatment patterns were concordant with National Comprehensive Cancer Network (NCCN) guidelines. CONCLUSION: The study results suggest that continuing CL gel maintenance therapy and combining treatments with CL gel are common practice in the real-world setting, with most maintained on a stable dosing schedule. Careful management of AEs may help patients maintain long-term optimal dosing with less treatment interruptions and dosing reductions.

Clinical complications in patients with primary and recurrent Clostridioides difficile infection: A real-world data analysis.

OBJECTIVE: Clostridioides difficile infection and recurrent C. difficile infection result in substantial economic burden and healthcare resource use. Sepsis and bowel surgery are known to be serious complications of C. difficile infection. This study evaluated clinical complications in patients with C. difficile infection and recurrent C. difficile infection during a 12-month period following the primary C. difficile infection. METHODS: A retrospective analysis of commercial claims data from the IQVIA PharMetrics Plus™ database was conducted for patients aged 18-64 years with an index C. difficile infection episode requiring inpatient stay or an outpatient visit for C. difficile infection followed by a C. difficile infection treatment. Each C. difficile infection episode ended after a 14-day C. difficile infection-claim-free period was observed. Recurrent C. difficile infection was defined as a further C. difficile infection episode within an 8-week window following the claim-free period. Clinical complications were documented over 12 months of follow-up and stratified by the number of recurrent C. difficile infection episodes (0 rCDI, 1 rCDI, 2 rCDI, and 3+ rCDI). RESULTS: In total, 46,571 patients with index C. difficile infection episode were included. During the 6-month pre-index, the mean (standard deviation) baseline Charlson comorbidity index score, by increasing the recurrent C. difficile infection group, was 1.2 (1.9), 1.5 (2.2), 1.8 (2.3), and 2.3 (2.5). During the 12-month follow-up, sepsis occurred in 16.5%, 27.3%, 33.1%, and 43.3% of patients, and subtotal colectomy or diverting loop ileostomy was performed in 4.6%, 7.3%, 8.9%, and 10.5% of patients, respectively, by increasing the recurrent C. difficile infection group. CONCLUSIONS: Reduction in recurrent C. difficile infection is an important step to reduce the burden of serious clinical complications, and new treatments are needed to reduce C. difficile infection recurrence.

Health care resource utilization and costs of recurrent Clostridioides difficile infection in the elderly: a real-world claims analysis.

BACKGROUND: Clostridioides difficile infection (CDI) affected an estimated 365,000 persons in the United States in 2017. Despite a nationally decreasing trend of CDI cases, the population incidence of recurrent CDI (rCDI) has not improved. Elderly individuals (aged ≥ 65 years) are at higher risk of CDI, rCDI, and complicated CDI compared with younger individuals. OBJECTIVE: To analyze Medicare fee-for-service data for 12 months after an initial CDI episode, in order to obtain real-world data on health care resource utilization (HRU) and costs for elderly patients with CDI and rCDI. METHODS: A retrospective cohort study of patients who were aged ≥ 65 years and had a first (index) CDI diagnosis from January 1, 2010, to December 31, 2016, and continuous enrollment in Medicare Parts A, B, and D during the 12-month pre-index and 12-month post-index periods was conducted. A CDI episode was identified by either an inpatient stay with CDI diagnosis code or an outpatient medical claim with a CDI diagnosis code plus a CDI treatment. Each CDI episode was followed by a 14-day CDI claim-free period after the last CDI claim or end of CDI treatment. rCDI was a second or subsequent episode of CDI that occurred within an 8-week window after the 14-day CDI claim-free period. The number of CDI and rCDI episodes, HRU, time to recurrence, and total all-cause direct medical costs were calculated over the 12-month pre-index (baseline) and 12-month follow-up periods and stratified by number of rCDI episodes (No rCDI, 1 rCDI, 2 rCDI, 3+ rCDI). RESULTS: A total of 268,762 patients with an index CDI were included. Mean age was 78.3 years, and 69.0% were female. HRU was higher during the 6 months immediately pre-index versus 7-12 months pre-index, including a higher proportion of patients with a hospital admission (55.1% vs. 27.5%) or emergency department visit (41.3% vs. 27.4%), respectively. Moreover, 34.7% of the study population experienced rCDI. Of those who experienced 1 recurrence, 59.1% had a second recurrence, and of those who had 2 recurrences, 58.4% had a third. During the 12-month follow-up, postacute care was used by at least 70% of each rCDI cohort. The proportion of patients with ≥ 4 hospital admissions during follow-up was highest for the 3+ rCDI cohort (24.9% of patients). During the 12-month follow-up, mean total all-cause direct costs were $76,024, $99,348, $96,148, and $96,517 for the No rCDI, 1 rCDI, 2 rCDI, and 3+ rCDI cohorts, respectively, largely driven by inpatient costs. Adjusted all-cause total costs were significantly higher for all 3 rCDI cohorts compared with the No rCDI cohort. CONCLUSIONS: Elderly individuals experienced high rates of recurrence after their first CDI episode, and especially after a prior recurrence. The intensity of HRU during follow-up was higher for patients who suffered recurrences. Patients with rCDI had the burden of higher costs of care, including the patient out-of-pocket responsibility, versus patients with a single CDI episode. DISCLOSURES: Funding for this study was provided by Ferring Pharmaceuticals. Nelson is an employee of Ferring Pharmaceuticals, and Scott, Boules, and Unni were employees of Ferring Pharmaceuticals at the time of this study. Teigland and Parente are employees of Avalere Health and provided consulting services to Ferring Pharmaceuticals. Feuerstadt has served as a consultant to and on the speakers bureau for Merck and Co. and has served as a consultant for Ferring Pharmaceuticals and Roche Pharmaceuticals. Portions of the data contained in this study appeared as an abstract/ePoster for the AMCP Annual Meeting 2020, April 2020.

Treatment with Repository Corticotropin Injection in Patients with Rheumatoid Arthritis, Systemic Lupus Erythematosus, and Dermatomyositis/Polymyositis.

PURPOSE: Repository corticotropin injection (RCI) is indicated for a number of autoimmune-mediated diseases including rheumatoid arthritis (RA), systemic lupus erythematosus (SLE), and dermatomyositis (DM)/polymyositis (PM). To better understand the practice patterns and outcomes of RCI in patients with RA, SLE, or DM/PM, we conducted a retrospective medical record analysis. PATIENTS AND METHODS: Participating providers selected deidentified medical records of patients meeting the inclusion criteria (age ≥18 years; physician-reported diagnosis of RA, SLE, or DM/PM; initiation of treatment with RCI between 1/1/2011 and 2/15/2016; ≥3 in-office visits with same site/provider). Collected data spanned 12 months before and after the first prescription date for RCI. Analyses included patient demographics and clinical history, RCI treatment patterns, and physician's impression of change. RESULTS: Data from 54 patients with RA, 30 patients with SLE, and 8 patients with DM/PM were analyzed. The most frequently reported reasons for initiating RCI were lack of efficacy with prior treatment, acute exacerbation of disease, and use as add-on to ongoing therapy. The most common initial RCI dosing, 80 U twice weekly, was used for 84% of patients with RA, 75% with SLE, and 86% with DM/PM. The mean duration of treatment was 4.8, 6.5, and 6.8 months for RA, SLE, and DM/PM, respectively. Among the 57 patients with data on physician's impression of change with RCI, 78.1% of patients with RA, 94.7% with SLE, and 66.7% with DM/PM had a rating of "improved," and the mean time to best impression of change was 3.4, 4.3, and 3.4 months for RA, SLE, and DM/PM, respectively. CONCLUSION: This study reports the real-world patient profile, use patterns, and outcomes of patients who used RCI for the treatment of RA, SLE, and DM/PM. These data can inform appropriate use and clinical expectations when using RCI.

Healthcare resource utilization and direct medical costs associated with index and recurrent Clostridioides difficile infection: a real-world data analysis.

Aims: This study aimed to evaluate all-cause economic outcomes, healthcare resource utilization (HRU), and costs in patients with Clostridioides difficile infection (CDI) and recurrent CDI (rCDI) using commercial claims from a large database representing various healthcare settings.Materials and methods: A retrospective analysis of commercial claims data from the IQVIA PharMetrics Plus database was conducted for patients aged 18-64 years with CDI episodes requiring inpatient stay with CDI diagnosis code or an outpatient medical claim for CDI plus a CDI treatment. Index CDI episodes occurred between 1 January 2010 and 30 June 2017, including only those where patients were observable 6 months before and 12 months after the index episode. Each CDI episode was followed by a 14-d claim-free period. rCDI was defined as another CDI episode within an 8-week window following the claim-free period. HRU, all-cause direct medical costs and time to rCDI were calculated over 12 months and stratified by number of rCDI episodes.Results: A total of 46,571 patients with index CDI were included. Mean time from one CDI episode to the next was approximately 1 month. In the 12-month follow-up period, those with no recurrence had 1.4 inpatient visits per person and those with 3 or more recurrences had 5.8. Most patients with 3 or more recurrences had 2 or more hospital admissions. The mean annual, total all-cause direct medical costs per patient were $71,980 for those with no recurrence and $207,733 for those with 3 or more recurrences.Limitations: The study included individuals 18-64 years only. A stringent definition of rCDI was used, which may have underestimated the incidence of rCDI.Conclusions: CDI and rCDI are associated with substantial healthcare resource utilization and direct medical costs. Timing of recurrences can be predictable, providing a window of opportunity for interventions. Prevention of multiple rCDI appears essential to reduce healthcare costs.

Patient-Reported Lupus Flare Symptoms Are Associated with Worsened Patient Outcomes and Increased Economic Burden.

BACKGROUND: Lupus flares significantly contribute to health resource utilization and hospitalizations. Identification of flare activity may be hindered since validated assessment scales are rarely used in clinical practice and flare severity may fall below clinician-assessed thresholds. Therefore, patient-reported outcomes of lupus flare frequency are important assessment tools for lupus management. OBJECTIVE: To better understand the relationship between lupus flares as reported by persons with lupus and specific direct and indirect costs, including hospital admission, unplanned urgent care (UC)/emergency department (ED) visits, work productivity loss, and nonwork activity impairment. METHODS: In this cross-sectional analysis, persons with lupus were drawn from 2 enriched sampling sources. Data were collected via an online survey and included individuals with self-reported physician's diagnosis of systemic lupus erythematosus, skin or discoid lupus, or lupus nephritis. Respondents were asked the total number of hospitalizations and ED/UC visits for any reason and for lupus-related hospitalizations and ED/UC visits. Work productivity loss and nonwork activity impairment were measured via the Work Productivity and Activity Impairment - General Health scale. The sample was stratified into those with 0 flares, 1-3 flares, 4-6 flares, and 7 or more flares, with 0 flares used as the reference. Chi-square tests for trend and analyses of variance were used to evaluate differences among flare frequency groups. Multivariable regression modeling was conducted to evaluate the independent relationship of flare frequency to health care use and productivity loss. RESULTS: We studied 1,288 survey respondents with known flare frequency in the past 12 months. Flare frequency increased with duration of illness. The mean number of lupus-related hospital admissions was significantly associated with increasing flare frequency for the total sample (F = 3.9; P < 0.009). Compared to patients with no flare, those who reported flare activities had 1.72-3.13 times higher rates of hospitalizations. The mean number of lupus-related ED/UC visits were also found to be significantly associated with increasing flare frequency for the total sample (F = 23.4; P < 0.001), and rates were increased by 6.98- to 16.12-fold for unplanned ED/UC visits depending on flare frequency. Rates of employment were significantly related to increasing flare frequency. With respect to work-related impairment, absenteeism increased with greater lupus flare frequency (F = 6.2; P < 0.001), as did presenteeism (F = 31.5; P < 0.001) and the combined value of total work productivity loss (F = 30.4; P < 0.001). Mean work-related activity impairment was 12%-32% more among patients who reported flare activities compared to those who reported no flares. CONCLUSIONS: Increased lupus-related flare frequency is associated with worsened patient outcomes as measured by increased hospitalizations, visits to the ED/UC, work productivity loss, and activity impairment. This association may be an important indicator of disease severity and resource burden and therefore suggests an unmet need among patients experiencing lupus-related flares. DISCLOSURES: This study was sponsored by Mallinckrodt Pharmaceuticals via grants to Vedanta Research and The Lupus Foundation of America. Katz received consulting fees from Vedanta Research, which received grant support from Mallinckrodt Pharmaceuticals to support data collection and analysis. Nelson and Connolly-Strong are employees of Mallinckrodt Pharmaceuticals and are stockholders in the company. Reed is an employee of Vedanta Research. Daly and Topf are employees of the Lupus Foundation of America, which received grant funding to support data collection. This study was a podium presentation at The American College of Rheumatology (ACR) Annual Meeting 2018; October 19-24, 2018; Chicago, IL.