Home intravenous antibiotherapy and the proper use of elastomeric pumps: Systematic review of the literature and proposals for improved use.

Over several decades, the economic situation and consideration of patient quality of life have been responsible for increased outpatient treatment. It is in this context that outpatient antimicrobial treatment (OPAT) has rapidly developed. The availability of elastomeric infusion pumps has permitted prolonged or continuous antibiotic administration by dint of a mechanical device necessitating neither gravity nor a source of electricity. In numerous situations, its utilization optimizes administration of time-dependent antibiotics while freeing the patient from the constraints associated with infusion by gravity, volumetric pump or electrical syringe pump and, more often than not, limiting the number of nurse interventions to one or two a day. That much said, the installation of these pumps, which is not systematically justified, entails markedly increased OPAT costs and is liable to expose the patient to a risk of therapeutic failure or adverse effects due to the instability of the molecules utilized in a non-controlled environment, instability that necessitates close monitoring of their use. More precisely, a prescriber must take into consideration the stability parameters of each molecule (infusion duration, concentration following dilution, nature of the diluent and pump temperature). The objective of this work is to evaluate the different means of utilization of elastomeric infusion pumps in intravenous antibiotic administration outside of hospital. Following a review of the literature, we will present a tool for optimized antibiotic prescription, in a town setting by means of an infusion device.

Home Infliximab Infusions Are Associated With Suboptimal Outcomes Without Cost Savings in Inflammatory Bowel Diseases.

INTRODUCTION: Biologic agents including infliximab are effective but costly therapies in the management of inflammatory bowel disease (IBD). Home infliximab infusions are increasingly payer-mandated to minimize infusion-related costs. This study aimed to compare biologic medication use, health outcomes, and overall cost of care for adult and pediatric patients with IBD receiving home vs office- vs hospital-based infliximab infusions. METHODS: Longitudinal patient data were obtained from the Optum Clinformatics Data Mart. The analysis considered all patients with IBD who received infliximab from 2003 to 2016. Primary outcomes included nonadherence (≥2 infliximab infusions over 10 weeks apart in 1 year) and discontinuation of infliximab. Secondary outcomes included outpatient corticosteroid use, follow-up visits, emergency room visits, hospitalizations, surgeries, and cost outcomes (out-of-pocket costs and annual overall cost of care). RESULTS: There were 27,396 patients with IBD (1,839 pediatric patients). Overall, 5.7% of patients used home infliximab infusions. These patients were more likely to be nonadherent compared with both office-based (22.2% vs 19.8%; P = .044) and hospital-based infusions (22.2% vs 21.2%; P < .001). They were also more likely to discontinue infliximab compared with office-based (44.7% vs 33.7%; P < .001) or hospital-based (44.7% vs 33.4%; P < .001) infusions. On Kaplan-Meier analysis, the probabilities of remaining on infliximab by day 200 of therapy were 64.4%, 74.2%, and 79.3% for home-, hospital-, and office-based infusions, respectively (P < .001). Home infliximab patients had the highest corticosteroid use (cumulative corticosteroid days after IBD diagnosis: home based, 238.2; office based, 189.7; and hospital based, 208.5; P < .001) and the fewest follow-up visits. Home infusions did not decrease overall annual care costs compared with office infusions ($49,149 vs $43,466, P < .001). DISCUSSION: In this analysis, home infliximab infusions for patients with IBD were associated with suboptimal outcomes including higher rates of nonadherence and discontinuation of infliximab. Home infusions did not result in significant cost savings compared with office infusions.

Economic Burden of Home Antimicrobial Therapy: OPAT Versus Oral Therapy.

BACKGROUND: There is increasing evidence that outpatient parenteral antimicrobial therapy (OPAT) is overused for children and that outcomes with oral therapy are equivalent. Our objective was to compare economic burden between OPAT and oral therapy, accounting for direct and indirect costs and caregiver quality of life (QoL). METHODS: We conducted a prospective cohort study of caregivers for children after hospitalization who were treated with prolonged antimicrobial therapy. We collected data about missed work and school and time spent administering therapy. Caregivers completed the Pediatric Quality of Life Inventory to assess QoL. Clinical information included length of stay, treatment indication, and type of therapy (OPAT versus oral therapy). Direct medical costs were obtained by using a microcosting system and accounted for medication, supplies, and home-nursing visits. The primary cost outcome was the mean daily cost of therapy. Multivariable models were developed to adjust for potential confounders. RESULTS: Two hundred and twelve caregivers completed surveys: 123 (58%) for oral therapy and 89 (42%) for OPAT. Caregivers administering OPAT reported more missed work, missed school for their children, time with daily medication administration (90 vs 6 minutes; P < .01) and lower QoL scores (77.8 vs 68.9) than caregivers administering oral therapy. The mean daily cost was $65 (95% confidence interval: $51-$78) for OPAT and $7 (95% confidence interval: $4-$9) for oral therapy. Relative differences in cost and QoL between groups did not change after model adjustment. CONCLUSIONS: The overall burden of OPAT is substantially higher than that of oral therapy, including higher direct and indirect costs and greater impact on caregiver QoL. These findings strongly support efforts to use oral therapy in place of OPAT when clinically appropriate.

Clinical efficacy, cost analysis and patient acceptability of outpatient parenteral antibiotic therapy (OPAT): a decade of Sheffield (UK) OPAT service.

Outpatient parenteral antimicrobial therapy (OPAT) has evolved relatively slowly in the UK. This study describes the OPAT service based in a large UK teaching hospital in Sheffield, and examines the clinical efficacy, patient acceptability and costs saved over a 10-year period. Data on 3812 episodes of OPAT administered between January 2006 and January 2016 were retrieved from a prospectively maintained electronic database. This study compared the real costs of the OPAT service with estimated costs of conventional inpatient care for these patient episodes, and analysed patient feedback questionnaires that were administered randomly between January 2014 and January 2015. A wide range of infections were managed during the 10-year period. Skin and soft tissue infections accounted for 57% of OPAT episodes. The total number of bed-days saved was 49,854. A successful outcome (cure or improvement) was found in 3357 (88%) episodes. Re-admission occurred in 265 (7%) episodes. The rates of healthcare-associated infections were low: 15 intravenous-line-related infections were recorded (0.3 per 1000 OPAT patient-days). Patient acceptance and satisfaction with OPAT were high. OPAT cost 15%, 39%, 40% and 44% of inpatient costs for an infectious diseases unit, national average costs, other departments (non-infectious diseases unit), and the minimum national average costs for each diagnostic category, respectively. This study shows that OPAT is safe, clinically efficacious and acceptable for treating a wide range of infections with high levels of patient satisfaction and substantial cost savings.

Costs of Providing Infusion Therapy for Rheumatoid Arthritis in a Hospital-based Infusion Center Setting.

PURPOSE: Many hospital-based infusion centers treat patients with rheumatoid arthritis (RA) with intravenous biologic agents, yet may have a limited understanding of the overall costs of infusion in this setting. The purposes of this study were to conduct a microcosting analysis from a hospital perspective and to develop a model using an activity-based costing approach for estimating costs associated with the provision of hospital-based infusion services (preparation, administration, and follow-up) in the United States for maintenance treatment of moderate to severe RA. METHODS: A spreadsheet-based model was developed. Inputs included hourly wages, time spent providing care, supply/overhead costs, laboratory testing, infusion center size, and practice pattern information. Base-case values were derived from data from surveys, published studies, standard cost sources, and expert opinion. Costs are presented in year-2017 US dollars. The base case modeled a hospital infusion center serving patients with RA treated with abatacept, tocilizumab, infliximab, or rituximab. FINDINGS: Estimated overall costs of infusions per patient per year were $36,663 (rituximab), $36,821 (tocilizumab), $44,973 (infliximab), and $46,532 (abatacept). Of all therapies, the biologic agents represented the greatest share of overall costs, ranging from 87% to $91% of overall costs per year. Excluding infusion drug costs, labor accounted for 53% to 57% of infusion costs. IMPLICATIONS: Biologic agents represented the highest single cost associated with RA infusion care; however, personnel, supplies, and overhead costs also contributed substantially to overall costs (8%-16%). This model may provide a helpful and adaptable framework for use by hospitals in informing decision making about services offered and their associated financial implications.

Home infusion: Safe, clinically effective, patient preferred, and cost saving.

BACKGROUND: As the U.S. healthcare payment system shifts from volume to value, identifying care approaches that improve outcomes while lowering costs are essential. We sought to understand the utility of home infusion versus medical-setting infusion as a mechanism to affect the three-part aim: better care, better health outcomes, and lower costs. STUDY DESIGN: Systematic review. METHODS: We searched MEDLINE, EMBASE, and Science Citation Index for articles related to the safety, clinical effectiveness, quality of life and satisfaction, and/or costs of home infusion as compared with infusion in an outpatient medical facility or hospital. RESULTS: Of 253 potentially relevant articles, 13 met all inclusion criteria. Study design, disease state, and outcomes varied considerably. As compared to medical setting infusion patients, home infusion patients were no more likely to experience adverse drug events or side effects (all p>0.05). Clinical outcomes were as good or better, e.g., for patients with hemophilia, a 40% (0.50-0.70) reduced likelihood of hospitalization for bleeding complications. Patients overwhelmingly preferred home infusion, reporting significantly better physical and mental well being and less disruption of family and personal responsibilities. Home infusion costs were significantly lower than medical setting infusion costs, with savings between $1928 and $2974 per treatment course. CONCLUSIONS: Home infusion care can provide safe, clinically effective care improve patients' quality of life and reduce healthcare costs. As the overhaul of the healthcare payment system gains momentum, the home infusion care delivery model offers strong promise as one in a set of approaches that can improve care and lower costs.

[Lysosomal Storage Diseases: Challenges in Multiprofessional Patient Care with Enzyme Replacement Therapy]. / Lysosomale Speichererkrankungen: Herausforderungen bei der sektorübergreifenden, multiprofessionellen Patientenversorgung mit Enzymersatztherapie.

Background Due to their rarity studies in (ultra-) rare diseases are difficult. Only for a minority of these diseases causal therapies are available. Development and production of enzyme replacement therapies (ERT) for example are challenging and expensive. The number of patients is low, costs per patient are high. We will focus on the challenges of providing long-term ERT to patients with lysosomal storage diseases (LSD) in an out- and inpatient setting based on a literature search in Pubmed and own experience. Many ERTs for LSDs have a positive cost-benefit ratio. Possible side-effects are severe allergic reactions. ERT is covered by the insurance companies when prescribed by a physician, however they are liable to recourse by the insurance company as the expenses for drugs of the prescribing physician will be above average. In most cases the recourse can be averted if diagnoses of individual patients are disclosed. Intravenous infusion of ERT is not well-regulated in Germany/Austria. Infusion on a ward is safe however often not covered by the insurance companies as patients do not stay overnight. Another option is infusion in a day-care setting, however the lump sum paid for infusion does not cover costs for ERT. On an individual basis, reimbursement for medication (ERT) has to be negotiated with the insurance companies before infusion takes place. Home infusions are feasible, however careful evaluations of the infusion-team and the risk for side-effects have to be performed on an individual basis, legal issues have to be considered. In- and outpatient ERT of patients with LSDs is challenging but feasible after individual evaluation of patient and infusion team.

Home treatment in paediatric patients with Hunter syndrome: the first Italian experience.

Hunter syndrome (mucopolysaccharidosis type II [MPS II], OMIM309900) is a rare X-linked lysosomal storage disorder caused by the deficiency of the enzyme iduronate-2-sulphatase, resulting in accumulation of glycosaminoglycans, progressive multisystem organ failure, and early death. Enzyme replacement therapy (ERT) with weekly intravenous infusions of idursulfase, a treatment for MPS II and commercially available since 2007, has been shown to improve certain symptoms and signs of the disease. The efficacy and safety data of this enzyme preparation have been widely reported and, after a change to the idursulfase Summary of Product Characteristics in March 2010, home ERT by infusion is now an option for selected patients. Previously reported experiences of home therapy in MPS II have shown increased treatment compliance and an improvement in quality of life for both patients and families. We report the results of the home therapy experience of 3 paediatric patients with MPS II in southern Italy. This pilot experience with home infusion is the first reported from Italy.

Management of suspected Lyme borreliosis: experience from an outpatient parenteral antibiotic therapy service.

OBJECTIVES: Lyme borreliosis (LB) is the most common human tick-borne infection in Europe and the USA. In this study we set out to analyse the outcome of patients treated for Lyme disease via outpatient parenteral antibiotic therapy (OPAT) and the appropriateness of this treatment using current guidelines. METHODS: This was a retrospective review of all patients with suspected LB managed via OPAT in Glasgow in 2000-11. RESULTS: Of 72 patients treated for suspected LB, 35 patients (49%) were treated in accordance with guidelines and 36 (50%) were treated with no specific guidelines. A definite improvement was seen in 20 patients (28%). Adverse reactions were documented in 29 (40%) patients with neutropenia, and mild liver function derangement was most commonly observed. CONCLUSION: These results show the complexity of translating well-substantiated regimens from clinical trials to actual clinical practice. OPAT was an effective way of administering parenteral therapy for Lyme disease but should not be undertaken lightly due to the rate of adverse events and low rates of success in certain patient groups seen in this study. In view of this, stricter criteria for inclusion to OPAT in line with published guidance should be applied to minimize patient harm and optimize success.

Medicare home infusion therapy reimbursement gap.

This research seeks to address the home infusion therapy reimbursement gap found within Medicare Part D. In particular, the research explored the reimbursement gap's impact on home health utilization, its contribution to the national health expenditure growth, and the potential fix of the problem by restructuring Medicare Part B to include a home infusion therapy benefit under its coverage. Previous studies found that there is a great cost avoidance opportunity available through home health and home infusion treatment, because such treatment avoids the high costs associated with hospitalization and nursing home and other long-term care facilities. Future implications of this topic are unclear, as the Affordable Health Care for America Act is equipped to cut Medicare services and reimbursements, in spite of current bipartisan legislation in both houses to cover the home infusion reimbursement gap.

Outpatient parenteral antibiotic therapy (OPAT) at home in Attica, Greece.

Outpatient parenteral antibiotic therapy (OPAT) is considered to be a cost-effective and safe alternative treatment strategy to hospitalization. We retrospectively evaluated data regarding the demographic and treatment characteristics of patients that sought medical advice from a network of physicians performing house-call visits and who received OPAT at home during a 17-month period (May 2009 to September 2010) in Attica, Greece. A total of 91 patients (69.2 % females) received intravenous antibiotic therapy at home during the evaluated period. The mean age [± standard deviation (SD)] of the patients was 85.3 (± 9) years. The main indications were pneumonia [46 patients (50.5 %)], urinary tract infection [25 (27.5 %)], and gastrointestinal tract infection [9 (9.9 %)]. Of the patients, 76.4 % received a beta-lactam, 17.5 % a fluoroquinolone, 15.3 % an imidazole, 8.7 % an aminoglycoside, and 5.4 % a lincosamide. The cure rate was 72.5 % and mortality was 27.5 %. The mean duration (± SD) of intravenous antibiotic treatment was 4.7 (± 3.3) days. The mean cost per patient was 637 and was comparable to the mean cost if the patient were to be hospitalized for the same infection. There was significant clinical effectiveness of OPAT at home in this mainly elderly population, at an acceptable cost.

Daptomicina en el paciente con hospitalización a domicilio / Daptomycin in home hospitalization

El tratamiento antimicrobiano parenteral ambulatorio (OPAT [outpatient parenteral antimicrobial therapy]) es un procedimiento muy extendido en Estados Unidos, que comporta ventajas tanto para el paciente como para los hospitales. En los últimos años, varios países europeos, como Reino Unido o Italia, han empezado a mostrar interés por OPAT, desarrollándolo a través de diferentes estructuras asistenciales. En España, son las unidades de hospitalización a domicilio el recurso más utilizado. La introducción de daptomicina, un antibiótico de administración única diaria, que permite su infusión rápida y que no precisa la monitorización de sus valores plasmáticos, facilita enormemente la ambulatorización del tratamiento de infecciones graves por microorganismos grampositivos. Los resultados de ensayos clínicos, de series de casos y de registros poscomercialización apoyan la eficacia y seguridad del uso de daptomicina en OPAT (AU)

Outpatient Parenteral Antimicrobial Therapy (OPAT) is widely used in the United States and has advantages for both patients and hospitals. In the last few years, several European countries such as the United Kingdom and Italy have begun to show interest in OPAT, developing this therapeutic modality through distinct healthcare structures. In Spain, the most widely used resources are hospital at home units. Daptomycin is an antibiotic that is administered in a single daily dose, which allows its rapid infusion, and does not require monitoring of plasma levels. These two factors greatly facilitate the ambulatory treatment of severe infections due to Gram-positive microorganisms. The results of clinical trials, case series and post-commercialization registries support the safety and efficacy of the use of daptomycin in OPAT (AU)

Modelling the resource implications of managing adults with Fabry disease in Norway favours home infusion.

BACKGROUND: The aim of this study was to estimate the resource implications and budget impact of managing adults with Fabry disease in Norway, from the perspective of the publicly funded healthcare system. METHODS: A decision model was constructed using published clinical outcomes and clinician-derived resource utilization estimates. The model was used to estimate the annual healthcare cost of managing a cohort of 64 adult Fabry patients in an average year. RESULTS: The expected annual cost of managing 60 existing Fabry patients and four new patients in Norway each year was estimated to be NOK 55·8 million (€6·7 million). In an average year, patients receiving enzyme replacement therapy (ERT) with agalsidase alfa (Replagal(®)) at 0·2 mg kg⁻¹ or agalsidase beta (Fabrazyme(®)) at 1·0 mg kg⁻¹ are collectively expected to make 586 attendances to their family practitioner's office for their infusions, which equates to 128 eight-hour days associated with ERT. Encouraging more patients to undergo home-based infusions has substantial potential to free-up community-based resources. In comparison, the community-related benefit that can be obtained by switching from agalsidase beta (1·0 mg kg⁻¹) to agalsidase alpha (0·2 mg kg⁻¹) is marginal, and dependent on the two doses being clinically equivalent. CONCLUSION: Maximizing the proportion of adults with Fabry disease undergoing home-based infusions has the potential to release community-based resources for alternative use by non-Fabry patients, thereby improving the efficiency of the publicly funded healthcare system in Norway.

Ambulatory high-dose methotrexate administration among pediatric osteosarcoma patients in an urban, underserved setting is feasible, safe, and cost-effective.

BACKGROUND: We describe the safety, feasibility, and provide a cost-estimate of outpatient high-dose methotrexate administration (HDMTX) among an urban, underserved population. PROCEDURE: A retrospective analysis of ambulatory HDMTX administration among osteosarcoma patients, at Montefiore Medical Center's Children's Hospital (Bronx, NY) was performed. HDMTX (12 g/m(2)) was given intravenously (IV) over 4 hr after urine alkalinization. Patients were discharged home to continue IV hydration and alkalinization delivered via a home infusion pump. Families were instructed to monitor urine pH overnight and management was adjusted according to our institution's treatment algorithm until MTX level ≤ 0.1 µmol/L. A cost estimate was performed to assess the difference in costs for outpatient versus hypothetical inpatient administrations. RESULTS: Of the 97 ambulatory HDMTX administrations, 99% were successfully completed. One patient failed outpatient administration secondary to home infusion pump malfunction. This patient successfully completed subsequent courses as an outpatient. Most patients (72%) had a MTX level of < 10 µmol/L at 24 hr post-HDMTX. No patients were found to have a MTX level of > 50 µmol/L at 24 hr. About 26% of courses were associated with grade III or IV neutropenia, 4% were associated with grade III or IV thrombocytopenia and 1% were associated with grade III/IV leukopenia. Compared to a hypothetical hospital inpatient stay, the hospital costs for ambulatory HDMTX were an average of $1400 less per cycle. CONCLUSION: Ambulatory HDMTX administration among an underserved, urban population is safe, feasible, and cost-effective.

[Daptomycin in home hospitalization]. / Daptomicina en el paciente con hospitalización a domicilio.

Outpatient Parenteral Antimicrobial Therapy (OPAT) is widely used in the United States and has advantages for both patients and hospitals. In the last few years, several European countries such as the United Kingdom and Italy have begun to show interest in OPAT, developing this therapeutic modality through distinct healthcare structures. In Spain, the most widely used resources are hospital at home units. Daptomycin is an antibiotic that is administered in a single daily dose, which allows its rapid infusion, and does not require monitoring of plasma levels. These two factors greatly facilitate the ambulatory treatment of severe infections due to Gram-positive microorganisms. The results of clinical trials, case series and post-commercialization registries support the safety and efficacy of the use of daptomycin in OPAT.

A cost analysis of Outpatient Parenteral Antibiotic Therapy (OPAT): an Asian perspective.

The concept of Outpatient Parenteral Antibiotic Therapy (OPAT) is relatively new in Asia. This study compared the actual costs and outcomes of care involving OPAT with conventional inpatient-only care at a university hospital in Singapore. Actual costs were obtained for selected patients enrolled in OPAT after 1 January 2005 and these costs were directly compared with those of age-, gender- and diagnosis-matched patients managed as inpatients only prior to the availability of OPAT in the preceding 12 months. Outcomes of patients were also considered. The OPAT and inpatient-only groups comprised 72 and 93 enrollments, respectively. Mean treatment duration for OPAT patients was 42.5 days versus 19 days for those receiving inpatient-only care (P < 0.001). The mean total treatment cost for OPAT and inpatient-only care was US$12 736 and $12 403, respectively (P = 0.706). Mean cost per day for care including an OPAT episode was US$278 versus $457 per day for inpatient-only care (P < 0.001). There was no difference in outcomes between the two groups. OPAT is a viable alternative to inpatient care as it is safe, effective and results in lower daily costs. The trend to longer treatment courses is worthy of further review.