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Identification of Cost-Saving Opportunities for the Use of Antithrombin III in Adult and Pediatric Patients.

ABSTRACT: Thrombate III is a human plasma-derived antithrombin III (AT-III) often utilized in patients on extracorporeal membrane oxygenation (ECMO) with suspected AT-III-mediated heparin resistance. It is supplied as 500-U and 1000-U vials, costing US$4.66 per unit. Literature is limited in describing the clinical value of AT-III in relation to its high cost. The primary objective was to determine conditions of use and associated cost of potentially unnecessary utilization of AT-III at The Johns Hopkins Hospital. Secondary objectives included evaluating the effect of AT-III on anticoagulation parameters and the overall cost utilized and wasted on AT-III. A retrospective cohort study was performed. The primary end point was the total cost associated with potentially unnecessary utilization of AT-III. There were 326 doses of AT-III administered to 65 patients in 2014. There were 177 (54%) potentially unnecessary doses associated with a cost of US$541 634. Antithrombin III repletion significantly increased median AT-III levels in non-ECMO and ECMO patients compared to baseline (non-ECMO: 62% vs 81%, P < .01; ECMO: 63% vs 81%, P < .01); however, 37.3% of ECMO and 49% of non-ECMO patients had therapeutic anticoagulation monitoring parameters prior to administration. A total cost of US$688 478 was spent on administered AT-III and US$417 194 (38%) was wasted. Utilizing restriction criteria and a new dosing strategy potentially results in estimated annual savings of US$556 000. Utilizing restriction criteria and alternative dosing strategies to mitigate waste and unnecessary use has the potential to result in significant cost savings.

SUBMITTER: Ciolek A

PROVIDER: S-EPMC6714634 | biostudies-literature | 2018 Jan

REPOSITORIES: biostudies-literature

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Identification of Cost-Saving Opportunities for the Use of Antithrombin III in Adult and Pediatric Patients.

Ciolek Alana A Lindsley John J Crow Jessica J Nelson-McMillan Kristen K Procaccini David D

Clinical and applied thrombosis/hemostasis : official journal of the International Academy of Clinical and Applied Thrombosis/Hemostasis 20170220 1

Thrombate III is a human plasma-derived antithrombin III (AT-III) often utilized in patients on extracorporeal membrane oxygenation (ECMO) with suspected AT-III-mediated heparin resistance. It is supplied as 500-U and 1000-U vials, costing US$4.66 per unit. Literature is limited in describing the clinical value of AT-III in relation to its high cost. The primary objective was to determine conditions of use and associated cost of potentially unnecessary utilization of AT-III at The Johns Hopkins ...[more]

PMID: 28301908

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Project description:With an incidence of 68 new cases per 100,000 people per year, an estimated total number of up to 350,000 new non-small-cell lung cancer (NSCLC) cases are diagnosed each year in the European Union. Up to 10% of NSCLC patients are eligible for therapy with novel ALK (anaplastic lymphoma kinase) inhibitors, as they have been diagnosed with a mutation in the gene coding for ALK. The ALK inhibitor therapy costs add up to approx. 9,000 € per patient per month, with treatment durations of up to one year. Recent studies have shown that up to 10% of ALK cases are misdiagnosed by nearly 40% of pathologic investigations. The current state-of-the-art ALK diagnostic procedure comprises a Fluorescent in situ Hybridization (FISH) assay accompanied by ALK inhibitor therapy (Crizotinib). The therapy success ranges between a full therapy failure and the complete remission of the tumor (i.e., healing), but the biomedical and systemic reasons for this range remain unknown so far. It appears that the variety of different ALK mutations and variants contributes to the discrepancy in therapy results. Although the major known fusion partner for ALK in NSCLC is the Echinoderm microtubule-associated protein-like 4 (EML4), of which a minimum of 15 variants have been described, an additional 20 further ALK fusion variants with other genes are known, of which three have already been found in NSCLC. We hypothesize that the wide variety of known (and unknown) ALK mutations is associated with a variable therapy success, thus rendering current companion diagnostic procedures (FISH) and therapy (Crizotinib) only partly applicable in ALK-related NSCLC treatment. In cell culture, differing sensitivity to Crizotinib has been shown for some fusion variants, but it is as yet unknown which of them are really biologically active in cancer patients, and how the respective variants affect the response to Crizotinib treatment. Moreover, it has been demonstrated that translocated ALK genes can also be observed in healthy tissues and are not compulsorily associated with tumors. Therefore, it is important to keep in mind that even for the known variants of ALK fusion genes, the biological function is not known for all variants, and that no information is available on the homogeneity of ALK fusion variants within a single tumor. These facts, in concert with data for ALK mutation prevalence and therapy outcomes of a German cohort of NSCLC patients, support the hypothesis that, by using novel companion diagnostic tools in combination with therapy outcome predictions, massive cost savings could be possible in European Health Care systems without a loss of patient care.

Project description:BackgroundThe most frequently prescribed regimens for the treatment of hospitalized adults with suspected or documented community-acquired bacterial pneumonia (CABP), an acute bacterial infection of the pulmonary parenchyma, are ceftriaxone plus a macrolide, or a respiratory fluoroquinolone. Although these regimens are consistent with expert guidelines, there are growing concerns regarding their safety and efficacy. Omadacycline is a once-daily antibiotic with oral and intravenous (IV) formulations; it was recently approved in the United States for the treatment of adults with CABP.ObjectiveTo estimate the cost impact of shortening hospital stay or avoiding hospitalization when using a treatment with an IV and an oral formulation, such as omadacycline, versus an IV-only drug regimen, such as ceftriaxone plus a macrolide, in adults with CABP who are not candidates for respiratory fluoroquinolone therapy.MethodsWe developed 2 conceptual healthcare decision models to identify potential cost-saving opportunities in hospitalized adults with CABP who receive omadacycline versus ceftriaxone plus a macrolide. The early hospital discharge model examined the cost impact of shifting patients with CABP from inpatient treatment with ceftriaxone plus a macrolide to inpatient IV omadacycline treatment and early hospital discharge with oral omadacycline. The hospital-avoidance model examined the cost impact of omadacycline treatment in the outpatient setting in patients with CABP who have low disease severity. The models defined the upper range of the daily acquisition cost for omadacycline that conferred cost-savings relative to inpatient treatment with ceftriaxone plus a macrolide.ResultsIn the early hospital discharge model, omadacycline showed cost-savings with a 2-day hospital stay reduction if the daily cost of omadacycline was ?$836, almost twice its wholesale acquisition cost. In the hospital-avoidance model, the daily omadacycline thresholds that still conferred cost-savings relative to inpatient ceftriaxone plus a macrolide ranged from $1302 to $1334, based on a daily wholesale acquisition cost of $450 for omadacycline, depending on the potential use of the emergency department and an observation unit.ConclusionThe study findings show that the targeted use of omadacycline for the treatment of select patient populations with CABP could result in cost-savings relative to inpatient treatment with ceftriaxone plus a macrolide.

Project description:Background:In April 2017 the Mexican Asthma Guidelines (GUIMA) were published. Before the launch, physicians' knowledge was explored related to key issues of the guideline. Methods:A SurveyMonkey® survey was sent out to board-certified physicians of 5 medical specialties treating asthma. Replies were analyzed per specialty against the GUIMA evidence-based recommendations. We present the treatment part here. Results:A total of 364 allergists (ALLERG), 161 pulmonologists (PULM), 34 ENTs, 239 pediatricians (PED) and 62 general practitioners (GPs) replied to the survey and 247-83-14-135-37 respectively finished it. Spirometry is not routinely indicated when asthma is very probable by ALLERG 54%, PULM 47%, ENT 39%, PED 65%, GP 64%. A fictitious case proposed to the physicians with intermittent asthma was erroneously treated with ICS by ALLERG 9%, PULM 11%, ENT 28%, PED 10%, GP 11%. The mild persistent case received mistakenly ICS-LABA by ALLERG 25%, PULM 26%, ENT 33%, PED 27%, GP 23%. The first-line option for moderate persistent asthma was ICS(median dose) instead of ICS(low)+LABA for ALLERG 29%, PULM 25%, ENT 17%, PED 27%, GP 23% and in severe asthma maintenance treatment PULM20%, ALLERG-ENT-PED-GP 22-34% failed to indicate LABA. Concerning the guidelines' recommendation to use one inhaler for maintenance & rescue in moderate-to-severe asthma, PULM45%, ALLERG-ENT-PED-GP 56-80% (p < 0.00001), erroneously indicated ICS-salmeterol could be used, instead of ICS-formoterol. Oral ?2 or theophylline are no longer recommended, but PULM 37% and ALLERG-ENT-PED-GP 42-62% (p < 0.01) still indicate their use. In severe asthma 61-73% of physicians consider adding LTRA to the treatment; only PULM38%, OTHERS12-25% consider adding tiotropium (p < 0.001) and 3-17% consider adding omalizumab, both guideline recommended add-ons. As for asthma in pregnancy, most surveyed are not aware budesonide is the 1st line option ICS. Finally, 81-97% of the group-members recognized allergen immunotherapy, as a viable add-on, in line with GINA/GEMA/GUIMA recommendations. Conclusions:An online survey could detect knowledge-gaps related to asthma treatment. Interestingly, surveyed physicians tended to over-treat the milder asthma cases, thus clearly leaving room for cost-savings. Caution should be taken in the promotion of the SMART (single-maintenance-and-reliever-treatment) approach, which can only be done with ICS-formoterol. Many physicians opt for other combinations not apt for this approach. Among all surveyed specialties there is ample room for improvement in mild and severe asthma management.

Project description:ObjectiveTo evaluate the benefits and harms of antithrombin III in critically ill patients.DesignSystematic review and meta-analysis of randomised trials.Data sourcesCENTRAL, Medline, Embase, International Web of Science, LILACS, the Chinese Biomedical Literature Database, and CINHAL (to November 2006); hand search of reference lists, contact with authors and experts, and search of registers of ongoing trials.Review methodsTwo reviewers independently selected parallel group randomised clinical trials comparing antithrombin with placebo or no intervention and extracted data related to study methods, interventions, outcomes, bias risk, and adverse events. Disagreements were resolved by discussion. Trials in any type of critically ill patients in intensive care were eligible. All trials, irrespective of blinding or language status, that compared any antithrombin III regimen with no intervention or placebo were included. Trials were considered to be at low risk of bias if they had adequate randomisation procedure, blinding, and used intention to treat analysis. Risk ratios with 95% confidence intervals were estimated with fixed and random effects models according to heterogeneity.Main outcome measuresMortality, length of stay in intensive care or hospital, quality of life, severity of sepsis, respiratory failure, duration of mechanical ventilation, incidence of surgical intervention, intervention effect among various populations, and adverse events (such as bleeding).Results20 trials randomly assigning 3458 patients met inclusion criteria. Eight trials had low risk of bias. Compared with placebo or no intervention, antithrombin III did not reduce overall mortality (relative risk 0.96, 95% confidence interval 0.89 to 1.03). No subgroup analyses on risk of bias, populations of patients, or with and without adjuvant heparin yielded significant results. Antithrombin III increased the risk of bleeding events (1.52, 1.30 to 1.78). Heterogeneity was observed in only a few analyses.ConclusionAntithrombin III cannot be recommended for critically ill patients based on the available evidence.

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Identification of Cost-Saving Opportunities for the Use of Antithrombin III in Adult and Pediatric Patients.

Publications

Identification of Cost-Saving Opportunities for the Use of Antithrombin III in Adult and Pediatric Patients.

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