Descriptive Review and Analysis of Immunoglobulin Utilization Management from 2,548 Prior Authorization Requests

Tonkovic, Brian; Rutishauser, Linda K.

doi:10.18553/jmcp.2014.20.4.357

Cited by 6 publications

(8 citation statements)

References 20 publications

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“…The findings revealed that more than half of the prescriptions for IVIG (57.5%) were for FDA off-label indications. Similar prescribing pattern studies have been conducted in several countries and the prevalence of prescriptions with off-label indications of IVIG ranged from 22.7 to 70.3% ( Rezaie et al, 2019 ; Tonkovic and Rutishauser, 2014 ; Toh et al, 2014 ; Ruiz-Antorán et al, 2010 ; Constantine et al, 2007 ; Pendergrast et al, 2005 ; El Ajez et al, 2019 ) ( Supplementary Table S3 ). Likewise, the prevalence of patients being prescribed with IVIG for an off-label indication ranged from 23.2 to 81.5% ( Chen et al, 2000 ; Pendergrast et al, 2005 ; Dawoud et al, 2012 ; Wu et al, 2013 ; Fakhari et al, 2018 ; Rezaie et al, 2019 ).…”

Section: Discussionsupporting

confidence: 59%

“…Common examples of off-label uses of IVIG which are supported by other guidelines but not FDA approved include neurological conditions such as Guillain-Barre Syndrome and myasthenia gravis as well as dermatological conditions such as toxic epidermal necrolysis ( Department of Health, 2011 ; Jurisdictional Blood Committee, 2012 ; Prairie Collaborative, 2018 ). Despite insufficient evidence, the use of IVIG for off-label indications is commonly practiced by physicians worldwide ( Dawoud et al, 2012 ; Tonkovic and Rutishauser, 2014 ; Shemer et al, 2018 ; Rezaie et al, 2019 ).…”

Section: Introductionmentioning

confidence: 99%

See 1 more Smart Citation

Prescribing Practices of Intravenous Immunoglobulin in Tertiary Care Hospitals in Malaysia: A Need for a National Guideline for Immunoglobulin Use

et al. 2022

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Rational use of drug involves the use of medicine as per clinical guidelines. Given the steady increase in the clinical utility of intravenous immunoglobulin (IVIG) either as licensed or off-label use, concerns are being raised about the possibility of supply shortages that could significantly impact patient care. Therefore, there is a need to regulate and to promote the rational use of this valuable medication. This cross-sectional chart review study attempts to evaluate the prescribing patterns of IVIG at two tertiary hospitals in Malaysia. Patients’ medical files and dispensing records were examined and compared with current guidelines. A total of 348 prescriptions for IVIG were written during the 1-year study period. The highest usage of IVIG was for neurological (47.9%), immunological (27.5%), and hematological conditions (20%). The number of prescriptions with the US Food and Drug Administration (FDA) licensed indications and off-label indications was 148 (42.5%) and 200 (57.5%), respectively. Age (OR: 1.02, 95% CI: 1.01–1.03, p = 0.003) and those admitted to the critical care units (OR: 11.11, 95% CI: 5.60–22.05, p < 0.001) were significant factors for receiving IVIG for an off-label indication. Most prescriptions (79%) had appropriate dosing. Significant factors associated with receiving inappropriate dose of IVIG include age (OR: 0.93, 95% CI: 0.89–0.97, p = 0.001) and those admitted to the critical care units (OR: 10.15, 95% CI: 3.81–27.06, p < 0.001). This study advocates the development and implementation of evidence-based clinical guidelines with prioritization protocol to ensure rational use of IVIG.

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Section: Discussionsupporting

confidence: 59%

Section: Introductionmentioning

confidence: 99%

Prescribing Practices of Intravenous Immunoglobulin in Tertiary Care Hospitals in Malaysia: A Need for a National Guideline for Immunoglobulin Use

et al. 2022

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“…Also, SID imposes an economic burden. Using PID as a model, some experts estimate that untreated immunodeficiency may cost tens of thousands of dollars annually per patient for acute or severe infections, emergency-department visits, and hospitalizations in the US [9]. In 2015 and 2016, immunoglobulin (Ig) replacement therapy (IGRT) expenditures for PID and SID were estimated to be more than £40 million in the UK [10].…”

Section: Introductionmentioning

confidence: 99%

A systematic literature review of the effects of immunoglobulin replacement therapy on the burden of secondary immunodeficiency diseases associated with hematological malignancies and stem cell transplants

Bonet

Waser²,

Cheng

et al. 2020

Expert Review of Clinical Immunology

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“…It is used for treating immunodeficiency and autoimmune diseases. [12] In many of these conditions, long-term administration of IG is needed. Primarily because of the laborious processes required for purification of IG from plasma, treatment is costly, particularly for chronic conditions.…”

Section: Introductionmentioning

confidence: 99%

“…Depending on the dose, infusion time, the length of treatment, and site of care, the estimated annual cost of IG therapy can ranges from $30,000 to $90,000 per patient. [23]…”

Section: Introductionmentioning

confidence: 99%

Outcome evaluation of a subcutaneous immunoglobulin clinical management program

et al. 2019

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Objective: The aim of this study is to compare clinical and cost outcomes of patients undergoing subcutaneous immunoglobulin (SCIG) therapy who were managed by a clinical management program to the matched controls in the United States. Methods: This was a retrospective cohort study using administrative claims data from the PharMetrics Plus™ (PMTX+) database. The patients from a high-touch SCIG clinical management program were matched to nonprogram patients in PMTX+ database using 1:4 propensity score matching without replacement. All patients were followed for 1 year during the study from September 1, 2011, to June 30, 2014, and both clinical and cost outcomes were compared between the two cohorts using the generalized estimating equation model. Findings: The clinical outcomes were measured by infection- and infusion-related adverse events (AEs). Most of them were not significantly different ( P > 0.05) between the intervention group and matched controls. Although the proportion of patients who had a mild less common AE was higher (4.4% vs. 0.0%;P = 0.04), it could be due to increased reporting among the intervention group. The annual adjusted mean total health-care costs of patients in the program ( n = 45) were $20,868 lower compared to matched controls ( n = 180), representing a 24% lower costs ($66,450 vs. $87,318;P = 0.009). Conclusion: This study may demonstrate that clinical management programs for SCIG may be associated with lower health-care costs and comparable infection and severe AE rates. The limitations of this study included a small sample size and a reliance on administrative claim data.

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Descriptive Review and Analysis of Immunoglobulin Utilization Management from 2,548 Prior Authorization Requests

Cited by 6 publications

References 20 publications

Prescribing Practices of Intravenous Immunoglobulin in Tertiary Care Hospitals in Malaysia: A Need for a National Guideline for Immunoglobulin Use

Prescribing Practices of Intravenous Immunoglobulin in Tertiary Care Hospitals in Malaysia: A Need for a National Guideline for Immunoglobulin Use

A systematic literature review of the effects of immunoglobulin replacement therapy on the burden of secondary immunodeficiency diseases associated with hematological malignancies and stem cell transplants

Outcome evaluation of a subcutaneous immunoglobulin clinical management program

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