Use of non-specific intravenous human immunoglobulins in Spanish hospitals; need for a hospital protocol

Ruíz-Antorán, Belén; Escasany, Antònia Agustí; Vallano, Antonio; Danés, Imma; Riba, N.; Escudero, Silvia Mateu; Costa, Joan; Santiago, Ma Blanca Sánchez; Laredo, Leonor; Quintana, José Antonio Durán; Castillo, Juan R.; Abad‐Santos, Francisco; Herrera, Concepción Payares; Rada, Belén Sádaba Díaz de; Ontañón, E. Gómez

doi:10.1007/s00228-010-0800-y

Cited by 21 publications

(45 citation statements)

References 32 publications

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“…Adult studies have demonstrated that only 60–70% of IVIG prescriptions are used for FDA‐approved indications. Approximately, one‐third of the remaining indications were off‐label prescriptions according to the FDA or local guidelines with little scientific evidential support . However, little is known about IVIG prescriptions in the paediatric population.…”

contrasting

confidence: 68%

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Use of intravenous immunoglobulin in an Asian paediatric population over a 10‐year period

Lee

Goh

et al. 2013

J Paediatrics Child Health

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contrasting

confidence: 68%

“…This figure is higher than the reported studies in adult and paediatric populations, which ranged between 42–58% . However, if approved off‐label indications such as Guillain Barre syndrome and dermatomyositis were included, then proportions of ‘approved’ indications were higher (more than 60%) …”

Section: Discussionmentioning

confidence: 60%

Use of intravenous immunoglobulin in an Asian paediatric population over a 10‐year period

Lee

Goh

et al. 2013

J Paediatrics Child Health

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“…These indications currently represent 20 to 60% of the use of Ig. (2) It is important to point out that Ig can be used as a replacement therapy (Figure 1) or as immunomodulatory and anti-inflammatory agents (Figures 2 & 3). …”

Section: Introductionmentioning

confidence: 99%

Clinical applications of immunoglobulin

Novaretti

Dinardo

2011

Rev. Bras. Hematol. Hemoter.

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Human immunoglobulin is the most used blood product in the clinical practice. Immunoglobulin applications have increased quickly since the elucidation of its immunomodulatory and antiinflammatory properties which turned this blood product into a precious tool in the treatment of numerous diseases that present with humoral immune deficiency or that cause immune system dysfunction. Currently, the approved indications for Ig are: primary immunodeficiencies, secondary immunodeficiencies (multiple myeloma or chronic lymphoid leukemia), Kawasaki syndrome, immune thrombocytopenic purpura, Guillain Barré syndrome, graft-versus-host disease following bone marrow transplantation and repeat infections in HIV children. On the other hand, there are numerous "off-label" indications of immunoglobulin, which represent 20-60% of all clinical applications of this drug. It is important to study all these indications and, above all, the scientific evidence for its use, in order to provide patients with a new therapeutic option without burdening the health system. This review results from a wide selection of papers identified in the Pubmed and Lilacs scientific electronic databases. A group of descriptors were used from human immunoglobulin to the names of each disease that immunoglobulin is clinically applied. Our main objective is to list the numerous indications of immunoglobulin, both authorized and "off-label" and to analyze these indications in the light of the most recent scientific evidence.

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“…In Spain, only some indications for the use of IVIGs have been authorized by the Spanish Medicines Agency on the basis of contributed evidence 9 . The authorized indications include replacement therapy and the subindications primary immunodeficiency (PID), secondary immunodeficiency (SID), and congenital AIDS in children (treatment of recurrent infections).…”

mentioning

confidence: 99%

“…A third authorized indication is allogeneic bone marrow transplantation. Within Spain, IVIGs are also used for a number of conditions not included in regulatory approvals and as a consequence are used off‐label with or without clinical scientific evidence supporting their use 1 , 9 …”

mentioning

confidence: 99%

Direct Medical Costs of Liquid Intravenous Immunoglobulins in Children, Adolescents, and Adults in Spain

Darbà

Restovic

Kaskens

et al. 2012

The Journal of Clinical Pharma

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The aim of this study was to determine health care resource utilization and direct medical costs in Spanish patients treated with intravenous immunoglobulins (IVIGs) in 2009. Cost-of-illness analyses were performed to estimate direct medical costs of patients treated with IVIGs. Prevalence data were obtained from the Spanish Primary Immunodeficiency registry. A semi-structured questionnaire was used to collect data on health care resource utilization and patient distribution. Drug, administration, and premedication costs were considered from the payer's perspective. Separate analyses were conducted for children and adolescents versus adults. The numbers of children and adolescents with replacement therapy were 724, with immunomodulation 243, and with allogeneic bone marrow transplantation 30. The numbers of adult patients were, respectively, 3450, 1134, and 172. Mean annual costs for children and adolescents were 6293 € with Privigen, 6292 € with Kiovig, 6939 € with Flebogamma, and 6559 € with Octagamocta. For adults, estimations were 17 106 € with Privigen, 17 103 € with Kiovig, 18 077 € with Flebogamma, and 17 423 € with Octagamocta. Direct medical costs for IVIGs were approximately 91.8 million €. Drug costs represented 94% of total costs. The choice for a certain IVIG treatment depends on individual patient characteristics and cost considerations.

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Use of non-specific intravenous human immunoglobulins in Spanish hospitals; need for a hospital protocol

Abstract: IVIG is prescribed for a significant number of non-authorised and non-accepted indications with a notable cost. There is an important variability in IVIG prescriptions between hospitals, indicating room for improvement in IVIG use and the need for a consensus of protocol use.

Cited by 21 publications

References 32 publications

Use of intravenous immunoglobulin in an Asian paediatric population over a 10‐year period

Use of intravenous immunoglobulin in an Asian paediatric population over a 10‐year period

Clinical applications of immunoglobulin

Direct Medical Costs of Liquid Intravenous Immunoglobulins in Children, Adolescents, and Adults in Spain

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