The Use of Intravenous Immunoglobulins in Belgium

Abstract

Background: In light of the limited supply of intravenous immunoglobulins, it is important to strive for their appropriate use. Off-label use needs to be discouraged because of the limited supply of intravenous immunoglobulins, their unproven effectiveness in many conditions, their high costs, and the risk of adverse effects. This study aims to document the use of intravenous immunoglobulins in registered and off-label conditions in Belgian hospitals. Methods: Data were derived from the IMS Health hospital disease database. For each condition, this database generated figures about the number of patients and the reimbursement value in 2007. Data were provided at the level of individual products. Results: In 2007, intravenous immunoglobulins were administered to 9,629 patients, amounting to a reimbursement value of EUR 33.5 million (or 17% of Belgian hospital drug expenditure). Around 50–60% of intravenous immunoglobulin use was associated with registered conditions and around 40–50% with off-label use, depending on how use was measured. Off-label use occurred in unspecified conditions, surgery, orthopedics and oncology. There was limited use in myasthenia gravis. The market was dominated by Multigam and Sandoglobuline, each of which made up 45–50% of intravenous immunoglobulin use. Conclusions: In addition to their use in registered conditions, intravenous immunoglobulins are used off-label in other conditions in Belgium. A number of options are proposed to discourage off-label use in light of the limited supply of intravenous immunoglobulins, their unproven effectiveness in many conditions, their high cost, and the risk of adverse effects.

Plasma collection and supply in Europe: Proceedings of an International Plasma and Fractionation Association and European Blood Alliance symposium

“…In 2007, IGs administered in Belgian hospitals constituted 17% of hospital drug expenditure where 50%–60% of the IG use was associated with approved indications and 40%–50% was off‐label, occurring in unspecified conditions (surgery, orthopaedics and oncology). The study demonstrated a rapid change in indication for investigational IG use, which may account for the high percentage of ‘off‐label’ use and poor documentation on the decision process for compassionate use and obtaining informed consent [24]. Computerized decision support for IG prescriptions showed 74 unique indications included in the final list of appropriate use and the appropriate dosages for each indication were programmed into the final order set, allowing a reduction in dose deviation [25].…”

Unraveling the Mystery of Polyvalent Immunoglobulins in Belgium: Do We Have an Indication?

“…Given all aforementioned uncertainties, the 15.4% off-label use should be taken as an approximation. A Belgian study in the hospital setting linked off-label use to around 40-50% of all Ig patients in the year 2007, although its methodological limitations, recognized by the author, may have resulted in an overestimation [18].…”

A systematic review of the cost and cost-effectiveness of immunoglobulin treatment in patients with hematological malignancies

“…An analysis of Ig reimbursement data in Belgian hospitals calculated a total annual Ig product cost of €33.5 million across approved conditions and off-label indications in 9,629 patients, which accounted for 17 percent of total hospital drug expenditure. The Ig treatment of 1,494 patients with secondary immunodeficiency or bone marrow transplantation amounted to €4 million (16). In France, the annual mean cost of Ig treatment per patient with secondary immunodeficiency has been estimated at over €20,000, of which €9,800 were Ig product costs and the remainder were hospital admission costs for Ig infusions and infections (17).…”