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Review
, 17 (6), 449-458

The Growing Importance of Achieving National Self-Sufficiency in Immunoglobulin in Italy. The Emergence of a National Imperative

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Review

The Growing Importance of Achieving National Self-Sufficiency in Immunoglobulin in Italy. The Emergence of a National Imperative

Albert Farrugia et al. Blood Transfus.

Abstract

Since the inception of industrial plasma fractionation during the Second World War, a succession of protein therapies isolated from plasma have determined the volume of plasma requiring collection, and have also shaped the economics of the industry. These so-called plasma drivers have successively included albumin, coagulation Factor VIII (FVIII) and, for the past thirty years, intravenously (IV) and subcutaneously (SC) administered immunoglobulin (IG) solutions. The sale of IG underpins the profitability of the industry and has experienced continuous growth over the past decades, as the result of growing clinical demand. Modelling this demand using decision analysis indicates that supplying the evidence-based indications for IG therapies will generate a need for IG which exceeds the current plasma collection capacity of most countries. A notable exception to this situation is the United States (US) of America, whose population of compensated plasma donors generates two thirds of the global supply of plasma for fractionation. The US is also the leading consumer of IG, and its health care providers pay the highest price for the product globally. Shortages of IG occur whenever the demand for the product outstrips the supply. Current shortages, following other historical periods of shortage, threaten the well-being of patients dependant on these products and incur heavy costs on health systems. In Italy, the national blood system, which is based on voluntary unpaid donors, reflects a policy of national self-sufficiency in blood-derived therapies (a strategic objective of the national blood system itself), based on solidarity as an ethical principle. This system has increased the collection of plasma for fractionation by 3.8% per annum over 2008-2017, in accordance to a plan for plasma procurement targeting a collection rate of 14.1 L of plasma per thousand (103) population by 2020. Over the same period, IG usage has increased by 8.5/per annum, to 89.2 g IG/103 population. In this paper, we review the factors which, increasingly, are causing an imbalance between the global supply and demand for IG, and we assess Italy's capacity to ensure that increasing this level of independence is no longer simply an ethical, but also an economic imperative, with implications for the security of Italy's health system.

Conflict of interest statement

Disclosure of conflicts of interest

GML is the Editor-in-Chief of Blood Transfusion and this manuscript has undergone additional external review as a result. The other Authors declare no conflicts of interest.

Figures

Figure 1
Figure 1
Immunoglobulin pharmacokinetics. IVIg: intravenous immunoglobulin fSCIg: facilitated subcutaneous immunoglobulin; SCIg: subcutaneous immunoglobulin; IgG: immunoglobulin G.
Figure 2
Figure 2
The world polyvalent IG market (Tons): 1986 to 2014. IG: immunoglobulin.
Figure 3
Figure 3
Immunoglobulin use in some countries, 2014–2018. IG: immunoglobulin.
Figure 4
Figure 4
Probability distribution of LTD the commonest PIDDs when compared to the total observed IG usage for various countries (shown as dots). The median is 64 g/103 population. LTD: latent therapeutic demand; PIDDs: primary immune deficiency disorders.
Figure 5
Figure 5
Global plasma collection (millions of litres) over time. Recovered and Source plasma.
Figure 6
Figure 6
Global immunoglobulin prices per gram.
Figure 7
Figure 7
Collection of plasma for fractionation by the Italian Regions (projections to 2020).

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