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110 Plasma KCE Reports 120 Key points • Reintroduction of source plasma collection at some sites, when required • Increased volume per collection • Usage of platelet additive solutions • Improvement of fractionation capacities: seeking to have two fractionators licensed for Canadian plasma • There is no universal definition of “self-sufficiency” but all selected countries have conducted an in-depth reflection on this concept, in connection with other subjects. • All selected countries have set up a monitoring system of self-sufficiency ratios, or at least a centralized data collection on the subject. • Clear connection between self-sufficiency and remuneration issues must be born in mind. • Australian policy is probably the most comprehensive policy as it has established a close connection between this dimension and all related issues within the framework of the National Blood Authority, which covers all aspects of blood and plasma supply. • A short synthetic table of foreign policies in displayed in the table below. Table 45: Summary Germany France Canada Australia Ethical Financial Non- Non- Nonframework Compensation allowed (Max:25€) to collector’s discretion Remunerated Remunerated Remunerated Collection Free Competition: EFS monopoly Canada Blood Red Cross Red Cr.,Private Delivery targets Service monopoly to LFB monopoly Fractionation Several institutions LFB Monopoly Two CSL Ltd on fraction. of fractionators Monopoly on EFS plasma (but expected around fractionation and no monopoly on 2014 sales (import if sales) unavailable) Self-Sufficiency Self-Sufficiency LFB Turnover Official definition Official definition Approach national ratios ratio Self-Sufficiency Regulatory data Routine and Routine and N.B.A.: follow-up collection compulsory data compulsory data All self-sufficiency Public annual reports collection collection aspects Self-Sufficiency Policy mix Policy mix Policy mix NBA policy: strategy Increas.collection Increasing Increasing All aspects: (demo. approach) collection collection, collection , and fractionation Increasing LFB- fractionation fractionation, capacity ; control of fractionation capacity ; contract with consumption capacity ; control control of CSL Ltd and of consumption consumption consumption
KCE Reports 120 Plasma 111 4.3 HOW TO STAY OR BECOME SELF SUFFICIENT There is no answer to the question of self sufficiency in terms of figures in this report. This is a political choice to be made in the light of the risk-aversion of Belgian decisionmakers. The fundamental question is to determine the desired level of independence. Supply security considerations must govern this choice. For this we need to determine whether the trend in demand in countries deemed to have a high level of consumption could lead to a shortage of derivative products. Such a risk could also result if the collection in these countries no longer covered their own requirements for derivatives. Price levels and volatility are another risk factor to be considered. Being more dependent on foreign supplies could mean suffering substantial price variations, which are the first adjustment variable affecting variations in supply and demand. Beyond a certain level of shortage, there are fears that simple purchasing power may no longer be enough. To minimise the cost of production for Belgian plasma derivatives for a given level of coverage, we could strive for: • A reduction in the demand for these products • An increasing of the capacities of collecting plasma • Transparency and better control of the supply of derivatives 4.3.1 Strategies to decrease IG use: lessons learned 4.3.1.1 Experience from other countries Several countries, confronted to increased IG consumption, shortage or risk of shortage, and growing cost, have published the measures that they planned or have undertaken to improve the supply and demand balance.(Hume, Anderson, TMR 2007; Constantine 2007, UK DOH National Immunoglobulin Database Update j , Australia k ). However, very few studies have evaluated the impact of these measures. Table 45 summarized the overall strategies used in different countries. We focus here on the reduction of IG use. The main measures taken or proposed include: Classifying indications in priority groups for IG treatment A list of indications for which IG can be used has been defined in most countries. In addition, a few countries such as France, the UK and Australia, that experienced shortage (or its risk), have decided on prioritization of IG use and classified indications (labeled or not) into groups or higher and lower priority. However, this classification has been applied in many different ways: • In Australia, very clear categories for priority setting have been established: 1. Conditions for which IG has an established therapeutic role; 2. conditions for which IVIg has an emerging therapeutic role; 3. conditions for which IVIg are used in exceptional circumstances; 4. conditions for which IVIg use is not indicated. • In the UK, three well defined categories have been established, coded by colour (red, blue and grey), to facilitate the clinician understanding of the level of priority. • In France, the drug agency (AFSSAPS) defined 7 groups, using different levels of priority, distinguishing labeled and non labeled indications, with no clear rationale; the priority of each group of indications above the others is not always clear. l j Source: National Immunoglobulin Database Update. DOH. http://www.dh.gov.uk/en/Publicationsandstatistics/Publications/PublicationsPolicyAndGuidance/DH_09767 0 k Source: Criteria for the clinical use of intravenous immunoglobulin in Australia. Australian Health Ministers’ Conference. December 2007. l Source: AFSSAPS: http://www.afssaps.fr/Infos-de-securite/Autres-mesures-de-securite/Proposition-dehierarchisation-des-indications-des-immunoglobulines-humaines-intraveineuses-IgIV-en-situation-detension-forte-sur-les-approvisionnements-pour-le-marche-francais2
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KCE Reports 120B Plasma i PRÉFACE
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