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Demand for Plasma Products in Australia

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Demand for Plasma Products in Australia
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     k  i   l  o  g  r  a  m  s  o   f  I  V  I  g  p  r  o   d  u  c  e   d  y  i  e   l   d  i  n  g  r  a  m  s  p  e  r   l  i  t  r  e  p  r  o  c  e  s  s  e   d 0200,000400,000600,000800,0001,000,0001,200,0001,400,0001,600,0001,800,0002000-012001-022002-032003-042004-052005-060.01.02.03.04.05.06.0 production yield 99 This chapter reviews usage of plasma products in Australia in recent years and thenmakes projections for future demand to 2015–16.It is first necessary to make acomment about plasma product production.The quantities of individual proteins that can be isolated from a litre of plasma dependupon the amounts of those proteins in the plasma,and the rate of yield that can beachieved during the fractionation process.In Australia,plasma collection has generallybeen targeted towards meeting the need for the plasma product in most demand.The relationship between the production of individual plasma products and therequired inputs of starting plasma is not uniform.For some products,includingintravenous immunoglobulin (IVIg) and plasma derived Factor VIII,the link isstraightforward,as the quantity of product that can be harvested from a specifiedquantity of starting plasma is relatively constant and thus there is a definable yield:thegreater the plasma input,the more product can be made.In the case of thehyperimmune immunoglobulins,however,the quantity of the specific antibody to beharvested can vary enormously between individual donations and thus across theplasma pool.A small volume of plasma containing a high level of a particular antibodycan yield as much or more product than a larger volume with a low level of antibody. Chapter6 Demand for plasma products in Australia Fig.6.1 Domestic IVIg production and yield Source:Derived from data supplied by CSL Bioplasma,2006.  Review of Australia’s Plasma Fractionation Arrangements 100 Prior to 2005,all plasma fractionated in Australia was employed in the production of immunoglobulins and Factor VIII;a small proportion of the total plasma fractionatedwas used in the manufacture of other products,including albumin and clottingfactors (other than Factor VIII).It was not until the late 1990s to early 2000s that supply pressures on IVIg started toemerge.The failure of supply to keep up with increasing demand was due not to alack of production capacity but rather to a growing shortage of raw plasma.Effortswere made to address this shortfall by both increasing plasma collections (includingcollections made via apheresis) and improving production yields.CSL Bioplasmasignificantly increased its yields of IVIg during the period 2000–01 to 2005–06 (fig.6.1).By 2003–04,however,it appeared that cyclical shortages of IVIg were going tobecome commonplace,due to variability in levels of plasma collected,combinedwith growing demand.These two factors were together starting to impact onAustralia’s ability to supply sufficient IVIg from domestic sources.In 2003–04,under the national blood arrangements,governments agreed to allow for the ongoing importation of IVIg manufactured from overseas-sourced plasma,andfor imported IVIg to be used as a contingency measure at times when the domesticproduct was in short supply.Ongoing importations first occurred in 2003–04,andcontinue today at an expanding rate.In the last decade there have also been shortages of other products.A shortage of Rh(D) immunoglobulin,requiring the importation of foreign product,has now beenovercome.The supply of domestic plasma derived Factor VIII has also been problematic.Ongoing shortages were experienced until the advent of recombinant alternativesmeant that the demand for plasma derived product could be fully met.The recentupgrading of donor restrictions,however,so as to exclude from the plasma pool usedin the manufacture of Factor VIII (Biostate®) all donations from people who havetravelled outside Australia and New Zealand since 1980 (see below),has started toexert pressure on supply.For the remaining plasma products manufactured in Australia,supply generally nowmeets or exceeds demand. Production of intravenous immunoglobulin (IVIg) Prior to 1999,CSL Bioplasma produced a 6% liquid formulation of IVIg,calledIntragam®.This product was manufactured using Cohn technology.In 1999–2000,CSL introduced Intragam® P,a new,chromatographically purified 6% IVIgpreparation.Intragam P offers improved specifications over those for Intragam andrepresents a higher yield of product from each litre of plasma processed.Improvements in IVIg yield arising from the introduction of Intragam P are reflectedin the increase in quantities of IVIg issued from 1999–2000 onwards (fig.6.2).The compound annual growth rate for IVIg issued in Australia in the period1994–95 to 2005–06 was 14.4%.This growth rate has been erratic,however,ranging  Review of Australia’s Plasma Fractionation Arrangements 101 from as low as 0.2% in 1997–98 to as high as 37% in 1995–96,suggesting that anumber of factors are influencing the supply and use of IVIg in Australia.As notedpreviously,the Australian rate of consumption of IVIg has been between that of North America and that of Europe,with 73 grams of product issued per 1000 headof population in 2005–06 (see table 2.1). Clinical drivers for IVIg usage In Australia,IVIg has been reported to have had some therapeutic value with respectto at least 70 clinical indicators.There is clear and unambiguous evidence for theclinical efficacy of IVIg in the treatment of primary immune deficiency (PID),idiopathic thrombocytopenic purpura (ITP),Kawasaki disease,andlymphoproliferative disorders (LPDs).The evidence presented in respect of a number of other indications,however,lacks rigorous clinical trial data and in fact in somecases there would appear to be little evidence-based support for the use of IVIg.As noted above,the supply of IVIg in Australia has been restricted by the limitedavailability of domestic plasma,together with growing demand,and supply shortageshave been reported from time to time.Some of these reported shortages,however,inat least one state,appear to be the result of restrictions on prescribing.This wouldsuggest that usage of IVIg might have been higher had more product been available.Nevertheless,all IVIg produced in Australia in recent years has been consumed,andsince at least 2003–04 some IVIg products have been imported to providecontingency stocks,given that there has been no domestic surplus.CSL Bioplasmameanwhile has increased IVIg production and rate of yield (fig.6.1) and in the latter half of 2006 reported large increases in prepayment inventories of IVIg. Fig.6.2 Intravenous immunoglobulin issued 020040060080010001200140016001800 1994-95 1995-96 1996-97 1997-98 1998-99 1999-00 2000-01 2001-02 2002-03 2003-04 2004-05 2005-06 IVIg 381 523 622 623 697 739 943 1102 1167 1345 1459 1667    k  i   l  o  g  r  a  m  s  o   f  I  V  I  g Source:Derived from data in:National Blood Authority,Distribution Report,June 2006,and Australian Red Cross BloodService,issue estimates for 2005–06,June 2006.Includes a three-year moving trend line.  Review of Australia’s Plasma Fractionation Arrangements 102 The product shortages that occurred in Australia in the late 1990s led to a review of the use of IVIg in Australia by the Blood and Blood Products Committee of theAustralian Health Ministers’Advisory Council (AHMAC). 1 The review report made anumber of recommendations relating to target levels for the distribution and supply of IVIg.Clinical guidelines were revised and conditions classified into three groups,basedon clear evidence with regard to patient benefit (see Chapter 5).The report alsorecommended that the supply of IVIg should be augmented through a combinationof increasing the amount of plasma collected and importing alternative IVIg.In 2004,acting on this recommendation and with the agreement of all Australiangovernments,the National Blood Authority (NBA) negotiated a standing offer for imported IVIg.As a result,imported product is now available to meet the supplyplans of all jurisdictions,and the clinical needs of patients,on a more secure basis andat a lower price than IVIg acquired under earlier,ad hoc arrangements. Production of intramuscular immunoglobulin (IMIg) Issues of intramuscular (normal) immunoglobulin (IMIg) over a four-year periodhave been as set out in figure 6.3.The reasons for the use of IMIg are mixed and range from management of chronicfatigue syndrome to prophylaxis for those at risk of hepatitis A,measles or poliomyelitis.A vaccine for hepatitis A is reducing the need for the use of IMIg inprotecting people travelling to countries where there is a risk of contracting hepatitisA.IMIg is also used instead of treatment with IVIg in some cases where self-administration is deemed appropriate.In other countries,a subcutaneous alternativeto IMIg (SCIg) is available for self-administration purposes. Fig.6.3 Intramuscular immunoglobulin (IMIg) issues Source:Derived from data held by the Department of Health and Ageing. 0246810121416    k  i   l  o  g  r  a  m  s  o   f  I  M  I  g 2002-032003-042004-052005-06IMIg12.114.913.213.0 1 Blood and Blood Products Committee, Review of the Use and Supply of Intravenous Immunoglobulins in Australia ,Blood andBlood Products Committee,Melbourne,2000;also available online at <http://www.nba.gov.au/PDF/ivig.pdf>.
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