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-990600-9684850nATIONAL REPORT ON THE ISSUE AND USE OF IMMUNOGLOBULIN (Ig)Annual Report 2017-18With the exception of any logos and registered trademarks, and where otherwise noted, all material presented in this document is provided under a Creative Commons Attribution 3.0 Australia licence.The details of the relevant licence conditions are available on the Creative Commons website (accessible using the links provided) as is the full legal code for the CC BY 3.0 AU licence.The content obtained from this document or derivative of this work must be attributed as the National Blood Authority National Report on the Issue and Use of Immunoglobulin (Ig) Annual Report 2017-18.ISSN 1839-1079 (online version)This report is available online at Bag 8430Canberra ACT 2601Phone: 13 000 BLOOD (13000 25663)Email: data@.au.auContents TOC \o "1-3" \h \z \u List of Tables PAGEREF _Toc25579714 \h 4List of Figures PAGEREF _Toc25579715 \h 4Introduction PAGEREF _Toc25579716 \h 5Report Snapshot PAGEREF _Toc25579717 \h 7Methodology PAGEREF _Toc25579718 \h 8Data quality PAGEREF _Toc25579719 \h 910 Year Trends PAGEREF _Toc25579720 \h 11Demand Trends PAGEREF _Toc25579721 \h 11Financial Trends PAGEREF _Toc25579722 \h 12Demographics PAGEREF _Toc25579723 \h 14Patient Numbers PAGEREF _Toc25579724 \h 14Geographic Distribution PAGEREF _Toc25579725 \h 15Age PAGEREF _Toc25579726 \h 16Weight PAGEREF _Toc25579727 \h 17Expenditure PAGEREF _Toc25579728 \h 19Clinical Indications PAGEREF _Toc25579729 \h 22Ig issues by criteria chapter PAGEREF _Toc25579730 \h 22Ig issues by medical condition PAGEREF _Toc25579731 \h 23Ig issues by specific condition PAGEREF _Toc25579732 \h 25Ig issues by clinical speciality PAGEREF _Toc25579733 \h 28Ig grams issued per 1,000 population PAGEREF _Toc25579734 \h 29Dosing PAGEREF _Toc25579735 \h 31IVIg and SCIg PAGEREF _Toc25579736 \h 33NHIg PAGEREF _Toc25579737 \h 40Appendix A – Background PAGEREF _Toc25579738 \h 42Appendix B – Acronyms and Glossary PAGEREF _Toc25579739 \h 46Appendix C – Conditions mapping table PAGEREF _Toc25579740 \h 49Appendix D – Dataset of Ig supply by state/territory 2017-18 PAGEREF _Toc25579741 \h 56Appendix E – Grams Ig Issued by State and Territory PAGEREF _Toc25579742 \h 78Appendix F – Unique Patients by Quarter and State and Territory PAGEREF _Toc25579743 \h 79Appendix G – System Source for Tables and Figures PAGEREF _Toc25579744 \h 80List of Tables TOC \h \z \c "Table" Table 1Growth in Ig grams issued since 2008-09 PAGEREF _Toc25579745 \h 11Table 2Percentage change in grams issued over time by state and territory PAGEREF _Toc25579746 \h 12Table 3Annual numbers of patients, treatment episodes and grams PAGEREF _Toc25579747 \h 14Table 4Basic numbers PAGEREF _Toc25579748 \h 14Table 5Patient numbers and average weight by age range PAGEREF _Toc25579749 \h 18Table 6Issues of domestic Ig compared with imported Ig PAGEREF _Toc25579750 \h 20Table 7Issues of domestic Ig compared with imported Ig and public versus private PAGEREF _Toc25579751 \h 21Table 8Ig issues (g) by Criteria chapter PAGEREF _Toc25579752 \h 22Table 9Ig issues by Criteria chapter (percentage) PAGEREF _Toc25579753 \h 22Table 10Ig grams issued for top 10 medical conditions over time PAGEREF _Toc25579754 \h 24Table 11Difference in grams issued for secondary hypogammaglobulinaemia (percentage) PAGEREF _Toc25579755 \h 24Table 12Patient numbers and age for the top 20 specific conditions by private and public facilities PAGEREF _Toc25579756 \h 26Table 13Ig grams issued by clinical speciality PAGEREF _Toc25579757 \h 28Table 14Grams of Ig issued by state and territory PAGEREF _Toc25579758 \h 29Table 15Grams of Ig issued per 1,000 population by state/ territory for top 10 specific conditions PAGEREF _Toc25579759 \h 30Table 16Ig grams per kg weight per episode PAGEREF _Toc25579760 \h 32Table 17Patient numbers for products issued by state and territory in 2017-18 PAGEREF _Toc25579761 \h 34Table 18Grams of product issued by state and territory in 2017-18 PAGEREF _Toc25579762 \h 35Table 19Treatment episode numbers for products issued by state and territory in 2017-18 PAGEREF _Toc25579763 \h 36Table 20Patient numbers for products issued by medical condition in 2017-18 PAGEREF _Toc25579764 \h 37Table 21Grams of product issued by medical condition in 2017-18 PAGEREF _Toc25579765 \h 38Table 22Treatment episodes for product issued by medical condition in 2017-18 PAGEREF _Toc25579766 \h 39Table 23NHIg issued from 2013-14 to 2017-18 PAGEREF _Toc25579767 \h 40Table 24Grams of NHIg issued by state and territory PAGEREF _Toc25579768 \h 41Table 25Grams per 1,000 population of NHIg issued by state and territory PAGEREF _Toc25579769 \h 41List of Figures TOC \h \z \c "Figure" Figure 1Ten year trends in issues of Ig PAGEREF _Toc25579784 \h 11Figure 2Ten year trends in expenditure on Ig PAGEREF _Toc25579785 \h 13Figure 3Patients per 1,000 population 2016-17 and 2017-18 PAGEREF _Toc25579786 \h 15Figure 4Grams of Ig per 1,000 population by state and territory over time PAGEREF _Toc25579787 \h 16Figure 5Patient age compared to average Australian age PAGEREF _Toc25579788 \h 16Figure 6Patient weights relative to Australian average PAGEREF _Toc25579789 \h 17Figure 7Ig expenditure as a proportion of the national blood budget PAGEREF _Toc25579790 \h 19Figure 8Ig grams issued by medical condition PAGEREF _Toc25579791 \h 23Figure 9Proportion of Ig used for top 10 medical conditions PAGEREF _Toc25579792 \h 25Figure 10Ig issues by clinical speciality PAGEREF _Toc25579793 \h 28Figure 11Percentage Ig issues by clinical speciality for top 10 medical conditions PAGEREF _Toc25579794 \h 29Figure 12Grams per episode by specific condition PAGEREF _Toc25579795 \h 31Figure 13Grams per kg weight by specific condition PAGEREF _Toc25579796 \h 32Figure 14NHIg grams issued and grams issued per 1,000 population PAGEREF _Toc25579797 \h 40IntroductionImmunoglobulin products, derived from pooled human plasma, are a precious and high cost resource. Strengthening immunoglobulin governance is a priority for the National Blood Authority (NBA), and a number of measures are being developed and implemented to ensure the sustainability of these products into the future.Immunoglobulin products analysed in this report include intravenous immunoglobulin (IVIg), subcutaneous immunoglobulin (SCIg) and normal human immunoglobulin (NHIg). Aggregated data for IVIg and SCIg is referred to as immunoglobulin (Ig) unless specifically stated. NHIg is reported separately. Ig products are used to treat a broad range of conditions, with applications in replacement and immune modulation therapy. This report provides an analysis of national data on national Ig supply in Australia in 2017-18, also considering trends in supply over the last ten years.In Australia it is estimated that over 99% of all Ig is supplied under national blood arrangements through contracts administered by the NBA. The NBA’s role is to coordinate national supply and demand planning for blood and blood products including supply risk management; to purchase blood and blood products on behalf of all Australian governments; to develop and implement national strategies to encourage better governance; to promote appropriate use of blood and blood products; and to provide expert advice to support government policy development. Further background is at REF _Ref384557528 \h \* MERGEFORMAT Appendix A.The national Ig Governance Program was introduced in 2014 to pursue governments’ objectives for Ig products funded and supplied under the national blood arrangements, namely to: ensure Ig product use and management reflects appropriate clinical practice and represents efficient, effective and ethical expenditure of government funds, in accordance with relevant national safety and quality standards for health care;ensure that access to Ig products is consistent with the criteria for access determined by governments; andimprove the capture of information of the need for, use of, and outcomes of treatment with Ig products to inform future decisions.?The NBA is responsible for administering the National Ig Governance Program which includes the development and maintenance of a national framework to access government-funded Ig. The current framework comprises a National Policy, the criteria for access, and BloodSTAR (Blood System for Tracking Authorisations and Reviews), a national online system. The National Policy: Access to Government-Funded Immunoglobulin Products in Australia (National Policy) released in November 2016, sets out the process that must be followed and describes the rules and requirements that must be complied with to access government-funded Ig products in Australia. The National Policy supports all those involved in the prescription, use and management of Ig to understand their roles and responsibilities under the governance arrangements.The Criteria for the Clinical Use of Immunoglobulin in Australia?(the Criteria) were developed in collaboration with expert specialist clinicians and identify the medical conditions and circumstances for which the use of Ig is considered to be clinically appropriate and where there are no safe, effective and cost-effective alternative treatments. First published in 2007, and revised in 2012 with another revision planned for 2018, the Criteria identifies the conditions and circumstances for which the use of Ig is funded under national blood arrangements. The Criteria clearly articulate sand standardises the qualifying and continuing Ig access requirements. It classifies the 93 conditions described in the Criteria into those for which Ig has an established therapeutic role (Chapter 5), has an emerging therapeutic role (Chapter 6) and those where Ig has application in exceptional circumstances only (Chapter 7). Ig is only supplied for these conditions unless purchased directly by a state or territory, hospital or individual (a Direct Order). Chapter 8 of the Criteria also outline those conditions for which Ig should not be supplied under national blood arrangements.Introduced in 2016, BloodSTAR was developed by the NBA on behalf of all Australian Governments to serve the needs of health providers and support users to meet their obligations under the National Policy. Through BloodSTAR, Prescribers can request patient authorisation for access to government-funded Ig. Under the governance arrangements, Dispensers may only dispense product to patients with an active authorisation in BloodSTAR. Nurses and Midwives can request product from Dispensers through BloodSTAR. BloodSTAR streamlines the authorisation process, reduces variability and standardises prescribing practices, and increases efficiency and transparency while strengthening decision-making and improving data capture. BloodSTAR was designed, developed, and implemented to all Australian states and territories except New South Wales (NSW). In addition to the clinical and diagnostic criteria for access to intravenous products, access to SCIg products is provided through an assurance framework for the appropriate use of the product. SCIg access rules are detailed on the NBA website at . Participation in the National SCIg program requires hospitals to establish their capability and capacity to manage a hospital-based SCIg program, where the hospital provides access to all resources and takes full accountability for the management and use of the product within defined governing requirements.NHIg may only be supplied for two purposes; for the treatment of susceptible contacts of measles, hepatitis A, poliomyelitis and rubella, as directed by public health officials; or for the treatment of immunodeficiency conditions for which the product is indicated for patients for whom IVIg and SCIg are both contraindicated. NHIg access rules are detailed on the NBA website at products should be prescribed and dispensed in accordance with any applicable state or territory legislative requirements. In-hospital management of Ig products must also be in accordance with the National Safety and Quality Health Service (NSQHS) Standards, in particular Standards 1, 2 and 7, and the Australian and New Zealand Society of Blood Transfusion (ANZSBT) Guidelines for the Administration of Blood Products and Guidelines for Transfusion and Immunohaematology Laboratory Practice.Ig comprises 50% of total blood expenditure in 2017-18. Demand for Ig continues to rise steadily at around 11% each year, and Australian grams per 1000 population use of this product is one of the highest among western countries. Demand for Ig is met through domestic and imported Ig products. Domestic Ig is manufactured by CSL Behring using plasma collected from voluntary, non-remunerated Australian donations. Both domestic and imported Ig are distributed by the Australian Red Cross Blood Service (Blood Service), with the Blood Service also being responsible for collection of data on behalf of governments for product funded under the national blood arrangements.Australia is in a unique position to provide analysis and commentary on the use of Ig due to national supply arrangements. This report begins with an analysis of Ig supply over the last ten years, then considers patient demographics, expenditure on Ig, clinical indications for which Ig was supplied and finally analyses the dose prescribed for various conditions. The top ten medical conditions account for 88.1% of all Ig supplied in 2017-18, and for this reason specific analysis focuses on these groups.Report Snapshot20955021463019,414 patients7,655 new patientsMedian age 63 yearsPATIENTSTotal cost of $579.59 million50% of total blood budgetEXPENDITURE6.13 million grams issued247 grams per 1,000 population47% imported productIg USE019,414 patients7,655 new patientsMedian age 63 yearsPATIENTSTotal cost of $579.59 million50% of total blood budgetEXPENDITURE6.13 million grams issued247 grams per 1,000 population47% imported productIg USEMethodologyThis report uses data from three primary sources, as follows:Data collected by the Blood Service under contractual arrangements with the NBA on behalf of all Australian governments. This data is collected either when an order is placed for Ig, or where imprest stock is dispensed for treatment. The data is collected into the Blood Service’s Supply Tracking Analysis Recording System (STARS) database.Data collected by the NBA on the units dispensed by Australian Health Providers to be administered to the patient. The data is collected into the NBA BloodNet and BloodSTAR systems.Data collected by the NBA on the units of Ig issued to Australian Health Providers (AHPs) and purchases from suppliers. This data is held in the NBA Integrated Data Management System (IDMS).Prior to 2016-17 authorisation and dispense data was collected by the Blood Service, and in 2016 all jurisdictions transitioned to using BloodSTAR except NSW as shown in the following table. The Blood Service entered information on current patients and authorisations into BloodSTAR using information from STARS. This data is known as legacy data. JurisdictionGo Live DateNorthern Territory14 July 2016South Australia1 August 2016Queensland22 August 2016Tasmania14 September 2016Victoria26 September 2016Australian Capital Territory24 October 2016Western Australia5 December 2016New South WalesTBAOver the nine years between 2008-09 and 2017-18, data has been captured on 64,033 patients. Caveats relating to the quality of this data are outlined below.This report includes data on the supply of NHIg from 2012-13 and SCIg from 2013-14, as SCIg products were not available in Australia before 2013-14. The report includes some terminology that may be unique to the Australian environment. A list of acronyms and definitions used in this report is at REF _Ref384558524 \h \* MERGEFORMAT Appendix B.The Criteria groups together a number of specific conditions into one medical condition. For example, primary immunodeficiency disease is a medical condition in the Criteria, with this group incorporating the numerous separate specific conditions. In some cases the analysis in this report will focus on the medical condition, while in other areas it will focus on the specific condition.Each specific condition has been classified according to its allocated clinical speciality. It is acknowledged that for some specific conditions this classification could fit into more than one clinical speciality. For example, there are immunological conditions affecting the blood that could potentially be mapped to either immunology or haematology. Where there appears to be significant overlap between clinical specialities, the specific condition was mapped as agreed by the National Immunoglobulin Governance Advisory Committee (NIGAC). In the majority of cases, the specific condition was mapped to the speciality most likely to be responsible for patients with that specific condition, noting that this can vary. REF _Ref384558593 \h \* MERGEFORMAT Appendix C provides the mapping of specific condition to clinical speciality.The summary of key items from the data file is provided for each specific condition at the state and territory level. The summary includes patient numbers, average age, average weight, grams of Ig used for the specific condition, grams per treatment episode and grams per 1,000 population ( REF _Ref379893813 \h \* MERGEFORMAT Appendix D). The source used for each figure and table is provided at REF _Ref379897557 \h \* MERGEFORMAT Appendix G.It should be noted that the grams per 1,000 population measure has previously been shown to be a poor indicator for benchmarking. Raw population figures do not take into account the underlying population age structure, hospital usage patterns, and cross-border referrals; nor do total issues take into account varying product wastage rates across time and jurisdictions. A study done by South Australia (SA) in 2010 (Australian Health Review article - "Red alert - a new perspective on patterns of blood use in the SA public sector") shows this and can be found at qualityThere are some factors relating to data quality which need to be considered when reading this report, as follows:The reconciliation of data held in STARS, BloodSTAR/BloodNet and IDMS indicates minor variances at a national level. In some cases these differences can be explained by product being ordered and recorded in IDMS the month prior to product actually being dispensed to a patient.Data is incomplete for some records in both patient and authorisation data. For example data from STARS and BloodSTAR may not include weight. Legacy data entered into BloodSTAR did not include weight.The ABS population series 3201.0 (Population by Age and Sex, Australian States and Territories) ended in June 2010 and was replaced by Australian Demographic Statistics (cat. No 3101.0). Series 3201.0 was utilised as the denominator for population statistics for Ig annual reports before 201112.Care should be taken when interpreting the data relating to the smaller states and territories as one or two patients can overly influence the data compared to larger states.There has been no adjustment for Ig dispensed in one state or territory for patients residing in a different state or territory.BloodSTAR and STARS jurisdictions or states and territories are based on the state or territory of the facility which dispensed the product, not the treating facility state or territory.Patient numbers were first reported in 2008-09. A small number of patients who did not receive product funded under national blood arrangements have been excluded from the total patient count.The STARS data has age and weight data recorded at treatment dates (first reported in 200910). This data changes over time. Age data is based on the patient’s age at 1 January each year for both STARS and BloodSTAR.Episodes in STARS were known as Treatment Episodes and in BloodSTAR these are known as Dispense Events. In this document we have used Treatment Episodes for consistency.Patient Counts are distinct counts and will not sum for National or Total rows and columns, as patients may have more than one specific condition, have product dispensed in more than one state or territory, have dispense events recorded at a private facility and at a public facility, have received IVIg and SCIg, or have received both domestic and imported product.Previous annual reporting for Ig named conditions as Primary Diagnosis or grouped conditions as Disease Category. In BloodSTAR these are known as Specific Conditions or Medical Conditions respectively. Conditions were also grouped to Disciplines previously and these are now known as Specialities in BloodSTAR.For 2016-17 and 2017-18 reports, Specific and Medical Conditions are based on the Criteria version?2. Dispense data can be entered into BloodSTAR at any time as long as there is a valid and active authorisation. This means that a Dispense Event may be recorded in one month although the actual Dispense Event was in another month, which means data for 2016-17 could be recorded in 2017-18.10 Year TrendsDemand TrendsIn 2017-18 a total of 6,128,717 grams of Ig was issued, representing an increase of 586,207 grams (10.6%) over 2016-17. Since 2008-09 there has been an on average 11.0% increase in Ig use, with the greatest proportion of that increase comprising imported products ( REF _Ref253556626 \h Figure 1).Figure SEQ Figure \* ARABIC 1Ten year trends in issues of IgTable SEQ Table \* ARABIC 1Growth in Ig grams issued since 2008-092008-092009-102010-112011-122012-132013-142014-152015-162016-172017-18Growth from previous year11%12%11%11%11%11%10%12%11%11%Average Growth from 2008-096%8%9%10%11%12%14%15%16%Total grams per 1,000 population111121133145158173188208227247Increase in grams per 1,000 population over previous year8%10%10%9%9%9%9%11%9%9%There has been a steady increase in demand for Ig over the last ten years, with increases of 10-12% per annum for the last ten years. While a proportion of this increase may be attributable to population increases, there has also been a steady increase of 8-11% per annum in the use of Ig per 1000 population ( REF _Ref386097734 \h Table 1) since the introduction of the Criteria in 2008.A breakdown of the year on year change in grams issued by state and territory has been provided in REF _Ref386096440 \h Table 2. Over the past ten years the Northern Territory (NT) has been growing at the fastest rate, followed by Queensland (QLD) and NSW. Rates for the smaller population states and territories must be viewed with some caution as there are many factors that could contribute to different use patterns. Further information about the breakdown of domestic and imported Ig by state over time can be found in REF _Ref386115776 \h \* MERGEFORMAT Appendix E.Table SEQ Table \* ARABIC 2Percentage change in grams issued over time by state and territoryNSWVICQLDSAWATASNTACT2008-0915%3%14%23%0%14%54%-14%2009-1013%11%15%12%-4%7%-18%20%2010-1111%10%16%-4%10%8%7%28%2011-1211%7%16%9%6%1%47%17%2012-1311%13%11%9%7%-6%21%12%2013-1410%11%12%15%6%14%1%12%2014-159%11%12%7%12%8%8%8%2015-1614%10%14%11%17%2%36%3%2016-1714%11%8%10%18%4%6%7%2017-1811%12%10%5%9%21%23%13%Average last 10 years12%10%13%10%8%7%18%11%Financial TrendsThe increase in demand for Ig places a financial burden on the Australian health system. In Australia, the total cost of domestic Ig supply comprises the cost of the plasma collected by the Blood Service, plus the cost of purchase of the finished Ig product from the supplier (CSL Behring). Imported plasma is purchased at a total product cost only.Total expenditure on Ig (excluding plasma for fractionation) in 2017-18 was $327.4 million, an increase of $23.9 million (7.9%) over 2016-17 ( REF _Ref253557293 \h Figure 2). The increased expenditure predominately represents increases in demand offset by lower imported Ig prices.There also continues to be an increase in the price of plasma for fractionation due to the increased ratio of apheresis to whole blood plasma for fractionation being supplied, resulting in an increase in the cost of domestic Ig. Combined with expenditure for plasma for fractionation, Ig accounts for a total expenditure of $579.6 million (excluding hyperimmune plasma for fractionation).Figure SEQ Figure \* ARABIC 2Ten year trends in expenditure on IgDemographicsPatient NumbersA total of 19,414 patients were issued Ig under the national blood arrangements during 2017-18 for 199,469 treatment episodes. This represents an 8.1% increase in the number of patients since 2016-17. A summary of some patient numbers is provided in REF _Ref477773716 \h \* MERGEFORMAT Table 3 and REF _Ref17898517 \h Table 4. A breakdown of unique patients by state and territory and quarter is provided in REF _Ref386115652 \h \* MERGEFORMAT Appendix F.Table SEQ Table \* ARABIC 3Annual numbers of patients, treatment episodes and gramsYearPatientsTreatment EpisodesTotal Grams Issued2013-1413,981122,7914,021,8612014-1514,983140,8554,433,1462015-1616,331159,0414,982,5032016-1717,958179,9975,542,5112017-1819,414199,4496,128,717Table SEQ Table \* ARABIC 4Basic numbers2017-18Total unique patient IDs with some weight data19,224Total unique patient IDs with an age recorded19,414Total unique patient IDs with more than one state or territory182Total unique patient IDs with two states or territories174Total unique patient IDs with three or more states or territories9Total unique patient IDs with more than one condition530Total unique patient IDs with two conditions496Total unique patient IDs with three or more conditions34Total unique patient IDs aged 65 and older9,162Total unique patient IDs aged 17 and younger1,716Total unique new patient IDs7,655Average Age57Median Age63Average Weight (kg)74Geographic DistributionNationally, 0.8 patients per 1,000 population received Ig in 2017-18. This varied between states and territories, ranging from 0.4 in WA and NT to 1.0 in QLD ( REF _Ref253558949 \h Figure 3). All states and territories show an increase in the number of patients per 1,000 population over the previous year.Details on the number of patients by specific condition are at REF _Ref379893813 \h \* MERGEFORMAT Appendix D.Figure SEQ Figure \* ARABIC 3Patients per 1,000 population 2016-17 and 2017-18There is significant variation between jurisdictions in Ig use in grams per 1,000 population, ranging from 126.9 in NT to 324.2 in QLD ( REF _Ref393362413 \h \* MERGEFORMAT Figure 4). Rates for the smaller population states and territories must be viewed with some caution as there are many factors that could contribute to their different use patterns. For example, patients may travel to larger states for specialist treatment. At the same time, the ACT services a much broader area. Comparing only the five largest Australian states, the variation in Ig use is 2.1 fold, ranging from 155.0 grams per 1,000 population in Western Australia (WA) to 324.2 grams per 1,000 population in QLD. The reason for this inter-state and territory variation is unknown but it may represent differences in clinical practice, differing patient populations with disease profiles, variable access to alternative therapies, or differences due to the availability of specialist services across Australia.While most states and territories have seen a continued increase in Ig issued per 1,000 population, TAS and NT increased by 20% and 23% in growth of Ig grams issued per 1,000 population, respectively, while the two largest states NSW and VIC increased by 8%. Figure SEQ Figure \* ARABIC 4Grams of Ig per 1,000 population by state and territory over timeAgeThe distribution of estimated age is shown in REF _Ref253559300 \h Figure 5 where it is compared with the age distribution of the Australian population at December 2015. A bimodal peak can be seen in the patient population treated with Ig, with the majority of Ig recipients either being very young, or over 55. The ageing population is expected to place a greater burden on Ig demand into the future, with the proportion of the world’s population over 60 years expected to more than double between 2015 and 2050.Figure SEQ Figure \* ARABIC 5Patient age compared to average Australian ageWeightIg dosing is dependent on the weight of the patient. For many conditions, the patient weight determines the initial dosing, with maintenance therapy titrated against IgG levels and the patient’s clinical response to therapy. Figure SEQ Figure \* ARABIC 6Patient weights relative to Australian averageNote: The above figure calculations relate to only 2017-18 patients. REF _Ref380064918 \h Figure 6 compares the weight of Ig recipients in Australia in 2017-18 and the Australian population using weight statistics from the ABS in 2011. There is a higher proportion of patients less than 55kg treated with Ig relative to the proportion in the Australian population. The average weight of adult Ig patients (78.8 kg) is slightly higher than the average weight of an Australian adult (77.7 kg). Prior to 2015-16 the average Ig patient weight was slightly lower than the average Australian adult weight, suggesting that the Ig population is getting heavier. Given that studies suggest that 63% of Australians are overweight or obese, the similarity in weight profiles between Ig recipients and the Australian population suggests that a large proportion of Ig recipients may also be overweight. While the current Criteria provides for dosing based on body weight, some limited studies suggest that dosing on lean body weight may be more appropriate. The amount of Ig prescribed for a patient may vary depending on the indication as well as a patient’s weight, as set out in the Criteria. When prescribing Ig, Prescribers should aim to use the lowest dose possible that achieves the appropriate clinical outcome for each patient. The dose may be adjusted for Ideal Body Weight for some patients and a calculator is available in BloodSTAR to facilitate this where appropriate. Further work needs to be done on ideal body weight dosing and the impacts on patient outcomes.With an increasingly obese population, increases in demand per patient may be expected if total (rather than lean) body weight dosing is continued. This area should be considered for future research.Care should be taken when analysing data in this report related to patient weight, as not all patients have weight recorded, and for those that do, the weight recorded may not be current. REF _Ref6838106 \h Table 5 shows the number of distinct patients and the average weight by age ranges for patients with dispenses in 2017-18.Table SEQ Table \* ARABIC 5Patient numbers and average weight by age range Age RangePatient CountsAverage WeightTreatment EpisodesGrams Dispensed0-478111 2,657 23,123 5-940224 2,580 37,38910-1431244 3,005 61,013 15-1722164 2,158 54,208 18-1913369 1,413 33,961 20-2439171 3,934 101,631 25-2945975 4,901 148,566 30-3456479 6,193 174,508 35-3960378 6,244 200,631 40-4466980 7,249 240,565 45-4991482 10,239 344,09450-541,12281 12,709 404,975 55-591,61081 17,898 594,561 60-642,06782 23,433 741,246 65-692,40980 25,550 798,340 70-742,52580 26,939 835,29775-791,99277 20,868 647,839 80-841,26175 12,707 383,079 85-8972071 6,543 191,256 90-9423469 2,004 53,812 95-1042561 227 5,640 Total19,41474 199,451 6,075,733 ExpenditureIn 2017-18, Australian expenditure on Ig products was $327.4 million, with additional expenditure of $252.2 million on plasma for fractionation (excluding hyperimmune plasma for fractionation) collected by the Blood Service, which is primarily directed to manufacture of Ig products.The cost of Ig as a proportion of the national blood budget is shown at REF _Ref393369871 \h Figure 7. Ig is the second largest budget item, representing 28% of the total budget for blood and blood products. Combined with expenditure for plasma for fractionation, Ig accounts for 50% of the total blood budget, at a total expenditure of $579.6 million (excluding hyperimmune plasma for fractionation).Figure 7Ig expenditure as a proportion of the national blood budgetOf the Ig supplied under national blood arrangements in Australia in 2017-18, 53% (3,225,722 grams) was manufactured domestically and 47% (2,902,995 grams) was imported from overseas ( REF _Ref254189034 \h Table 6). This represents a 19.1% increase in product importation from 2016-17 (465,667 grams). Domestic supply is driven by the amount of plasma for fractionation collected in Australia and this increased by 6.0% in 2017-18 over 2016-17. Intragam P, Intragam 10 (IVIg) and Evogam (SCIg) were Ig products manufactured domestically in 2017-18. The imported products available were Privigen (IVIg), Flebogamma (IVIg) and Hizentra (SCIg). When a patient is allocated to receive one of the imported products it is the clinician’s choice as to which product they order. Supply of Privigen constituted 61.7% of the supply of imported Ig. REF _Ref23236969 \h Table 7 shows the split between Ig issues for domestic and imported products, by public and private Australian Health Providers (AHPs) for 2017-18.Table SEQ Table \* ARABIC 6Issues of domestic Ig compared with imported Ig?NSW?NSWVICQLDSAWATASNTACTAUSDomestic Ig Intragam Pgm15,52260900000016,131$(m)$1$0$0$0$0$0$0$0$1Intragam 10gm1,065,420719,710858,243167,880199,21065,05310,69059,3383,145,543$(m)$64$43$52$10$12$4$1$4$190Evogamgm23,27811,29216,3396,6635,34128851233664,049$(m)$1$1$1$0$0$0$0$0$4Total Domesticgm1,104,220731,611874,582174,543204,55165,34111,20259,6743,225,722$(m)$67$44$53$11$12$4$1$4$195Imported IgFlebogammagm371,574211,600242,55549,95366,84620,3659144,820968,626$(m)$17$10$11$2$3$1$0$0$44Privigengm650,825386,175461,74069,530123,51538,37019,19041,2951,790,640$(m)$29$17$21$3$6$2$1$2$81Hizentragm53,50824,77230,75718,1725,8183,86406,838143,729$(m)$3$1$2$1$0$0$0$0$8Total Importedgm1,075,907622,547735,052137,655196,17962,59920,10452,9532,902,995$(m)$49$28$33$6$9$3$1$2$132Proportion of domestic to imported Iggm %51%54%54%56%51%51%36%53%53%$(m) %58%61%61%62%58%58%43%59%60%Note: $(m) excludes the costs for plasma for fractionation.Table SEQ Table \* ARABIC 7Issues of domestic Ig compared with imported Ig and public versus private?NSW?NSWVICQLDSAWATASNTACTAUSDomestic Ig Publicgm 789,013 423,166 318,202 140,426 136,400 48,451 11,202 59,674 1,926,531 Privategm 315,207 308,445 556,380 34,118 68,151 16,890 - - 1,299,191 Total Domesticgm 1,104,220 731,611 874,582 174,543 204,551 65,341 11,202 59,674 3,225,722 Imported IgPublicgm 867,222 401,581 359,462 125,015 147,539 47,756 20,104 52,953 2,021,632 Privategm 208,685 220,966 375,591 12,640 48,640 14,843 - - 881,364 Total Importedgm 1,075,907 622,547 735,052 137,655 196,179 62,599 20,104 52,953 2,902,995 Total Ig Publicgm 1,656,235 824,747 677,663 265,441 283,939 96,207 31,306 112,627 3,948,163 Privategm 523,892 529,411 931,971 46,758 116,791 31,733 - - 2,180,555 Total Iggm 2,180,126 1,354,158 1,609,634 312,198 400,729 127,940 31,306 112,627 6,128,717 Domestic to ImportedPublicgm%47.6%51.3%47.0%52.9%48.0%50.4%35.8%53.0%48.8%Privategm%60.2%58.3%59.7%73.0%58.4%53.2%0.0%0.0%59.6%Total Iggm%50.6%54.0%54.3%55.9%51.0%51.1%35.8%53.0%52.6%Ig as portion of NationalPublicgm%41.9%20.9%17.2%6.7%7.2%2.4%0.8%2.9%100.0%Privategm%24.0%24.3%42.7%2.1%5.4%1.5%0.0%0.0%100.0%Total Iggm%35.6%22.1%26.3%5.1%6.5%2.1%0.5%1.8%100.0%Population %32.0%25.8%20.0%7.0%10.4%2.1%1.0%1.7%Grams Per 1000 PopulationPublic 209.3 129.2 136.5 153.6 109.9 183.4 126.9 270.8 159.4 Private 66.2 82.9 187.7 27.1 45.2 60.5 - - 88.0 Total Ig 275.4 212.1 324.2 180.7 155.0 243.8 126.9 270.8 247.4 Clinical IndicationsIg issues by criteria chapterThe Criteria classifies medical conditions into four chapters based on the level of evidence supporting the use of Ig, as follows:Chapter 5, conditions for which Ig has an established therapeutic roleChapter 6, conditions for which Ig has an emerging therapeutic roleChapter 7, conditions for which Ig has application in exceptional circumstances onlyChapter 8, conditions for which Ig use is not supported.Ig was predominately issued for medical conditions within Chapter 5 ( REF _Ref6761247 \h Table 8). The relative distribution by chapter has remained relatively stable since 2008 ( REF _Ref386098763 \h Table 9). Chapter 8 issues of 313 grams are mainly for emergency sepsis cases. Refer to Appendix D for further information. Table SEQ Table \* ARABIC 8Ig issues (g) by Criteria chapter2013-142014-152015-162016-172017-18Chapter 53,409,1003,785,6154,223,8664,620,9165081838Chapter 6463,361494,489535,596645,636721,766Chapter 7148,581178,221216,927220,122271,817Chapter 8005837313Total4,021,0424,458,3264,976,3945,487,5116,075,733Table SEQ Table \* ARABIC 9Ig issues by Criteria chapter (percentage)2013-142014-152015-162016-172017-18Chapter 585%85%85%84%93%Chapter 612%11%11%12%13%Chapter 74%4%4%4%5%Chapter 80%0%0%0%0%For conditions where Ig is used only in exceptional circumstances (Chapter 7), six medical conditions accounted for 62.5% of those issues. These medical conditions were Limbic Encephalitis – nonparaneoplastic (88,621 grams), Paraneoplastic neurological syndromes (27,500 grams), Devic disease (neuromyelitis optica) (14,348 grams), Potassium channel antibody-associated encephalopathy (13,605 grams), Pure red cell aplasia (13,053 grams) and Susac syndrome (12,855 grams). While use in these medical conditions represents a small proportion of total Ig use, closer examination of these medical conditions may be warranted. While Ig may be issued in life threatening situations prior to diagnosis or in situations where the diagnosis is unclear at the time of treatment, in 2017-18 there were no cases where funded Ig was supplied for a medical condition not supported in the Criteria (excluding Direct Orders where alignment with the Criteria is not required as it is not funded under the national blood arrangements). Refer to Appendix D for further information. Data to support compliance with all aspects of qualifying criteria for each specific condition is not always collected in STARS.Ig issues by medical conditionThe top ten medical conditions account for 88.1% of all Ig supplied, with the top three medical conditions accounting for 56.3%.Acquired hypogammaglobulinaemia — haematological malignancy and post HSCT is the medical condition for which the greatest percentage of Ig was issued in 2017-18 (23.1%), closely followed by chronic inflammatory demyelinating polyneuropathy (CIDP) (21.2%). Primary immunodeficiency diseases (PID) with antibody deficiency accounted for 11.9% of total Ig use ( REF _Ref253562849 \h \* MERGEFORMAT Figure 8 and REF _Ref17898841 \h Table 10).Since 2013-14 there has been greater than 16% increase in Ig issues for secondary hypogammaglobulinaemia (including iatrogenic immunodeficiency) and a 15% increase in issues for myasthenia gravis (MG) and inflammatory myopathies. This is compared with the 11% increase in Ig over this period for all medical conditions. Figure SEQ Figure \* ARABIC 8Ig grams issued by medical conditionTable SEQ Table \* ARABIC 10Ig grams issued for top 10 medical conditions over time2013-142014-152015-162016-172017-18% Change 2017-18 to 2016-17Acquired hypogammaglobulinaemia 862,898982,7731,106,7211,228,4051,401,78914.1%Chronic inflammatory demyelinating polyneuropathy 857,533974,2581,071,1351,171,5811,290,61210.2%Primary immunodeficiency diseases558,617614,781660,816701,547725,3263.4%Myasthenia gravis 313,940348,336402,881456,346514,01712.6%Inflammatory myopathies230,473249,229293,422329,182377,47914.7%Multifocal motor neuropathy 239,314256,041293,458331,142354,4347.0%Secondary hypogammaglobulinaemia 110,024126,561145,497180,831222,13622.8%Immune thrombocytopenic purpura (ITP) — adult186,640187,621210,094211,868218,1823.0%Kidney transplantation97,07090,03188,258122,994126,5872.9%Guillain–Barré syndrome 108,929105,567124,692114,184122,1397.0%Kidney transplantation fell into the top ten medical conditions in 2016-17 with a 39.4% growth over 2015-16; however in 2017-18 the growth was only 2.9%. Further investigation may be warranted for this change year on year. Secondary hypogammaglobulinaemia continued to see the highest increase in use at 22.8% over 201617 and is in all states and territories except SA and ACT ( REF _Ref23237026 \h Table 11). In 2017-18 grams per patient ranged from 85 grams in NT and 153 grams in SA to 237 grams in NSW and 254 grams in QLD.Table SEQ Table \* ARABIC 11Difference in grams issued for secondary hypogammaglobulinaemia (percentage)2013-142014-152015-162016-172017-18NSW8%20%15%19%20%VIC-7%11%20%56%38%QLD7%15%16%17%20%SA15%-9%-20%34%-2%WA-24%6%38%33%12%TAS-2%-3%-7%-12%38%NT-73%120%-82%-17%423%ACT41%454%22%146%-11%Total3%15%15%24%23%The top ten medical conditions by state and territory by proportion are depicted in REF _Ref23859700 \h Figure 9.Figure SEQ Figure \* ARABIC 9Proportion of Ig used for top 10 medical conditionsIg issues by specific conditionThe top twenty specific conditions account for 89.0% of all Ig supplied, with the top ten specific conditions accounting for 75%. Population based data on Ig issues maybe particularly interesting for specific conditions where the majority of patients receive Ig as it can provide an estimation of disease prevalence. REF _Ref6840888 \h Table 12 provides an overview of the specific conditions that use the most Ig by private and public dispensing facilities, including data on total Ig use, patient numbers and average age.Table SEQ Table \* ARABIC 12Patient numbers and age for the top 20 specific conditions by private and public facilitiesPrivatePublicTotalSpecific Conditions (Top 20)Igg (% of total)Patientsn (% of total)Average AgeIgg (% of total)Patientsn (% of total)Average AgeIgg (% of total)Patientsn (% of total)Average AgeChronic inflammatory demyelinating polyneuropathy453,940 (7%)935 (2%)65836,672 (14%)1,772 (4%)631,290,612(21%)2,595 (6%)64Common variable immunodeficiency disease 154,138 (3%)504 (4%)57484,440 (8%)1,464 (4%)49638,578 (11%)1,876 (8%)51Myasthenia gravis175,046 (3%)397 (5%)64338,972 (6%)829 (4%)61514,017 (8%)1,174 (8%)62Chronic lymphocytic leukaemia213,115 (4%)815 (1%)73222,108 (4%)891 (2%)71435,223 (7%)1,632 (3%)72Non-Hodgkin lymphoma242,312 (4%)961 (4%)70180,505 (3%)756 (4%)66422,817 (7%)1,651 (7%)68Multifocal motor neuropathy 106,698 (2%)176 (2%)59247,736 (4%)406 (3%)58354,434 (6%)560 (5%)59Multiple myeloma187,335 (3%)746 (1%)72166,670 (3%)790 (2%)69354,006 (6%)1,458 (3%)70Secondary hypogammaglobulinaemia 90,184 (1%)383 (1%)61131,953 (2%)628 (3%)53222,136 (4%)953 (4%)56Polymyositis57,458 (1%)133 (0%)63149,263 (2%)399 (2%)61206,720 (3%)513 (2%)62Guillain–Barré syndrome24,458 (0%)149 (1%)5597,681 (2%)610 (2%)52122,139 (2%)754 (3%)52Kidney transplantation post-transplant10,435 (0%)32 (0%)53110,390 (2%)422 (1%)48120,825 (2%)449 (1%)48Other relevant haematological malignancies61,642 (1%)263 (0%)6755,971 (1%)387 (1%)47117,613 (2%)625 (2%)55Dermatomyositis19,774 (0%)50 (1%)5676,636 (1%)208 (1%)4696,410 (2%)250 (2%)48Limbic encephalitis, nonparaneoplastic23,971 (0%)90 (0%)5164,650 (1%)283 (1%)4588,621 (1%)365 (1%)46Specific antibody deficiency29,234 (0%)109 (1%)6059,364 (1%)237 (2%)4888,598 (1%)334 (2%)52Inclusion body myositis24,129 (0%)52 (1%)7050,221 (1%)125 (2%)7174,349 (1%)170 (2%)70Post-haemopoietic stem cell transplantation24,949 (0%)124 (1%)5447,192 (1%)349 (2%)3972,141 (1%)443 (2%)43ITP with life-threatening haemorrhage 20,298 (0%)135 (1%)6351,160 (1%)359 (1%)5871,457 (1%)490 (2%)60ITP refractory acute20,358 (0%)132 (0%)6250,122 (1%)328 (0%)5770,479 (1%)456 (0%)58ITP in specific circumstances (surgery, other therapy contraindicated, chronic ITP)23,868 (0%)133 (0%)6441,415 (1%)279 (1%)6265,283 (1%)407 (1%)62Ig issues by clinical specialityThe number of grams of Ig issued categorised according to clinical speciality is shown in REF _Ref253563362 \h Figure 10. Some specific conditions prior to 2017-18 were classified as mixed, in that they fell across more than one clinical speciality. Other specific conditions fall within a clinical speciality other than neurology, haematology or immunology, such as use in transplant or dermatology. These are considered under ‘Other’ in REF _Ref253563362 \h Figure 10 and REF _Ref18415610 \h Table 13 replicates this data.Since 2013-14, there has been a 1.6 fold increase in Ig issues for neurological conditions, compared with a 1.5 fold increase for both haematological conditions and immunological conditions.Figure SEQ Figure \* ARABIC 10Ig issues by clinical specialityTable SEQ Table \* ARABIC 13Ig grams issued by clinical speciality2013-142014-152015-162016-172017-18Neurology1,916,7922,120,1112,407,9952,672,2612,977,065Haematology1,116,0371,234,8161,390,8241,530,3401,710,717Immunology746,828828,735885,9331,053,7121,135,762Other241,386274,664291,643231,199252,189There is significant variation across Australia in Ig use for each clinical speciality (as allocated). REF _Ref253563789 \h Figure 11 shows that in WA issues for neurological conditions represent a greater proportion of total issues than for other states, and haematological conditions are less than other states and territories. The reason for this inter-state and territory variation is unknown, but it may represent differences in clinical practice, differing disease profiles in the patient populations, variable access to alternative therapies or differences due to the availability of specialist services across Australia.Figure SEQ Figure \* ARABIC 11Percentage Ig issues by clinical speciality for top 10 medical conditionsIg grams issued per 1,000 populationThe amount of Ig issued per 1,000 population for each specific condition varies between state and territory. Complete data for specific conditions by state and territory can be found at REF _Ref379894780 \h \* MERGEFORMAT Appendix D. REF _Ref393303801 \h \* MERGEFORMAT Table 14 shows a breakdown of the proportion of Ig issued in each state and territory with a comparison to the proportion of the population in each state and territory.Of the top 10 specific conditions the highest variation between the five largest states and territories in Ig use per 1,000 population is seen in multiple myeloma and secondary hypogammaglobulinaemiaa. In total, for the five largest states, there was proportionally low Ig issues per 1,000 population in South Australia (SA) and WA respectively, and high in QLD. The reason for the significant variation between these states is unknown, and further studies may be required to ascertain the significance of this finding. Table SEQ Table \* ARABIC 14Grams of Ig issued by state and territoryIg issued (g)Proportion of total Ig issuedProportion of Australian populationGrams per 1,000 populationNSW2,180,12635.6%32.0%275VIC1,354,15822.1%25.8%212QLD1,609,63426.3%20.0%324SA312,1985.1%7.0%181WA400,7296.5%10.4%155TAS127,9402.1%2.1%244NT31,3060.5%1.0%127ACT112,6271.8%1.7%271Total6,128,717100%100%247 REF _Ref6843471 \h Table 15 shows the top 10 specific conditions by the Ig grams issued per 1,000 population by state and territory. The fold variation REF _Ref6843471 \h Table 15 is a measure describing difference in the Ig grams per 1,000 population between the state being issued the least to the state being issued the most, using only data from the five largest states in Ig use. For example, a low value of 30 and a high value of 60 correspond to a fold variation of 2, or in common terms, a two-fold increase.Table SEQ Table \* ARABIC 15Grams of Ig issued per 1,000 population by state/ territory for top 10 specific conditionsSpecific ConditionNSW VICQLDSAWATASNTACTAUSFold VariationChronic inflammatory demyelinating polyneuropathy6044672545502038522.7Common variable immunodeficiency disease 391725181216752263.2Myasthenia gravis211423138171118183.0Chronic lymphocytic leukaemia2022327129026214.8Non-Hodgkin lymphoma1613321352469176.3Multifocal motor neuropathy 1410152317152222142.3Multiple myeloma1611231232137148.0Secondary hypogammaglobulinaemia 1081523121497.8Polymyositis1061210488982.7Guillain–Barré syndrome5555466751.5DosingFigure SEQ Figure \* ARABIC 12Grams per episode by specific condition REF _Ref386112223 \h \* MERGEFORMAT Figure 12 shows that there is significant variance in the dosing of the top 10 specific conditions by grams per episode where dosing is calculated as number of grams administered in each episode. The definition of episode in the data is not uniform and therefore this data should be interpreted with caution. Variations are expected as the dose (g/kg) and frequency of dose also varies. Also note that the Criteria requires the lowest possible dose to achieve the desired clinical outcome, so the dose is not ‘mandated’ but rather suggested and guided to the lower end to achieve efficacy which may contribute to the differences in dosing between conditions. Dosing in neurological conditions is higher than for haematological and immunological conditions, as provided for in the Criteria. For dosing information for other conditions refer to REF _Ref379895385 \h \* MERGEFORMAT Appendix D.The grams per kilogram were calculated for each dispense event ( REF _Ref386112223 \h \* MERGEFORMAT Figure 12 and REF _Ref23237097 \h \* MERGEFORMAT Table 16). From this data it is difficult to assess whether the dosing strategy utilised was in accordance with that provided for under the Criteria. This is particularly difficult as the patient weight data is not updated or present for every dispense event (particularly for those recorded in STARS and transitioned to BloodSTAR) for every episode and may change over time.Figure SEQ Figure \* ARABIC 13Grams per kg weight by specific conditionTable SEQ Table \* ARABIC 16Ig grams per kg weight per episodeSpecific Condition<=0.4 g/kg/episoden (%)0.4 – 0.99 g/kg/episoden (%)1 – 2 g/kg/episoden (%)>2 g/kg/episoden (%)No weight Datan(%)Ig Average g/kg/episodeChronic inflammatory demyelinating polyneuropathy10,949 (33%)19,523 (59%)1,917 (6%)160 (0%)615 (2%)0.51Common variable immunodeficiency disease 10,533 (46%)10,717 (47%)148 (1%)34 (0%)1,231 (5%)0.43Myasthenia gravis5,407 (37%)8,302 (57%)616 (4%)49 (0%)201 (1%)0.47Chronic lymphocytic leukaemia8,375 (53%)7,233 (46%)14 (0%)2 (0%)230 (1%)0.38Non-Hodgkin lymphoma9,017 (55%)7,050 (43%)19 (0%)2 (0%)205 (1%)0.37Multifocal motor neuropathy 7,160 (54%)5,855 (44%)4 (0%)0 (0%)151 (1%)0.38Multiple myeloma1,935 (24%)5,115 (64%)777 (10%)33 (0%)165 (2%)0.58Secondary hypogammaglobulinaemia 4,681 (51%)4,302 (47%)35 (0%)4 (0%)118 (1%)0.38Polymyositis1,638 (30%)3,388 (62%)400 (7%)19 (0%)63 (1%)0.51Guillain–Barré syndrome1,076 (42%)1,152 (45%)248 (10%)101 (4%)8 (0%)0.55Note: n is the number of Treatment EpisodesIVIg and SCIgIn March 2013, the JBC approved the introduction of SCIg under the national blood arrangements. In 2015-16 the NBA established arrangements for supply of the following SCIg products:Evogam 16% 0.8g/5ml and 3.2g/20ml supplied by CSL Behring (Australia) Pty Ltd (domestic)Gammanorm 16% 1650mg/10ml and 3300mg/20ml supplied by Octapharma Australia Pty Ltd (imported)Hizentra 5% 1g/5ml, 2g/10ml, 4g/20ml and 10g/50ml supplied by CSL Behring (Australia) Pty Ltd (imported).In 2017-18 only Evogam and Hizentra were issued to patients for SCIg.In addition to the clinical and diagnostic criteria for access to immunoglobulin products, access to SCIg products is provided through an assurance framework for the appropriate use of the product. The first phase of implementation was through hospital-based management arrangements. SCIg access rules are detailed on the NBA website at . Participation in the National SCIg program requires hospitals to establish their capability and capacity to manage a hospital-based SCIg program, where the hospital provides access to all resources and takes full accountability for the management and use of the product within defined governing requirements. Further work will be undertaken to support supply of SCIg for other pathways of care.The medical conditions that SCIg can be used for are:primary immunodeficiency diseases with antibody deficiencyspecific antibody deficiencyacquired hypogammaglobulinaemia secondary to haematological malignancies, or post-haemopoietic stem cell transplantation (HSCT)secondary hypogammaglobulinaemia unrelated to haematological malignancies, or post-haemopoietic stem cell transplantation (HSCT)These products are authorised and distributed by the Blood Service in the same manner as IVIg.Tables 17-19 show the patient numbers, grams issued and treatment episodes, by state and territory for IVIg and SCIg products in 2017-18. Tables 20-22 show patient numbers, grams issued and treatment episodes by medical conditions for IVIg and SCIg products in 2017-18.Table SEQ Table \* ARABIC 17Patient numbers for products issued by state and territory in 2017-18IVIgSCIgStateFlebogamma 5 percentFlebogamma 10 percentIntragam PIntragam 10Privigen 10 percentSCIg EvogamSCIg HizentraTotalNSW3957684442,0051,997801867,230VIC111690172,6151,197721104,447QLD344546<52,7731,325591114,833SA14180<571022033531,114WA31175570523217381,126TAS859<5215116<511392NT<5<5<55755<50112ACT517024098<525357AUS9022,4244759,2125,19926252519,414Note: The national patient count only includes one count for each patient. This may result in the sum of the state and territory totals being greater than the national total. In addition, each patient may have received multiple products, meaning the total number of patients for each state/territory may not match the total of the patient counts for each product.Table SEQ Table \* ARABIC 18Grams of product issued by state and territory in 2017-18IVIgSCIgStateFlebogamma 5 percentFlebogamma 10 percentIntragam PIntragam 10Privigen 10 percentSCIg EvogamSCIg HizentraTotalNSW140,629242,41519,2451,063,803657,86026,13351,8782,201,962VIC34,283169,325711703,848377,3909,98821,3891,316,934QLD93,191145,630-15852,278457,98516,50228,8831,594,453SA2,29045,705120165,60368,4705,68316,456304,327SA9,34655,26542191,388122,7854,7745,559389,159TAS2,65517,2053965,16038,1002783,714127,151NT1586653910,58518,715410030,572ACT8603,955058,61841,4102696,066111,178AUS283,411680,16520,1813,111,2821,782,71564,036133,9456,075,733Table SEQ Table \* ARABIC 19Treatment episode numbers for products issued by state and territory in 2017-18IVIgSCIgStateFlebogamma 5 percentFlebogamma 10 percentIntragam PIntragam 10Privigen 10 percentSCIg EvogamSCIg HizentraTotalNSW3,9095,88082333,48015,9873,6736,46270,221VIC1,0694,2723324,5369,7847761,54741,968QLD3,2844,719432,31414,59748897256,349SA731,18465,8131,7063661,12310,265SA3551,541106,8602,99021845912,420TAS9939552,1871,033151283,862NT530630138640732ACT2811202,107993243683,632AUS8,82218,133887107,59847,4765,56411,059199,449Table SEQ Table \* ARABIC 20Patient numbers for products issued by medical condition in 2017-18IVIgSCIgMedical ConditionFlebogamma 5 percentFlebogamma 10 percentIntragam PIntragam 10Privigen 10 percentSCIg EvogamSCIg HizentraTotalAcquired hypogammaglobulinaemia — haematological malignancy and post HSCT49782035,239426381495,766Primary immunodeficiency diseases (PID) with antibody deficiency39291541,731751802972,174Secondary hypogammaglobulinaemia (including iatrogenic immunodeficiency)3661197421302035953Specific antibody deficiency (SAD)9<519309142546374Note: Each patient may have received multiple products per diagnosis, so the total number of patients for each medical condition may not match the total of the patient counts for each product.Table SEQ Table \* ARABIC 21Grams of product issued by medical condition in 2017-18IVIgSCIgMedical ConditionFlebogamma 5 percentFlebogamma 10 percentIntragam PIntragam 10Privigen 10 percentSCIg EvogamSCIg HizentraTotalAcquired hypogammaglobulinaemia — haematological malignancy and post HSCT12,03812,0256,9931,234,92693,8005,34536,6641,401,790Primary immunodeficiency diseases (PID) with antibody deficiency10,9787,1457,620547,80122,98548,77580,023725,325Secondary hypogammaglobulinaemia (including iatrogenic immunodeficiency)8,2317,470708168,11825,0854,6177,908222,136Specific antibody deficiency (SAD)1,17763558583,4012,5655,2999,350103,011Table SEQ Table \* ARABIC 22Treatment episodes for product issued by medical condition in 2017-18IVIgSCIgMedical ConditionFlebogamma 5 percentFlebogamma 10 percentIntragam PIntragam 10Privigen 10 percentSCIg EvogamSCIg HizentraTotalAcquired hypogammaglobulinaemia — haematological malignancy and post HSCT43244830346,4083,7032942,93654,483Primary immunodeficiency diseases (PID) with antibody deficiency41628139220,1637804,4506,63033,106Secondary hypogammaglobulinaemia (including iatrogenic immunodeficiency)400329326,9021,0222485629,487Specific antibody deficiency (SAD)5328233,4841235729295,207NHIgIn 2013–14, as a result of the introduction of SCIg as discussed above, demand for NHIg reduced significantly by 18.8 %. CSL Behring (Australia) Pty Ltd produces NHIg from hyperimmune plasma specially collected by the Blood Service. The volume of product is limited by the availability of this specialised plasma, and by production scheduling arrangements in CSL Behring (Australia) Pty Ltd’s manufacturing facility.Demand for NHIg further declined in 2014-15 by 78% as a result of implementation of the NHIg policy outlining the national position on access and use under the national blood arrangements.NHIg may only be supplied for two purposes; for the treatment of susceptible contacts of measles, hepatitis A, poliomyelitis and rubella, as directed by public health officials; and for the treatment of immunodeficiency conditions for which the product is indicated for patients for whom IVIg and SCIg are both contraindicated. NHIg access rules are detailed on the NBA website at 23-25 and REF _Ref17895942 \h Figure 14 show the grams issued and the grams issued per 1,000 population by states and territories for either purpose listed above.Figure SEQ Figure \* ARABIC 14NHIg grams issued and grams issued per 1,000 populationTable SEQ Table \* ARABIC 23NHIg issued from 2013-14 to 2017-18Product2013-142014-152015-162016-172017-18Normal Immunoglobulin 2VI - 2ml (grams)65416711243110Normal Immunoglobulin 2VI - 5ml (grams)24,6495,4093,2542,8061,484Total (grams)25,3035,5763,3662,8491,594Grams Per 1,000 Population1.090.240.140.120.06Table SEQ Table \* ARABIC 24Grams of NHIg issued by state and territory?2013-142014-152015-162016-172017-18NSW6,91582238351345VIC6,7472,278489411465QLD2,7741,4721,134401171SA4,4319369801,16494WA3,45859384839TAS272154433539NT1913512154ACT514480432424437OTHER0 80 0 0 0 Australia25,302 5,5763,366 2,849 1,594 Table SEQ Table \* ARABIC 25Grams per 1,000 population of NHIg issued by state and territoryPer 1,000 Population2013-142014-152015-162016-172017-18NSW0.930.010.030.050.04VIC1.160.380.080.070.07QLD0.590.310.240.080.03SA2.640.550.570.680.05WA1.380.020.010.020.02TAS0.530.300.080.070.07NT0.790.140.050.060.02ACT1.331.221.081.041.05AustraliaAppendix A – BackgroundSecuring supply of ImmunoglobulinImmunoglobulin (Ig) is made from donated human plasma. The supply of Australian donated human plasma is sourced from the Australian Red Cross Blood Service (Blood Service) and sent to CSL Behring Ltd to manufacture domestic Ig. The NBA has contractual arrangements with both the Blood Service and CSL Behring Ltd for these services. In accordance with government policy, the NBA also maintains contractual arrangements with international suppliers to ensure sufficient supply to meet Australian clinical demand within the context of a finite international supply.The following table shows the domestic and imported products supplied under NBA arrangements (including IgG concentration and method of administration) by financial year.YearDomestic products suppliedSupplier2003-04 to 2012-13Intragam P (6% intravenous)Normal Human Immunoglobulin (intramuscular1)CSL Behring2013-14 to 2017-18Intragam P (6% intravenous)Evogam (16.5% subcutaneous)Normal Human Immunoglobulin (intramuscular1)CSL BehringFrom2017-18Intragam 10 (10% intravenous)Evogam (16.5% subcutaneous)Normal Human Immunoglobulin (intramuscular1)CSL BehringYearImported products suppliedSupplier2004-05 to2009-10Sandoglobulin (intravenous)Octagam (5% intravenous)CSL BehringOctapharma2010-11Sandoglobulin (intravenous)Octagam (5% intravenous)Flebogamma (5% intravenous)CSL BehringOctapharmaLateral Grifols2011-12 to 2012-13 Octagam (5% intravenous)Flebogamma (5% intravenous)Kiovig (10% intravenous2)OctapharmaGrifolsBaxter Healthcare2013-14 to 2014-15Octagam (5% intravenous)Gammanorm (16% subcutaneous)Flebogamma (5% intravenous)Kiovig (10% intravenous2)OctapharmaGrifolsBaxter Healthcare 2015-16Octagam (5% intravenous)Gammanorm (16% subcutaneous)Kiovig (10% intravenous2) Flebogamma (5% and 10% intravenous)Privigen (10% intravenous)Hizentra (20% SCIg)OctapharmaBaxter HealthcareGrifolsCSL Behring2016-17 to 2017-18Flebogamma (5% and 10% intravenous)Privigen (10% intravenous)Hizentra (20% subcutaneous)GrifolsCSL BehringNotes1.The TGA approved Product Information for normal human immunoglobulin provides for intramuscular infusion, but the product is also infused by subcutaneous infusion in some cases.2.The TGA approved Product Information for these IVIg products provides for subcutaneous infusion as well as intravenous infusion, but the products were supplied under NBA arrangements for intravenous purposes only.In addition to contracting for supply of domestic and imported Ig products, the NBA undertakes annual national supply planning in conjunction with all Australian governments, and continuously monitors demand against approved supply plans. The NBA also undertakes national supply risk assessments and applies staged supply risk management actions as necessary, including under the National Blood Supply Contingency Plan agreed by all Australian governments.Criteria to access to Ig under the national blood arrangements The Criteria for the Clinical Use of Immunoglobulin in Australia (the Criteria) was approved by Health Ministers in December 2007 together with a funding policy statement which limited access to Ig funded under the national blood arrangements only to patients who meet the criteria published in the Criteria. Under the national blood arrangements, Ig is funded 63% by the Commonwealth government, with the remaining 37% being funded by the state and territory to which the product is supplied. Patients can access the Ig outside of the Criteria but this is not funded under the national blood arrangements. Further information on how to access Ig can be found here .au/Intravenous-Ig .Access to Ig under the Criteria is based on the following principles: Ig products should be directed to patients who are most likely to benefit and for whom there are no safe and effective alternative treatments, the Criteria should be based on best available evidence, and access to Ig should be at the lowest effective dose. The Criteria for the Clinical Use of Ig in Australia was updated in 2012 and 2016. The first two editions were published in hard copy with Version 2 being adapted for electronic publication in BloodSTAR. The Criteria to determine patient eligibility can be found here 2016, all authorisation requests for patient-specific access to Ig under the Criteria must be submitted through BloodSTAR. BloodSTAR standardises and manages access to the supply of immunoglobulin products by enabling authorisation requests to be submitted electronically and work-flowed to an authoriser for assessment and approval. BloodSTAR enables collection of improved national data and enhance the ability to further develop the Criteria and provide an improved evidence base for practice improvement and research.Further information on BloodSTAR is available at .The Ig Governance ProgramIn 2012, on behalf of all Australian Governments, the NBA commissioned a review of the adequacy of the existing intravenous Ig (IVIg) authorisation and clinical governance arrangements, with a view to recommending options for improvements to deliver Governments’ goals for the management of IVIg in particular. The National Ig Governance Program was introduced in 2014 to achieve Governments’ objectives for Ig products funded and supplied under the national blood arrangements, namely to: ensure Ig product use and management reflects appropriate clinical practice and represents efficient, effective and ethical expenditure of Government funds, in accordance with relevant national safety and quality standards for health care;ensure that access to Ig products is consistent with the criteria for access determined by Governments; andimprove the capture of information of the need for, use of, and outcomes of treatment with Ig products to inform future decisions. An integrated network of National Immunoglobulin Governance Committees?has been established, including the National Immunoglobulin Governance Advisory Committee and specialist working groups. The advice and recommendations of this committee network fundamentally informs the development, implementation and ongoing operation of the other governance program measures.The NBA published the Ig Governance National Policy in November 2014 with the second edition released in July 2016 to coincide with the launch of BloodSTAR. The document describes the authorisation arrangements for access to government-funded immunoglobulin products. This includes an explanation of roles, responsibilities, authority and accountability of those involved in requesting authorisation, authorising, supplying, managing and using immunoglobulin products throughout the supply chain within health services. The Guidelines for Managing Blood and Blood Product Inventory provide better practice processes that can be used by health providers to ensure risks associated with receipt, storage, collection and transport of blood and blood products are mitigated. It also identifies improvement opportunities for implementation. In 2016-17, the NBA developed Module 2 to supplement the overarching inventory management principles and support the implementation of BloodSTAR. The module aims to assist health providers in meeting the requirements of the National Policy by:describing how to establish and manage stock levels outlining the Ig product ordering models identifying different methods to determine ordering requirements/triggers providing recommendations for good practice. For further information on the Ig Governance Program go to the NBA website at B – Acronyms and GlossaryAcronymsACTAustralian Capital TerritoryAHMACAustralian Health Ministers’ Advisory CouncilAHPAustralian Health ProviderANCAAnti-neutrophil cytoplasmic antibody AUSAustraliaBloodNetThe national online ordering and inventory management systemBloodSTARBlood System for Tracking Authorisations and ReviewsDODirect OrderHIVHuman immunodeficiency virusHSCTHematopoietic stem cell transplantationIDMSIntegrated Data Management SystemIgImmunoglobulin products including IVIg and SCIgITPIdiopathic thrombocytopenic purpuraIVIgIntravenous immunoglobulinJBCJurisdictional Blood CommitteeJDOJurisdictional Direct OrderNBANational Blood AuthorityNHIgNormal human immunoglobulinNIGACNational Immunoglobulin Governance Advisory CommitteeNSWNew South WalesNTNorthern TerritoryPANDASPaediatric autoimmune neuropsychiatric disorder associated with streptococcal infections QLDQueenslandSASouth AustraliaSCIgSubcutaneous ImmunoglobulinSTARSSupply Tracking Analysis Recording SystemTASTasmaniaTGATherapeutic Goods AdministrationTSSToxic shock syndromeVICVictoriaWAWestern AustraliaGlossary of termsTerm DescriptionBlood productsProducts manufactured from human bloodBlood ServiceThe Australian Red Cross Blood ServiceCondition Clinical conditions are categorised according to the quality of the available evidence and whether immunoglobulin treatment is considered beneficial. Specific conditions (previously known as primary diagnosis) within a medical condition (previous known as disease category). In some instances the medical condition may be the same as the specific condition, for example – Myasthenia gravis is the specific condition and the medical conditionCriteria for the clinical use of immunoglobulin in Australia (the Criteria)A document describing the conditions, indications and patient qualifying and review criteria for which Ig is funded under national blood arrangements by all Australian governmentsDirect Orders (DO)Previously known as Jurisdictional Direct Orders (JDO). Arrangements implemented by the NBA with suppliers to facilitate the purchase of Ig for the treatment of conditions not satisfying the Criteria for the clinical use of Ig in AustraliaFractionationA manufacturing process that separates blood plasma into specific protein fractionsImprest stockHealth provider orders of product for stock that is maintained at a certain levelIntravenous immunoglobulinAn immunoglobulin product derived from donated human plasma that is administered intravenouslyJurisdiction Any of the parties to the Australian National Blood Agreement, being the Australian Government and all state and territory governmentsMinimum Product InventoryThe minimum inventory of Ig held by CSL Behring to meet contract obligationsNational Blood AgreementThe Agreement signed by all governments in 2003 that sets out the objectives for governments for the management of the Australian blood sectorNational blood arrangementsArrangements, including funding arrangements, established under the National Blood AgreementNational CSL ReserveThe reserve of inventory of Ig that CSL Behring manages on behalf of the NBA for contingency purposesNormal immunoglobulinAn immunoglobulin product derived from human plasma that is administered by intramuscular injection (as opposed to intravenous or sub-cutaneous injection)PlasmaThe liquid part of the blood containing antibodies and other proteinsSpecialityClassification of the conditions according to the clinical speciality, previously disciplineSubcutaneous immunoglobulinAn immunoglobulin product derived from donated human plasma that is administered subcutaneouslyTreatment episodeOne instance or episode of a treatment plan, for example a treatment plan may be made up of 4 episodes over 4 months with an episode occurring every 4 weeks (4 treatment episodes) OR 1 dose of transfused product every two weeks for 6 months would be 13 treatment episodesAppendix C – Conditions mapping tableSpecific ConditionMedical ConditionChapterSpecialityChronic lymphocytic leukaemiaAcquired hypogammaglobulinaemia — haematological malignancy and post HSCT5HaematologyMultiple myelomaAcquired hypogammaglobulinaemia — haematological malignancy and post HSCT5HaematologyNon-Hodgkin lymphomaAcquired hypogammaglobulinaemia — haematological malignancy and post HSCT5HaematologyOther relevant haematological malignanciesAcquired hypogammaglobulinaemia — haematological malignancy and post HSCT5HaematologyPost-haemopoietic stem cell transplantationAcquired hypogammaglobulinaemia — haematological malignancy and post HSCT5HaematologyChronic inflammatory demyelinating polyneuropathyChronic inflammatory demyelinating polyneuropathy (CIDP)5NeurologyGuillain–Barré syndromeGuillain–Barré syndrome (GBS)5NeurologyITP associated with HIVImmune thrombocytopenic purpura (ITP) — adult5HaematologyITP in pregnancyImmune thrombocytopenic purpura (ITP) — adult5HaematologyITP in specific circumstances (surgery, other therapy contraindicated, chronic ITP, concurrent risk factors)Immune thrombocytopenic purpura (ITP) — adult5HaematologyITP refractory acuteImmune thrombocytopenic purpura (ITP) — adult5HaematologyITP with life-threatening haemorrhage or potential life-threatening haemorrhageImmune thrombocytopenic purpura (ITP) — adult5HaematologyDermatomyositisInflammatory myopathies: polymyositis (PM), dermatomyositis (DM) and inclusion body myositis (IBM)5NeurologyInclusion body myositisInflammatory myopathies: polymyositis (PM), dermatomyositis (DM) and inclusion body myositis (IBM)5NeurologyPolymyositisInflammatory myopathies: polymyositis (PM), dermatomyositis (DM) and inclusion body myositis (IBM)5NeurologyKawasaki diseaseKawasaki disease5ImmunologyLambert–Eaton myasthenic syndromeLambert–Eaton myasthenic syndrome (LEMS)5NeurologyMultifocal motor neuropathy with or without persistent conduction blockMultifocal motor neuropathy (MMN)5NeurologyMyasthenia gravisMyasthenia gravis (MG)5NeurologyNeonatal haemochromatosisNeonatal haemochromatosis (NH)5HaematologyCommon variable immunodeficiency disease (CVID)Primary immunodeficiency diseases (PID) with antibody deficiency5ImmunologyOther primary immunodeficiencyPrimary immunodeficiency diseases (PID) with antibody deficiency5ImmunologySevere combined immunodeficiency (SCID)Primary immunodeficiency diseases (PID) with antibody deficiency5ImmunologyTransient hypogammaglobulinaemia of infancyPrimary immunodeficiency diseases (PID) with antibody deficiency5ImmunologyWiskott–Aldrich syndromePrimary immunodeficiency diseases (PID) with antibody deficiency5ImmunologyX-linked agammaglobulinaemiaPrimary immunodeficiency diseases (PID) with antibody deficiency5ImmunologyStiff person syndromeStiff person syndrome5NeurologyAcute disseminated encephalomyelitisAcute disseminated encephalomyelitis (ADEM)6NeurologyChurg-Strauss syndromeANCA-positive systemic necrotising vasculitis6ImmunologyMicroscopic polyangiitisANCA-positive systemic necrotising vasculitis6ImmunologyPR3 or MPO ANCA-positive idiopathic rapidly progressive glomerulonephritisANCA-positive systemic necrotising vasculitis6ImmunologyWegener granulomatosisANCA-positive systemic necrotising vasculitis6ImmunologyAutoimmune haemolytic anaemiaAutoimmune haemolytic anaemia (AIHA)6HaematologyBullous pemphigoidBullous pemphigoid (BP)6DermatologyCicatricial pemphigoid/ mucous membrane pemphigoidCicatricial pemphigoid (CP) or Mucous Membrane Pemphigoid (MMP)6DermatologyEvans syndromeEvans syndrome6HaematologyFeto-maternal/neonatal alloimmune thrombocytopenia (Antenatal)Feto-maternal/neonatal alloimmune thrombocytopenia (FMAIT/NAIT)6HaematologyFeto-maternal/neonatal alloimmune thrombocytopenia (Neonatal)Feto-maternal/neonatal alloimmune thrombocytopenia (FMAIT/NAIT)6HaematologyHaemophagocytic syndromeHaemophagocytic syndrome6HaematologyIgM para-proteinaemic neuropathyIgM paraproteinaemic demyelinating neuropathy6NeurologyITP in childrenImmune thrombocytopenic purpura (ITP) — in children 15 years and younger6HaematologyKidney transplantation post-transplantKidney transplantation6NephrologyKidney transplantation pre-transplantKidney transplantation6NephrologyMultiple sclerosis - severe relapse with no response to high dose methylprednisoloneMultiple sclerosis (MS)6NeurologyMultiple sclerosis in pregnancy and the immediate post-partum periodMultiple sclerosis (MS)6NeurologyMultiple sclerosis in young patients severe/relapsing/remitting in whom other therapies have failedMultiple sclerosis (MS)6NeurologyOpsoclonus myoclonus ataxiaOpsoclonus-myoclonus ataxia (OMA)6NeurologyPemphigus foliaceusPemphigus foliaceus (PF)6DermatologyPemphigus vulgarisPemphigus vulgaris (PV)6DermatologyPost-transfusion purpuraPost-transfusion purpura (PTP)6HaematologySecondary hypogammaglobulinaemia (excluding haematological malignancies)Secondary hypogammaglobulinaemia (including iatrogenic immunodeficiency)6ImmunologySolid organ - heartSolid organ transplantation (other than kidney)6Transplant MedicineSolid organ - heart/lungSolid organ transplantation (other than kidney)6Transplant MedicineSolid organ - liverSolid organ transplantation (other than kidney)6Transplant MedicineSolid organ - lungSolid organ transplantation (other than kidney)6Transplant MedicineSolid organ - otherSolid organ transplantation (other than kidney)6Transplant MedicineIgG subclass deficiency (existing authorisation)Specific antibody deficiency (SAD)6ImmunologySpecific antibody deficiencySpecific antibody deficiency (SAD)6ImmunologyToxic epidermal necrolysis/Stevens–Johnson syndromeToxic epidermal necrolysis (TEN)/ Stevens–Johnson syndrome (SJS)6DermatologyStaphylococcal TSSToxic shock syndrome (TSS)6ImmunologyStreptococcal TSSToxic shock syndrome (TSS)6ImmunologyAcute leukaemia in childrenAcute leukaemia in children7HaematologyAutoimmune congenital heart blockAutoimmune congenital heart block (neonatal lupus)7ImmunologyAutoimmune neutropeniaAutoimmune neutropenia7ImmunologyAutoimmune uveitisAutoimmune uveitis7ImmunologyCatastrophic antiphospholipid syndromeCatastrophic antiphospholipid syndrome7ImmunologyAcquired haemophiliaCoagulation factor inhibitors7HaematologyAcquired von Willebrand syndromeCoagulation factor inhibitors7HaematologyCoagulation factor inhibitorsCoagulation factor inhibitors7HaematologyInhibitors to factor IX in haemophilia BCoagulation factor inhibitors7HaematologyInhibitors to factor VIII in haemophilia ACoagulation factor inhibitors7HaematologyDevic disease (neuromyelitis optica)Devic disease (neuromyelitis optica)7NeurologyDiabetic amyotrophyDiabetic amyotrophy7NeurologyDiabetic lumbosacral radiculoplexus neuropathyDiabetic amyotrophy7NeurologyEpidermolysis bullosa acquisitaEpidermolysis bullosa acquisita7DermatologyEpilepsy (rare childhood cases)Epilepsy7NeurologyGraves ophthalmopathyGraves ophthalmopathy7NeurologyHaemolytic disease of the newbornHaemolytic disease of the newborn (HDN)7HaematologyHaemolytic transfusion reactionHaemolytic transfusion reaction7HaematologyHashimoto encephalopathyHashimoto encephalopathy7NeurologyHIV in childrenHIV in children7ImmunologyLimbic encephalitis, nonparaneoplasticLimbic encephalitis — nonparaneoplastic7NeurologyMyocarditis in childrenMyocarditis in children7ImmunologyPANDAS/tic disordersPaediatric autoimmune neuropsychiatric disorder associated with streptococcal infection (PANDAS)7NeurologyCerebellar degenerationParaneoplastic neurological syndromes7NeurologyLimbic encephalitisParaneoplastic neurological syndromes7NeurologySubacute sensory neuropathyParaneoplastic neurological syndromes7NeurologyPotassium channel antibody-associated encephalopathyPotassium channel antibody-associated encephalopathy7NeurologyPure red cell aplasiaPure red cell aplasia (PRCA)7HaematologyPure white cell aplasiaPure white cell aplasia (PWCA)7HaematologyPyoderma gangrenosumPyoderma gangrenosum7DermatologyRasmussen syndromeRasmussen syndrome7NeurologyScleromyxedemaScleromyxedema7NeurologySj?gren’s syndromeSj?gren’s syndrome7ImmunologySusac syndromeSusac syndrome7ImmunologySystemic capillary leak syndromeSystemic capillary leak syndrome (SCLS)7HaematologyAcute optic neuritisAcute optic neuritis8ImmunologyAcute rheumatic feverAcute rheumatic fever8ImmunologyAdrenoleukodystrophyAdrenoleukodystrophy8NeurologyAmegakaryocytic thrombocytopeniaAmegakaryocytic thrombocytopenia8HaematologyAntiphospholipid syndrome (non-obstetric)Antiphospholipid syndrome (non-obstetric)8HaematologyAplastic anaemia/pancytopeniaAplastic anaemia/pancytopenia8HaematologyAsthmaAsthma8ImmunologyAtopic dermatitis/eczema — adultAtopic dermatitis/eczema — adult8DermatologyAutismAutism8NeurologyAutologous haemopoietic stem cell transplantationAutologous haemopoietic stem cell transplantation8HaematologyBeh?et’s diseaseBeh?et’s disease8DermatologyCardiac surgery with bypass — prophylaxisCardiac surgery with bypass — prophylaxis8ImmunologyCongestive cardiac failureCongestive cardiac failure8DermatologyCrohn’s diseaseCrohn’s disease8ImmunologyDiamond Blackfan syndromeDiamond Blackfan syndrome8HaematologyFemale infertilityFemale infertility8ImmunologyGlomerulonephritis — IgA nephritisGlomerulonephritis — IgA nephritis8NephrologyHaemolytic uraemic syndromeHaemolytic uraemic syndrome8HaematologyHenoch–Sch?nlein purpuraHenoch–Sch?nlein purpura8NephrologyHIV/AIDS — adultHIV/AIDS — adult8ImmunologyIdiopathic dilated cardiomyopathyIdiopathic dilated cardiomyopathy8ImmunologyLinear IgA diseaseLinear IgA disease8DermatologyLupus cerebritisLupus cerebritis8NeurologyLupus nephritisLupus nephritis8NephrologyMotor neuron disease/amyotrophic lateral sclerosisMotor neuron disease/amyotrophic lateral sclerosis8NeurologyMyalgic encephalomyelitisMyalgic encephalomyelitis8NeurologyNarcolepsy/cataplexyNarcolepsy/cataplexy8NeurologyNephrotic syndromeNephrotic syndrome8ImmunologyObsessive compulsive disordersObsessive compulsive disorders8ImmunologyPolyneuropathy of critical illnessPolyneuropathy of critical illness8NeurologyRecurrent fetal loss (with or without antiphospholipid syndrome)Recurrent fetal loss (with or without antiphospholipid syndrome)8ImmunologyRheumatoid arthritisRheumatoid arthritis8ImmunologySepsisSepsis8ImmunologySickle cell diseaseSickle cell disease8HaematologySystemic lupus erythematosus (SLE)Systemic lupus erythematosus (SLE)8ImmunologyUlcerative colitisUlcerative colitis8ImmunologyAppendix D – Dataset of Ig supply by state/territory 2017-18Specific Condition NSWVICQLDSAWATASNTACTNationalChronic inflammatory demyelinating polyneuropathyPatients9995687191001505010472,595Average Age656363656261606464Average Weight828283858584868382Grams472,417278,432333,70643,235115,96726,0675,00515,7851,290,612Grams/Episode423931364237613438Grams per 1,000 Population614568254550203953Chronic lymphocytic leukaemiaPatients6203724009493399261,632Average Age727472717271667572Average Weight787777807680727977Grams168,09090,683114,31522,64220,1519,1482,8297,366435,223Grams/Episode292625262427252527Grams per 1,000 Population22152313818111818Common variable immunodeficiency disease (CVID)Patients920320350111100285691,876Average Age534753514652424551Average Weight7272757210173807474Grams311,301107,889124,54230,94232,1928,4631,81021,440638,578Grams/Episode202427222327502322Grams per 1,000 Population40172618131675326DermatomyositisPatients10353501321<511250Average Age514448614152?4648Average Weight67687180103130?6672Grams33,27918,83823,3665,1658,8501,250?5,66396,410Grams/Episode354132342974?3535Grams per 1,000 Population435332?144Guillain–Barré syndromePatients239194159526718916754Average Age535152505159395952Average Weight787477787782668077Grams42,69029,16325,7117,9559,2983,2451,3632,715122,139Grams/Episode353933332639435535Grams per 1,000 Population555546675Inclusion body myositisPatients63474115<5<5<5170Average Age717168717181?6870Average Weight808485796768?8282Grams21,07625,86419,6155,758338890?81074,349Grams/Episode353835292647?3035Grams per 1,000 Population344302?23ITP associated with HIVPatients<5<5<5<5Average Age?646546????61Average Weight?707670????71Grams?135225140????500Grams/Episode?277570????50Grams per 1,000 Population?000????0ITP in pregnancyPatients351111<59<5<573Average Age313328293231?3331Average Weight7772736974134?8976Grams6,2981,1851,37534076590?41010,463Grams/Episode574235575145?6851Grams per 1,000 100000?10ITP in specific circumstances (surgery, other therapy contraindicated, chronic ITP, concurrent risk factors)Patients1288611641245<5<5407Average Age656061666249417762Average Weight788077768475898079Grams21,90810,75823,1654,8753,35553834034565,283Grams/Episode504941523590348646Grams per 1,000 Population325311113ITP refractory acutePatients13612311039349<5<5456Average Age615759555953387758Average Weight787879817885886879Grams23,30816,10218,7285,8083,8352,07036027070,479Grams/Episode515239445083609047Grams per 1,000 Population334314113ITP with life-threatening haemorrhage or potential life-threatening haemorrhagePatients1711111115619679490Average Age596457624961476160Average Weight777776828095667777Grams29,96214,32514,3308,0832,0006001,0801,07871,457Grams/Episode544936555467605749Grams per 1,000 Population423511433Kawasaki diseasePatients17296521944775402Average Age444237234Average Weight181719131626141418Grams7,6334,1032,0734951,53038821813516,573Grams/Episode333021201939221928Grams per 1,000 Population110011101Lambert–Eaton myasthenic syndromePatients688<5<524Average Age625559?76??7359Average Weight807075?65??6073Grams2,8433,9973,848?625??60011,912Grams/Episode383834?37??6037Grams per 1,000 Population011?0??10Multifocal motor neuropathy with or without persistent conduction blockPatients21499131534213712560Average Age595857606162595859Average Weight798180868177968881Grams109,58762,92676,10139,46343,9387,6555,5309,235354,434Grams/Episode464335444841795843Grams per 1,000 Population141016231715222315Multiple myelomaPatients547306423904145<5131,458Average Age717170686766647070Average Weight777977818082947978Grams127,51868,099114,43321,5337,42211,2688002,935354,006Grams/Episode302624232428312427Grams per 1,000 Population161123133223715Myasthenia gravisPatients366328352386612<5201,174Average Age616362635947626062Average Weight828082798075888181Grams156,017141,890157,03011,42031,7324,965?10,965514,017Grams/Episode37382932312803934Grams per 1,000 Population20233271210?2721Neonatal haemochromatosisPatients<5<5<5<59Average Age0240?0???11Average Weight1533?3???25Grams33,08320?5???3,110Grams/Episode3563?3???49Grams per 1,000 Population000?0???0Non-Hodgkin lymphomaPatients52432656711068446161,651Average Age696868696866586268Average Weight767776797679817076Grams128,29881,259159,57122,72113,18412,7491,4903,546422,817Grams/Episode292524212328292125Grams per 1,000 Population161333135256917Other primary immunodeficiencyPatients4447171111<5<57141Average Age444425374831492841Average Weight5661475910467766862Grams12,03712,4422,8762,6842,1219266751,28435,044Grams/Episode182116191817241519Grams per 1,000 Population221212331Other relevant haematological malignanciesPatients3039415032399<55625Average Age564661593867707455Average Weight695871726075758068Grams51,30914,71436,3435,1425,5452,6788801,003117,613Grams/Episode272223231929312024Grams per 1,000 Population727325425PolymyositisPatients2068113443297511513Average Age636160675573565762Average Weight788381778085798080Grams75,46736,46957,23416,95011,1133,9701,8603,658206,720Grams/Episode363935392941453936Grams per 1,000 Population106121048898Post-haemopoietic stem cell transplantationPatients159121112261866443Average Age453448503538?4643Average Weight665868826262?6865Grams23,30017,15822,1775,4291,9381,213?91872,131Grams/Episode262021142324?2021Grams per 1,000 Population335312?23Severe combined immunodeficiency (SCID)Patients91414<5<541Average Age231522620???19Average Weight4439472053???42Grams3,2602,8412,9853081,316???10,710Grams/Episode1518191136???18Grams per 1,000 Population00101???0Stiff person syndromePatients51920<5<5<5<588Average Age585559616637?4057Average Weight807279718670?6578Grams26,2193,45011,2083901,9202,450?63046,267Grams/Episode464735303045?2641Grams per 1,000 Population312015?22Transient hypogammaglobulinaemia of infancyPatients<5<5<57Average Age?26480????18Average Weight?39585????27Grams?9313510????238Grams/Episode?23171????11Grams per 1,000 Population?000????0Wiskott–Aldrich syndromePatients<5<5<5Average Age0???35???21Average Weight5???65???41Grams24???745???769Grams/Episode3???27???21Grams per 1,000 Population0???0???0X-linked agammaglobulinaemiaPatients36471766<5<5116Average Age3034252219?24929Average Weight58625661170?483966Grams13,15516,4105,4782,2151,779?69026139,988Grams/Episode2521282620?161223Grams per 1,000 Population23111?312Chapter 5 TotalPatients5,9503,3743,9909308723068428215,623Average Age605861605461495660Average Weight757477778079747676Grams1,866,9931,062,3031,350,587263,698321,660100,62024,92991,0495,081,838Grams/Episode313228293332423031Grams per 1,000 Population239170277154125194101224208Chapter 6??????????Acute disseminated encephalomyelitisPatients281023<5<5<5<569Average Age393119?312113128Average Weight576239?1843495650Grams5,4982,4202,958?1406587833012,288Grams/Episode282127?933884127Grams per 1,000 Population101?00411Autoimmune haemolytic anaemiaPatients3332228<56<5106Average Age595259563474?8057Average Weight746476655775?5070Grams6,4353,5434,0803,928505690?4019,220Grams/Episode474132502333?4041Grams per 1,000 Population111201?01Bullous pemphigoidPatients18710<5<5<540Average Age726865756885??70Average Weight877094607370??83Grams12,1732,80511,660170518420??27,745Grams/Episode577053284353??56Grams per 1,000 Population202001??1Cicatricial pemphigoid/ mucous membrane pemphigoidPatients<5512<5<5<5<528Average Age686466585860?4963Average Weight9910275708963?10683Grams3,1505,5506,2331,4002,0102,510?1,59022,443Grams/Episode908845402693?6656Grams per 1,000 Population011115?41Evans syndromePatients<5<5<5<511Average Age35624060????48Average Weight79418079????72Grams1,1751453551,205????2,880Grams/Episode78293957????58Grams per 1,000 Population0001????0Feto-maternal/neonatal alloimmune thrombocytopenia (Antenatal)Patients<5<5<5<5<516Average Age3035323028???31Average Weight6863905870???68Grams3,4131,3831,6701,3731,910???9,748Grams/Episode7449525360???59Grams per 1,000 Population00011???0Feto-maternal/neonatal alloimmune thrombocytopenia (Neonatal)Patients966<5<5<526Average Age36015?0?04Average Weight1117348?6?213Grams5061,465231,535?10?103,548Grams/Episode2351381?3?341Grams per 1,000 Population0001?0?00Haemophagocytic syndromePatients22139<5<550Average Age5049426630???48Average Weight6976517467???68Grams2,4151,5881,250475720???6,448Grams/Episode5369284072???47Grams per 1,000 Population00000???0IgG subclass deficiency (existing authorisation)Patients1020<5<5<5<541Average Age696771667261??68Average Weight10173677617466??84Grams3,8506,8133931,0381,2131,108??14,413Grams/Episode212417272326??23Grams per 1,000 Population010102??1IgM para-proteinaemic neuropathyPatients341425<5<55<587Average Age727468667471?7571Average Weight817988877492?6683Grams13,8345,04012,5559703,1082,373?21038,089Grams/Episode403334264341?2136Grams per 1,000 Population213115?12ITP in childrenPatients40623913<5<5<56168Average Age95667812106Average Weight382226392431503729Grams3,7173,1331,5651,4538049319049311,122Grams/Episode341824251626483825Grams per 1,000 Population010101110Kidney transplantation post-transplantPatients9023454124013<57449Average Age455051444450455248Average Weight727878757984788477Grams16,95573,04515,5532,2556,4004,9253481,345120,825Grams/Episode253122313843193729Grams per 1,000 Population2123129135Kidney transplantation pre-transplantPatients55186<5<585Average Age4850554753???49Average Weight7379717576???75Grams4,150750399338125???5,762Grams/Episode388252825???25Grams per 1,000 Population10000???0Microscopic polyangiitisPatients<5<5<5<511Average Age?5626?40?51?43Average Weight?9566?69?64?77Grams?670360?1,600?65?2,695Grams/Episode?6140?34?33?39Grams per 1,000 Population?00?1?0?0Multiple sclerosis - severe relapse with no response to high dose methylprednisolonePatients5<5<5<510Average Age49?35?14??5942Average Weight72?65?66??10075Grams1,285?260?80??4002,025Grams/Episode31?19?16??13332Grams per 1,000 Population0?0?0??10Multiple sclerosis in pregnancy and the immediate post-partum periodPatients<5<5<5Average Age3633??????34Average Weight10082??????86Grams320965??????1,285Grams/Episode4064??????56Grams per 1,00000??????0Multiple sclerosis in young patients severe/relapsing/remitting in whom other therapies have failedPatients22<5<5<5<532Average Age403759??41?4342Average Weight806887??68?6578Grams5,8738551,375??83?4508,635Grams/Episode323131??83?2832Grams per 1,000 Population100??0?10Opsoclonus myoclonus ataxiaPatients77<5<5<524Average Age261718513???22Average Weight4329287216???37Grams1,3698835101,290203???4,254Grams/Episode2418155212???23Grams per 1,000 Population00010???0Pemphigus foliaceusPatients<5<5<5<5Average Age575255?????55Average Weight618471?????71Grams1201681,080?????1,368Grams/Episode408437?????40Grams per 1,000 Population000?????0Pemphigus vulgarisPatients128<5<5<5<531Average Age5555546561??6757Average Weight86659970116??6686Grams11,4243,0405,8602802,220??1,93324,756Grams/Episode8265432546??4158Grams per 1,000 Population10101??51Post-tranfusion purpuraPatients<5<5Average Age55???????55Average Weight83???????83Grams160???????160Grams/Episode80???????80Grams per 1,000 Population0???????0PR3 or MPO ANCA-positive idiopathic rapidly progressive glomerulonephritisPatients9<5<515Average Age614474?????61Average Weight9112381?????94Grams3,3835853,925?????7,893Grams/Episode509851?????53Grams per 1,000 Population001?????0Secondary hypogammaglobulinaemia (excluding haematological malignancies)Patients345223285214729<513953Average Age565460435056736656Average Weight726773507975767271Grams81,69348,32572,4133,2178,0826,4011701,837222,136Grams/Episode262223181627191623Grams per 1,000 Population108152312159Solid organ - heartPatients10<5<5<517Average Age531373?46???45Average Weight724566?64???65Grams1,135308265?65???1,773Grams/Episode265129?11???27Grams per 1,000 Population000?0???0Solid organ - heart/lungPatients12<513Average Age44???24???42Average Weight67???48???66Grams2,165???30???2,195Grams/Episode37???10???35Grams per 1,000 Population0???0???0Solid organ - liverPatients5<56Average Age17??66????25Average Weight45??65????49Grams1,078??130????1,208Grams/Episode36??65????38Grams per 1,000 Population0??0????0Solid organ - lungPatients275985<56103Average Age464751485244??47Average Weight626664634571??65Grams4,16510,612635625901,360??17,487Grams/Episode512012274522??24Grams per 1,000 Population120003??1Solid organ - otherPatients<53Average Age?49??????49Average Weight?75??????75Grams?838??????838Grams/Episode?52??????52Grams per 1,000 Population?0??????0Specific antibody deficiencyPatients14246532563<5<56334Average Age545753524444123752Average Weight6971736711691277279Grams36,89812,60614,6805,90915,731656402,08088,598Grams/Episode182222211935101719Grams per 1,000 Population523361054Staphylococcal TSSPatients172167<5<5<555Average Age532418245334?1633Average Weight824757507595?6061Grams2,1731,768550413210190?605,363Grams/Episode8447555270190?6062Grams per 1,000 Population000000?00Streptococcal TSSPatients4568301111<56175Average Age494246404063?4645Average Weight807885747285?8279Grams6,7638,8703,8331,6551,300635?88323,938Grams/Episode8167626462159?12671Grams per 1,000 Population111111?21Toxic epidermal necrolysis/Stevens–Johnson syndromePatients2032<5<59<569Average Age5850?57?38474252Average Weight7971?78?79766075Grams3,2205,015?580?2551,30812010,498Grams/Episode7055?73?324512057Grams per 1,000 Population01?0?0500Wegener granulomatosisPatients<5<5Average Age???31????31Average Weight???70????70Grams???138????138Grams/Episode???28????28Grams per 1,000 Population???0????0Chapter 6 TotalPatients1,0048816111322058119562,963Average Age514752444453424649Average Weight716870638875696971Grams240,489203,183164,43630,37346,33722,1722,99811,779721,766Grams/Episode292827312335392928Grams per 1,000 Population313334181843122930Chapter 7??????????Acute leukaemia in childrenPatients<515<518Average Age?137?0???8Average Weight?4326?7???27Grams?250350?3???603Grams/Episode?5013?3???19Grams per 1,000 Population?00?0???0Autoimmune neutropeniaPatients5<55<5<5<5<515Average Age55245451?57494752Average Weight61506465?841165867Grams615120888130?1601,4301153,458Grams/Episode32173165?806511542Grams per 1,000 Population0000?0600Autoimmune uveitisPatients<5<5<5Average Age?5553?????54Average Weight?8747?????77Grams?550210?????760Grams/Episode?5526?????42Grams per 1,000 Population?00?????0Catastrophic antiphospholipid syndromePatients<5<5<5<5<513Average Age50645155??40?51Average Weight87607293??50?77Grams1,54825689360??200?2,821Grams/Episode43252972??50?40Grams per 1,000 Population0000??1?0Cerebellar degenerationPatients<575<5<5<5<526Average Age666376526869?6265Average Weight777766896974?8276Grams6652,3151,275710840510?7357,050Grams/Episode283228475327?2932Grams per 1,000 Population000001?20Coagulation factor inhibitorsPatients6<57621Average Age50836160????60Average Weight42658568????66Grams1,7682002,6031,610????6,180Grams/Episode481005435????46Grams per 1,000 Population0011????0Devic disease (neuromyelitis optica)Patients23<58<5<540Average Age5333544735???50Average Weight7377676676???71Grams8,9091,1652,3144701,490???14,348Grams/Episode3547243438???34Grams per 1,000 Population10001???1Diabetic amyotrophyPatients<5108<5<524Average Age6461615639???61Average Weight6178728560???73Grams1,4422,6702,690275125???7,202Grams/Episode2435253418???28Grams per 1,000 Population00100???0Epidermolysis bullosa acquisitaPatients<5<5<5<5Average Age90???71??4865Average Weight81???116??7291Grams160???3,063??1,6654,888Grams/Episode40???75??5063Grams per 1,000 Population0???1??40Epilepsy (rare childhood cases)Patients<56<5<5<518Average Age121212?33??11Average Weight425137?1419??39Grams1,1881,365843?11240??3,547Grams/Episode372719?1040??26Grams per 1,000 Population000?00??0Graves ophthalmopathyPatients<5<5<5Average Age??57?57???57Average Weight??82?54???71Grams??880?630???1,510Grams/Episode??40?21???29Grams per 1,000 Population??0?0???0Haemolytic disease of the newbornPatients23255128<5<577Average Age33600?002Average Weight981333?437Grams9452,7469454031?5184,729Grams/Episode24313632?5325Grams per 1,000 Population00000?000Haemolytic transfusion reactionPatients<5<5<5<56Average Age5756?0???4936Average Weight14770?3???6059Grams60230?5???120415Grams/Episode6038?3???6038Grams per 1,000 Population00?0???00Hashimoto encephalopathyPatients125<5<522Average Age404079?42???42Average Weight767886?60???74Grams4,3951,210420?1,574???7,599Grams/Episode383935?26???35Grams per 1,000 Population100?1???0Limbic encephalitisPatients191311<5<548Average Age606158?4722??58Average Weight697167?7959??70Grams4,6204,1252,703?1,41360??12,920Grams/Episode315425?2860??34Grams per 1,000 Population111?10??1Limbic encephalitis, nonparaneoplasticPatients13969131711<5<5<5365Average Age455144504850485746Average Weight676977727778756772Grams29,49812,02039,4789555,20061029856388,621Grams/Episode333127324331302630Grams per 1,000 Population428121114Myocarditis in childrenPatients<517<5<5<527Average Age44700???3Average Weight18192646???16Grams68780903035???1,003Grams/Episode34201887???18Grams per 1,000 Population00000???0PANDAS/tic disordersPatients9<5920Average Age101212?????11Average Weight334859?????46Grams5,2981,2033,343?????9,843Grams/Episode654132?????46Grams per 1,000 Population101?????0Potassium channel antibody-associated encephalopathyPatients145<5<5<5<530Average Age465251715652??50Average Weight728375596484??73Grams5,3401,8052,0256152,5751,245??13,605Grams/Episode344846174030??36Grams per 1,000 Population100012??1Pure red cell aplasiaPatients151215<5<5<5<548Average Age474455632936?7549Average Weight697176636585?5672Grams3,5432,2235,0951102931,735?5513,053Grams/Episode384345375941?5542Grams per 1,000 Population001003?01Pure white cell aplasiaPatients<5<5Average Age????12???12Average Weight????34???34Grams????35???35Grams/Episode????35???35Grams per 1,000 Population????0???0Pyoderma gangrenosumPatients<585<5<520Average Age7762604538???62Average Weight8796938272???91Grams1,8154,0252,805988750???10,383Grams/Episode4959676627???55Grams per 1,000 Population01110???0Rasmussen SyndromePatients127<5<5<525Average Age35183035???6030Average Weight714756131???6263Grams5,3463,1851,030765???32510,651Grams/Episode42343248???1937Grams per 1,000 Population1100???10ScleromyxedemaPatients<5<5<5<5<514Average Age7167667351???66Average Weight7377905775???74Grams2,5082,7256001,8751,500???9,208Grams/Episode5232353844???39Grams per 1,000 Population00011???0Sj?gren’s syndromePatients11<5<5<5<519Average Age59863765???6059Average Weight77617171???7574Grams3,533125590665???2,6557,568Grams/Episode31182839???5937Grams per 1,000 Population0000???70Subacute sensory neuropathyPatients<588<5<5<5<529Average Age6165657057?627864Average Weight6163857281?826573Grams8951,0352,9206331,135?6532607,530Grams/Episode3124323557?332232Grams per 1,000 Population00100?310Susac syndromePatients10<5617Average Age443349?????45Average Weight857585?????84Grams7,0552,5803,220?????12,855Grams/Episode586849?????57Grams per 1,000 Population101?????1Systemic capillary leak syndromePatients7<5<5<5<5<516Average Age487037038??6744Average Weight767983588??7071Grams3,2452,6301,34320360??1,8409,438Grams/Episode4361501033??7151Grams per 1,000 Population00000??50Chapter 7 TotalPatients329219264555711820959Average Age444144383746445243Average Weight656071515774686264Grams94,45551,30679,34610,25521,1614,3602,5858,350271,817Grams/Episode373730353835454435Grams per 1,000 Population12816688112111Chapter 8??????????Antiphospholipid syndrome (non-obstetric)Patients<5<5Average Age??????42?42Average Weight??????60?60Grams??????60?60Grams/Episode??????60?60Grams per 1,000 Population??????0?0SepsisPatients<5<55Average Age?3641?????39Average Weight?3659?????49Grams?14385?????228Grams/Episode?7117?????33Grams per 1,000 Population?00?????0Chapter 8 TotalPatients<5<5<56Average Age?3641???42?39Average Weight?3659???60?51Grams1438560288Grams/Episode?7117???60?36Grams per 1,000 Population?00???0?0JDO IssuePatients<5<5Average Age3???????3Average Weight13???????13Grams25???????25Grams/Episode25???????25Grams per 1,000 Population0???????0TotalPatients7,2304,4474,8331,1141,12639211235719,414Average Age585559575259475457Average Weight747276748078737474Grams2,201,9621,316,9341,594,453304,326389,158127,15130,571111,1776,075,733Grams/Episode313128303133423130Grams per 1,000 Population282211326177152245124273249Note: The national patient count only includes one count for each patient. This may result in the sum of the state and territory totals being greater than the national total.Appendix E – Grams Ig Issued by State and Territory??NSWVICQLDSAWATASNTACT2007-08Imported Ig105,633111,01085,05518,41638,44511,740?16,875?Domestic Ig599,126423,170400,144108,596148,98652,7556,82527,3932008-09Imported Ig249,905131,228171,36727,60442,89519,965?14,200?Domestic Ig562,320417,574383,865128,511143,62853,74510,50322,8412009-10Imported Ig252,416101,930200,26431,24416,24817,110?11,550?Domestic Ig668,526507,038439,089143,285162,96361,6868,61033,2252010-11Imported Ig136,72893,835107,79827,38330,1088,8438011,900?Domestic Ig887,016577,260631,545139,296167,74576,1979,09945,5402011-12Imported Ig265,995144,284183,43535,77559,90012,1383014,708?Domestic Ig874,995570,969674,277145,134150,29473,49113,44052,4462012-13Imported Ig467,371321,085361,65472,61392,91416,4369,55126,648?Domestic Ig804,375484,680589,662123,810132,10864,3056,74448,4802013-14Imported Ig469,174312,713291,46087,90170,70924,06910,42930,626?Domestic Ig934,478584,561771,037138,876168,29567,7766,03653,7232014-15Imported Ig593,045416,868458,189107,343111,57041,60812,86132,199?Domestic Ig930,412579,560735,658135,795155,97757,9874,86359,2102015-16Imported Ig724,960451,770584,275103,165159,63148,00318,48941,264?Domestic Ig1,004,528643,340771,182167,599152,90053,2075,58952,6012016-17Imported Ig914,742480,381639,087114,989174,90849,71218,20545,305?Domestic Ig1,057,386732,525821,999182,943192,43755,9697,21554,7102017-18Imported Ig1,075,907622,547735,052137,655196,17962,59920,10452,953?Domestic Ig1,104,220731,611874,582174,543204,55165,34111,20259,674Appendix F – Unique Patients by Quarter and State and TerritoryYearQuarterNSWVICQLDSAWATASNTACTAUST2009-10Q12,4341,3671,644400380183231126,508Q22,4961,3781,667440356177201096,619Q32,5541,3861,682395353183151026,640Q42,6021,4511,752413371189221206,8892010-11Q12,6921,4921,839420376197221437,148Q22,7811,5331,886394394205211327,315Q32,7521,5321,884396376211151307,262Q42,7911,6221,946417385197231427,4962011-12Q12,9211,6582,047419407199271427,794Q22,9711,6282,115428413206221377,898Q32,9491,5902,150430401203231507,860Q42,9611,6322,215458405202291548,0192012-13Q13,1071,7512,391449449205321688,494Q23,1391,8092,360462436196261718,557Q33,2111,7532,298454410183331648,465Q43,3091,8212,378463425187361708,7372013-14Q13,4061,8902,472506435204361819,081Q23,4281,9712,510481472209361729,237Q33,4401,9522,583502454213301889,317Q43,5502,0422,660493513215341889,6532014-15Q13,7132,1502,7635455182384118910,099Q23,7252,1692,7195065212283220210,057Q33,7332,1612,7725305102152519110,096Q43,8462,2492,8685555142233120210,4402015-16Q14,1012,3543,0265875542344620211,033Q24,1032,3463,0675915832253819811,081Q34,1612,3583,0735955832264119711,164Q44,2632,4003,1326016022275020711,4242016-17Q14,4422,4743,2026416502263921111,827Q24,4992,5163,2796516822174016112,022Q34,6222,5833,2966456632144622112,253Q44,7722,6733,4036446802285421912,6212017-18Q14,9722,8183,5286657422495523513,215Q24,9572,7853,5766917282566123413,238Q35,0162,8483,5766997132725524613,387Q45,1712,9933,6667187752866226813,878Appendix G – System Source for Tables and Figures TOC \h \z \c "Table" Table 1Growth in Ig grams issued since 2008-09IDMSTable 2Percentage change in grams issued over time by state and territoryIDMSTable 3Annual numbers of patients, treatment episodes and gramsSTARS and BloodSTAR Table 4Basic numbersSTARS and BloodSTAR Table 5Patient numbers and average weight by age rangeSTARS and BloodSTAR Table 6Issues of domestic Ig compared with imported IgIDMS Table 7Issues of domestic Ig compared with imported Ig and public versus privateIDMS Table 8Ig issues (g) by criteria chapterSTARS and BloodSTAR Table 9Ig issues by criteria chapter (percentage)STARS and BloodSTAR Table 10Ig grams issued for top 10 medical conditions over timeSTARS and BloodSTAR Table 11Difference in grams issued for secondary hypogammaglobulinaemia (percentage)STARS and BloodSTAR Table 12Patient numbers and age for the top 20 specific conditions by private and public facilitiesSTARS and BloodSTAR Table 13Ig grams issued by clinical specialitySTARS and BloodSTAR Table 14Grams of Ig issued by state and territoryIDMS Table 15Grams of Ig issued per 1,000 population by state and territory for top 10 specific conditionsSTARS and BloodSTAR Table 16Ig grams per kg weight per episodeSTARS and BloodSTAR Table 17Patient numbers for products issued by state and territory in 2017-18STARS and BloodSTAR Table 18Grams of product issued by state and territory in 2017-18 PAGEREF _Toc18845782 \h 36Table 19Treatment episode numbers for products issued by state and territory in 2017-18STARS and BloodSTAR Table 20Patient numbers for products issued by medical condition in 2017-18STARS and BloodSTAR Table 21Grams of product issued by medical condition in 2017-18STARS and BloodSTAR Table 22Treatment episodes for product issued by medical condition in 2017-18STARS and BloodSTAR Table 23NHIg issued from 2013-14 to 2017-18IDMS Table 24Grams of NHIg issued by state and territoryIDMS Table 25Grams per 1,000 population of NHIg issued by state and territoryIDMS TOC \h \z \c "Figure" Figure 1Ten year trends in issues of IgIDMS Figure 2Ten year trends in expenditure on IgIDMS Figure 3Patients per 1,000 population 2016-17 and 2017-18STARS and BloodSTAR Figure 4Grams of Ig per 1,000 population by state and territory over timeIDMS Figure 5Patient age compared to average Australian ageSTARS and BloodSTAR Figure 6Patient weights relative to Australian averageSTARS and BloodSTAR Figure 7Ig expenditure as a proportion of the national blood budgetIDMS Figure 8Ig grams issued by medical conditionSTARS and BloodSTAR Figure 9Proportion of Ig used for top 10 medical conditionsSTARS and BloodSTAR Figure 10Ig issues by clinical specialitySTARS and BloodSTAR Figure 11Percentage Ig issues by clinical speciality for top 10 medical conditionsSTARS and BloodSTAR Figure 12Grams per episode by specific conditionSTARS and BloodSTAR Figure 13Grams per kg weight by specific conditionSTARS and BloodSTAR Figure 14NHIg grams issued and grams issued per 1,000 populationIDMS REF _Ref379893813 \h \* MERGEFORMAT Appendix D – Dataset of Ig supply by state/territory ………………………………………………………………………………………………………………………………STARS and BloodSTAR REF _Ref393440546 \h Appendix E – Grams Ig Issued by State and Territory …………………………………………………………………………………………………………………………………………….……..…..IDMS REF _Ref393440549 \h Appendix F – Unique Patients by Quarter and State and Territory …………………………………………………………………………………………………………. STARS and BloodSTAR ................
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