List of Tables - National Blood Authority | National Blood ...



-990600-9048750nATIONAL REPORT ON THE ISSUE AND USE OF IMMUNOGLOBULIN (Ig)Annual Report 2016-17With 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 2016-17.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 _Toc25579331 \h 4List of Figures PAGEREF _Toc25579332 \h 4Introduction PAGEREF _Toc25579333 \h 5Report Snapshot PAGEREF _Toc25579334 \h 7Methodology PAGEREF _Toc25579335 \h 8Data quality PAGEREF _Toc25579336 \h 910 Year Trends PAGEREF _Toc25579337 \h 11Demand Trends PAGEREF _Toc25579338 \h 11Financial Trends PAGEREF _Toc25579339 \h 12Demographics PAGEREF _Toc25579340 \h 14Patient Numbers PAGEREF _Toc25579341 \h 14Geographic Distribution PAGEREF _Toc25579342 \h 15Age PAGEREF _Toc25579343 \h 16Weight PAGEREF _Toc25579344 \h 17Expenditure PAGEREF _Toc25579345 \h 19Clinical Indications PAGEREF _Toc25579346 \h 22Ig issues by criteria chapter PAGEREF _Toc25579347 \h 22Ig issues by medical condition PAGEREF _Toc25579348 \h 23Ig issues by specific condition PAGEREF _Toc25579349 \h 25Ig issues by clinical speciality PAGEREF _Toc25579350 \h 28Ig grams issued per 1,000 population PAGEREF _Toc25579351 \h 29Dosing PAGEREF _Toc25579352 \h 31IVIg and SCIg PAGEREF _Toc25579353 \h 33NHIg PAGEREF _Toc25579354 \h 40Appendix A – Background PAGEREF _Toc25579355 \h 42Appendix B – Acronyms and Glossary PAGEREF _Toc25579356 \h 46Appendix C – Conditions mapping table PAGEREF _Toc25579357 \h 49Appendix D – Dataset of Ig supply by state/territory 2016-17 PAGEREF _Toc25579358 \h 56Appendix E – Grams Ig Issued by State and Territory PAGEREF _Toc25579359 \h 79Appendix F – Unique Patients by Quarter and State and Territory PAGEREF _Toc25579360 \h 80Appendix G – System Source for Tables and Figures PAGEREF _Toc25579361 \h 81List of Tables TOC \h \z \c "Table" Table 1Growth in Ig grams issued since 2007-08 PAGEREF _Toc25579362 \h 11Table 2Percentage change in grams issued over time by state and territory PAGEREF _Toc25579363 \h 12Table 3Annual numbers of patients, treatment episodes and grams PAGEREF _Toc25579364 \h 14Table 4Basic numbers PAGEREF _Toc25579365 \h 14Table 5Patient numbers and average weight by age range PAGEREF _Toc25579366 \h 18Table 6Issues of domestic Ig compared with imported Ig PAGEREF _Toc25579367 \h 20Table 7Issues of domestic Ig compared with imported Ig and public versus private PAGEREF _Toc25579368 \h 21Table 8Ig issues (g) by Criteria chapter PAGEREF _Toc25579369 \h 22Table 9Ig issues by Criteria chapter (percentage) PAGEREF _Toc25579370 \h 22Table 10Ig grams issued for top 10 medical conditions over time PAGEREF _Toc25579371 \h 24Table 11Difference each year in grams issued for kidney transplantation (percentage) PAGEREF _Toc25579372 \h 24Table 12Patient numbers and age for the top 20 specific conditions by private and public facilities PAGEREF _Toc25579373 \h 26Table 13Ig grams issued by clinical speciality PAGEREF _Toc25579374 \h 28Table 14Grams of Ig issued by state and territory PAGEREF _Toc25579375 \h 29Table 15Grams of Ig issued per 1,000 population by state/territory for top 10 specific conditions PAGEREF _Toc25579376 \h 30Table 16Ig grams per kg weight per episode PAGEREF _Toc25579377 \h 32Table 17Patient numbers for products issued by state and territory in 2016-17 PAGEREF _Toc25579378 \h 34Table 18Grams of product issued by state and territory in 2016-17 PAGEREF _Toc25579379 \h 35Table 19Treatment episode numbers for products issued by state and territory in 2016-17 PAGEREF _Toc25579380 \h 36Table 20Patient numbers for products issued by medical condition in 2016-17 PAGEREF _Toc25579381 \h 37Table 21Grams of product issued by medical condition in 2016-17 PAGEREF _Toc25579382 \h 38Table 22Treatment episodes for product issued by medical condition in 2016-17 PAGEREF _Toc25579383 \h 39Table 23NHIg issued from 2012-13 to 2016-17 PAGEREF _Toc25579384 \h 40Table 24Grams of NHIg issued by state and territory PAGEREF _Toc25579385 \h 41Table 25Grams per 1,000 population of NHIg issued by state and territory PAGEREF _Toc25579386 \h 41List of Figures TOC \h \z \c "Figure" Figure 1Ten year trends in issues of Ig PAGEREF _Toc25579387 \h 11Figure 2Ten year trends in expenditure on Ig PAGEREF _Toc25579388 \h 13Figure 3Patients per 1,000 population 2015-16 and 2016-17 PAGEREF _Toc25579389 \h 15Figure 4Grams of Ig per 1,000 population by state and territory over time PAGEREF _Toc25579390 \h 16Figure 5Patient age compared to average Australian age PAGEREF _Toc25579391 \h 16Figure 6Patient weights relative to Australian average PAGEREF _Toc25579392 \h 17Figure 7Ig expenditure as a proportion of the national blood budget PAGEREF _Toc25579393 \h 19Figure 8Ig grams issued by medical condition PAGEREF _Toc25579394 \h 23Figure 9Proportion of Ig used for top 10 medical conditions PAGEREF _Toc25579395 \h 25Figure 10Ig issues by clinical speciality PAGEREF _Toc25579396 \h 28Figure 11Percentage Ig issues by clinical speciality for top 10 medical conditions PAGEREF _Toc25579397 \h 29Figure 12Grams per episode by specific condition PAGEREF _Toc25579398 \h 31Figure 13Grams per kg weight by specific condition PAGEREF _Toc25579399 \h 32Figure 14NHIg grams issued and grams issued per 1,000 population PAGEREF _Toc25579400 \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 2016-17, 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 citeria 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 Intravenous 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, the Criteria identifies the conditions and circumstances for which the use of Ig is funded under national blood arrangements.The Criteria clearly articulates and 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 outlines 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 49% of total blood expenditure in 2016-17. 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 88.3% of all Ig supplied in 2016-17, and for this reason specific analysis focuses on these groups.Report Snapshot20955021463017,958 patients7,682 new patientsMedian age 63 yearsPATIENTSTotal cost of $530.15 million49% of total blood budgetEXPENDITURE5.54 million grams issued227 grams per 1,000 population44% imported productIg USE017,958 patients7,682 new patientsMedian age 63 yearsPATIENTSTotal cost of $530.15 million49% of total blood budgetEXPENDITURE5.54 million grams issued227 grams per 1,000 population44% 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 2016-17, data has been captured on 56,379 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 this 2016-17 report 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 2016-17 a total of 5,542,511 grams of Ig was issued, representing an increase of 560,008 grams (11.2%) over 2015-16. Since 2007-08 there has been an on average 11.3% 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 2007-082007-082008-092009-102010-112011-122012-132013-142014-152015-162016-17Growth from previous year13%11%12%11%11%11%11%10%12%11%Average Growth from 2007-085%8%9%10%11%12%13%15%16%Total grams per 1,000 population102111121133145158173188208227Increase in grams per 1,000 population over previous year11%8%10%10%9%9%9%9%11%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 territoryNSWVICQLDSAWATASNTACT2007-0818%8%16%14%6%5%1%29%2008-0915%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%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 2016-17 was $303.6 million, an increase of $7.2 million (2.4%) over 2015-16 ( REF _Ref253557293 \h Figure 2). The increased expenditure predominately represents increases in demand offset by decreases in 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. In 2016-17 this increase was offset by a reduced cost by the Blood Service due to efficiencies recognised. Combined with expenditure for plasma for fractionation, Ig accounts for a total expenditure of $530.2 million (excluding hyperimmune plasma for fractionation).Figure SEQ Figure \* ARABIC 2Ten year trends in expenditure on IgDemographicsPatient NumbersA total of 17,958 patients were issued Ig under the national blood arrangements during 2016-17 for 179,997 treatment episodes. This represents a 10.0% increase in the number of patients since 2015-16. A summary of some patient numbers is provided in REF _Ref477773716 \h Table 3 and REF _Ref386098046 \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 Issued2012-1313,102110,1833,622,4332013-1413,981122,7914,021,8612014-1514,983140,8554,433,1462015-1616,331159,0414,982,5032016-1717,958179,9975,542,511Table SEQ Table \* ARABIC 4Basic numbers2016-17Total unique patient IDs with some weight data17,744Total unique patient IDs with an age recorded17,958Total unique patient IDs with more than one state or territory117Total unique patient IDs with two states or territories115Total unique patient IDs with three or more states or territories<5Total unique patient IDs with more than one condition389Total unique patient IDs with two conditions370Total unique patient IDs with three conditions19Total unique patient IDs aged 65 and older8,094Total unique patient IDs aged 17 and younger1,669Total unique new patient IDs7,682Average Age57Median Age63Average Weight (kg)75Geographic DistributionNationally, 0.7 patients per 1,000 population received Ig in 2016-17. This varied between states and territories, ranging from 0.3 in NT to 0.9 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, except Tasmania (TAS) and the NT.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 2015-16 and 2016-17There is significant variation between jurisdictions in Ig use in grams per 1,000 population, ranging from 103.3 in the NT to 299.2 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 143.3 grams per 1,000 population in Western Australia (WA) to 299.2 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.Prior to 2014-15 WA had shown only slight increases in the number of grams issued per 1,000 population, while most states and territories have seen a continued increase in Ig issued per 1,000 population. However, in 2015-16 and 2016-17 WA had the highest increase in growth of Ig issued per 1,000 population as noted in REF _Ref393362413 \h \* MERGEFORMAT Figure 4, but none the less WA(except NT) remains the lowest Ig issued per 1,000 population.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 2016-17 patients. REF _Ref380064918 \h \* MERGEFORMAT Figure 6 compares the weight of Ig recipients in Australia in 2016-17 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 (78.5 kg) is slightly higher than the average weight of an Australian adult (77.7 kg). This is a change from previous years where it has been lower, 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 2016-17.Table SEQ Table \* ARABIC 5Patient numbers and average weight by age range Age RangePatient CountsAverage WeightTreatment EpisodesGrams Dispensed0-4782122,53923,4175-9380252,45934,86910-14305452,89055,42115-17200642,37450,95018-19106691,29026,96020-24395704,159110,54025-29420744,109134,02330-34569785,676172,18835-39565776,493193,30840-44674807,182241,54445-49844819,005299,02450-541,1128311,926407,53855-591,5668116,963562,02660-641,9408220,583651,58965-692,2338023,316732,96870-742,1858022,964716,44375-791,7227717,366533,91480-841,1247411,224333,31885-89639705,722162,98690-94174671,58539,62395-10423631724,862Total17,95875179,9975,487,511ExpenditureIn 2016-17, Australian expenditure on Ig products was $303.6 million, with additional expenditure of $226.6 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 49% of the total blood budget, at a total expenditure of $530.2 million (excluding hyperimmune plasma for fractionation).Figure SEQ Figure \* ARABIC 7Ig expenditure as a proportion of the national blood budgetOf the Ig supplied under national blood arrangements in Australia in 2016-17, 56% (3,105,183 grams) was manufactured domestically and 44% (2,437,328 grams) was imported from overseas ( REF _Ref254189034 \h Table 6). This represents a 14.3% increase in product importation from 2015-16 (305,772 grams). Domestic supply is driven by the amount of plasma for fractionation collected in Australia and this increased by 6.0% in 2016-17 over 2015-16. Intragam P, Intragam 10 (IVIg) and Evogam (SCIg) were Ig products manufactured domestically in 2016-17. The imported products available were Kiovig (IVIg), Octagam (IVIg), Privigen (IVIg), Flebogamma (IVIg), Hizentra (SCIg) and Gammanorm (SCIg). When a patient is allocated to receive one of the imported products it is the clinician’s choice as to which product they order. Supply of Privigen constituted 63.7% of the supply of imported Ig. REF _Ref6761179 \h Table 7 shows the split between Ig issues for domestic and imported products, by public and private Australian Health Providers (AHPs) for 2016-17.Table SEQ Table \* ARABIC 6Issues of domestic Ig compared with imported Ig?NSW?NSWVICQLDSAWATASNTACTAUSDomestic Ig Intragam Pgm833,259515,505558,645125,001129,67838,7484,62040,8332,246,289$(m)$52$32$35$8$8$2$0$3$139Intragam 10gm202,535208,198244,74552,02356,66516,8902,28813,628796,970$(m)$13$13$15$3$4$1$0$1$49Evogamgm21,5928,82218,6095,9196,09433130725061,924$(m)$1$1$1$0$0$0$0$0$4Total Domesticgm1,057,386732,525821,999182,943192,43755,9697,21554,7103,105,183$(m)$66$45$51$11$12$3$0$3$193Imported IgKioviggm3,5821,8461,198000006,625$(m)$0$0$0$0$0$0$0$0$0Octagamgm6,0741,3731,047000008,494$(m)$0$0$0$0$0$0$0$0$1Gammanormgm2240000003228$(m)$0$0$0$0$0$0$0$0$0Flebogammagm371,178141,616165,02739,03853,99816,5317902,583790,758$(m)$17$6$7$2$2$1$0$0$36Privigengm501,585332,585449,53566,195116,03530,67517,41537,9651,551,990$(m)$23$15$20$3$5$1$1$2$70Hizentragm32,1002,96222,2819,7564,8752,50604,75479,234$(m)$2$0$1$1$0$0$0$0$5Total Importedgm914,742480,381639,087114,989174,90849,71218,20545,3052,437,328$(m)$42$22$29$5$8$2$1$2$111Proportion of domestic to imported Iggm %54%60%56%61%52%53%28%55%56%$(m) %61%68%64%68%60%60%35%62%63%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 Publicgm772,012 424,069 306,590 153,558 124,418 44,539 7,215 54,710 1,887,111 Privategm285,374 308,456 515,409 29,385 68,019 11,430 - - 1,218,072 Total Domesticgm1,057,386 732,525 821,999 182,943 192,437 55,969 7,215 54,710 3,105,183 Imported IgPublicgm745,092 304,448 310,356 108,779 128,944 39,668 18,145 45,305 1,700,735 Privategm169,651 175,933 328,732 6,210 45,965 10,044 60 - 736,593 Total Importedgm914,742 480,381 639,087 114,989 174,908 49,712 18,205 45,305 2,437,328 Total Ig Publicgm1,517,104 728,517 616,945 262,337 253,361 84,207 25,360 100,015 3,587,845 Privategm455,024 484,389 844,141 35,595 113,983 21,474 60 - 1,954,665 Total Iggm1,972,128 1,212,905 1,461,086 297,931 367,345 105,681 25,420 100,015 5,542,511 Domestic to ImportedPublicgm%50.9%58.2%49.7%58.5%49.1%52.9%28.4%54.7%52.6%Privategm%62.7%63.7%61.1%82.6%59.7%53.2%0.0%0.0%62.3%Total Iggm%53.6%60.4%56.3%61.4%52.4%53.0%28.4%54.7%56.0%Ig as portion of NationalPublicgm%42.3%20.3%17.2%7.3%7.1%2.3%0.7%2.8%100.0%Privategm%23.3%24.8%43.2%1.8%5.8%1.1%0.0%0.0%100.0%Total Iggm%35.6%21.9%26.4%5.4%6.6%1.9%0.5%1.8%100.0%Population %32.0%25.6%20.0%7.0%10.5%2.1%1.0%1.7%100.0%Grams Per 1000 PopulationPublic194.5 116.7 126.3 152.8 98.8 162.0 103.0 245.6 147.1 Private58.3 77.6 172.9 20.7 44.5 41.3 0.2 - 80.2 Total Ig252.9 194.3 299.2 173.5 143.3 203.3 103.3 245.6 227.3 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 837g are mainly for emergency sepsis cases. Refer to Appendix D for further information. Table SEQ Table \* ARABIC 8Ig issues (g) by Criteria chapter2012-132013-142014-152015-162016-17Chapter 53,025,4523,409,1003,785,6154,223,8664,620,916Chapter 6453,352463,361494,489535,596645,636Chapter 7120,979148,581178,221216,927220,122Chapter 839005837Total3,599,8314,021,0424,458,3264,976,3945,487,511Table SEQ Table \* ARABIC 9Ig issues by Criteria chapter (percentage)2012-132013-142014-152015-162016-17Chapter 584%85%85%85%84%Chapter 613%12%11%11%12%Chapter 73%4%4%4%4%Chapter 8<1%0%0%0%0%For conditions where Ig is used only in exceptional circumstances (Chapter 7), five medical conditions accounted for 54.4% of those issues. These medical conditions were Limbic Encephalitis – nonparaneoplastic (66,445g), Paraneoplastic neurological syndromes (18,557g), Devic disease (neuromyelitis optica) (12,597g), Potassium channel antibody-associated encephalopathy (11,312g) and Sj?gren’s syndrome (10,928g). 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 2016-17 there were only two 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, but has improved with the introduction of BloodSTAR.Ig issues by medical conditionThe top ten medical conditions account for 88.3% of all Ig supplied, with the top three medical conditions accounting for 56.5%.Acquired hypogammaglobulinaemia — haematological malignancy and post HSCT is the medical condition for which the greatest percentage of Ig was issued in 2016-17 (22.4%), closely followed by chronic inflammatory demyelinating polyneuropathy (CIDP) (21.3%). Primary immunodeficiency diseases (PID) with antibody deficiency accounted for 12.8% of total Ig use ( REF _Ref253562849 \h \* MERGEFORMAT Figure 8 and REF _Ref23156299 \h Table 10).Since 2012-13 there has been a greater than 15% increase in Ig issues for both myasthenia gravis (MG) and inflammatory myopathies, a more than 14% increase for secondary hypogammaglobulinaemia (including iatrogenic immunodeficiency) and a more than 12% increase in issues for acquired hypogammaglobulinaemia — haematological malignancy and post HSCT, and multifocal motor neuropathy (MMN). 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 time2012-132013-142014-152015-162016-17% Change 2016-17 to 2015-16Acquired hypogammaglobulinaemia 771,071862,898982,7731,106,7211,228,40511.0%Chronic inflammatory demyelinating polyneuropathy 758,271857,533974,2581,071,1351,171,5819.4%Primary immunodeficiency diseases509,364558,617614,781660,816701,5476.2%Myasthenia gravis 257,966313,940348,336402,881456,34613.3%Multifocal motor neuropathy 209,791239,314256,041293,458331,14212.8%Inflammatory myopathies)188,362230,473249,229293,422329,18212.2%Immune thrombocytopenic purpura (ITP) — adult178,738186,640187,621210,094211,8680.8%Secondary hypogammaglobulinaemia 106,484110,024126,561145,497180,83124.3%Kidney transplantation84,93197,07090,03188,258122,99439.4%Guillain–Barré syndrome 104,360108,929105,567124,692114,184-8.4%Kidney transplantation grams dispensed falls into the top ten medical conditions in 2016-17, replacing specific antibody deficiency. NSW, Victoria (VIC) and QLD all showed an increase in dispenses of Ig for kidney transplantation in 2016-17 ( REF _Ref23156358 \h Table 11). In 2016-17 grams per patient ranged from 112 grams in SA, 110 grams in NT and 128 grams in NSW to 321 grams in QLD and 428 grams in TAS.Table SEQ Table \* ARABIC 11Difference each year in grams issued for kidney transplantation (percentage)2012-132013-142014-152015-162016-17NSW24%-8%-11%-13%43%VIC-5%28%4%-3%45%QLD71%-12%1%-15%46%SA34%23%-57%66%-2%WA122%7%-44%24%20%TAS-23%196%-15%28%22%NT99%-19%-98%2980%-61%ACT450%395%-88%268%-63%Total18%14%-7%-2%39%The top ten medical conditions by state and territory by proportion of all conditions are depicted in REF _Ref17050562 \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% 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 may 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 polyneuropathy418,305 (8%)920 (2%)64753,276 (14%)1,553 (4%)621,171,581 (21%)2,379 (6%)63Common variable immunodeficiency disease 158,688 (3%)535 (4%)57459,940 (8%)1,346 (4%)49618,627 (11%)1,808 (8%)51Myasthenia gravis157,223 (3%)384 (5%)62299,123 (5%)753 (4%)60456,346 (8%)1,090 (8%)61Chronic lymphocytic leukaemia184,966 (3%)784 (1%)73198,161 (4%)801 (2%)71383,127 (7%)1,526 (3%)72Non-Hodgkin lymphoma210,297 (4%)850 (4%)69162,778 (3%)675 (4%)65373,074 (7%)1,483 (7%)67Multifocal motor neuropathy 96,589 (2%)175 (1%)59234,553 (4%)366 (2%)58331,142 (6%)527 (2%)58Multiple myeloma165,469 (3%)687 (2%)71138,975 (3%)666 (3%)68304,444 (6%)1,302 (4%)70Polymyositis51,506 (1%)127 (0%)62131,379 (2%)332 (2%)60182,885 (3%)446 (2%)61Secondary hypogammaglobulinaemia 74,824 (1%)302 (1%)60106,008 (2%)514 (3%)51180,831 (3%)781 (4%)55Kidney transplantation post-transplant10,068 (0%)34 (1%)50107,497 (2%)421 (2%)47117,564 (2%)442 (3%)47Guillain–Barré syndrome27,347 (0%)173 (0%)5786,837 (2%)528 (1%)52114,184 (2%)690 (1%)54Other relevant haematological malignancies55,810 (1%)231 (1%)6654,904 (1%)348 (1%)49110,714 (2%)555 (2%)56Dermatomyositis18,447 (0%)51 (1%)6164,001 (1%)176 (2%)4782,448 (2%)218 (3%)50Specific antibody deficiency25,865 (0%)96 (0%)5954,886 (1%)216 (1%)4780,751 (1%)301 (2%)51ITP refractory acute24,493 (0%)158 (1%)6351,156 (1%)332 (2%)5975,648 (1%)482 (2%)60Limbic encephalitis, nonparaneoplastic16,129 (0%)67 (0%)5150,316 (1%)215 (1%)4666,445 (1%)279 (1%)47ITP in specific circumstances (surgery, other therapy contraindicated, chronic ITP)23,648 (0%)124 (0%)6540,221 (1%)278 (2%)5963,868 (1%)396 (2%)61Inclusion body myositis22,543 (0%)58 (1%)6841,307 (1%)99 (2%)7163,850 (1%)152 (2%)70Post-haemopoietic stem cell transplantation18,900 (0%)90 (0%)5338,147 (1%)299 (1%)3957,046 (1%)375 (1%)42ITP with life-threatening haemorrhage 15,861 (0%)102 (0%)6439,851 (1%)294 (0%)5655,712 (1%)395 (0%)58Ig issues by clinical specialityThe number of grams of Ig issued categorised according to clinical speciality is shown in REF _Ref253563362 \h Figure 10 and REF _Ref23156566 \h Table 13. Some specific conditions prior to 2016-17 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. Since 2012-13, 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 speciality2012-132013-142014-152015-162016-17Neurology1,649,3581,916,7922,120,1112,407,9952,672,261Haematology1,026,1771,116,0371,234,8161,390,8241,530,340Immunology695,298746,828828,735885,9331,053,712Other228,947241,386274,664291,643231,199There is significant variation across Australia in Ig use for each clinical speciality (as allocated). REF _Ref23156659 \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 kidney transplantation pre-transplant. In total, for the five largest states, there was proportionally low Ig issues per 1,000 population in SA and WA, and proportionally 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 populationNSW1,972,12835.6%32.0%253VIC1,212,90521.9%25.6%194QLD1,461,08626.4%20.0%299SA297,9315.4%7.0%173WA367,3456.6%10.5%143TAS105,6811.9%2.1%203NT25,4200.5%1.0%103ACT100,0151.8%1.7%246Total5,542,511100%100%227 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 in REF _Ref6843471 \h Table 15 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 polyneuropathy5442612345402433482.7Common variable immunodeficiency disease 381626191217650253.1Myasthenia gravis191221136131019163.8Chronic lymphocytic leukaemia18192971110022194.2Non-Hodgkin lymphoma1411311241849157.7Multifocal motor neuropathy 1310152014142018141.9Multiple myeloma15921731814128.5Polymyositis861010342883.1Secondary hypogammaglobulinaemia 96122390576.4Kidney transplantation post-transplant112411101157.9DosingFigure SEQ Figure \* ARABIC 12Grams per episode by specific condition REF _Ref386112223 \h 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 an 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 _Ref17031558 \h Figure 13 and REF _Ref386094763 \h 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) 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 polyneuropathy7,282 (25%)12,571 (43%)1,194 (4%)120 (0%)8,139 (28%)0.51Common variable immunodeficiency disease 6,518 (30%)7,304 (34%)73 (0%)7 (0%)7,731 (36%)0.41Myasthenia gravis3,462 (28%)5,341 (43%)295 (2%)36 (0%)3,253 (26%)0.47Chronic lymphocytic leukaemia5,733 (40%)4,721 (33%)4 (0%)0 (0%)3,731 (26%)0.38Non-Hodgkin lymphoma5,830 (41%)4,245 (30%)18 (0%)4 (0%)4,172 (29%)0.37Multifocal motor neuropathy 1,283 (18%)3,473 (47%)549 (8%)18 (0%)1,985 (27%)0.59Multiple myeloma4,645 (41%)3,719 (33%)2 (0%)1 (0%)2,939 (26%)0.37Polymyositis1,097 (23%)2,205 (46%)222 (5%)9 (0%)1,256 (26%)0.50Secondary hypogammaglobulinaemia 2,729 (37%)2,650 (36%)50 (1%)5 (0%)1,948 (26%)0.39Kidney transplantation post-transplant1,324 (37%)1,349 (38%)444 (13%)58 (2%)376 (11%)0.56Note: 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 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 2016-17. Tables 20-22 show patient numbers, grams issued and treatment episodes by medical conditions for IVIg and SCIg products in 2016-17.Table SEQ Table \* ARABIC 17Patient numbers for products issued by state and territory in 2016-17IVIgSCIgStateFlebogamma 5 percentFlebogamma 10 percentIntragam PIntragam 10Kiovig 10 percentOctagam 5 percentOctagam 10 percentPrivigen 10 per centSCIg EvogamSCIg GammanormSCIg HizentraTotalNSW5017073,4942,4207595811,5158071186,627VIC1124002,361568382516992560104,134QLD2503452,2884433715241,295580634,428SA101036342052200161290181,043WA39132572130<50<5276210311,115TAS84316335007100<508339NT0<533130004200083ACT<561704800084<5<518308AUS9151,7329,6523,8541731351284,4442461026017,958Note: 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 2016-17IVIgSCIgStateFlebogamma 5 percentFlebogamma 10 percentIntragam PIntragam 10Kiovig 10 percentOctagam 5 percentOctagam 10 percentPrivigen 10 per centSCIg EvogamSCIg GammanormSCIg HizentraTotalNSW153,229217,040.00850,740185,5504,6193,7644,529499,99023,68726738,2751,981,690VIC39,31196,465.00520,668188,7383,1601,4591,175324,0107,75502,6691,185,409QLD70,49289,075.00572,562227,2381,4487801,050446,59018,275021,8771,449,386SA2,94533,390.00129,43543,0801,9850063,4404,61008,506287,391SA15,09137,745.00128,61349,36080030112,7855,33604,131353,171TAS2,75114,030.0040,92914,8600028431,02021602,332106,422NT0625.004,4521,78800016,9803070024,152ACT332,780.0041,54412,32800038,480318404,06299,583AUS283,850491,150.002,288,943722,94011,2916,0037,0681,533,29560,50530781,8525,487,204Note: The use of 307 grams of NHIg for one patient is not included in the above table.Table SEQ Table \* ARABIC 19Treatment episode numbers for products issued by state and territory in 2016-17IVIgSCIgStateFlebogamma 5 percentFlebogamma 10 percentIntragam PIntragam 10Kiovig 10 percentOctagam 5 percentOctagam 10 percentPrivigen 10 per centSCIg EvogamSCIg GammanormSCIg HizentraTotalNSW4,3835,42326,8565,86212211512012,3574,198503,99863,484VIC1,1422,48117,1736,5036938258,400880023736,948QLD2,6582,63021,5848,50456263214,173861095151,475SA898814,5091,48842001,56941807039,699WA4419424,2501,726<50<52,615446059311,016TAS1003631,5115360078391201593,527NT02213662000325500550ACT<5651,5144530008754263423,298AUS8,81412,80777,53325,12429117918541,1536,862566,983179,997Table SEQ Table \* ARABIC 20Patient numbers for products issued by medical condition in 2016-17?IVIgSCIg?Medical ConditionFlebogamma 5 percentFlebogamma 10 percentIntragam PIntragam 10Kiovig 10 percentOctagam 5 percentOctagam 10 percentPrivigen 10 per centSCIg EvogamSCIg GammanormSCIg HizentraTotalAcquired hypogammaglobulinaemia — haematological malignancy and post HSCT48614,1261,8892292334631<5435,217Primary immunodeficiency diseases (PID) with antibody deficiency28411,6566335579116291602,120Secondary hypogammaglobulinaemia (including iatrogenic immunodeficiency)2718546260<5<5<56729030754Specific antibody deficiency (SAD)75270880<50724028343Note: 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 2016-17IVIgSCIgMedical ConditionFlebogamma 5 percentFlebogamma 10 percentIntragam PIntragam 10Kiovig 10 percentOctagam 5 percentOctagam 10 percentPrivigen 10 per centSCIg EvogamSCIg GammanormSCIg HizentraTotalAcquired hypogammaglobulinaemia — haematological malignancy and post HSCT11,75212,830814,995267,11881926967797,7006,241.6715,9991,228,405Primary immunodeficiency diseases (PID) with antibody deficiency5,7276,910439,440123,03337817842723,38045,36530056,410701,547Secondary hypogammaglobulinaemia (including iatrogenic immunodeficiency)7,0864,940106,02935,243651109520,0353,999.203,230180,831Specific antibody deficiency (SAD)1,48064562,88918,33502802,1704,899.206,06996,515Table SEQ Table \* ARABIC 22Treatment episodes for product issued by medical condition in 2016-17IVIgSCIgMedical ConditionFlebogamma 5 percentFlebogamma 10 percentIntragam PIntragam 10Kiovig 10 percentOctagam 5 percentOctagam 10 percentPrivigen 10 per centSCIg EvogamSCIg GammanormSCIg HizentraTotalAcquired hypogammaglobulinaemia — haematological malignancy and post HSCT43846830,52610,188329263,841425<51,38947,319Primary immunodeficiency diseases (PID) with antibody deficiency25026016,1274,634105117195,482554,65532,203Secondary hypogammaglobulinaemia (including iatrogenic immunodeficiency)3322074,2351,507<55<579735102787,719Specific antibody deficiency (SAD)55232,5947930<5010260406434,815NHIgIn 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 _Ref18655743 \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 2012-13 to 2016-17Product2012-132013-142014-152015-162016-17Normal Immunoglobulin 2VI - 2ml (grams)69965416711243Normal Immunoglobulin 2VI - 5ml (grams)30,46624,6495,4093,2542,806Total (grams)31,16525,3035,5763,3662,849Grams Per 1,000 Population1.361.090.240.140.12Table SEQ Table \* ARABIC 24Grams of NHIg issued by state and territory?2012-132013-142014-152015-162016-17NSW9,6346,91582238351VIC6,9036,7472,278489411QLD1,6402,7741,4721,134401SA6,5434,4319369801,164WA5,2613,458593848TAS3442721544335NT24191351215ACT816514480432424OTHER0 0 80 0 0 Australia31,1655 25,302 5,5763,366 2,849 Table SEQ Table \* ARABIC 25Grams per 1,000 population of NHIg issued by state and territoryPer 1,000 Population2012-132013-142014-152015-162016-17NSW1.310.930.010.030.05VIC1.211.160.380.080.07QLD0.360.590.310.240.08SA3.932.640.550.570.68WA2.141.380.020.010.02TAS0.670.530.300.080.07NT0.100.790.140.050.06ACT2.151.331.221.081.04Australia1.361.090.240.140.12Appendix 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 2016-17Intragam P (6% 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 Behring2016-17Flebogamma (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) exist 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 intravenous 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 FractionationA 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 2016-17Specific Condition?NSWVICQLDSAWATASNTACTAUSChapter 5??????????Chronic inflammatory demyelinating polyneuropathyPatients912518644841593811372,379Average Age646362666161596363Average Weight828384828184928083Grams420,647259,475296,52239,123115,58320,7275,87613,6291,171,581Grams/Episode413832374533673338Grams per 1,000 Population544261234540243348Chronic lymphocytic leukaemiaPatients581328369105912810251,526Average Age727372707068617572Average Weight787677807686737578Grams146,91977,459104,91022,24114,6316,7502,5447,675383,127Grams/Episode292624252429282527Grams per 1,000 Population19122113613101916Common variable immunodeficiency disease (CVID)Patients84630935511610429<5681,808Average Age534954524250514851Average Weight737073697670867472Grams293,756101,892128,79033,02930,8448,6701,42520,221618,627Grams/Episode212526221924492222Grams per 1,000 Population38162619121765025DermatomyositisPatients8053441212513218Average Age504952544149?5150Average Weight666473799682?6870Grams26,53816,93220,7285,6655,1613,100?4,32582,448Grams/Episode354036333256?3436Grams per 1,000 Population334326?113Guillain–Barré syndromePatients250155150435916<514690Average Age54535164555374454Average Weight827978757473258779Grams47,31123,77722,7776,5998,1742,5201502,877114,184Grams/Episode344236363135303936Grams per 1,000 Population645435175Inclusion body myositisPatients44553415<5<5<5<5152Average Age746966716878?7570Average Weight808282797771?8081Grams16,64227,23713,9765,208402356?3063,850Grams/Episode353736312732?3035Grams per 1,000 Population243301?03ITP associated with HIVPatients<5<5<57Average Age?335438????40Average Weight?787372????75Grams?235225189????649Grams/Episode?343838????36Grams per 1,000 Population?000????0ITP in pregnancyPatients34192287<5<592Average Age3032293130?193030Average Weight7976728767?566276Grams6,5142,0834,1121,4471,174?5760515,992Grams/Episode6156534859?574356Grams per 1,000 10110?011ITP in specific circumstances (surgery, other therapy contraindicated, chronic ITP, concurrent risk factors)Patients1159010928417<5<5396Average Age626063615863585861Average Weight817879778293876980Grams21,22110,24721,2614,2724,87182338778763,868Grams/Episode494941415269654946Grams per 1,000 Population324222223ITP refractory acutePatients112150112484111<56482Average Age606060616170517360Average Weight757779828380738078Grams20,25018,49619,6919,9344,0041,0493021,92475,648Grams/Episode505541515952765349Grams per 1,000 Population334622153ITP with life-threatening haemorrhage or potential life-threatening haemorrhagePatients158798241198<55395Average Age566156586565646858Average Weight747478788286748476Grams25,3929,39510,9506,1461,5758093531,09255,712Grams/Episode465238625362396447Grams per 1,000 Population322412132Kawasaki diseasePatients1731235318316<5<5411Average Age433232553Average Weight171716141615192517Grams6,7514,7481,9855321,25326515315215,838Grams/Episode312428172629385127Grams per 1,000 Population110001101Lambert–Eaton myasthenic syndromePatients6712<526Average Age606669?75???67Average Weight758883?65???82Grams2,9623,1344,260?650???11,006Grams/Episode394035?41???38Grams per 1,000 Population011?0???0Multifocal motor neuropathy with or without persistent conduction blockPatients185101126444613<513527Average Age595758605961595658Average Weight808180858381918781Grams104,29465,05371,22534,83536,4487,0534,8907,345331,142Grams/Episode454435495334604743Grams per 1,000 Population131015201414201814Multiple myelomaPatients536259376583833<591,302Average Age717070666665607270Average Weight777976878484767078Grams114,93354,193104,65712,7336,4509,5442621,673304,444Grams/Episode302724232527222227Grams per 1,000 Population1592173181412Myasthenia gravisPatients353291311416913<5181,090Average Age616261645949375661Average Weight817982827868808581Grams144,019119,154140,14811,81827,2164,992358,966456,346Grams/Episode373631293328354034Grams per 1,000 Population1819297111002219Neonatal haemochromatosisPatients<5<5<5<511Average Age2624?028???22Average Weight6962?3107???60Grams5,1193,711?8800???9,638Grams/Episode8079?4100???80Grams per 1,000 Population11?00???0Non-Hodgkin lymphomaPatients45329752310753365151,483Average Age686867686766606367Average Weight767977778079837377Grams108,16870,601149,87620,38510,2219,3841,0103,430373,074Grams/Episode292724222623292426Grams per 1,000 Population141131124184815Other primary immunodeficiencyPatients433414129<5<5<5120Average Age424725334931472640Average Weight536548528157766660Grams12,22110,2182,6232,7222,02886968869432,061Grams/Episode122117161619251215Grams per 1,000 Population221212321Other relevant haematological malignanciesPatients2778112826339<56555Average Age565460673166666456Average Weight706774716480837771Grams46,58014,16836,1225,7124,1952,3562051,376110,714Grams/Episode272523191925292624Grams per 1,000 Population627325135PolymyositisPatients186751094322<5<57446Average Age625861645779505961Average Weight778481777479918480Grams65,80135,07349,52817,9348,6252,0105053,410182,885Grams/Episode354334353044634536Grams per 1,000 Population86101034288Post-haemopoietic stem cell transplantationPatients164868022175<5<5375Average Age443746433640593242Average Weight706268736476506967Grams22,38912,75815,7333,2931,5521,0208022457,046Grams/Episode282123192018203224Grams per 1,000 Population323212012Severe combined immunodeficiency (SCID)Patients111019<5<543Average Age2117201623???20Average Weight3840404170???41Grams2,3072,2564,213113755???9,643Grams/Episode1215181631???16Grams per 1,000 Population00100???0Stiff person syndromePatients42720<55<5<577Average Age595358615836?3156Average Weight827279717770?6978Grams20,3613,65311,0122852,6431,989?24040,182Grams/Episode424436263449?2240Grams per 1,000 Population312014?12Wiskott–Aldrich syndromePatients<5<5<5<5Average Age3215??33???28Average Weight6052??81???68Grams66168??713???947Grams/Episode3324??26???26Grams per 1,000 Population00??0???0X-linked agammaglobulinaemiaPatients39481866<5<5<5121Average Age32332720195329830Average Weight606059605278522559Grams12,14016,5446,5822,1061,6596074143740,269Grams/Episode26212729133023923Grams per 1,000 Population231110312Chapter 5 TotalPatients5,5043,1313,6628668532645725214,488Average Age595961615560525660Average Weight757577777678757676Grams1,693,297962,6551,241,902246,326291,62484,34419,66281,1084,620,916Grams/Episode313328303430442931Grams per 1,000 Population21715425414311416280199190Chapter 6??????????Acute disseminated encephalomyelitisPatients301527<5<5581Average Age37242401329??28Average Weight59465794568??55Grams5,9742,4694,13420361682??13,640Grams/Episode333134101836??32Grams per 1,000 Population101001??1Autoimmune haemolytic anaemiaPatients3735227<5<5<5107Average Age53706373595165?63Average Weight68797471769159?74Grams6,2704,4563,0483,37551825545?17,966Grams/Episode42483632182845?38Grams per 1,000 Population1112000?1Bullous pemphigoidPatients21611<5<5<543Average Age706968756484??69Average Weight8476891326870??83Grams14,1493,0537,478400542560??26,182Grams/Episode475446672462??47Grams per 1,000 Population202001??1Churg-Strauss syndromePatients<5<5Average Age????63???63Average Weight????80???80Grams????185???185Grams/Episode????23???23Grams per 1,000 Population????0???0Cicatricial pemphigoid/ mucous membrane pemphigoidPatients<5<57<5<5<5<521Average Age617370724745?4865Average Weight828782728750?9783Grams3,6654,2583,2022,2951,728470?3,14518,763Grams/Episode807139342278?8750Grams per 1,000 Population011111?81Evans syndromePatients<510<5<515Average Age17586226????51Average Weight47787766????74Grams1051,062320181????1,668Grams/Episode265916026????54Grams per 1,000 Population0000????0Feto-maternal/neonatal alloimmune thrombocytopenia (Antenatal)Patients5<5<5<5<5<519Average Age2932232634??027Average Weight7978507686??370Grams5,7172,1391,2783,8331,713??914,688Grams/Episode9953497182??373Grams per 1,000 Population10021??01Feto-maternal/neonatal alloimmune thrombocytopenia (Neonatal)Patients155<5<5<5<5<531Average Age207000?02Average Weight8317322?27Grams691151,2091633?31,940Grams/Episode22347233?326Grams per 1,000 Population000000?00Haemophagocytic syndromePatients15149<5<5<544Average Age4244524645?38?45Average Weight6068638058?59?64Grams1,9712,1921,40340417?152?6,175Grams/Episode4752314052?15?42Grams per 1,000 Population00000?1?0IgG subclass deficiency (existing authorisation)Patients1121<5<5<5<542Average Age686582657156??65Average Weight9974607718667??84Grams4,4917,363511,0751,1061,679??15,764Grams/Episode312310242322??25Grams per 1,000 Population110103??1IgM para-proteinaemic neuropathyPatients381134656<5<5102Average Age736967647270547069Average Weight818183737382986581Grams15,5113,63012,6371,3503,8091,42729515538,814Grams/Episode383029305446745235Grams per 1,000 Population213113102ITP in childrenPatients254050198<5<5<5149Average Age6678651367Average Weight292930362921702630Grams3,6212,1922,1162,2392402527014710,875Grams/Episode332122322411701626Grams per 1,000 Population000100000Kidney transplantation post-transplantPatients7224864202412<5<5442Average Age444850454044412447Average Weight727881777278906578Grams11,53972,03121,8802,5613,7425,311239263117,564Grams/Episode233219273944272928Grams per 1,000 Population11241110115Kidney transplantation pre-transplantPatients441975<5<579Average Age485045574539??49Average Weight758188858455??78Grams2,9651,010563245392255??5,430Grams/Episode391116412828??23Grams per 1,000 Population000000??0Microscopic polyangiitisPatients<5<5<5<57Average Age?5030?35?41?40Average Weight?12370?60?83?91Grams?456146?316?530?1,448Grams/Episode?4624?21?44?34Grams per 1,000 Population?00?0?2?0Multiple sclerosis - severe relapse with no response to high dose methylprednisolonePatients7<5920Average Age495249?????50Average Weight767079?????76Grams1,6187771,491?????3,886Grams/Episode283239?????33Grams per 1,000 Population000?????0Multiple sclerosis in pregnancy and the immediate post-partum periodPatients<5<5<5Average Age34?27?????29Average Weight63?77?????72Grams125?118?????243Grams/Episode25?39?????30Grams per 1,0000?0?????0Multiple sclerosis in young patients severe/relapsing/remitting in whom other therapies have failedPatients19<5<5<525Average Age404259????4543Average Weight849087????6084Grams7,076767835????2008,878Grams/Episode332838????2033Grams per 1,000 Population100????00Opsoclonus myoclonus ataxiaPatients137<5<5<528Average Age14252502???16Average Weight3034157112???30Grams2,0051,0324871,355227???5,105Grams/Episode201913658???21Grams per 1,000 Population00010???0Pemphigus foliaceusPatients<5<5<56Average Age655555?????56Average Weight629285?????84Grams3201,5751,195?????3,090Grams/Episode408733?????50Grams per 1,000 Population000?????0Pemphigus vulgarisPatients12<57<5<524Average Age593559?55??4156Average Weight887088?111??7088Grams7,7731,5583,490?1,824??27814,923Grams/Episode617145?47??3554Grams per 1,000 Population101?1??11Post-tranfusion purpuraPatients<5<5Average Age????84???84Average Weight????58???58Grams????60???60Grams/Episode????60???60Grams per 1,000 Population????0???0PR3 or MPO ANCA-positive idiopathic rapidly progressive glomerulonephritisPatients<5<5611Average Age644772?????68Average Weight8920081?????91Grams3401982,549?????3,087Grams/Episode349945?????45Grams per 1,000 Population001?????0Secondary hypogammaglobulinaemia (excluding haematological malignancies)Patients28718023015471610781Average Age565357514261596355Average Weight7264745663801006370Grams68,25634,92660,4143,2987,2054,646332,055180,831Grams/Episode272123201627331823Grams per 1,000 Population9612239057Solid organ - heartPatients10<5<5<514Average Age481354?51???44Average Weight814268?65???73Grams1,494221445?120???2,279Grams/Episode204423?120???23Grams per 1,000 Population000?0???0Solid organ - heart/lungPatients5<5<5<510Average Age521943?33???36Average Weight704259?84???62Grams1,18517654?140???1,555Grams/Episode311027?70???26Grams per 1,000 Population000?0???0Solid organ - liverPatients<5<5<56Average Age26?2460????30Average Weight40?7674????55Grams207?221825????1,253Grams/Episode35?625????16Grams per 1,000 Population0?00????0Solid organ - lungPatients22666<5<5<5104Average Age445138515048??49Average Weight586757585671??64Grams3,1239,055531855346735??14,645Grams/Episode272212203827??23Grams per 1,000 Population010001??1Solid organ - otherPatients<5<5Average Age?37??????37Average Weight?59??????59Grams?862??????862Grams/Episode?57??????57Grams per 1,000 Population?0??????0Specific antibody deficiencyPatients11744492067<57301Average Age525551554651114051Average Weight716971717384277271Grams32,16111,13313,6845,42115,8052141202,21380,751Grams/Episode182323191715101919Grams per 1,000 Population423360053Staphylococcal TSSPatients13115<55<539Average Age40504126398??39Average Weight797664657243??71Grams1,9761,330539497550209??5,101Grams/Episode948967415552??73Grams per 1,000 Population000000??0Streptococcal TSSPatients4251191011<5<5<5141Average Age464242385054455044Average Weight80737463721057610075Grams6,3466,1142,3278811,54820035960418,377Grams/Episode75688042772005115172Grams per 1,000 Population110110111Toxic epidermal necrolysis/Stevens–Johnson syndromePatients25226<5<5<5<564Average Age5137?545937503445Average Weight6768?758466658569Grams3,4833,219?8462903785023419,059Grams/Episode5459?457395844356Grams per 1,000 Population01?001210Wegener granulomatosisPatients<5<5<5<5Average Age?736130????49Average Weight?6510078????80Grams?25180353????558Grams/Episode?254527????31Grams per 1,000 Population?000????0Chapter 6 TotalPatients8858125841372036417352,722Average Age504952464449434449Average Weight706972647072726670Grams214,152179,289148,02231,95843,18417,2762,3459,411645,636Grams/Episode302925282233372928Grams per 1,000 Population272930191733102326Chapter 7??????????Acute leukaemia in childrenPatients97<517Average Age?98?6???9Average Weight?3238?22???33Grams?947112?58???1,117Grams/Episode?3911?10???28Grams per 1,000 Population?00?0???0Autoimmune neutropeniaPatients<55<5<5<5v14Average Age525748?45?485952Average Weight537273?67?1194173Grams665514475?130?1,209903,083Grams/Episode395130?22?714545Grams per 1,000 Population000?0?500Autoimmune uveitisPatients<5<5<5Average Age4959??????57Average Weight9574??????79Grams2351,012??????1,247Grams/Episode3463??????54Grams per 1,000 Population00??????0Catastrophic antiphospholipid syndromePatients8<5<5<516Average Age373867?45???45Average Weight7511374?86???83Grams1,617579675?280???3,151Grams/Episode445334?56???43Grams per 1,000 Population000?0???0Cerebellar degenerationPatients<576<5<5<5<521Average Age706064556564?4862Average Weight638165757083?7473Grams3101,1351,310601,365540?1484,868Grams/Episode282621306530?3030Grams per 1,000 Population000011?00Coagulation factor inhibitorsPatients<5<55<5<516Average Age7175556855???63Average Weight54651026750???75Grams1,3191203,6101,075100???6,224Grams/Episode4760743150???54Grams per 1,000 Population00110???0Devic disease (neuromyelitis optica)Patients24<555<5<5<540Average Age5030505757645?49Average Weight70596668871875?69Grams7,8077901,3854751,800125215?12,597Grams/Episode35382025691654?34Grams per 1,000 Population1000101?1Diabetic amyotrophyPatients<56615Average Age637163?????65Average Weight787675?????76Grams1,1911,4961,160?????3,847Grams/Episode264231?????33Grams per 1,000 Population000?????0Epidermolysis bullosa acquisitaPatients<5<5<55Average Age?72??69??4764Average Weight?79??126??8199Grams?474??3,190??1,8005,464Grams/Episode?95??69??5867Grams per 1,000 Population?0??1??40Epilepsy (rare childhood cases)Patients55<5<5<517Average Age151316?87??13Average Weight455147?2730??45Grams8431,882941?40060??4,126Grams/Episode303824?3330??31Grams per 1,000 Population000?00??0Graves ophthalmopathyPatients<5<5<5Average Age??52?55???53Average Weight??76?47???70Grams??1,360?95???1,455Grams/Episode??40?32???39Grams per 1,000 Population??0?0???0Haemolytic disease of the newbornPatients2523<5109<5<5880Average Age0022070001Average Weight33493254237Grams837981321,40063451,727Grams/Episode332035833316Grams per 1,000 Population000010000Haemolytic transfusion reactionPatients<5<5<5Average Age45??0????23Average Weight60??3????32Grams180??3????183Grams/Episode60??3????46Grams per 1,000 Population0??0????0Hashimoto encephalopathyPatients8<5<5518Average Age424478?47???46Average Weight777978?65???74Grams2,9401,050446?1,993???6,428Grams/Episode303525?34???31Grams per 1,000 Population000?1???0Limbic encephalitisPatients111216<57<5<5<553Average Age484847724017735849Average Weight688676776268565674Grams2,2402,1792,4164957791351102528,605Grams/Episode3036322625135371831Grams per 1,000 Population000000010Limbic encephalitis, nonparaneoplasticPatients8763102712<5<5<5279Average Age495144395943432847Average Weight727075687070546772Grams19,54212,00627,6359673,8639522201,26166,445Grams/Episode303429263829225031Grams per 1,000 Population326122133Myocarditis in childrenPatients<518<5<5<5<529Average Age32151?0?2Average Weight11117188?2?11Grams69444246230?6?635Grams/Episode1414122115?6?14Grams per 1,000 Population00000?0?0PANDAS/tic disordersPatients13<55<5<523Average Age914101813???11Average Weight3348506060???41Grams2,1582,1961,283125132???5,893Grams/Episode4131312533???34Grams per 1,000 Population00000???0Potassium channel antibody-associated encephalopathyPatients15<5<5<5<5<527Average Age475755605951??52Average Weight757473537287??75Grams6,0986081,1046081,4701,425??11,312Grams/Episode383253363627??36Grams per 1,000 Population100013??0Pure red cell aplasiaPatients121312<5<539Average Age563451?8848??48Average Weight745176?8288??69Grams3,0608253,292?801,560??8,816Grams/Episode363638?8040??38Grams per 1,000 Population001?03??0Pyoderma gangrenosumPatients612<5<5<523Average Age675960534728??59Average Weight7997686970100??88Grams2,5005,978200690670???10,038Grams/Episode69524057420??54Grams per 1,000 Population01000???0Rasmussen SyndromePatients13<5<5<5<522Average Age34443934???3637Average Weight727268137???5772Grams3,8471,3701,146660???7897,812Grams/Episode43312947???2536Grams per 1,000 Population0000???20ScleromyxedemaPatients5<5<5<5<515Average Age6664687236???62Average Weight7575805784???73Grams2,7313,4459602,190280???9,606Grams/Episode4537693540???41Grams per 1,000 Population01010???0Sj?gren’s syndromePatients13<55<5<525Average Age57814655???5256Average Weight72677272???7572Grams4,5105271,4601,511???2,92010,928Grams/Episode33201847???5734Grams per 1,000 Population1001???70Subacute sensory neuropathyPatients<577<5<521Average Age6364556465?49?61Average Weight5578867262?80?75Grams9558722,260428250?320?5,085Grams/Episode2642322736?80?33Grams per 1,000 Population00000?1?0Susac syndromePatients9513Average Age49?47?????48Average Weight87?86?????86Grams7,746?2,776?????10,522Grams/Episode61?39?????53Grams per 1,000 Population1?1?????0Systemic capillary leak syndromePatients7<55<5<516Average Age395633???06640Average Weight688272???18069Grams1,5992,2003,352???31,7608,914Grams/Episode397142???38852Grams per 1,000 Population001???040Chapter 7 TotalPatients275202200446115921824Average Age424245424438363442Average Weight646073536268584764Grams74,24142,72559,4629,37918,3644,8022,0869,064220,122Grams/Episode363731334431514735Grams per 1,000 Population107125798229Chapter 8?Aplastic anaemia/pancytopeniaPatients<5<5Average Age?79??????79Average Weight?78??????78Grams?78??????78Grams/Episode?78??????78Grams per 1,000 Population?0??????0SepsisPatients<5<5Average Age?41??????41Average Weight?82??????82Grams?663??????663Grams/Episode?133??????133Grams per 1,000 Population?0??????0Chapter 8 TotalPatients55Average Age?49??????49Average Weight?82??????82Grams741741Grams/Episode?124??????124Grams per 1,000 Population?0??????0choreaPatients<5<5Average Age??????10?10Average Weight??????32?32Grams??????60?60Grams/Episode??????60?60Grams per 1,000 Population??????0?0contact with a measles patientPatients<5<5Average Age???81????81Average Weight???92????92Grams???36????36Grams/Episode???36????36Grams per 1,000 Population???0????0TotalPatients6,6274,1344,4281,0431,1153398330817,958Average Age575660585257495457Average Weight747377747477737375Grams1,981,6901,185,4091,449,386287,699353,171106,42224,15299,5835,487,511Grams/Episode313228303230443030Grams per 1,000 Population25419029716813820598245225Note: 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??NSWVICQLDSAWATASNTACT2006-07Imported Ig103,27088,39879,39318,37520,57711,065?7170Domestic Ig493,172407,244337,30192,958155,82150,5836,73226,4702007-08Imported 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 Ig1,057,386732,525821,999182,943192,43755,9697,21554,710Appendix F – Unique Patients by Quarter and State and TerritoryYearQuarterNSWVICQLDSAWATASNTACTAUST2009-10Q12,4341,3671,644400380183231126,508Q22,4961,3781,667440356177201096,619Q32,5541,3861,682395353183151026,640Q42,6021,4511,752413371189221206,8892010-11Q12,6921,4921,839420376197221437,148Q22,7811,5331,886394394205211327,315Q32,7521,5321,884396376211151307,262Q42,7911,6221,946417385197231427,4962011-12Q12,9211,6582,047419407199271427,794Q22,9711,6282,115428413206221377,898Q32,9491,5902,150430401203231507,860Q42,9611,6322,215458405202291548,0192012-13Q13,1071,7512,391449449205321688,494Q23,1391,8092,360462436196261718,557Q33,2111,7532,298454410183331648,465Q43,3091,8212,378463425187361708,7372013-14Q13,4061,8902,472506435204361819,081Q23,4281,9712,510481472209361729,237Q33,4401,9522,583502454213301889,317Q43,5502,0422,660493513215341889,6532014-15Q13,7132,1502,7635455182384118910,099Q23,7252,1692,7195065212283220210,057Q33,7332,1612,7725305102152519110,096Q43,8462,2492,8685555142233120210,4402015-16Q14,1012,3543,0265875542344620211,033Q24,1032,3463,0675915832253819811,081Q34,1612,3583,0735955832264119711,164Q44,2632,4003,1326016022275020711,4242016-17Q14,4422,4743,2026416502263921111,827Q24,4992,5163,2796516822174016112,022Q34,6222,5833,2966456632144622112,253Q44,7722,6733,4036446802285421912,621Appendix G – System Source for Tables and Figures TOC \h \z \c "Table" Table 1Growth in Ig grams issued since 2007-08IDMSTable 2Percentage change in grams issued over time by state and territoryIDMSTable 3Annual numbers of patients, treatment episodes and gramsSTARS and BloodSTARTable 4Basic numbersSTARS and BloodSTAR Table 5Patient numbers and average weight by age rangeSTARS and BloodSTAR Table 6Issues of domestic Ig compared with imported IgIDMSTable 7Issues of domestic Ig compared with imported Ig and public versus privateIDMSTable 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 kidney transplantation (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 2016-17STARS and BloodSTAR Table 18Grams of product issued by state and territory in 2016-17STARS and BloodSTAR Table 19Treatment episode numbers for products issued by state and territory in 2016-17STARS and BloodSTAR Table 20Patient numbers for products issued by medical condition in 2016-17STARS and BloodSTAR Table 21Grams of product issued by medical condition in 2016-17STARS and BloodSTAR Table 22Treatment episodes for product issued by medical condition in 2016-17STARS and BloodSTAR Table 23NHIg issued from 2012-13 to 2016-17IDMSTable 24Grams of NHIg issued by state and territoryIDMSTable 25Grams per 1,000 population of NHIg issued by state and territoryIDMS TOC \h \z \c "Figure" Figure 1Ten year trends in issues of IgIDMSFigure 2Ten year trends in expenditure on IgIDMSFigure 3Patients per 1,000 population 2015-16 and 2016-17STARS 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 budgetIDMSFigure 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 ................
................

In order to avoid copyright disputes, this page is only a partial summary.

Google Online Preview   Download