Annual Report 2018/19

December 2019 Compiled by Mark Foster MDSAS

www.ivig.nhs.uk

CHAPTER Database Overview 11 Rob Hollingsworth

Introduction

This year we are celebrating ten years of the National Immunoglobulin Database. Over this period the database has time and again proved its worth during product shortages, recalls, monitoring of changes in prescribing practices and national product procurement. The database is unique in its completeness and ability to provide the detailed information required to manage immunoglobulin therapy nationally. The database continues to adapt to changes in service needs and prescribing policies, with this year seeing the introduction of IT developments for Sub Regional Immunoglobulin Assessment Panels (SRIAP)s and Home Therapy Management for patients.

Since its inception ten years ago, the database has captured information on almost 90,000 patients and 105,000 separate treatment episodes. Trusts have entered over 1.6 million treatment entries, accounting for over 47 million grams of immunoglobulin recorded on the database - this equates in value (at an average price of per gram of £34) to almost £1.6 billion.

The continuing success of the database is thanks to the hard work of those entering data and I would as always like to thank Trusts and their staff that continue to support and provide data to the National Im- munoglobulin Database. The considerable work undertaken to manage the collection and entry of data is recognised and very much appreciated. NHS England, through its continuing support for the database have also been fundamental to the long-term success of the database.

This year the database has been involved in devising IT solutions to support stakeholders with the introduction of SRIAPs. In addition, the database has also been helping to manage product shortage situations and monitor prescribing practices, providing information, and working closely with NHS England, CMU and Trusts. The CMU continues to utilise the database to support the supply and procurement of immunoglobulins.

Referencing data from the database, the annual increase in immunoglobulin sales continues at approximately 10%. In-line with previous expectations it is expected that national costs for immunoglobulin products will be around £240 million per annum next year.

Database Developments

During the year the database has developed and piloted an IT solution to support the introduction of SRI- APs. The solution allows Trusts to make electronic referral requests for treatment to Panels using the Na- tional Immunoglobulin Database. Panels are able to access the referral requests and respond to Trusts with a decision on the prescribing of Ig therapy. During the pilot, the solution was very well received by Trusts and Panels. Feedback gathered from the pilots has been utilised to further develop the solution before wider roll-out.

www.ivig.nhs.uk Page 3 National Immunoglobulin Database Report 2018/19

The database continues to be used extensively by NHS England to support commissioning and therapy initiatives for immunoglobulins. Initiatives for Immune Thrombocytopenic Purpura (ITP) dosing in accordance to guidelines, monitored through the database, are estimated to have saved almost £5 million in 2018/19.

The highly successful patient home diary application for immunoglobulin patients on home therapy has now been launched. The system links patients in community with hospital clinicians, allowing them to review patient’s therapy diary entries in real-time. Treatment centres wishing to use the system should contact us at [email protected].

Annual Meeting

The annual database meeting is to be held at The Royal College of Physicians, London. The event is again a great success with all available places for the meeting taken. A big thank you must go to all our speakers, and to all attendees and sponsors who, with their feedback and support, help make the meeting so successful.

Annual Report

This report provides an analysis of immunoglobulin usage across England. Communications from key stakeholders are also included. Feedback on the annual report is very welcome from all stakeholders. If there is something additional that you would like to see in the report then please send your suggestions to support@ mdsas.com.

www.ivig.nhs.uk Page 4

CHAPTER Commissioning Update 21 Rob Coster

Overview

NHS England is the responsible commissioner for immunoglobulin (Ig), which is one of the top ten high cost drugs commissioned. In 2018/19 NHS England spent £228million on Ig, with the volumes purchased increasing by approximately 10% each year.

Globally there is increasing demand and a rapidly increasing range of clinical indications that are treated with Ig, therefore there is need to manage supply and to ensure that all those patients that meet the indications for use in the commissioning criteria have access to this often lifesaving treatment. NHS England over the last three years has been working with MDSAS, clinicians and patient groups to responsibly plan and manage this valuable resource, to safeguard access for those in need.

The project to improve this stewardship includes the following:

• Development of Criteria for Commissioning of Ig, updating the previous guidelines. • The implementation of Sub Regional Ig Assessment panels • Reviews of long-term patients and dosing of Ig treatments. • Improved recording f usage and outcome data on the MDSAS Ig database

Criteria for Commissioning of Ig

NHS England has produced criteria for commissioning to move away from commissioning by colour coding to an evidence-based policy approach with either a routinely or not routinely commissioned position.

As a principle, unless clinical practice identifies changes to blue, red or black indications, these will be translat- ed directly into routinely commissioned (red / blue) or not routinely (black) commissioned positions. Phase 1 of this updated commissioning criteria has been completed and published for immunology, haematology, neurology and some infectious diseases. The criterias have been developed by the Ig policy working group following wide consultation with specialty experts, relevant scientific societies and the respective Clinical Reference Groups for haematology, immunology, neurology and infectious diseases. Recommendations on Ig dose and outcomes are based on a combination of available evidence and expert opinion. These have been published and are available and cover approximately 75% of current Ig usage.

Phase 2 covering rheumatology, dermatology, remaining infectious disease and other indications will be published in March/April 2020. This document will be a complete criterion for commissioning document. NHS England will continue to commission grey indications in line with the Current Clinical Guidelines for Ig use (2nd edition update; July 2011) until phase 3 is complete.

The third phase will be based on a detailed evidence review of the use of Ig in disorders previously categorised as grey indications including new/emerging indications, where the evidence base is weak or absent, or the disease was rare. As with red and blue indications, only those grey indications which are supported by adequate evidence of Ig efficacy will be commissioned once this review is complete in 2021. www.ivig.nhs.uk Page 5 National Immunoglobulin Database Report 2018/19

Sub Regional Immunoglobulin Assessment Panels

Over the past 18 months NHS England has established, and now funds, 21 Sub-Regional Immunoglobulin Assessment Panels (SRIAPs) aimed at improving Ig stewardship and reducing variation in decision making across England. These panels have been reviewing new and current Ig usage against the criteria for commissioning and we are now seeing the benefit of this hard work with declining growth.

Resources and a range of data to support trusts and commissioners with the development and running of SRIAPS are also in development. This includes improving the quality of data to enhance forecasting capabil- ity via the MDSAS database, CMU usage and a minimum data set.

Reviews of long-term patients and dosing of Ig treatments

One of the core purposes of the SRIAPs is to review usage in long-term patients and dosing for new users. A key area of success over the past 18 months has been the usage of Ig in immune thrombocytopenia (ITP). Historically about 60% of dosage was 2g/kg to 40% 1g/kg. Resent data now shows the that usage has shifted to 20%/80% split, a significant shift in practice to decrease usage and representing net savings of £4.78 million in 2018/19.

We have also seen SRIAPs introduce ideal body weight or maximum body weight calculations to improve dosing.

NHS England will be looking at use in other high usage areas such as CIPD and secondary immune deficiencies and looking to SRIAPs to implement and spread good practice in these areas to also significantly impact Ig usage in the next 18 months

Improved recording of outcome data of MDSAS database

Over the last three years there has been a significant improvement in the amount of data recorded onto the Ig database. We have seen increased numbers and greater recording of outcomes in most areas. Disappoint- ingly since the removal of the medicine’s optimisation CQUIN we have seen a slight downturn in recording of outcomes in 18/19 but hopefully we will see this improve in 19/20 as SRIAPs become more established and will require this information to effectively carry out their reviews of existing patients, encouraging an improved quality of data recording in this area.

NHS England has also been working with MDSAS to develop an electronic referral form for SRIAPs. This has been piloted recently and with the release of the updated version based on user feedback we will be rolling this out across the country in 2020. The form will allow all referrals to be entered straight on to the database, improving data capture and providing valuable data on referring patterns and improving effective- ness of panel processes and with future developments of including review patients in this process, will also aid in the continuing development of effective Ig stewardship.

NHS England would like to thank all those involved in the work to improve Ig stewardship over the last couple of years. The hard work of SRIAPS, clinicians, pharmacists, the Commercial Medicines Unit, patient groups, MDSAS and commissioners has seen a significant improvement in the overall position of Ig and we must continue the good work to ensure that this valuable resource remains available to those that require it the most.

www.ivig.nhs.uk Page 6

CHAPTER NHS Purchasing 31 Darryn Boardman

Contract Picture

All Immunoglobulin (Ig) purchased in England and Northern Ireland is covered by a national framework agreement tendered and managed by the Commercial Medicines Unit (CMU) at NHS England. The purpose of the framework is to maintain a robust supply chain, supporting the best patient care and delivering value for money, whilst complying with procurement law. NHS Wales and NHS Scotland have separate agree- ments which are managed directly by the relevant procurement teams.

The current framework commenced on 1st July 2017 for an initial period of twelve months. The contract was extended for a twelve month period from 1st July 2018 until 30th June 2019 and for a further 12 month period from 1st July 2019 until 30th June 2020. The framework provides access to over seven million grams of Ig from seven contracted suppliers.

Increasing Ig Usage

Growth on both previous and current Ig frameworks has remained steady at just under 10% year on year.

Sales in the twelve months prior to the framework were 5,695,718g.

Sales in Year 1 of the framework were 6,194,613g, a growth rate of 8% versus previous year.

Sales in Year 2 of the framework were 6,745,697g, a growth rate of 9% versus previous year.

Allocations for Year 3 of the framework are 7,575,127, a growth rate of 12%

Spend in the twelve months prior to the framework was £170m, £138m IVIg and £32m SCIg.

Spend in Year 1 of the framework was £208m, £164m IVIg and £44m SCIg.

Spend in Year 2 of the framework was £229m, £180m IVIg and £49m SCIg.

Spend forecast at allocated volumes for Year 3 is £319m, £250m IVIg and £69m SCIg.

www.ivig.nhs.uk Page 7 National Immunoglobulin Database Report 2018/19

Market Disruptions

The UK Ig market has had to cope with fluctuating supply over the first two years of the framework.

Takeda, formerly Shire, withdrew Kiovig from the market in early 2018 and have had constrained supply on Cuvitru. BPL had manufacturing plant issues which led to severely restricted availability throughout 2018. LFB had manufacturing plant issues which have led to severely restricted availability throughout both 2018 and 2019.

Working closely with suppliers the CMU managed to mitigate all the shortages and offer alternative products for all affected Trusts. The global Ig market continues to see exponential growth, with additional treatment diagnoses and sustained growth in high dose neurology driving global volumes to an all-time high.

External factors such as EU exit and future drug tariffs could impact the UK market in several ways. The CMU and DHSC have been working with all suppliers on contingency planning and all have committed to support the market through any transition periods. Stock-holding plans have been put in place to alleviate the need for bulk purchasing.

Immunoglobulin Stakeholders

The Ig stakeholder group is essential to the delivery of a successful framework. The ongoing support and collaboration of this group ensures that increasing access to product and best value are at the forefront of its delivery. The CMU will continue to work pro-actively with Clinicians, Pharmacists, Commissioners, MDSAS and the CRG to support the best available outcomes.

Forecasting Demand

Year 3 forecasting delivered the highest level of Trust responses ever in Ig allocation planning. Working with the suppliers and national stakeholders allowed the CMU to increase allocated volumes of Ig by 12%. Over 75% of allocation increase requests were fully met, with a further 15% partially met. Only 10% of allocation requests could not be met with the requested product and in these cases, Trusts were offered alternative products.

The CMU continues to work with Trusts to review changes to demand and will communicate updates as nec- essary.

Contacting CMU

For further information on the framework agreement, contracting process or if you wish to be formally en- gaged as part of the stakeholder group, please contact CMU at [email protected] or 07702 410392.

www.ivig.nhs.uk Page 8 National Immunoglobulin Database Report 2018/19

Report Page

Table 1.1 Immunology - volume of recorded immunoglobulin and patients on Ig therapy 2018/19 10

Table 1.2 Neurology - volume of recorded immunoglobulin and patients on Ig therapy 2018/19 10

Table 1.3 Haematology - volume of recorded immunoglobulin and patients on Ig therapy 2018/19 10

Table 1.4 Infectious diseases - volume of recorded immunoglobulin and patients on Ig therapy 2018/19 11

Table 1.5 Other & unlisted - volume of recorded immunoglobulin and patients on Ig therapy 2018/19 11

Table 1.6 Breakdown of grey usage 12

Figure 1.1 Yearly number of patients on immunoglobulin therapy 2014/15 - 2018/19 13

Figure 1.2 Yearly number of patients on immunoglobulin therapy by speciality 2014/15 - 2018/19 13

Table 2.1 Recorded volume of immunoglobulin and patients on Ig therapy by SRIAP 2018/19 14

Table 2.2 Recorded volume of immunoglobulin and patients on Ig therapy - top 50 Trusts 2018/19 15-16

Figure 2.1 Yearly recorded volume of immunoglobulin by regime 2014/15 - 2018/19 17

Figure 2.2 Yearly recorded volume of immunoglobulin by speciality 2014/15 - 2018/19 17

Table 3 Recorded volumes of immunoglobulin by brand 2018/19 18

Figure 3.1 Yearly number of patients on IV and SC immunoglobulin therapy 2018/19 19

Figure 3.2 Yearly recorded volume of IV and SC immunoglobulin 2018/19 19

Figure 3.3 Monthly recorded volume of the top 10 IV immunoglobulin products 2018/19 20

Figure 3.4 Yearly recorded volume of the top 10 IV immunoglobulin products 2014/15 - 2018/19 20

Figure 3.5 Monthly recorded volume of subcutaneous immunoglobulin products 2018/19 21

Figure 3.6 Yearly recorded volume of subcutaneous immunoglobulin products 2014/15 - 2018/19 21

Figure 3.7 Monthly recorded volume of immunoglobulin by supplier 2018/19 22

Figure 3.8 Yearly recorded volume of immunoglobulin by supplier 2014/15 - 2018/19 22

Table 4.1 Number of grey patients on Ig therapy with outcomes recorded 2014/15 - 2018/19 23

Table 4.2 Number of long-term patients on Ig therapy with Follow-Ups recorded 2014/15 - 2018/19 23

Table 4.3 Number of short-term patients on Ig therapy with outcomes recorded 2014/15 - 2018/19 23

Table 5.1 ITP dosage data 2015 - 2019 24

Table 5.2 ITP usage data 2014/15 - 2018/19 24

www.ivig.nhs.uk Page 9 National Immunoglobulin Database Report 2018/19

Table 1.1Immunology - volume of recorded immunoglobulin and patients on Ig therapy 2018/19 Condition Patients Volume (g)

Primary immunodeficiencies 3,998 1,514,760 Secondary antibody deficiencies 3,928 991,511 Specific antibody deficiency 279 93,887 Thymoma with immunodeficiency 37 15,906 HSCT in primary immunodeficiencies 38 5,533

Total 8,280 2,621,597

Table 1.2 Neurology - volume of recorded immunoglobulin and patients on Ig therapy 2018/19 Condition Patients Volume (g)

Chronic inflammatory demyelinating polyradiculoneuropathy 1,553 1,239,547 Multifocal motor neuropathy 683 626,102 Myasthenia gravis 775 215,355 Inflammatory myopathies 394 167,117 Guillain–Barré syndrome 1,030 165,565 Stiff person syndrome 108 65,627 Paraprotein-associated demyelinating neuropathy (IgM) 48 28,548 Rasmussens Encephalitis 10 6,360

Total 4,601 2,514,222

Table 1.3 Haematology - volume of recorded immunoglobulin and patients on Ig therapy 2018/19

Condition Patients Volume (g)

Immune thrombocytopenic purpura 1,875 234,400 Autoimmune haemolytic anaemia 208 28,709 Alloimmune thrombocytopenia 62 26,875 Coagulation factor inhibitors 46 21,273 Haemophagocytic syndrome 115 14,950 Acquired red cell aplasia 60 9,863 Haemolytic disease of the fetus and newborn 209 6,397 Post-transfusion hyperhaemolysis 30 3,650 Post -transfusion purpura 7 605

Total 2,612 346,721

www.ivig.nhs.uk Page 10 National Immunoglobulin Database Report 2018/19

Table 1.4 Infectious diseases - volume of recorded immunoglobulin and patients on Ig therapy 2018/19

Diagnosis Patients Volume (g)

Post-exposure prophylaxis to a tetanus prone wound 444 1,246 Treatment of clinically suspected tetanus 27 747 Measles (immunosuppressed individuals) 24 229 Post-exposure prophylaxis for viral infection 5 32 Varicella zoster 1 15 Polio - Prophylaxis in immunosuppressed persons 1 10 Protection of hepatitis A in household and other close contacts 2 2

Total 504 2,281

Table 1.5 Other & unlisted - volume of recorded immunoglobulin and patients on Ig therapy 2018/19 Speciality Condition Patients Volume (g)

Greys Grey and unlisted Conditions 914 299,649 Others Transplantation (Solid Organ) 204 27,164 Others Staphylococcal toxic shock syndrome 190 23,680 Others Kawasaki disease 324 12,719

Others Necrotising (PVL-associated) staphylococcal sepsis 77 9,668

Others Toxic epidermal necrolysis, Stevens Johnson syndrome 38 4,843 Others Autoimmune uveitis 15 3,210 Others Severe or recurrent Clostridium difficile colitis 61 2,232 Others Autoimmune congenital heart block 23 874

Total 1,846 384,037

Total Patients Volume (g)

2018/19 17,220 5,868,858

www.ivig.nhs.uk Page 11 National Immunoglobulin Database Report 2018/19

Table 1.6 Breakdown of grey usage 2018/19 Diagnosis Patients Volume (g)

Unlisted Conditions 406 106,397 Autoimmune encephalitis (including NMDA and VGKC antibodies) 230 41,138 Chronic ITP 58 17,632 Systemic vasculitides and ANCA disorders 37 14,763 Pyoderma gangrenosum 31 12,120 Acute disseminated encephalomyelitis 27 7,684 Neuromyotonia 19 6,911 Atopic dermatitis/eczema <10 5,302 CNS vasculitis 13 5,030 Opsoclonus Myoclonus 17 4,733 Systemic lupus erythematosus 13 4,385 Other systemic vasculitides <10 3,805 Vasculitic neuropathy <10 2,965 Urticaria <10 2,470 Paraneoplastic disorders 14 2,355 SLE without secondary immunocytopenias (including juvenile) <10 2,335 Autoimmune neutropenia 15 1,832 Post-exposure prophylaxis to a tetanus prone wound (tetanus Ig is not available) 445 1,259 Acquired red cell aplasia NOT due to parvovirus B19 <10 1,180 Treatment of clinically suspected tetanus (tetanus Ig is not available) 29 937 PANDAS <10 931 Haemolytic uraemic syndrome <10 690 Systemic juvenile idiopathic arthritis <10 650 Aplastic anaemia/pancytopenia <10 515 Autoimmune diabetic proximal neuropathy <10 455 Catastrophic antiphospholipid syndrome <10 330 Acute idiopathic dysautonomia <10 280 Measles (immunosuppressed individuals) 24 229 Systemic lupus erythematosus with secondary immunocytopenias <10 180 Intractable childhood epilepsy <10 65 Varicella zoster <10 15 Polio - Prophylaxis in immunosuppressed persons <10 10 Protection of hepatitis A in household and other close contacts <10 <10

Total* 1,449 249,582 1449 249582 *Incorrectly registered patients defaulted to grey have been removed, which explains the variance from ‘Greys’ in table 1.5

www.ivig.nhs.uk Page 12 National Immunoglobulin Database Report 2018/19

Figure 1.1 Yearly number of patients on immunoglobulin therapy 2014/15 - 2018/19 Diagnosis Patients Volume (g)

Unlisted Conditions 406 106,397 Autoimmune encephalitis (including NMDA and VGKC antibodies) 230 41,138 Chronic ITP 58 17,632 Systemic vasculitides and ANCA disorders 37 14,763 Pyoderma gangrenosum 31 12,120 Acute disseminated encephalomyelitis 27 7,684 Neuromyotonia 19 6,911 Atopic dermatitis/eczema <10 5,302 CNS vasculitis 13 5,030 Opsoclonus Myoclonus 17 4,733 Systemic lupus erythematosus 13 4,385 Other systemic vasculitides <10 3,805 Vasculitic neuropathy <10 2,965 Urticaria <10 2,470 Paraneoplastic disorders 14 2,355 SLE without secondary immunocytopenias (including juvenile) <10 2,335 Figure 1.2 Yearly number of patients on immunoglobulin therapy by speciality 2014/15 - 2018/19 Autoimmune neutropenia 15 1,832 Post-exposure prophylaxis to a tetanus prone wound (tetanus Ig is not available) 445 1,259 Acquired red cell aplasia NOT due to parvovirus B19 <10 1,180 Treatment of clinically suspected tetanus (tetanus Ig is not available) 29 937 PANDAS <10 931 Haemolytic uraemic syndrome <10 690 Systemic juvenile idiopathic arthritis <10 650 Aplastic anaemia/pancytopenia <10 515 Autoimmune diabetic proximal neuropathy <10 455 Catastrophic antiphospholipid syndrome <10 330 Acute idiopathic dysautonomia <10 280 Measles (immunosuppressed individuals) 24 229 Systemic lupus erythematosus with secondary immunocytopenias <10 180 Intractable childhood epilepsy <10 65 Varicella zoster <10 15 Polio - Prophylaxis in immunosuppressed persons <10 10 Protection of hepatitis A in household and other close contacts <10 <10

Total* 1,449 249,582 1449 249582

www.ivig.nhs.uk Page 13 National Immunoglobulin Database Report 2018/19

Table 2.1 Recorded volume of immunoglobulin and patients on Ig therapy by SRIAP 2018/19

Region Panel Volume (g) Patients

London North Central London 610,385 1,483

London North East London 289,271 811

London North West London 216,098 895 London South London 319,011 1,187

Total 1,434,765 4,376

Midlands & East Central / South West Midlands 312,173 904 Midlands & East East Midlands 351,832 1,145 Midlands & East East of England 642,312 1,764 Midlands & East North / West Midlands 153,956 580

Total 1,460,273 4,393

North Cheshire & Mersey 156,976 477 North Greater Manchester - Salford 262,237 517 North Greater Manchester & Lancs 209,084 798 North Humber, Coast & Vale 97,471 289 North North & West Yorkshire 245,067 783 North North East & Cumbria 285,366 934 North South Yorkshire 212,448 566

Total 1,468,649 4,364

South Kent & Medway 130,687 464 South Peninsula 237,345 584 South South West 260,610 780 South Southampton/Hampshire 227,754 764 South Sussex & Surrey 202,665 607 South Thames Valley 298,921 838

Total 1,357,981 4,037

England total 5,721,668 17,170

Northern Ireland Belfast 147,190 550

Total 5,868,858 17,720

www.ivig.nhs.uk Page 14 Volumes of immunoglobulin recorded (grams) and number of patients treated

National Immunoglobulin Database Report 2018/19

Table 2.2 Recorded volume of immunoglobulin and patients on Ig therapy in the top 50 Trusts 2018/19

Trust Volume (g) Patients

UNIVERSITY COLLEGE LONDON HOSPITALS NHS FOUNDATION TRUST 281,478 391

ROYAL FREE NHS TRUST 258,690 611

CAMBRIDGE UNIVERSITY HOSPITALS NHS FOUNDATION TRUST 257,990 506

SALFORD ROYAL NHS FOUNDATION TRUST 237,559 353

BARTS HEALTH NHS TRUST 214,429 490

SHEFFIELD TEACHING HOSPITALS NHS FOUNDATION TRUST 184,603 383

OXFORD RADCLIFFE HOSPITALS NHS TRUST 176,863 435

BELFAST HEALTH AND SOCIAL CARE TRUST 147,190 550

LEEDS TEACHING HOSPITALS NHS TRUST 140,720 433

THE NEWCASTLE UPON TYNE HOSPITALS NHS FOUNDATION TRUST 134,873 391

UNIVERSITY HOSPITALS OF LEICESTER NHS TRUST 134,159 295

NOTTINGHAM UNIVERSITY HOSPITALS NHS TRUST 124,842 397

KING’S COLLEGE HOSPITAL NHS FOUNDATION TRUST 117,461 399

HEART OF ENGLAND NHS FOUNDATION TRUST 111,543 275

UNIVERSITY HOSPITAL BIRMINGHAM NHS FOUNDATION TRUST 109,433 220

IMPERIAL COLLEGE HEALTHCARE NHS TRUST 100,722 388

EAST SUFFOLK AND NORTH ESSEX FOUNDATION TRUST 98,844 292

SOUTHAMPTON UNIVERSITY HOSPITALS NHS TRUST 97,307 329

NORTH BRISTOL NHS TRUST 96,519 232

WALTON CENTRE FOR NEUROLOGY AND NEUROSURGERY NHS TRUST 89,660 120

LANCASHIRE TEACHING HOSPITALS NHS FOUNDATION TRUST 85,012 161

PLYMOUTH HOSPITALS NHS TRUST 82,997 226

FRIMLEY PARK HOSPITAL NHS FOUNDATION TRUST 76,911 181

ST GEORGE’S HEALTHCARE NHS TRUST 75,806 209

SOUTH TEES HOSPITALS NHS TRUST 75,418 188

www.ivig.nhs.uk Page 15 National Immunoglobulin Database Report 2018/19

Table 2.2 Recorded volume of immunoglobulin and patients on Ig therapy - top 50 Trusts 2018/19

Trust Volume (g) Patients

ROYAL CORNWALL HOSPITALS NHS TRUST 69,905 119

GUY’S AND ST THOMAS’ NHS FOUNDATION TRUST 68,693 277

UNIVERSITY HOSPITALS OF NORTH MIDLANDS 63,778 193

BRIGHTON AND SUSSEX UNIVERSITY HOSPITALS NHS TRUST 62,797 151

MAIDSTONE AND TUNBRIDGE WELLS NHS TRUST 62,307 203

ROYAL BROMPTON AND HAREFIELD NHS TRUST 60,829 186

MANCHESTER UNIVERSITY NHS FOUNDATION TRUST 59,386 327

HULL AND EAST YORKSHIRE HOSPITALS NHS TRUST 56,541 155

NORFOLK AND NORWICH UNIVERSITY HOSPITAL NHS FOUNDATION TRUST 55,689 144

ROYAL DEVON AND EXETER NHS FOUNDATION TRUST 49,913 136

GLOUCESTERSHIRE HOSPITALS NHS FOUNDATION TRUST 43,994 91

EAST KENT HOSPITALS NHS TRUST 42,835 114

EAST SUSSEX HOSPITALS NHS TRUST 42,175 122

SOUTHEND UNIVERSITY HOSPITAL NHS FOUNDATION TRUST 42,051 119

MID YORKSHIRE HOSPITALS NHS TRUST 41,071 109

WESTERN SUSSEX HOSPITALS NHS FOUNDATION TRUST 39,792 131

ROYAL UNITED HOSPITAL BATH NHS TRUST 35,548 91

ROYAL PAPWORTH HOSPITAL NHS FOUNDATION TRUST 35,117 101

GREAT ORMOND STREET HOSPITAL FOR CHILDREN NHS TRUST 32,336 249

EPSOM AND ST HELIER UNIVERSITY HOSPITALS NHS TRUST 31,703 111

UNIVERSITY HOSPITALS COVENTRY AND WARWICKSHIRE NHS TRUST 31,448 123

UNIVERSITY HOSPITALS OF DERBY AND BURTON NHS FOUNDATION TRUST 30,612 220

BARKING, HAVERING AND REDBRIDGE HOSPITALS NHS TRUST 30,375 96

YORK TEACHING HOSPITALS NHS FOUNDATION TRUST 30,360 97

LONDON NORTH WEST UNIVERSITY HEALTHCARE NHS TRUST 30,073 206

www.ivig.nhs.uk Page 16 National Immunoglobulin Database Report 2018/19

Figure 2.1 Yearly recorded volume of immunoglobulin by regime 2014/15 - 2018/19

Figure 2.2 Yearly recorded volume of immunoglobulin by speciality 2014/15 - 2018/19*

* Data has been presented as per the updated 2019 commissioning guidance

www.ivig.nhs.uk Page 17 National Immunoglobulin Database Report 2018/19

Table 3 Recorded volumes of immunoglobulin by brand 2018/19

Product Type Supplier Brand Volume (g)

Intravenous 4,713,109

Biotest Intratect 10% 147,253

Biotest Intratect 5% 153,221

BPL Gammaplex 61,880

BPL Vigam Liquid 14,200

CSL Privigen 2,767,247

Grifols Flebogamma 5% 310,857

Grifols Gamunex 10% 493,119

LFB Iqymune 10% 104,968

LFB Tegeline 4,826

Octapharma Octagam 10% 445,273

Octapharma Octagam 5% 16,905

Octapharma Panzyga 115,777

Takeda Gammagard 1,979

Takeda Kiovig 75,605

Sub-cutaneous 1,155,748

BPL Subgam 76,698

CSL Hizentra 20% 449,197

Octapharma Gammanorm 235,053

Takeda Cuvitru 326,585

Takeda HyQvia 13,803

Takeda Subcuvia 16% 54,413

Total 5,868,858

www.ivig.nhs.uk Page 18 National Immunoglobulin Database Report 2018/19

Figure 3.1 Yearly number of patients on IV and SC immunoglobulin therapy 2018/19

Figure 3.2 Yearly recorded volume of IV and SC immunoglobulin 2018/19

www.ivig.nhs.uk Page 19 National Immunoglobulin Database Report 2018/19

Figure 3.3 Monthly recorded volume of the top 10 IV immunoglobulin products 2018/19

Figure 3.4 Yearly recorded volume of the top 10 IV immunoglobulin products 2014/15 - 2018/19

www.ivig.nhs.uk Page 20 National Immunoglobulin Database Report 2018/19

Figure 3.5 Monthly recorded volume of subcutaneous immunoglobulin products 2018/19

Figure 3.6 Yearly recorded volume of subcutaneous immunoglobulin products 2014/15 - 2018/19

www.ivig.nhs.uk Page 21 National Immunoglobulin Database Report 2018/19

Figure 3.7 Monthly recorded volume of immunoglobulin by supplier 2018/19

Figure 3.8 Yearly recorded volume of immunoglobulin by supplier 2014/15 - 2018/19

www.ivig.nhs.uk Page 22 National Immunoglobulin Database Report 2018/19

Table 4.1 Number of grey patients on Ig therapy with outcomes recorded 2014/15 - 2018/19

Year 2014/15 2015/16 2016/17 2017/18 2018/19

Grey Requests 778 762 790 716 1,185

Requests with Outcomes 241 268 347 626 927

Percentage 31% 35% 43% 87% 78%

Table 4.2 Number of long-term patients on Ig therapy with Follow-Ups recorded 2014/15 - 2018/19

Year 2014/15 2015/16 2016/17 2017/18 2018/19

Long-term Patients 8,177 8,950 9,976 10,988 10,910

Patients with Follow-Up 4,037 5,145 6,234 8,472 7,570

Percentage 50% 57% 62% 77% 69%

Table 4.3 Number of short-term patients on Ig therapy with outcomes recorded 2014/15 - 2018/19

Year 2014/15 2015/16 2016/17 2017/18 2018/19

Short-term Patients 5,173 5,697 6,099 6,337 6,348

Patients with Outcomes 1,738 1,772 2,345 3,303 3,396

Percentage 36% 31% 38% 52% 53%

www.ivig.nhs.uk Page 23 National Immunoglobulin Database Report 2018/19

Table 5.1 ITP Dosage data 2015 - 2019

Year 2015 2016 2017 2018 2019

1g/kg and under 44% 50% 64% 73% 81%

2g/kg and over 56% 50% 36% 27% 19%

Table 5.2 ITP Usage data 2014/15 - 2018/19 Treatment Year Volume (g) Avg episode usage Episodes

2014/15 253,289 1,603 158g

2015/16 318,604 1,963 162g

2016/17 332,735 2,135 156g

2017/18 271,905 2,038 133g

2018/19 227,680 2,024 112g

* Treatment episodes may contain more than one course of treatment