Report of National Plasma Product Expert Advisory Group (NPPEAG) For Approval by the NHS Board Chief Executives Group

Transcription

1 Report of National Plasma Product Expert Advisory Group (NPPEAG) 2017 For Approval by the NHS Board Chief Executives Group

2 Table of Contents Purpose... 1 Summary... 1 Background to Plasma Products... 1 Clinical Guidelines... 2 Batch Management... 3 Usage Report... 3 Specialist Immunoglobulin... 3 Albumin Use... 4 Immunoglobulin Database... 4 Adverse Event monitoring... 4 Tenders for supply of products Months Stock Holding and Management of Shortages... 5 Financial Report... 6 Future Work Planned by NPPEAG... 7 Conclusion... 8 APPENDIX 1: NATIONAL PLASMA PRODUCT EXPERT ADVISORY GROUP... 9 Remit... 9 Membership... 9 APPENDIX 2: BREAKDOWN BY PRODUCT GROUP BY HEALTH BOARD APPENDIX 3: SAMPLE DATA EXTRACT FROM NATIONAL IVIG DATABASE... 12

3 Purpose 1. The purpose of this report is to: Report to the Chief Executives Group on the work achieved by the National Plasma Product Expert Advisory Group (NPPEAG); Summarise current usage and expenditure trends on plasma products for Scotland; and Outline and seek approval of proposed future work of NPPEAG. Summary 2. The budget and responsibility for plasma products transferred to NHS Boards from 1 April 2009, and delivery transferred from NHS National Services Scotland (NSS), Scottish National Blood Transfusion Service (SNBTS) to NHS Board pharmacies on a planned transitional basis thereafter with all boards transitioned by end NHS Board Chief Executives set up NPPEAG to: oversee the transfer of responsibility to NHS Board pharmacies provide a mechanism to manage demand develop guidelines for use and protocols for managing shortages review products requirements (types & volumes) and agree volumes to be procured on committed volumes contracts audit plasma product usage against guidelines provide source of expert advice and obtain SIGN/ADTC agreement of new indications for use as appropriate report to the NHS Board Chief Executives Group. 4. NPPEAG was established in 2009 and meets 3-4 times a year. Membership is contained in Appendix A. Background to Plasma Products 5. Fractionated plasma products derived from human plasma are a diverse group of prescription only medicines used for both prophylaxis and treatment of a wide range of clinical conditions. The main groups of products under the responsibility of NPPEAG: Specialist immunoglobulins e.g. anti-d, anti-hepatitis B; Volume expanders e.g. albumin; Immunoglobulin products (IVIgG and subcutaneous immunoglobulin); and Coagulation Factors: Four factor concentrate 6. These products are procured through national contracts by NHS National Services Scotland (NSS), National Procurement, on behalf of NHS Boards, and distributed directly to NHS Boards through SNBTS. The national contracts have been negotiated at current market pricing and have allowed NHS Scotland to procure a greater volume of plasma products than would have been possible through the NSS manufacturing plant as well as avoiding shortages, experienced in England. 1

4 7. Since its establishment, NPPEAG has: Recommended a preferred service delivery model for the supply of plasma products; Overseen and monitored the transfer to pharmacy; Overseen the procurement and distribution of plasma products; Developed and published a range of clinical guidelines for management of plasma products; Provided clinical advice on management of demand and usage of products against guidelines including during shortages and when demand is high; and Provided advice as an expert body in the use of blood and plasma products safety and transmitted infections. Agreed and established a national stockholding for anti-rabies and Clinical Tetanus to allow distribution of these rarely used products nationally when required. Clinical Guidelines 8. The Clinical Guidelines for use of intravenous immunoglobulin (IVIgG) are currently being reviewed by the UK Guidelines Group. Initially this will be a review of any urgently required updates, followed by a longer term full update, to include process advice and opportunities for IVIgG optimisation. A Cochrane Review of grey indications in which therapeutic immunoglobulin is currently used is being considered. NPPEAG has developed and published guidelines on other plasma product use in support of clinically and cost effective use in NHS Scotland. Guidelines are reviewed and updated every two years. Health Protection Scotland (HPS) also publishes and maintains guidelines for use of plasma products in infectious disease these can be found on the HPS website. 9. Current published NPPEAG Guidelines are as follows: Clinical Guidelines for Immunoglobulin Use, Second Edition, October 2009 Clinical Guidelines for Immunoglobulin Use, Second Edition Update, March 2012 Protocol for the Reversal of Over-Anticoagulation with Warfarin, January 2013 Guidelines for the Usage of Human Albumin Solution (HAS), September 2014 Clinical Guidelines for Immunoglobulin Use, Third Edition, 2016 (in development) Tetanus Interim Guidance available through the HPS website. And, as above: Input from NPPEAG representatives into a Cochrane Review process aimed at defining the therapeutic value of grey indications immunoglobulin usage. 10. These systematically developed statements have been developed for clinical users to (primarily) promote and preserve: Evidence-based use of plasma products Consistency of use of plasma products in patient care Access to safe, high quality products Security of supply Optimal utilisation of scarce and expensive products. 2

5 Batch Management 11. The following guidance was developed in the past year by NPPEAG for pharmacies and clinicians to minimise donor exposure whilst minimising wastage of expensive product: 11.1 Product detail and batch number(s) must be contemporaneously and accurately recorded for every episode where immunoglobulin is infused (including home-based infusions) Minimising short-term and lifelong exposure to plasma donor numbers and facilitating traceability are central factors in reducing and managing clinical risk Utilising the minimum number of product batches possible (ideally unitary but to a maximum of two) within a single infusion event, as determined by local circumstance is considered best practice. This practice would be followed as far as possible however at times it may be more appropriate to use more than two batches to ensure a patient receives their treatment and this should be agreed with the treating clinician Mixed use of different immunoglobulin products or formulations within a single infusion event is not justifiable under any circumstances 12. All NPPEAG guidelines are available on the NSS / NSD website: Usage Report 13. The trend from 2006 to 2009 prior to the transfer of responsibility for the control of plasma products to NHS Board pharmacies and the publication of guidelines by National Plasma Product Expert Advisory Group (NPPEAG) had been a steady increase in usage. Since the publication of guidelines and implementation of controls by hospital pharmacies, usage has stabilised. From local audit we know that the increased use is driven not only by new patients but the longevity of patients on therapy. Specialist Immunoglobulin 14. NPPEAG has looked into some particular trends to ascertain why there had been increases in usage. An area of recent interest has been the use of immunoglobulin in Hepatitis B. There has been no change in NSS Health Protection Scotland (HPS) guidelines for the use of product in the reporting period and so Boards were asked to ensure implementation of the national guidelines for use available from HPS. One board in particular appeared to have significantly higher use that would be expected from their demography. Hepatitis A outbreak given the recent outbreak of Hepatitis A in some Board areas, NPPEAG wrote out to advise on the need to hold some available stock of the Normal Immunoglobulin product for prevention of transmission in susceptible contacts. 3

6 Albumin Use 15. Not only has NPPEAG refreshed the Albumin guidelines, it has influenced the use of Albumin in plasma exchange and this halved the current total national use over the period of a year by advising major users in apheresis to alternate with a different plasma volume expander. This should be an ongoing saving. 16. This information and the ability to take action would be difficult without national oversight. 17. Albumin 20% solution has increased significantly in the last year and users have been asked to look at their indications for use to ensure its appropriateness, especially in the context of increased unit cost. Immunoglobulin Database 18. Following a launch meeting in April 2015, the database piloted in the Southern General Hospital, Glasgow; Dumfries and Galloway Royal Infirmary and St John s, Livingston. Over late 2016/3 early 2017, the database was rolled out across all territorial Health Boards. The attached sample report (Appendix 3) shows about 92% of IVIG used in the financial year 2016/17 has been recorded in the database. The first suite of data has been shared with Scottish Boards. It is planned to share these on an annual frequency. A national Standing Operating Procedure (SOP) has been produced for input of data to assure consistency of approach. 19. It had been noted that the number of grey indications for use represented around 5% of total spend and so Medical Directors and Directors of Finance were given this information to ensure they have processes in place to manage such requests. Adverse Event monitoring 20. In the past year, NPPEAG has agreed criteria for recording adverse events to infusions of Immunoglobulins. The recording of adverse events was implemented on the database in April 2017 and reports have been created within the database to monitor these. A national SOP has been produced to record adverse events into the database. Tenders for supply of products 21. National Procurement is responsible for tendering to obtain plasma products to meet the requirements of NHS Scotland in maintaining supply of product at competitive pricing while ensuring compliance to EU procurement legislation. There are currently three relevant frameworks managed by National Procurement. 22. Anti-D/Four Factor concentrate and Hyper Immunes The framework covering these products was re-tendered and awarded with support from NPPEAG. The new framework commenced August 2017 and is due to expire July There is an option to extend the framework agreement by two further periods of up to twelve months each. 4

7 23. Albumin The current contract has been in place since March Following agreement with NPPEAG, a twelve month extension option was recently utilised taking the expiry date to February A further twelve month extension option remains on this framework. However, National Procurement is preparing to retender this requirement in IVIgG and subcutaneous IgG The framework covering these products was retendered and awarded with support from NPPEAG. The new framework commended August 2017 and is due to expire July There is an option to extend the framework agreement by two further periods of up to twelve months each. 25. These contracts cover an annual spend of circa 25 million spend for NHS Scotland. Overall spend on these products within NHS Scotland continues to be among the highest spend on medicines. Following the recent procurement processes, NHS Scotland has seen a significant increase in pricing across a range of products within this specialist area. The increase in pricing is reflective of global market conditions; however, the availability of these frameworks has enabled NHS Scotland to continue to secure supply of these critical products at a competitive price when benchmarked elsewhere in the UK. 3 Months Stock Holding and Management of Shortages 26. Shortage is caused in part by manufacturing issues leading to batch failures or in part due to the marketplace, with reasons such as increased costs in manufacturing leading to suppliers looking at emerging markets where they can charge more for their products. 27. Several products have experienced shortage in the past 2 years. 28. There have been various Interruptions to the supply of IVIgG over the last few years; in particular, supplies of Octagam from Octopharma have been disrupted on 2 occasions. On the first occasion, 3 months stock was ring-fenced for PID and SID patients, with other users switched to an alternative IVIgG product from available stock. On the second occasion, we managed to continue to supply patients, however, stock holding was reduced to 2 weeks at different intervals. 29. The supply of Anti-D 500iu has been interrupted on various occasions over the last year because of manufacturing issues. Due to the failure to supply by this company we have had to implement a temporary change in practice to all health boards where the larger 1500iu dose was given until the manufacturer was able to resume supply of the other dose sizes. National oversight and the 3 month stock held at SNBTS allowed smooth transition in a controlled manor which did not expose patient to risk. The Anti-D dosing regimen is unique to the UK and work has begun to look at ways of reducing further risk of immunisation due to a single manufacturer failure. 30. Other specific immunoglobulins, i.e. Anti-Rabies, Anti Zoster and Anti Tetanus, have experienced shortage at various intervals over the year along with high price increases. Only one company is licensed for these products in the UK. 31. On all of these occasions Scotland would have stocked out of these products if a 3 month buffer stock was not held at SNBTS. 5

8 Financial Report 32. In 2009/10, the year in which the majority of Boards transitioned to local management, the total direct procurement on plasma products in Scotland was 16.41m. For 2 years the level of expenditure on plasma products levelled out, representing more local control over expenditure and reductions relating to contract prices. 2014/15 saw a return to significant increases, mainly in relation to IV Immunoglobulin, anecdotally, driven by usage, not price. Expenditure dropped a little in 2015/16, however the growth since then has spiked once again as shown in the table below. The use of the National IVIgG Database has been promoted in order to provide more information in relation to the drivers for change in future years and to understand future growth predictions. Year on Year % Growth 13% 12% 9% 7% 3% 4% 10/11 11/12 12/13 13/14 14/15 15/16 16/17 17/18 Est 0% -4% 6

9 33. In comparison with experience in England, the table below demonstrates that the rate of increase in Scotland of 9% per annum. In NHS England spend in 2016/17 was around 165 million and is anticipated to increase by 10% per annum. In addition the NHS England contract awarded in July 2017 created a further impact on total cost of IG provision in England with total spend predicted to be 192 million per annum for 2017/18 Year Scotland 2015/ million 2016/ million Increase 2 million Percent increase 9% 34. The expenditure split across Plasma products is shown in the chart below, showing clearly that the expenditure on IV Immunoglobulin is by far the largest spend and the driver for the increases, along with Subcutaneous Product Analysis of Plasma Expenditure ( m) 2009/10 to 2016/17 & Est 2017/ /10 10/11 11/12 12/13 13/14 14/15 15/16 16/17 17/18 Est IVIgG Subcut Coagulation 4 factor conc. Albumin Hyperimmunes 35. National committed contracts have worked well in achieving best value for money on the range of products in previous years, but with growing demand and longevity of patients on therapy, the current level of growth could continue or indeed increase further. 36. Appendix 2 shows a table of the breakdown of plasma product procured by product group. 7

10 Future Work Planned by NPPEAG 37. Future work will be to: 37.1 Review Anti-D dosing in pregnancy given the shortages experienced and fragility of supply We will now review the adverse events reported on a 6 monthly basis Now that all Boards are inputting into the database national reports are now being collated and sent out to the Boards on an annual basis Ask the finance subgroup has reviewed the first full year of data from database. 8

11 Conclusion 38. The implementation of the national database for immunoglobulin will help considerably in auditing practice and ensuring finance follows patients. 39. Local audits of practice are reassuring of the compliance with guidelines and also demonstrate the increasing number of patients being treated. Dr Rachel Green NPPEAG Chair (On behalf of NPPEAG) 9

12 Appendix 1: National Plasma Product Expert Advisory Group Remit The aim of the National Plasma Product Expert Advisory Group (NPPEAG) is to: develop / commission clinical guidelines on the prescribing of these products; develop / commission protocols for managing shortages; provide an opportunity for NHS Board representatives to audit plasma product usage against guidelines and explore trends in the use of plasma products (reporting annually to BCEs) review products requirements (types & volumes) and advise volumes to be procured on committed volumes contracts through NSS National Procurement provide a source of expert advice and obtain SIGN/ADTC agreement of new indications for use as appropriate. Membership Chairman Dr Rachel Green Consultant in Transfusion Medicine Assistant Secretary Assistant Secretary Scottish National Blood Transfusion Service (SNBTS) Business Development Ms Jenny Allen Business Support Administrator Directorate, NHS NSS Mrs Ruth Meechan Executive Assistant Business Development Directorate, NHS NSS Dr Alan Mathers Obstetrician NHS GG&C Mr Andrew Crawford Plasma Products SNBTS Manager Mrs Christine Gilmour Pharmacy Director NHS Lanarkshire Mr Robert Girvan Policy Adviser Scottish Government & Social Care Directorates (SGHSC) Mrs Hazel Johnstone Commodity Manager National Procurement, NHS NSS Dr Rick Herriot Immunologist NHS Grampian Dr Oliver Koch Consultant in Infectious NHS Lothian Diseases Mr William Malcolm Pharmaceutical Adviser Health Protection Scotland Mr Peter Mulholland Principal Pharmacist NHS GG&C Mrs Karen Patterson Pharmacist NHS Lanarkshire Mrs Sue Rees Representative UK Primary Immunodeficiency Patient Support (UKPIPS) Dr Richard Soutar Consultant Haematologist NHS GG&C Dr Susan Walsh Director Primary Immunodeficiency UK (PID UK) Ms Fiona Watt Patient Representative Primary Immunodeficiency UK (PID UK) Prof Hugh Willison Neurologist NHS GG&C Mrs Margaret Wolfenden Finance Manager NHS Lothian 10

13 Appendix 2 Scotland Plasma Expenditure 2009/10 to 2016/17 by Product Breakdown by product group by Health Board - Actual Orders April 2016 to Mar 2017 Hyperimmunes HEALTH BOARD IVIgG Subcut Coagulation 4 factor conc. Albumin Anti-D Anti - Tetanus Anti - Hepatitis B im Anti - Zoster Anti - Hep B iv Anti - Rabies TOTAL Current Share % AYRSHIRE AND ARRAN 529, ,748 55,300 99,894 35,772 14,101 5,859 14, ,013,222 4% BORDERS 288, ,306 22,120 29,050 9, , ,697 2% DUMFRIES AND GALLOWAY 558,791 16,417 35,700 45,677 14,237 1, , ,811 3% FIFE 635, ,434 45,640 84,560 39,725 2,785 9,321 8, ,400 4% FORTH VALLEY 700, ,392 31,920 45,756 35,845 9,989 4,527 22, ,078,219 5% GRAMPIAN 2,190, ,392 70, ,842 69,507 59,070 13,315 42, ,297 2,894,146 12% GREATER GLASGOW 5,956, , , , ,354 30,041 41,543 91, ,726 7,772,960 33% GOLDEN JUBILEE 3, ,720 10, ,596 0% HIGHLAND 845,180 22,929 20,860 48,250 24,275 9,716 3,196 16, ,205 4% LANARKSHIRE 622, , , ,173 56,008 4,945 7,190 44, ,328,907 6% LOTHIAN 2,470, , , , ,648 7,252 16,412 35, ,836 3,886,753 17% SHETLAND % TAYSIDE 1,527, ,331 34, ,490 46,803 5, , ,196,312 9% WESTERN ISLES 80,647 11,721 8,400 1,988 3, , ,601 0% 16/17 16,410,165 3,446, ,540 1,572, , , , , ,858 23,438,829 % Year on Year Movement 7% 27% 17% (3)% 5% 98% (27)% 1% 0% (43)% 9% 15/16 15,306,026 2,703, ,750 1,616, ,198 73, , , ,993 21,483,592 14/15 15,930,784 2,118, ,458 1,573, ,197 55, , , ,671 21,446,544 13/14 15,064,404 1,945, ,501 1,649, ,752 47, , ,377 65,100 48,997 20,529,373 12/13 13,685,984 1,458, ,005 1,295, ,680 43, , ,320 58,800 37,244 18,305,396 11/12 12,069,192 1,142, ,399 1,118, ,750 38, , ,960 65,861 17,008 16,218,945 10/11 11,669,550 1,050, ,276 1,115, ,629 31, , ,320 51,948 28,182 15,702,378 09/10 11,942, ,235 1,048,160 1,311, ,633 29, , ,600 26,099 49,296 16,406,253 11

14 Appendix 3 Sample data extract from National IVIG Database Background Data for 2013/14 and 2014/15 consists primarily from a part of NHS GGC and NHS D&G (during the pilot of the database). From early 2015 the other territorial health boards started record their usage onto the database. This was not fully implemented till the middle of This accounts for the apparent large increase in some graphs of the period 2015/16. A more accurate trend will be available from April 2018 when the 2017/18 report will be available Figure 1 Patient registrations by Health Board 2016/17 Figure 2 Yearly number of patients treated 2013/ /17 12

15 Figure 3 Monthly number of patients treated by speciality 2016/17 Figure 4 Yearly number of patients treated by speciality 2013/ /17

16 Figure 5.1 Number of patients treated by Health Board 2016/17 Figure 5.2 Number of patients treated for top 10 diagnoses 2016/17 Diagnosis Patients Primary immunodeficiencies 316 Other Conditions 286 Chronic inflammatory demyelinating polyradiculoneuropathy 160 Chronic lymphocytic leukaemia 126 Secondary antibody deficiencies 125 Immune thrombocytopenic purpura - Acute 97 Myasthenia gravis 96 Guillain Barré syndrome 76 Multifocal motor neuropathy 64 Multiple Myeloma 53 Figure 5.3 Number of patients treated by Health Board 2016/17 Health Board Patients NHS GREATER GLASGOW AND CLYDE 525 NHS LOTHIAN 286 NHS GRAMPIAN 250 NHS LANARKSHIRE 115 NHS HIGHLAND 86 NHS FORTH VALLEY 84 NHS TAYSIDE 65 NHS DUMFRIES AND GALLOWAY 61 NHS AYRSHIRE AND ARRAN 55 NHS BORDERS 53 NHS FIFE 46

17 Figure 6 Recorded monthly immunoglobulin use by Indication 2016/17 Figure 7 Recorded yearly immunoglobulin use by Indication 2013/ /17

18 Figure 8 Volume of immunoglobulin recorded by Health Board 2016/17 Figure 9 Volume of immunoglobulin used for the top 10 diagnoses 2016/17 Diagnosis 2016/17 Primary immunodeficiencies Chronic inflammatory demyelinating polyradiculoneuropathy Other Conditions Multifocal motor neuropathy Myasthenia gravis Chronic lymphocytic leukaemia Secondary antibody deficiencies Immune thrombocytopenic purpura Acute Guillain Barré syndrome Multiple Myeloma 10260