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) 2015 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 Hepatitis B Immunoglobulin (HBIg)... 3 Albumin Use... 4 IvIgG 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... 10

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 ivig optimisation. 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 and in development: Clinical Guidelines for Immunoglobulin Use, Third Edition, 2016 (in development) 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. Hepatitis B Immunoglobulin (HBIg) 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 see Appendix 2. 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. Working with clinicians, a prospective audit is underway to ensure use of this specific immunoglobulin is in line with national guidance. 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. IvIgG Database 17. The database that has been used in NHS England allowing a demonstration of appropriate use and reporting to enable funding to follow the patient was piloted in 3 Health Boards in 2014 (NHS Greater Glasgow & Clyde, Lothian and Dumfries & Galloway). NPPEAG presented at the Caldicott Guardians meeting in January 2014 to seek their approvals for this UK database. A national Standing Operating Procedure (SOP) has been produced for input of data to assure consistency of approach. Following a launch meeting in April 2015 the database was implemented in all territorial Health Boards. At the end of one year data entry the data will be analysed to enable accurate allocation of immunoglobulin budget across Health Boards. Adverse Event monitoring 18. In the past year, NPPEAG has agreed criteria for recording adverse events to infusions of Immunoglobulins. It is planned that these will be used in the national database to record adverse events which will influence our management of changeover of product. Tenders for supply of products 19. 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. 20. Anti-D/Four Factor concentrate and Hyper Immunes The current contract has been in place since August 2013 and was due to expire in July 2015, however with input from NPPEAG an extension has been agreed to extend the current framework for a further two years to July Albumin - The current contract for Albumin is due to expire at the end of February 2016, with no extension options. National Procurement is currently retendering this requirement with support from NPPEAG. 22. IVIgG and subcutaneous IgG - The current contract has been in place since September 2014 and expires in August 2016 with an option of two further extensions of 12 months. 23. These contracts cover an annual spend of circa 19 million spend for NHS Scotland and, although there has been some recent cost pressures due to the increase in world-wide demand of plasma based products, the pricing remains 4

7 competitive when benchmarked elsewhere in the UK. Recent tenders have achieved savings of around 94,000 while continuing to secure supply of these critical products for NHS Scotland. 3 Months Stock Holding and Management of Shortages 24. 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. 25. Several products have experienced shortage in the past 2-3 years. 26. The number one ranked supplier of IVIgG to Scotland failed to supply in September An early tender of the IVIgG contract needed to be implemented with immediate effect. The 3 month national stock holding of the product was low at this time due to manufacturing issues however with 3 months supply of other brands held, the shortage was managed with no compromised safety or change of brands for individual patients. The stock holding also allowed NPPEAG to carry out a managed transition of other patients onto the new brand. 27. The supply of Anti-D 250iu and 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 had to implement a 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. 28. Other specific immunoglobulins, i.e. Anti-Rabies, Anti Zoster and Anti Tetanus and Albumin, have experienced shortage at various intervals over the year. Only one company is licensed for these products in the UK. 29. 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 30. 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 has dropped a little in 2015/16. The use of the National IVIgG Database will provide more information in relation to the drivers for change in future years. 31. In comparison with experience in England, the table below demonstrates that the rate of increase in Scotland is lower than that in England. Year Scotland England 2013/ million 136 million 2014/ million 148 million Increase 870, million Percent increase 5.8% 8.8% 32. 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. 6

9 33. National committed contracts have worked well in achieving best value for money on the range of products and this has allowed more patients to be treated for the same cost, but with growing demand and longevity of patients on therapy, there is potential for this level of growth to continue or indeed increase. 34. Appendix 2 shows a table of the breakdown of plasma product procured by product group. Future Work Planned by NPPEAG 35. Future work will be to: 35.1 Review Anti-D dosing in pregnancy given the shortages experienced and fragility of supply Move forward adverse event reporting and outcomes into the database to better manage patients Perform an economic modelling on home therapy for immunoglobulins and the potential to include a larger group of patients and thus increase availability of day unit beds in the acute sector Ask the finance subgroup to review first year of data from database and to consider allocation of funds dependent on use 7

10 Conclusion 36. The implementation of the national database for immunoglobulin will help considerably in auditing practice and ensuring finance follows patients. 37. Local audits of practice are reassuring of the compliance with guidelines and also demonstrate the increasing number of patients being treated. Dr Rachel Green, SNBTS NPPEAG Chair (On behalf of NPPEAG) 8

11 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 Associate Medical Director SNBTS/GGC Secretary Mrs Deirdre Evans Director, National Specialist & Screening Services Mr Andrew Crawford Plasma Products Manager SNBTS NHS National Services Scotland Mrs Fiona Genasi Nurse Consultant in Travel Health Protection Glasgow, Medicine Clifton House, Glasgow Mrs Christine Gilmour Pharmacy Director NHS Lanarkshire, Hamilton Observer Mr Robert Girvan Policy Adviser SGHSC Asst Secretary Dr Richard Herriot Immunologist Aberdeen Royal Infirmary Dr Oliver Koch Consultant in Infectious Diseases NHS Lothian Mrs Rae McNairney Patient Representative Primary Immunodeficiency UK (PID UK) Dr Alan Mathers Obstetrician Princess Royal Maternity Hospital, Glasgow Mrs Ruth Meechan Executive Assistant NHS National Services Scotland Mr Peter Mulholland Principal Pharmacist NHS Greater Glasgow & Clyde Ms Karen Patterson Pharmacist NHS Lanarkshire Mrs Sue Rees Representative UK Primary Immune-deficiency Patient Support (UKPIPS) Mr Stuart Gillespie Commodity Manager National Procurement NHS National Services Scotland Dr Richard Soutar Consultant Haematologist NHS Greater Glasgow & Clyde Dr Susan Walsh Director Primary Immunodeficiency UK (PID UK) Prof Hugh Willison Neurologist Queen Elizabeth University Hospital, Glasgow Mrs Margaret Wolfenden Finance Manager NHS Lothian 9

12 Appendix 2 Scotland Plasma Expenditure 2009/10 to 2015/16 by Product Breakdown by product group by Health Board - Actual Orders April 2015 to October 2015 Hyperimmunes HEALTH BOARD IVIgG Coagulation 4 factor conc. Albumin Subcut Anti-D Anti - Tetanus Anti - Hepatitis B im Anti - Zoster Anti - Hep B iv Anti - Rabies TOTAL AYRSHIRE AND ARRAN 295,680 37,107 13, ,507 18,521 2,115 13,846 16, ,597 BORDERS 178,734 4,481 3,003 18,371 6, ,331 10, ,069 DUMFRIES AND GALLOWAY 337,183 22,404 14,202 6,699 6,289 1,080 3,195 6, ,051 FIFE 461,283 2,240 24,885 45,358 19, ,923 5, ,348 FORTH VALLEY 433,828 24,364 6, ,354 19,603 1,710 3,728 19, ,570 GRAMPIAN 1,329,680 40,327 23,639 98,671 34,838 13,348 26,628 30, ,005 1,604,924 GREATER GLASGOW 3,255, ,218 93, ,722 86,706 7,899 22,368 45, ,843 4,098,422 GOLDEN JUBILEE 14,107 3,081 2, ,493 HIGHLAND 407,743 11,482 2,800 7,821 13,889 3,494 5,858 3, ,586 LANARKSHIRE 432,104 52,089 45, ,601 27,564 1,165 4,527 24, ,561 LOTHIAN 1,395,052 58,249 31, ,280 56,044 2,110 3,728 29, ,958 1,939,111 TAYSIDE 835,688 19,603 25, ,159 28,389 1,305 3,462 12, ,031,544 WESTERN ISLES 48,098 6, , , /16 TOTAL YTD 9,425, , ,531 1,457, ,889 35,570 96, , ,805 12,278,194 15/16 Estimated Full Year 16,157, , ,196 2,499, ,952 60, , , ,952 21,048,333 % Year on Year Movement 1% (6)% (69)% 18% 4% 11% 22% 7% 0% 59% (2)% 14/15 Comparison 15,930, ,458 1,573,285 2,118, ,197 55, , , ,671 21,446,544 13/14 Comparison 15,064, ,501 1,649,045 1,945, ,752 47, , ,377 65,100 48,997 20,529,373 12/13 Comparison 13,685, ,005 1,295,118 1,458, ,680 43, , ,320 58,800 37,244 18,305,396 11/12 Comparison 12,069, ,399 1,118,737 1,142, ,750 38, , ,960 65,861 17,008 16,218,945 10/11 Comparison 11,669, ,276 1,115,804 1,050, ,629 31, , ,320 51,948 28,182 15,702,378 09/10 Comparison 11,942,723 1,048,160 1,311, , ,633 29, , ,600 26,099 49,296 16,406,253 10