In 2004, the Scottish Government recognised that "Hepatitis C is one of the most serious and significant public health risks of our generation". 1 By December 2006, Health Protection Scotland ( HPS) estimated that 50,000 persons in Scotland had been infected with the Hepatitis C virus and that 38,000 were chronic carriers (Figure 1). 2,3
Figure 1: Hepatitis C epidemiological landscape (estimates): Scotland, 2006.
Around 90% of those infected acquired their virus through injecting drug use behaviour (sharing needles/syringes and other injecting paraphernalia) and the majority of these were former injectors who remained undiagnosed. 4 It was estimated that only 20% of the 38,000 chronically infected individuals had ever been in specialist care and only 5% had received a course of antiviral therapy which i) has been deemed cost effective by the National Institute for Health and Clinical Excellence ( NICE) and Quality Improvement Scotland ( QIS), 5,6 ii) achieves sustained viral clearance in 50-60% of instances 6-8 and iii) is likely to have a major impact in reducing the rate of Hepatitis C disease progression (naturally, 5-15% of carriers develop cirrhosis within 20 years). 9 As at December 2006, HPS estimated that around 2,100 Hepatitis C infected persons were living with cirrhosis and that 1,000-1,500 injecting drug users ( IDUs) were becoming infected annually. 2
Following an extensive consultation in 2005, the Health Minister and Chief Medical Officer launched Scotland's Action Plan for Hepatitis C in September 2006. 10
Its aims are:
- To prevent the spread of Hepatitis C particularly among IDUs.
- To diagnose Hepatitis C infected persons, particularly those who would most benefit from treatment.
- To ensure that those infected receive optimal treatment, care and support.
The Plan is a two-phased one:
Action Plan Phase I: generating the evidence base for the Phase II Actions
Phase I, undertaken during September 2006 to March 2008, involved increasing awareness about Hepatitis C among professionals and gathering evidence through numerous surveys and other investigations to inform proposals for the development of Hepatitis C services during Phase II. Additionally, NHS Boards received £2 million in each of 2006/07 and 2007/08 to support a limited amount of service development during this period.
Phase I was co-ordinated by HPS. An Action Plan Co-ordinating Group ( APCG), comprising representatives of key stakeholder groups ( Appendix 1), oversaw the implementation of the Action Plan; the APCG was supported by Working Groups, corresponding to the three areas of i) Testing, Treatment, Care and Support, ii) Prevention, and iii) Education, Training and Awareness-raising (Appendices 2,3,4), and an Implementation Group/Project Team ( Appendix 5), and was accountable to the Scottish Government Public Health & Wellbeing Directorate.
Nearly all of the 41 Phase I actions have been delivered and only one - the piloting of an in-prison needle and syringe exchange scheme - has been rescheduled to be implemented during Phase II. A report on Phase I progress was published in December 2007. 11
Under the auspices of the APCG, the actions for Phase II were generated by its three working groups. Each, during the first half of 2007, oversaw the implementation of actions involving the generation of evidence; during the second half, they translated the evidence into proposed key issues and actions. Initial proposals were shared with i) the APCG, ii) NHS Board Hepatitis C Executive Leads, appointed during Phase I ( Appendix 6) and, iii) nearly 200 stakeholders at a consultation event held in the Royal College of Physicians, Edinburgh; issues, evidence and proposed actions were presented to the stakeholders who indicated their approval/disapproval through a digital voting system, and via email and proforma correspondence after the event.
The working groups modified the actions in accordance with the findings of the consultation and, by early 2008, they were approved by the APCG. Approval, by the Minister for Public Health, was given for the Phase II Plan to be launched on World Hepatitis Day, May 19, 2008.
Action Plan Phase II: improving services
Phase II covers the three years 2008/09, 2009/10 and 2010/11. For each of its actions the following have been identified: desired outcome(s), performance measures to gauge progress in achieving the desired outcome(s), timescales, the lead organisation(s) accountable for delivering the action and key network(s) to support the lead organisation(s) ( Appendix 7).
The actions are categorised into those for i) Testing, Treatment, Care and Support, ii) Prevention, iii) Information Generating and iv) Co-ordination activities. Generally, they are high level in nature, allowing NHS Boards, in particular, the freedom to develop services in the context of their particular circumstances regarding existing arrangements for Hepatitis C service provision and the epidemiology of infection in their area. Guidelines, standards and local/national networks will ensure that approaches taken are effective, efficient and, where appropriate, consistent.
A multi-disciplinary approach, manifested by the establishment of several local and national networks comprising representatives from all relevant disciplines and organisations, will be adopted. A considerable emphasis is placed on co-ordination and monitoring to ensure that organisations, accountable to the Scottish Government, deliver actions effectively, efficiently and to time.
The Action Plan is designed to improve all services applicable to the prevention of, and diagnosis and care of persons with, Hepatitis C, ranging from those that provide education to young people in schools about the dangers of injecting drug use and Hepatitis C to the treatment of infected persons with antiviral drugs and the associated social support required to support them and their families through what, often, is a challenging journey.
In the context of Hepatitis C being a condition which affects, mainly, people who are vulnerable and marginalised, the Action Plan recognises the crucial role of the voluntary and local authority sectors in providing education, training and social support services and the huge opportunity for Hepatitis C-related prevention, diagnosis and treatment in Scotland's prisons.
The timescales for actions are interdependent to ensure that service development is undertaken in an integrated manner; for example, awareness campaigns to promote Hepatitis C testing will only be undertaken (in 2009) once the workforce has been trained and Testing, Treatment, Care and Support services required to manage the resulting increased demand for these, have been established.
Services will be planned and arranged in year one (2008/09), fully activated in year two (2009/10) and further developed in year three (2010/11). Accordingly, of £43.2m made available for the Plan over the three years, £5.6m (13%), £16.3m (38%), and £21.3m (49%), respectively, is being allocated for the first, second and third years. A total of £36.7m (85%) of the £43.2m, will be distributed among the 14 NHS Boards for the development of Prevention (£8m) and Testing/Treatment/Care and Support (£28.7m) services. In recognition of the importance of social support for people infected with, and affected by, Hepatitis C, approximately £3 million of this latter allocation is being dedicated to agencies, including Non Governmental Organisations ( NGOs), providing such services; these include the UK Hepatitis C Resource Centre which has been, and continues to be, instrumental in the development and implementation of the Action Plan. A new funding formula, accounting for the size of the i) overall, ii) IDU, iii) Hepatitis C infected and iv) prison population (reflecting the responsibility of Boards with prisons to ensure that inmates have access to NHS Hepatitis C services) in each NHS Board area, was adopted to distribute funding equitably.
The Plan's three-year duration aligns with the Scottish Government spending review cycle; it is appreciated, however, that in 2011/12 and beyond, some of the Phase II actions will no longer apply, some will need to be maintained, and some, further developed. The Scottish Government, continuously, will review the progress made with, and performance of, the Action Plan, and decisions regarding post-Phase II arrangements will be made in 2010/11. It is anticipated that, by 2011, actions will have led to considerable increases in the numbers of persons diagnosed with Hepatitis C and the numbers of infected persons having cleared their virus through antiviral therapy, and early signs that the numbers of transmissions of Hepatitis C among IDUs are starting to decline.
The Presentation of the Action Plan
The following sections on Testing, Treatment, Care and Support, Prevention, and Information Generating, provide detail on i) how evidence was attained to generate the actions, ii) examples of evidence, iii) the main issues stemming from the evidence, iv) the actions designed to address the issues and, v) the desired outcomes to be generated by the actions. The final section outlines a framework for the co-ordination of the Action Plan nationally, by HPS, and locally, by the NHS Boards. All of the above is referenced in a summary table which, for each action, also provides information on the lead organisation(s), the supporting networks and performance indicators ( Appendix 7).
The evidence to support the issues and actions is referenced and can be accessed via the Hepatitis C Scotland website ( www.hepcscotland.co.uk). Note that, unless specifically stated, evidence applies to Scotland as a whole. Detailed NHS Board specific information, where available, can be obtained from HPS (Email: HCVActionPlan@hps.scot.nhs.uk ).