SCOTTISH INFECTED BLOOD SUPPORT SCHEME
CLINICAL REVIEW GROUP
On 18 March 2016, the Cabinet Secretary for Health and Sport committed to undertake a further scientific and clinical review of the latest international evidence regarding the impact of hepatitis C (HGV) infection to inform the criteria of the new Scottish Infected Blood Support Scheme. This was in response to the recommendations of the Scottish Financial Review Group.
Proposal 5 of the Financial Review Group report stated that:
- The current thresholds for Stage 1 (chronic HGV infection) and Stage 2 (advanced HGV) of the Skipton Fund should be the subject of a specific, evidence-based review to create new criteria based on health impact, rather than focusing predominantly on liver damage.
- This review should also thoroughly evaluate the criteria for attributing HGV to the cause of death, including death certificate data.
The Financial Review Group was clear that the scheme parameters should be subject to more detailed future review, having regard to the latest international evidence on the impact of infections, including the clinical consequences of HGV infection and the causal consequences. The remit of this review should be to establish qualification criteria which better reflect the total health impact of infection, including psychological impact.
The Cabinet Secretary has asked that a task-and-finish review group be established to deliver these recommendations – the Clinical Review Group (CRG). The Cabinet Secretary has asked that Professor David Goldberg of Health Protection Scotland/ Glasgow Caledonian University chair the group as an independent, pre-eminent expert.
The CRG should include representatives of infected patient groups to ensure the process is credible to the wider community and that it can understand the issues and questions which need to be addressed. The CRG should also include relevant independent clinical experts (hepatology/infectious disease/psychiatry) and academics (epidemiologists, researchers). Other technical expertise – virology, haematology- can be called upon if needed.
The members of the Scottish Infected Blood Financial Review Group will be invited to give evidence based on their own experiences and the previous discussions of the group, providing a vehicle to secure the perspectives of stakeholder groups beyond that provided by the patient group representatives who are members of the CRG.
The previous scoping exercises carried out by the Scottish Infected Blood Forum and the Financial Review consultation exercise will also provide an evidence base.
Terms of Reference
The Clinical Review Group will take an independent role in providing advice to Scottish Ministers on the broad health impact of chronic hepatitis C infection on those who acquired it as a result of NHS treatment before September 1991 with infected NHS blood, blood products or tissue. This will be based upon an assessment of the latest international scientific and clinical evidence, without undue regard to any one particular interest or any personal concerns.
Specifically, the Clinical Review Group should:
- Consider the latest clinical and scientific evidence published in peer-reviewed journals and any recent systematic reviews of the clinical and causal consequences of infection with hepatitis C virus (HGV). The strength of this evidence should be assessed. The assessment should include hepatic and extrahepatic conditions associated with chronic HGV infection and any serious, long term side-effects caused by treatments for HGV. Psychological impacts should also be considered.
- Consider the related impacts on quality of life and life expectancy, including whether the relevant adverse events are reversible, long term or permanent in terms of health impact.
- Consider the causal relationships between HGV infection and the manifestation in question. This should include any moderating or mediating factors (e.g. age, gender, comorbidity, infected blood acquisition route, lifestyle risks, socioeconomic factors) that influence the strength of any relationship.
- Compare the mortality data in individuals infected with HGV versus individuals with no evidence of infection. Assess the strength of the relationship to particular causes of death for those infected.
- Consider the extent to which the achievement of a sustained viral response, via treatment or otherwise, leads to improvement in the infected person’s general condition, symptoms, quality of life and life expectancy.
- Also consider personal evidence provided to the advocacy groups by those who are infected describing health impacts related to HGV or its treatments, including the Financial Review consultation response and Scottish Infected Blood Forum scoping exercise.
- Consider how any conclusions may inform policy and practice in addressing the needs of people infected with chronic HGV via infected blood.
- Advise on any additional targeted research that may be required to inform future policy and practice decisions.
A report on these matters should be submitted to Scottish Ministers for their consideration.
The Group will be chaired by Professor David Goldberg, Consultant in Public Health Medicine and Consultant Clinical Epidemiologist.