12. Term of Reference 4
Provide a view on i) the challenges of assessing the extent of the hepatitis C infection impact at an individual level, ii) whether or not such an assessment should be undertaken and, if so, iii) what would be the optimal approach to such assessment.
Views were sought as to whether or not a method, permitting the robust and rigorous assessment of the impact of hepatitis C on the individual who has not progressed to advanced liver disease, could be developed and command the confidence of both assessors (clinical staff) and assessees (patients).
The model of assessment implemented in England in relation to beneficiaries of the English Infected Blood Support Scheme in late 2017 - following the publication of “Infected Blood: Government response to consultation on special category mechanism and other support in England. 2017”- was used as an example ( 26 ). The key decisions made, in relation to the England approach, were as follow:
- Type Two or Three Cryoglobulinemia accompanied by Membranoproliferative glomerulonephritis ( MPGN) will be added to the Stage Two criteria.
- “...from November 17, introducing Special Category Mechanism to enable people with Stage One infection having a substantial and long-term negative impact on their daily lives, to apply for the higher payment received by those with HIV or Stage Two hepatitis infection”.
In England, people belonging to the Stage One category were written to, told about the change to policy and, were invited to apply if appropriate.
For cases where the application related to either i) mental health problems or ii) chronic fatigue or both i) and ii) the applicant had to answer the following two questions:
- Does your hepatitis C infection or its treatment make it difficult for you to carry out regular daily activities such as leaving your home, using public transport or shopping for essentials, as a result of mental health problems (such as feeling depressed or feeling anxious)?
Yes/No and if Yes, occasionally/monthly/weekly/most days/daily
- Does your hepatitis C infection or its treatment make it difficult for you to carry out regular daily activities such as walking more than 50 meters, climbing stairs, lifting objects from the ground or a work surface in the kitchen, or physical tasks such as gardening?
Yes/No and if Yes, occasionally/monthly/weekly/most days/daily
The attending hospital doctor or viral hepatitis nurse had to respond in the following way:
- Confirm that the patient is suffering from mental health problems and/or fatigue and provide detail about the nature of the problems.
- Answer the following question. In your opinion how likely is it that your patient’s a) mental health problems and/or b) fatigue are attributable to their hepatitis C infection (or its treatment effects)?
Not likely/possible/highly likely/definite.
The England model was shared and discussed with i) Scotland’s Viral Hepatitis Clinical Leads Groups (clinical leads and/or hepatitis C coordinators from Scotland’s NHS boards) and ii) the Clinical Review of the Impacts of Hepatitis C Group.
There was a general agreement that the England model, i) did not take account of the past impacts of hepatitis C on the current and future lives of infected people and their widows/widowers/civil partners, ii) would likely have a deleterious effect on the doctor-patient relationship and iii) was not robust enough to allow assessment with any precision.
A range of alternative models were explored; these included drawing distinction between different groups of people with chronic hepatitis C using “uncontestable” thresholds based on, for example, the length of time between the date of first knowledge of hepatitis C and the latest date of still being known to be infected, the number/duration of interferon based treatments experienced, the route of acquisition of hepatitis C (i.e. blood factor or blood transfusion) and current age. All such thresholds, however, were regarded as too blunt to be used to differentiate the degree of lifetime impact of hepatitis C on the health and wellbeing of infected people.
The complexity of the impacts of hepatitis C on the individual, particularly from a psychosocial perspective, was viewed as so considerable that it would be inappropriate to undertake any such individual assessment, no matter how sophisticated and rigorous it might be, on the grounds that the end result would often be an unfair one, subject to contestability.
- At the individual level, an overall assessment of impact is very challenging i) because of the complexity of teasing out the contribution of hepatitis C to ill health among people of varying ages who usually have other conditions (co-morbidities), ii) because it spans over many years, iii) because so much of the impact is unrecorded in patient files due to the absence of any comprehensive, systematic and ongoing assessment (i.e. “no one asked us!”) iv) because some patient records are no longer available and v) because, in many instances, patients did not disclose, in particular, the psychosocial impacts of hepatitis C to their attending healthcare professionals due to, for example, embarrassment, feeling uncomfortable, stoicism or self-denial.
- Patients’ representatives, and the patients themselves through the conversations as described in this Report , were of the view that any form of “means testing” would be unfair, enormously stressful to both patients and their healthcare assessors, and would compromise the ethos of SIBSS beneficiaries supporting and caring for each other—an ethos that has been nurtured over many years.
- It was, however, recognised by the Clinical Review Group that, while the great majority of people with chronic HCV had been affected by their infection, some had not been appreciably affected and for those who had been affected, there had been a spectrum of impact – both clinical and non-clinical (e.g. employment, ambition, relationships). Accordingly any assessment which was just clinically-based would ignore the very considerable non clinical impacts as described in this Report.
- Key Recommendation
From an award perspective, the Clinical Review Group appreciated the dilemma of the unfairness, impracticality, divisiveness and stress of formal individual assessment on the one hand and the failure of a non-differentiating ”blanket approach” to recognise differences in hepatitis C impact on the other. To address this dilemma, the Clinical Review Group favours, unanimously, the following approach:
People with chronic HCV (including those who have cleared their virus through treatment), or their widows, widower or partners, who are currently SIBSS beneficiaries or who become eligible to be SIBSS beneficiaries in the future, should be asked to self-declare hepatitis C impact in the following simple way.
- If they themselves considered that their (or their spouse’s/partner’s) hepatitis C had not appreciably affected their life, they would not be eligible for a chronic HCV annual payment award; however if the situation changed in the future and they considered that hepatitis C was now affecting their life, they could apply for a chronic HCV award as below.
- If they themselves considered that their (or their spouse’s/partner’s) hepatitis C had seriously affected and continued to affect their life, they would be eligible for a chronic HCV award at a higher level.
- If they themselves considered that their (or their spouse’s/partner’s) hepatitis C had affected and continued to affect their life, but not seriously, they would be eligible for a chronic HCV award at a lower level.
- Accordingly, those applying for a chronic HCV award would have to declare themselves in one of two categories. A definition of ‘serious’ would be provided to assist the decision making; this definition would be to the satisfaction of the Clinical Review Group. There would be no requirement for the applicant to justify the application and the category they declared themselves in. The process would be entirely based on trusting the judgement of the potential applicant. There would be no requirement for a healthcare professional to be involved.
- In the context of the available evidence as outlined in this report and the vast collective experience of its members , the Clinical Review Group deemed this approach to be optimal for the following reasons:
- It has patient and healthcare professional support, it is simple to administer, it aims to ensure that those with the greatest need receive the greatest benefit, it avoids patient/healthcare professional conflict and any need for an appeals process, it reduces stress among applicants to a minimum, it is person-centred recognising that the individual’s perception of hepatitis C is critical, it promotes both individual and collective responsibility and it sends out a loud and clear message saying “you are trusted to make the appropriate declaration”.