Research paperManaging expense and expectation in a treatment revolution: Problematizing prioritisation through an exploration of hepatitis C treatment ‘benefit’
Introduction
The hepatitis C virus (HCV) treatment landscape has been transformed by the recent development and licencing of direct-acting antiviral (DAA) treatments. Highly effective, tolerable, and simple to deliver, DAAs have been heralded as a therapeutic revolution, portending the global “end of HCV” (Sussman, Remien, & Kanwal, 2014), and enabling “eradication in the United Kingdom by 2030” (Williams et al., 2014). Given that 130–150 million people live with chronic HCV globally, with 217,000 situated in the United Kingdom (UK), eradication is not a modest aspiration. Particularly as these revolutionary drugs are not available for all. Pharmaceutical pricing is a primary barrier to widespread access, with list prices for DAA regimes in the region of £39,000 per 12-week course in the UK and $83,000 in the United States (US). In the US and Canada, DAA treatment eligibility is commonly restricted to people with advanced liver fibrosis (Barua et al., 2015, Marshall et al., 2016). In the UK, DAA access is limited to 10,000 people per year, with the National Health Service taking an unprecedented step in restricting treatments recommended as ‘cost-effective’ by their national guidance body (National Institute for Health and Clinical Excellence, 2015). Only a few countries (such as Australia and France) publicly subsidise these treatments for all, without disease stage restriction. Consequently, widespread enthusiasm for the DAA “pharmacological revolution” is tempered with debate about fiscal management and rationing modalities (Doyle et al., 2015; Hickman, Martin, & Huxtable, 2017; Martin et al., 2016).
Pharmaceutical rationing acts to shape in the present the future health and wellbeing of specific populations (Novas, 2006). Who these populations are and how their futures are constructed depends on the vision embraced (Hedgecoe & Martin, 2003). Two visions, or HCV treatment prioritisation scenarios, dominate the literature, each targeting specific populations. The first: scale up and prioritise DAA treatment for people with advanced liver disease (measured by fibrosis stage), thus curtailing severe liver morbidity (SLM). The second: scale up and prioritise DAA treatment for people who inject drugs (PWID), thus reducing incident infections and population prevalence (Innes, Goldberg, Dusheiko et al., 2014; Innes, Goldberg, Dillon, & Hutchinson, 2014; Martin et al., 2016). The two visions are not mutually exclusive and are often conceptualised as a step-wise process, with health systems ideally encompassing both aims (Doyle et al., 2015: 1068).
Of interest are the evidence and assumptions drawn on and created by these visions and the populations obscured or negated in this process. Discourses of mathematical modelling, including in relation to HCV treatment affordability, cost-effectiveness, and benefit, play a central role in determining prioritisation debate. For example, Innes, Goldberg, Dillon et al. (2014) model the scenarios outlined above (reducing SLM vs incident infections) asking of their audience “which public health outcomes do we value the most?”. They recommend that people with mild fibrosis who never, or no longer, inject drugs, are directed away from DAA access, as HCV cure among this group does not contribute to the aforementioned public health outcomes (cf., Martin et al., 2016). Given patient expectation and the promise of highly effective and tolerable DAAs, how might this de-prioritisation directive play out in practice?
The authors advise that clinicians practice patient ‘expectation management’, as: “more realistic expectations may lead to patients making more conservative treatment choices if the benefits on offer are accepted to be modest” (Innes, Goldberg, Dillon et al., 2014, emphasis added). Here, a specific clinical and epidemiological conceptualisation of treatment ‘benefit’ is drawn on: the attainment of additional life years and healthy life years. A simulation model calculating these outcomes finds that the benefits of a SVR (sustained virological response or HCV ‘cure’) for older individuals (∼60 years) are minimal with only a <3% chance of additional life years and healthy life years, whereas the benefits of an SVR for younger individuals (∼30 years) with cirrhosis are high, at >55% (Innes, Goldberg, Dusheiko et al., 2014). Notably, the model is described as measuring “patient important benefits”, illustrating a slippage between and conflation of specific clinical benefits with broader social and experiential benefits. A similar conflation occurs in a BMJ article, which states: “Since most people infected with HCV never develop symptoms and will die from other causes, exposing them to the harms of [DAA] treatment with no possible benefit might outweigh the benefits for the minority who develop end stage liver disease.” (Koretz, Lin, Ioannidis, & Lenzer, 2015; emphasis added). Here, the case for restricted DAA treatment access is predicated on two interrelated assumptions: HCV is asymptomatic and the ‘benefits’ of an SVR are only measurable in clinical or population health terms.
Traditionally, PWID have been a focus of treatment access dispute. Concerns about PWID suitability for interferon-based regimes have been framed in terms of toxicity, multi-morbidities, adherence and re-infection, at times masking deeper concerns about the ‘worthiness’ of PWID for treatment (Rhodes, Harris, & Martin, 2013). A growing body of literature both exposes and refutes these concerns, demonstrating: adherence and successful outcomes; low re-infection occurrence; and the citizenship work undertaken by PWID attempting treatment access (Grebely et al., 2011, Rhodes et al., 2013). Most influential in rehabilitating the image of PWID as a priority treatment population, has been the modelling work on which the vision of viral elimination is based (Martin et al., 2013). Here treatment is operationalised as a prevention strategy promising significant reductions in incident infections and population prevalence. The advent of DAA therapies, with their reduced risk profile, enhances this public health potential.
We can see, therefore, the emergence of discursive shift in the HCV treatment landscape, one informed by and impacting on questions of treatment prioritisation. This shift, from ‘managing risk and difficulty’ (‘difficult patients’, toxic regimes, uncertain efficacy, complex monitoring) to ‘managing expense and expectation’ (expectant patients, efficacious regimes, cost and capacity restrictions) is nested within a broader aspirational discourse of biomedical innovation and promise. The visions associated with this promise are framed in population-health terms, with a specific focus on those who are very ill and on those who are engaging in risk practices. This paper engages with the assumptions underpinning these visions to explore the concept of ‘patient important benefit’, with a focus on the populations often obscured or negated in DAA treatment prioritisation debates. Data are generated from interviews with a range of people seeking HCV treatment, to explore participants’ narratives of HCV treatment expectation and map their anticipatory accounts to those of post treatment ‘benefit’. Many – no longer injecting, with minimal to moderate fibrosis (Metavir stage <F3) – fall outside current treatment prioritisation scenarios and into the category of patients requiring ‘expectation management’.
Section snippets
Methods
This paper draws on longitudinal qualitative data generated for a study exploring HCV treatment transitions, decision-making, support needs and service delivery from 2012 to 2015. The study received ethical approval from National Research Ethics Service London-Chelsea (12/LO/0652) and London School of Hygiene and Tropical Medicine Research Ethics Committee (6115). Participants provided signed consent prior to data collection, received a £20 reimbursement for each interview and are assigned
Treatment decision-making
The nurse turns her chair to face Connor and says there are two options – the protease inhibitors with interferon, but also clinical trials coming up of the new interferon free drugs … For him “to think about” – there will be no injection and up to 4 pills a day. He says “I just want to get started as quick as I can” … The one reason he doesn’t want to enter the trial is the possible delay in starting treatment. (Observation notes, Dec 2012)
Throughout the study period the promise of more
Discussion
At a time of HCV treatment transition, most participants chose to commence a complex and potentially debilitating interferon-based regime rather than wait for the DAAs. This is notable regarding participants with minimal fibrosis, for whom treatment deferral and ‘expectation management’ are increasingly proposed (Innes, Goldberg, Dillon et al., 2014, Rice, 2015). Commencing treatment was spoken of with urgency—as holding the promise of movement from a place of stasis and disconnection to the
Conclusion
In this period of transition from ‘managing risk and difficulty’ to ‘managing expense and expectation’ it is crucial that the impact of HCV on the social is accorded weight in clinical literature and practice. The existential promise of treatment to alleviate social suffering can render expectations impervious to clinical management—posing problems for clinicians assigned this task. Treatment systems fashion the accounts of those engaged with them, as well as pre-selecting research accounts
Acknowledgements
Thank you to all the participants who gave their time for this study. Also to Professors Lisa Maher and Charlotte Paul for valuable comment on manuscript drafts. The study was funded by The National Institute of Health Research, grant number [NIHR-PDF-2011-04-031]. This article/paper/report presents independent research funded by the National Institute for Health Research (NIHR) (and Health Education England if applicable). The views expressed are those of the author(s) and not necessarily
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