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Patient empowerment can be an overlooked, yet critical success factor for putting a dent in Fatty Liver disease. In this conversation, the panelists investigate the economics of pathway design while identifying challenges and opportunities for effective solutions.

The preceding dialogue has suggested that the guideline processes are too focused on opportunities for private sector product developers to make money. Roger Green challenges this idea by identifying FIB-4 as the first stage test across all guidelines and pathways. He notes FIB-4 is an inexpensive test that will not profit manufacturers. Louise Campbell agrees before shifting focus to challenges obstructing effective pathway design. She notes a disconnect between systems and the lack of integrating agents and organizations to implement multi-specialty clinical care pathways.

Robert Mitchell-Thain responds with two key points: NAFL-D is not merely a liver disease and any solution must play on the potential for partnerships between organizations and professionals. He asks the group to envision a world where patients are identified earlier in disease and supported with such strong information and tools that many may never need medication. Louise endorses this viewpoint before highlighting a specific shortcoming in UK health systems. She points out that focus is oriented toward high cost individuals, downstream in disease progression, who cost 3.6B pounds per year. Such a strategy fails to provide sufficient support to earlier stage patients who will cost 19B pounds collectively.

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Patient empowerment can be an overlooked, yet critical success factor for putting a dent in Fatty Liver disease. This conversation details the involvement of three patient advocates in developing clinical care pathways and guidelines.

Louise Campbell opens with a suggestion that companies focus mostly on purchasers of medication. This rarely includes patients, who are more often considered end users in advanced economies. Emphasizing the resourcefulness of patient advocates, she expresses gratification that our panelists feel better listened to in the development processes today than in the past. She shares her perspective that liver disease needs to be part of every conversation across metabolic health. Louise notes approvingly of a recently attended primary care meeting where liver played a significant role. Michael Betel adds that AASLD now hosts significant patient contributions - a new and major improvement. 

Roger shifts to focus on how closely the advocates are involved in developing clinical care pathways and guidelines. He refers to recurring conversations on the podcast with physician advocates. Those considering the totality of disease are looking for ways to simplify and structure pathways and guidelines to best benefit the whole system. Robert Mitchell-Thain builds on the idea that it is important to create and adopt patient-friendly guidelines. He suggests that it is equally important to develop tools which allow patients to understand and utilize these guidelines. Michael mentions his contributions to the Canadian guidelines being developed. Wayne Eskridge expresses concern that too much focus of the guidelines is on drugs and not enough on self-care from earlier in the disease cascade. 

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One critical success factor for putting a dent in Fatty Liver disease – one we do not discuss very often on the podcast – is patient empowerment.  This conversation begins by carrying over thoughts on the future of digital therapeutics as a Pharma-supported patient wellness tool with advocates Michael Betel, Wayne Eskridge and Robert Mitchell-Thain.

Robert connects the idea with a comprehensive patient support tool the PBC Foundation has built for patients. Delivered as an app, this tool hosts features on disease information, self-care and ways the Foundation can provide service to patients. Robert offers a detailed glimpse into each of these functions. This prompts Wayne to ask a series of practical questions around the delivery of similar hypothetical tools in the Fatty Liver space: How will they be approved, prescribed and paid for? Robert returns to discuss the PBC Foundation free app as an example. Of the many benefits served, Robert highlights the app’s contribution toward surveying the patient population, their journey and improving experience through patient feedback. The ability to generate patient-centric data is invaluable for presentations to medical societies and whomever else can utilize it to improve self-care tools and experiences. Such efforts are pivotal in defense to what Robert terms the “psychological warfare” put forth by major food manufacturers. 

Roger then turns to Wayne and Michael, asking for something accomplished in the last year consistent with the charter of their organization. Wayne introduces a project called the Wellness League hosted by the Fatty Liver Foundation. This project is designed as an ecosystem for the nonprofit community to address the challenge of distributing information and promoting on-ground education. Michael celebrates the accomplishment of gaining Canadian charity status for the Fatty Liver Alliance.

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One critical success factor for putting a dent in Fatty Liver disease – one we do not discuss very often on the podcast – is patient empowerment. In this conversation, Roger Green and Louise Campbell are joined by patient advocates Michael Betel, Wayne Eskridge and Robert Mitchell-Thain to discuss patients’ perspectives and the extent they are considered in the clinical trial design process.

Louise leads with the question: When planning drug trials, to what degree do BioPharma companies focus on the eventual needs of the patient? Each advocate expresses significantly different perspectives. Robert starts by answering a different question: Do companies “get it?” He states that of the myriad of views held by industry partners, his focus remains on harnessing the efforts of those championing patient-centricity. 

Michael refers to his unique experience of having worked both for commercial pharma and non-profit organizations. He believes that while the patient journey matters tremendously, it’s not considered in the earliest stages of drug development. Wayne’s answer echoes this sentiment while emphasizing that interest in patient needs is driven out of marketing, not clinical development. He does note patient sensitivity has improved in recent years. 

Roger follows up, spurring investigation into the distinction between driving perpetual drug use versus creating accessible, valuable therapeutic solutions. Robert carefully discloses his discomfort with industry and NAFLD, but not NASH. He states that all three guests have improved their lived experiences with NAFLD without medical intervention. For Robert, these successes correlate with early interventional lifestyle changes, highlighting the importance of peer support. Michael returns to his idea that drug companies seek to remove barriers that limit access to treatment. Wayne expresses concern for the potential of conflicting motivators to pit social values against the accountabilities a company holds for making market systems work.

The conversation finishes with a segue into the future of digital therapeutics as a Pharma-supported patient wellness tool.

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One critical success factor for putting a dent in Fatty Liver disease – one we do not discuss very often on the podcast – is patient empowerment.  In this episode, Roger Green and Louise Campbell are joined by patient advocates Michael Betel, Wayne Eskridge and Robert Mitchell-Thain to discuss patients’ perspectives and their contributions to improving healthy liver outcomes.

Louise opens conversation by asking whether trial designs incorporate patient perspective from the outset or as an adaptation. Robert suggests there are a myriad of views held by industry partners, but ultimately emphasizes the value of harnessing the efforts of those championing patient-centricity. Michael shares his unique experience of having worked both for commercial pharma and non-profit organizations. He believes companies seek to remove barriers that limit access to treatment. Wayne notes the recent trend of industry including more patient input into development processes.

Roger spurs deeper investigation into the distinction between marketing perpetual treatment cycles and creating accessibility in receiving life-changing therapies. Robert carefully discloses his discomfort with industry and NAFLD, but not NASH. All three guests have improved their lived experiences with NAFLD without medical intervention. Robert correlates these successes with early interventional lifestyle changes, highlighting the importance of peer support. Later on, he also acknowledges the importance of trusted partnerships between clinicians, academia and other support organizations. Michael returns to his idea that drug companies seek measurable success in the treatment of patients, which does not equate to perpetual drug therapy. Wayne expresses concern for the potential of conflicting motivators to pit social values against the accountabilities a company holds for making market systems work.

Discussion shifts to panelists’ impressions on the phenomenon of digital therapeutics in the imminent future. Roger notes the economics and ability to make money in digital therapeutics will be different than in drugs, but the ability to support patients that way will be real. Robert connects the idea to his work with primary biliary cholangitis (PBC) and a health monitoring app the PBC Foundation developed for patients. Of the many benefits served, Robert notes the app’s contribution toward surveying the patient population, their journey and improving patient experience through patient feedback.

Roger turns to Wayne and Michael for something accomplished in the last year, consistent with the charter of their organization. Wayne introduces a project called the Wellness League hosted by the Fatty Liver Foundation. This project is designed as an ecosystem for the nonprofit community to address the challenge of distributing information and promoting on-ground education. Michael highlights the accomplishment of gaining Canadian charity status for the Fatty Liver Alliance.

Louise prompts further discussion on economic drivers of industry. The group investigates purchaser influence and patient advocacy represented at major meetings and events. Roger notes physician advocates considering the totality of disease are looking for ways to simplify and structure pathways and guidelines to best benefit the whole system. The guests outline their own contributions to these efforts from the position of patient advocate.

These are only a few insights from a far larger set that emerges during this discussion. Surf on for the full story. 

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This conversation From the Vault comes from Season 3 Episode 13.4, part of NASH Tsunami’s coverage of the first NICE meeting on FibroScan. 

Season 3, Episode 13 looks at the NICE Draft Guidance Evaluating FibroScan use in Community and Primary Care settings. This conversation focuses on underlying tensions between a methodology designed to assess big-ticket spending on critical moments of disease and a population screening approach that centers on wellness care more than illness care.

The conversation starts with Roger Green noting an inherent tension between short-term health economic tests driving a decision not to compensate and longer-term healthcare priorities that rely on patients who cannot afford the test being able to take it. Ian Rowe describes this as a tension inherent in the UK system and therefore, not a “real issue.” In contrast, Jörn Schattenberg notes a significant structural issue in that, as Ian noted earlier, NICE relies on companies to provide the necessary data, but the costs of providing that data might be excessive for a small diagnostics company like Echosens, although not for a major drug company.

Jörn goes on to raise the issue of reimbursing wellness vs. illness; this is economics of illness analysis done for a process that enhances wellness. Louise Campbell suggests a parallel analysis of the cost of expensive HCC drugs like sorafenib that are highly costly but provide only 3-6 months added longevity. In the end, Roger Green asks one thing each participant would like to see vs. something they are confident they will see. Answers vary, but they suggest that the current system is not a particularly effective way to assess this kind of analysis and that, beyond that, this specific analysis might benefit from some different looks at data. In the end, Louise Campbell notes that the comment period ends on March 9 and invites as many people as possible to comment before then.

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Amidst a shifting diagnostic pathway, the UK’s National Institute for Health and Care Excellence (NICE) reconsiders its position on vibration controlled transient elastography (VCTE) in the community. This final conversation centers around how to create and train on delivering meaningful test results to patients. 

Roger Green begins with his note that in recent NASH Tsunami episodes, panelists have stated that their countries could not automate FIB-4 simply because liver enzyme tests are not standard in blood panels. This prompts Will Alazawi to suggest that a campaign similar to the one for people with diabetes on learning their HbA1c levels might go a long way toward driving between enzyme collection and FIB-4 use. Ian Rowe asks which number would be used for the liver. Louise answers that FibroScan results provide multiple metrics worth considering. She adds that while FibroScan offers substantial value, acquisition is too expensive to provide at scale. However, the less expensive tests are not adequately standardized or validated as predictive at an individual level. 

The rest of the conversation centers on ways to consider and use tests before finishing with the closing question. Roger asks the panelists for one thing in this system worth improving. Ian calls for a clear pathway capable of efficient decision making. Louise hopes for NICE to take action on liver health to drive accessibility in primary care. Kate extends this sentiment to address inequities across communities. Will is looking for stronger signaling to answer patients' concerns: how bad is their Fatty Liver or fibrosis? Finally, Roger offers his US-centric response: if we can appropriately identify the liver’s place in multi-metabolic life, the field moves closer to acknowledgement as a big ticket item. 

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Amidst a shifting diagnostic pathway, the UK’s National Institute for Health and Care Excellence (NICE) reconsiders its position on vibration controlled transient elastography (VCTE) in the community. This conversation begins with Will Alazawi concluding his comments on the link between liver outcomes and socioeconomic status. The group then explores a range of factors contributing to inequity. Roger speaks to his marketing research experience which revealed physicians' frustration with an inability to drive patients toward sustaining lifestyle management goals. Will suggests that the challenges are not strictly socioeconomic, but concedes that a number of variables remain immeasurable at this point in time. For example, he poses a few yet to be answered questions: how much space do people have in their homes? Is there access to healthy food? What financial impediments exist? Louise and Kate comment on misunderstandings about alcohol consumption and liver health. All agree that an excess of “good quality” alcohol has the same deleterious effects on liver health as does an excess of cheap drink. 

Discussion shifts back toward accessible pathways. Will and Louise suggest that the challenge lies in deploying hepatologist skills into the community more effectively. Kate questions who will administer the FibroScans in primary care, pointing to the shortage of nurses in the UK amongst other challenges. Ian thinks it may be impossible to implement solutions for every issue discussed in a scalable, cost effective way. He asserts that testing needs to be deliverable in a way that is meaningful to patients. Establishing a simple, communicable testing metric with accessible points of administration is key. This seems more difficult and expensive to achieve in the context of liver health than it has for identifying other successful metrics such as reading blood pressure. 

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Amidst a shifting diagnostic pathway, the UK’s National Institute for Health and Care Excellence (NICE) reconsiders its position on vibration controlled transient elastography (VCTE) in the community. Professor Ian Rowe and Dr Kathryn Jack discuss navigating a scarcity of relevant data for evaluating pathway development alongside Surfers Roger Green and Louise Campbell. 

Roger prompts this conversation by asking the group whether there is a developed paradigm for how to adopt technology in places where the data is arriving in real time. He notes the difference between how this process is approached in open markets such as the US versus data-reliant markets similar to the UK. Ian describes a process used in oncology called “commissioning through evaluation,” where the NHS pays for medications while collecting the necessary real-world data to conduct evaluation. This point introduces political influence on decision making processes. Roger notes the resulting polarity in healthcare expenditure between the US and the UK. 

Roger continues to spur discussion on the political pressures and metaphorical issues that shape the differences between cancer and liver disease management. Louise analyzes the linkages between poor liver health and non-hepatic cancers, insisting on a more robust consideration of the liver-to-cancer link. Ian mentions the ever increasing challenge for hepatology of treating more aggressively and effectively with NITs while simultaneously conducting research on the best way to do so. Kate suggests utilizing the nurses and allied health professionals that are willing to become involved in research and drive the required data forward. 

At this point, Professor Will Alazawi joins the panel with an impressive debut. He returns to the idea that due to stigmas, liver and cancer do not occupy the same imagination in the general public. His ideas link socioeconomic strata with liver outcomes, suggesting marginalized patients are more likely to encounter complications of liver disease.

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Amidst a shifting diagnostic pathway, the UK’s National Institute for Health and Care Excellence (NICE) reconsiders its position on vibration controlled transient elastography (VCTE) in the community. In this conversation, Roger Green and Louise Campbell are joined by Dr Kathryn Jack and Professor Ian Rowe to discuss the dynamic challenges of using FibroScan and other noninvasive tests (NITs) for best practice.

Louise begins by reflecting on the experience of the second public meeting around considering access to FibroScan for primary care. In describing the evaluation process, she notes a shift from analyzing costs per test to a broader focus around how these tests are positioned in the wider pathway. Ian agrees that FibroScan does not fit well within the traditional framework of NICE. Analytical challenges and out of system data obscure answers to critical questions such as what is the cost effectiveness of FibroScan in primary versus secondary care. Kate highlights the value of developing an early screening pathway. She shares her experience that when scanning patients, cirrhosis presents in those who have never been diagnosed with Fatty Liver. This is a pivotal opportunity to deliver a targeted intervention and support for the unwittingly cirrhotic population. For Kate, the decision to reimburse FibroScan community use is a “no-brainer.” 

Ian challenges the practicality behind the idea that every patient in primary care should receive FibroScan. “It's important to bear in mind what NICE was asked and then to try and understand how we use FibroScan as part of the wider pathways.” He suggests community non-invasive fibrosis screening, but not necessarily FibroScan.