Surfing the MASH Tsunami

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This conversation is part of a March, 2023 interview between co-hosts Louise Campbell and Roger Green and Jeff McIntyre of Global Liver Institute, one of the guests on the S5 E2 panel. This particular conversation focuses largely on Jeff’s insights around the imminent anticipated drug approvals of obeticholic acid (which was withdrawn several months later) and resmetirom (whose PDUFA date is next month).

Jeff's analysis includes mixed levels of enthusiasm around a draft report from ICER which includes pricing estimates for these drugs. The contention lies in the draft’s reference to NASH as a non-progressive disease - a position which the panelists readily refute. Jeff’s positive note is that the report carefully considers patient perspective and he was able to participate as an expert reviewer.

The conversation shifts to speculations around the future standard for noninvasive testing and biomarkers. Jeff emphasizes the “need for a noninvasive that can be scaled with the least amount of burden to primary care providers and the patient populations that need them.” Roger Green points to the various guidelines’ referral to FIB-4 as such a test. This summons quote of Quentin Anstee's repeated admonition that “we not let the perfect be the enemy of the good.” For whatever shortcomings of FIB-4, if it can be done now and it's two generations of successive approximation of what we've had before.

As the session winds down, Louise Campbell asserts further comments around the ICER draft and NASH as a progressive disease. She recollects the podcast’s recent conversation with Tim Jobson, founder of Predictive Health Intelligence, (S4 E5) which discusses developing a simple tool to identify patients at risk of liver disease by analyzing the results of blood tests given throughout their lives.

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Leading MASLD patient advocates Jeff McIntyre (Global Liver Institute), Milan Mishkovikj (European Liver Patients Association), Tony Villiotti (NASH kNOWledge) and Wayne Eskridge (Fatty Liver Foundation) describe their respective organizations' priority 2024 MASH programs to co-hosts Louise Campbell and Roger Green.

In this conversation, the advocates each describe their respective organizations' top project for 2024. Wayne Eskridge goes first, describing the Fatty Liver Foundation's annual "flagship" study, The State of NAFLD and NASH Care in America. This study, which has been going on for "a few years," surveys patients' experiences around diagnosis and treatment of their SLDs. This year, which increased focus on non-invasive testing and the anticipated availability of a MASH drug, should yield particularly interesting results. Tony Villiotti talks about the extensive "liver awareness" education work NASH kNOWledge is conducting with over 250 schools and community centers in the Pittsburgh area. As part of NASH kNOWledge's ongoing effort to communicate to children on their own level, Tony anticipates his 10-year-old grandson accompanying the team this year, dressed in a "Livvy the Liver" costume. Milan Mishkovikj discusses a program where ELPA leadership conducts liver screenings at the European Parliament in Brussels, which provides opportunities not only to teach legislators and executives about their liver disease but also to learn their own liver health status. Jeff McIntyre discusses GLI's Advanced Advocacy Academy, or A3, a program to create and educate liver health advocates across the globe. To use Jeff's phrase, the program is starting to "grow roots" and become a self-sustaining year-round activity. Louise Campbell notes that the common theme in all four programs is that they are patient-focused, and most are children-focused. 

Roger's final question is to ask what will constitute success for each organization over the next 12 months. The answers vary in specifics but carry the basic themes of education, access and drug approval common to the rest of the conversation. 

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Leading MASLD patient advocates Jeff McIntyre (Global Liver Institute), Milan Mishkovikj (European Liver Patients Association), Tony Villiotti (NASH kNOWledge) and Wayne Eskridge (Fatty Liver Foundation) join Louise Campbell and Roger Green to explore the roles advocacy groups might play in supporting patient access through drug information, education and advocacy processes. 

The conversation starts with Roger. He takes note of advocates' sense that they are held outside the access process and asks whether and how that might change. Wayne suggests the question itself is highly optimistic, noting that in a fragmented payer structure, the only advocate organization large enough to have impact is GLI, and he commends them for doing so. Louise comments that while patients take the medications, "they are not the market. The market is the payer." In the UK, the market is either NICE or the private insurers, and these payers look for cost effectiveness. She also notes that MASH drugs might find themselves competing against diet and exercise, incretin agonists and other interventions yet to come that are not steatosis-specific. Prescribers make decisions within the context of guidelines (what Louise describes as "ticking boxes").

Tony notes that payers are the "final frontier" in terms of communicating with patients and assessing their needs. Jeff notes that this range of access-related issues are what he described earlier as the "second half" that starts subsequent to drug approval. He notes that in the US, this relates not only to private insurers but also CMS and the VA system, since most of the early MASH patients will be older than 65. He views patient activism and advocacy as the vehicles patients can use to affect the value process and achieve wider, simpler availability to medications. Milan looks at these same questions from a European perspective, and notes that government payers care about total cost of disease. For MASH, this probably involves liver cancer more than any other disease sequel. 

As the conversation ends, Roger comments that in his past work as a pricing consultant, he always advised clients that education and communication were keys to long-term success. In his vision, a patient who does not see the value in medication will not take it. This will lead the prescriber to believe it doesn't work well and, over time, not to prescribe it. 

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Leading patient advocates Jeff McIntyre (Global Liver Institute), Milan Mishkovikj (European Liver Patients Association), Tony Villiotti (NASH kNOWledge) and Wayne Eskridge (Fatty Liver Foundation) join Louise Campbell and Roger Green to discuss what Jeff calls "the second half" - the hard work on coding and patient access that will follow the first MASH drug approval. 

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Leading patient advocates Jeff McIntyre (Global Liver Institute), Milan Mishkovikj (European Liver Patients Association), Tony Villiotti (NASH kNOWledge) and Wayne Eskridge (Fatty Liver Foundation) discuss their expectations for life after the resmetirom PDUFA data and, with it, the potential for the first MASH drug approval, with Louise Campbell and Roger Green. 

The conversation starts with Roger noting a funny coincidence; the March 14 PDUFA data for resmetirom is Pi Day, which means the first MASH drug approval might come on the math geek's favorite day of the year. He asks panelists to describe their moods as they look forward to the event. All five other panelists Advocates describe their "guarded optimism" regarding whether resmetirom will be approved. Wayne Eskridge also notes the potential for confusion and disappointment because not every patient who anticipates receiving the new drug will do so. Louise Campbell and Milan Mishkovikj describe how US approval might affect their respective countries and regions. Going last, Jeff McIntyre describes the extensive planning GLI is doing to prepare for a PDUFA decision that might raise as many questions as it answers, particularly around coding, reimbursement and definition of appropriate patients. When he has finished discussing the questions we might all face arouind the initial FDA ruling on resmetirom, he goes on to describe a possible approval path for countries outside the US.

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00:00:00 Surf's Up: Season 5 Episode 2
Co-hosts Louise Campbell and Roger Green sit with four leading MASLD patient advocates (Tony Villiotti of NASH kNOWledge, Wayne Eskridge of the Fatty Liver Foundation, Jeff McIntyre of the Global Liver Institute, and  Milan Mishkevikj of the European Liver Patients Association) to discuss their plans and actions for MASH patients in 2024. The discussion covers the advocates' hopes and concerns for the year and the programs and efforts each considers top priority. 

00:04:09 Meet Milan Mishkovikj
North Macedonian patient advocate  Mishkovikj, a key leader in the ELPA, discusses how he became involved in liver patient advocacy and shares one fact about himself that might surprise you. 

00:11:25 Groundbreaker
Panelists share one piece of good personal or professional news from the previous week.

00:15:52 Anticipating Pi Day
Every year, Pi Day is March 14. This year, that date has extra significance: the PDUFA Date for resmetirom approval at FDA. Advocates describe their "guarded optimism" regarding whether resmetirom will be approved. Wayne notes the potential for confusion and disappointment because not every patient who anticipates receiving the new drug will do so. Louise and Milan describe how US approval might affect their respective countries and regions. Jeff describes the extensive planning GLI is doing to prepare for a PDUFA decision that might raise as many questions as it answers, particularly around coding, reimbursement and definition of appropriate patients. He also describes a possible approval path for countries outside the US.

00:26:42 Post-Approval Planning
 As Jeff puts it, "We have to be planning for the second half while we're playing the first half on this," with essential questions about the implications of labeling on the topics he mentioned earlier. Roger asks what role patients might play in access decisions, to learn that the advocates have largely been "blocked out" of the process. GLI anticipates driving conversations with health systems around policies and access. The other US advocates do not anticipate doing so. Milan describes how ELPA will work with EMA, the European Parliament and other relevant groups. Louise adds private insurers and governmental payers to the critical post-launch lobbying and discussion targets.

00:38:43 Where Does the Patient Fit?
Roger asks where patients fit in the decision paradigms and how that might change over time. Louise shares her view that while patients might consume the medications, the real customer is either the prescriber or payer. Tony describes payers as "the last frontier" in learning how patients feel. Jeff returns to a range of "here and now" access issues GLI can address now. Milan and Roger discuss perspectives on the interplay of regulators, payers, providers and patients.

00:49:13 Advocates' Key Programs
Each advocate describes one key program they will run in 2024. Wayne describes FLF's State of NASH Care in America survey. Tony describes NASH kNOWledge's children's education programs. Milan describes continuing pilot programs ELPA started in 2023 to education the European Parliament. Jeff discusses GLI's Advanced Advocacy Academy, which "grew roots" worldwide in 2023. At different points earlier in the discussion, each advocate commended the support they get from GLI.

00:56:30 Closing Question
Roger asks what will tell each advocate whether they've been successful when they look back on 2024, 12 months from the recording date. Answers are powerful and vary by organization.

01:02:55 Business Report
News on audience metrics, the upcoming Question of the Week, next week's nomenclature discussion and this week's Vault conversation.

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After a month off in January, SurfingMASH returns for the 2024 calendar year. In this last segment of Episode 1, the co-hosts explore the complexities surrounding advertising and accessibility of metabolic agents in the US market, with a particular focus on how these factors might influence public engagement and healthcare provider education.

The tone of this segment demonstrates concern that gaps or inaccuracies in consumer information might affect patient treatment in the care pathways, as providers who may not yet be equipped to handle inquiries about newly approved liver treatments deal with issues of proper prescribing and access.

Louise Campbell starts this conversation by reflecting on the challenges and frustrations caused by price and access disparities when DAAs entered the Hepatitis C market. In her UK practice, native Egyptians went back to Egypt to purchase DAAs at £1,000, which meant that the UK care team lost control of patient information.  She highlights the importance of educating not just physicians but also allied health professionals who spend more time with patients, to ensure they can have informed discussions about new medications and their management. She proposes exploring education strategies and designing clinical pathways to support the effective introduction of new treatments. She mentions upcoming recommendations for fatty liver in Australia as an example of progress in liver health management.

Roger Green expresses interest in delving into diagnostics challenges, especially considering the rapid uptake of semaglutide and tirzepatide as weight loss drugs offered by telemedicine providers outside the traditional care paradigm. He worries about the potential this model has to leave treaters with inadequate or inaccurate knowledge of their patients, and advocates for a more educated approach by payers to include liver-aware diagnostics in metabolic disease management to better serve patient needs and prevent liver-related complications. 

Jörn Schattenberg also advocates for broader, deeper education campaigns while noting that there appear to be few if any interactions between GLP-1s and resmetirom based on clinical trial reports.

This conversation underscores the interconnected challenges of drug marketing, healthcare provider education, and diagnostic practices in the evolving landscape of liver treatment and highlights the need for a multifaceted approach to address these issues effectively.

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After a month off in January, SurfingMASH returns for the 2024 calendar year. In this conversation, the group examines the explosion of telemarketer-driven consumer advertising for GLP-1 agents as anti-obesity medicines and asks what impact this might have on diagnosis, treatment and monitoring of MASH in the US. 

Specifically, the participants discuss the potential impact and concerns surrounding the use of weight-loss drugs, including semaglutide, and the impending approval of drugs for treating fatty liver disease. They highlight the challenge of ensuring patients receive comprehensive care that includes liver health assessments, especially with the rise of telemedicine and commercial approaches to medication distribution. The dialogue underscores the necessity of educating healthcare providers beyond physicians, such as Allied Health professionals, to have informed discussions about these medications and their management.

The discussion also delves into the issues of drug pricing, the black market for medications, and the importance of proper education for all healthcare providers to prevent misuse and ensure the right patient populations are being treated. Jörn Schattenberg notes the significance of preparing for drugs that are weight neutral, addressing the obesity epidemic without exacerbating liver disease issues. He emphasizes the need for specialists to assess treatment responses and manage patient care effectively.

Roger Green expresses concerns about the commercialization of healthcare leading to suboptimal patient education and care, particularly in the context of obesity treatment. He plans to engage with payers to discuss the implications of new treatments on healthcare systems.

Louise Campbell raises questions about drug-drug interactions and the broader implications of new treatments being prescribed outside their intended patient populations. Jörn reassures that no major issues were identified in clinical trials regarding drug-drug interactions and believes that standard clinical practices can manage any potential concerns.

The conversation reflects a complex landscape of treating liver and obesity-related conditions, highlighting the need for comprehensive education, careful patient assessment, and a multidisciplinary approach to healthcare in the face of new and emerging treatments.

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After a month off in January, SurfingMASH returns for the 2024 calendar year. In this conversation, the group explores the goal of provider and patient liver education, key goals for liver awareness and the potential for direct-to-consumer advertising of GLP-1s for weight loss to garble the "liver awareness" message. 

The dialogue underscores the concern that the convenience of telemedicine and the allure of easily accessible obesity treatments might lead patients to overlook comprehensive health assessments, especially for liver disease. The conversation reveals a broader concern about the health system's ability to ensure that treatments like Novo Nordisk's weight loss drug are used responsibly and with proper medical oversight.

Louise emphasizes the importance of being "liver aware" and advocates for integrating liver health into overall health assessments. She suggests that everyone, especially those prescribed weight loss medications, should have basic liver function tests to identify any underlying liver conditions that could be exacerbated by such treatments. The discussion also touches on the dangers of the black market and non-prescribed use of weight loss drugs, highlighting the need for education and responsible prescribing practices.

The conversation shifts to the potential impact of drug approval publicity and the need for health systems to educate both patients and healthcare providers on the comprehensive management of obesity, including liver health considerations. The speakers express concern that the hype around new treatments could overshadow the importance of holistic health assessments and lead to missed opportunities for diagnosing and treating liver disease.

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After a month off in January, SurfingMASH returns for the 2024 calendar year. In this conversation, Louise Campbell describes how VCTE can serve as a behavioral monitor, Roger Green reviews some changes in the podcast this year and the group begins to discuss why "liver awareness" should become an important concept. 

As this conversation starts, a joke from Roger Green about "VCTE as lie detector" leads Louise Campbell to note that personal trainers should consider looking at "internal health" (fat in organs) instead of "external health" (general obesity). She also discusses the ability to link her digital app, MyLife365.me, to VCTE measurements.

Roger Green becomes the last co-host to discuss his last couple of months. He outlines a couple of upcoming changes in the SurfingMASH podcast, including a new "Question of the Week" segment.

After describing the new segment, Roger shifts the conversation to focus on some practical issues surrounding the potential for increased demand on the clinical care pathway once a MASH drug is approved. Jörn Schattenberg notes that we will need dramatic increases in provider education over time for them to step into an active role in the pathway. He believes that drug approval will speed this process.

Throughout the entire episode, a question re-emerges about the goal of liver education. In the past, this podcast has discussed "liver health" and "liver wellness" as if the liver is the target and goal. In this conversation (and later in the episode) the concept of "liver awareness" bubbles up. "Liver awareness" refers to appreciation of the role the liver plays in all metabolic health.5