Surfing the MASH Tsunami

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Surfing NASH returns to preview the second Innovations in NAFLD Care Workshop (INCBCN) to be held in Barcelona from 26-27 May, 2023. Conference founders and directors Jeff Lazarus and Jörn Schattenberg discuss what makes the event unique with Louise Campbell and Roger Green.

Roger leads this conversation with the note that for this year, Surfing NASH will be working closely with the conference to provide timely coverage from Barcelona. He then asks Jeff to elaborate on some of the feedback received from last year’s inaugural meeting. Immediately Jeff underscores that this meeting fills an important gap between the heavy-hitting conferences in NAFLD and NASH. Specifically, the INCBCN Workshop exists to explore dynamic and nuanced insights into both liver disease and holistic liver health in a smaller, more multidisciplinary forum. He recaps receiving positive feedback and what considerations are informing the follow-up program. It’s important to Jeff that leading KOLs in a range of disciplines from around the world have an opportunity to explore their ideas in an engaged setting. One of last year’s success indicators was that people stayed in the room, interacting from the moment of arrival in the morning through later in the evening. Jörn joins to note his enthusiasm around the practical component of this workshop in that it invests in ideas of implementation and engaging stakeholders beyond hepatology.

From here, Roger leads discussion into a breakdown of the Day 1 sessions. Jeff first expresses excitement for an opening talk by Ramon Bataller which considers alcohol intake alongside Fatty Liver diseases. This presentation focuses on the reality that many of those living with NAFLD and NASH do in fact consume alcohol. Jeff then points to the whole of Session 2 where Ken Cusi has organized a panel focusing on the challenges of Fatty Liver from a diabetes perspective. Lastly, Jeff notes an impactful lecture by Harriet Rumgay titled the Epidemic Burden of NAFLD and Cancer. This talk reminds that much of the daily work in liver health serves cancer prevention and primes Episode 13.2 for a deeper look into this topic.

If you enjoy the episode, have questions or interest around its contents and Fatty Liver disease, we kindly ask that you submit reviews wherever you download our discussions. Alternatively, you can write to us directly at [email protected].

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Surfing NASH returns to preview the second Innovations in NAFLD Care Workshop (INCBCN) to be held in Barcelona from 26-27 May, 2023. Conference founders and directors Jeff Lazarus and Jörn Schattenberg discuss what makes the event unique with Louise Campbell and Roger Green.

From the outset, Jeff underscores that this meeting fills an important gap between the heavy-hitting conferences in NAFLD and NASH. The INCBCN Workshop exists to explore dynamic and nuanced insights into both liver disease and holistic liver health in a smaller, more multidisciplinary forum. He recaps receiving positive feedback and building a follow-up program from last year’s inaugural event which witnessed state-of-the-art talks by leading KOLs across differing specialties. Jörn notes his enthusiasm around the practical component of this workshop in that it invests in ideas of implementation and engaging stakeholders beyond hepatology.

From here, Roger leads discussion into a breakdown of the sessions comprising the two days. Jeff immediately expresses excitement for an opening talk by Ramon Bataller which considers alcohol intake. He next points to Session 2 where Ken Cusi has organized discussion on the challenges of Fatty Liver from a diabetes perspective. Lastly, Jeff notes an impactful lecture by Harriet Rumgay titled the Epidemic Burden of NAFLD and Cancer. This talk reminds that much of the daily work in liver health serves cancer prevention. Roger recalls Hannah Mamuszka’s note from last week on the degree to which all obesogenic cancers are related to Fatty Liver disease.

At this point, Louise expands on the importance of early screening in populations who are unaware of their liver health and the need to drive education for those at risk to know when and what to ask their providers. She notes the nonlinear progression to liver cancer, a recently recurring theme on the podcast. She goes on to commend the convergence of fields, citing the various associations’ (including the American Heart Association and American Diabetes Association) growing inclusion of Fatty Liver in recommendations around risk assessment. Concluding Day 1, Jeff elaborates on a Patient Organisation session that includes a speaker from the World Organization of Family Doctors.

Moving into Day 2, friends of the podcast Alina Allen and Mazen Noureddin will be opening with two exciting topics. Alina will be giving a presentation titled Automation, Artificial Intelligence and Machine Learning for Patient Identification and Risk Stratification. Following, Mazen will be detailing How to Overcome Barriers of Implementation - Bridging the Gap Between Science and Current Care Pathways. Later there will be an entertaining debate on whether being vegetarian offers a cure for NAFLD (led by Shira Zelber-Sagi and Camilla Dalby Hansen). The group then discusses the input of allied health professionals in the program and a few additional elements yet to be mentioned, including Zobair Younossi on payers and a talk by Stephen Harrison. As the session winds down, Roger asks the panelists what the impact of this event will be and how will it inform next year's program. Stay tuned for more exclusive coverage from Barcelona and view the full program here.

If you enjoy the episode, have questions or interest around its contents and Fatty Liver disease, we kindly ask that you submit reviews wherever you download our discussions. Alternatively, you can write to us directly at [email protected].

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This conversation From the Vault starts with Chris Estes describing the processes he and his colleagues at the Center for Disease Analysis Foundation have used to build a disease model for NAFLD and NASH prevalence in 15 countries. Chris discusses some of the unique challenges that modeling NASH presents. Among other items, these include (a) spontaneous regression of disease; (b) “excess” mortality (mortality not from a liver disease where NASH is a contributing factor); and (c) interplay of demographics (gender, age, race, etc.) and co-morbidities (most notably Type 2 diabetes) with the disease.

When Chris ends his initial comments, Jörn Schattenberg asks about the viability of using obesity as the anchor for increasing prevalence estimates instead of diabetes, noting the varying definitions of BMI across countries. Chris notes that obesity is imperfect but adds that we have robust, stable, long-term obesity databases in most countries, whereas diabetes estimates are newer and many people with diabetes do not recognize they have the disease.

The last element in this conversation starts with Alina Allen noting that for clinical trial development, researchers test patients with a range of diagnostics. As a result, they do not need to develop estimates based on (or even linked directly to) obesity or diabetes. Alina asks what models can tell us that can help bring down high placebo rates in double-blinded, placebo-controlled clinical trials. Chris mentions meta-analyses as recently as seven years ago that exhibited negative disease progression over time and adds that any assessment of F3 (or even F2) fibrosis is affected by the concomitant disease.

This conversation is sponsored by Resoundant Resoundant, a Mayo Clinic company, and the developers of Magnetic Resonance Elastography. MRE is widely available with over 2000 locations worldwide and can be done as a low-cost, rapid exam in just 5 minutes. Together with PDFF, this quantitative exam is called an Hepatogram – a powerful non-invasive alternative to liver biopsy in many cases. For more information, visit www.resoundant.com on the web.

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Last week, Jeff McIntyre of the Global Liver Institute introduced a draft report from the Institute for Clinical and Economic Review (ICER) on resmetirom and obeticholic acid for NASH. Jeff, an expert reviewer of the report, returns with the Surfers to expand on the contents, its shortcomings and potential implications. Among the panelists are Veronica Miller of the Liver Forum and new guest, Hannah Mamuszka, who is founder and CEO of Alva10.

This wrap-up conversation explores what the panels believe will be the impact of the ICER document for different stakeholder communities. Louise Campbell focuses on how stakeholders will look at price. Jörn Schattenberg uses Veronica phrase, "the genie is out of the bottle," to describe its impact. Veronica suggests that the paper will make an impression on how people think about the drugs, which is challenging given the analytical issues raised throughout the preceding conversations. Jeff asserts that patient involvement can help resolve some of these challenges and issues raised. He suggests the fact that ICER has introduced patients into the process as an excellent step forward. Hannah provides a variety of reasons why patients will be particularly important in this story. She notes that the generations of patients who are most affected by this disease, including Gen X and millennials, are people who tend not to visit primary care doctors. To hear the rest of her take and the final thoughts of Roger Green, tune in for this final session.

This episode was recorded in the presence of a live virtual audience. If you have interest in attending future recordings, please write to us at [email protected]. If you enjoy the episode, have questions or interest around its contents and Fatty Liver disease, we kindly ask that you submit reviews wherever you download our discussions.

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Last week, Jeff McIntyre of the Global Liver Institute introduced a draft report from the Institute for Clinical and Economic Review (ICER) on resmetirom and obeticholic acid for NASH. Jeff, an expert reviewer of the report, returns with the Surfers to expand on the contents, its shortcomings and potential implications. Among the panelists are Veronica Miller of the Liver Forum and new guest, Hannah Mamuszka, who is founder and CEO of Alva10.

Veronica begins this segment with comments alluding to the dichotomy of the biopsy. On one hand, there is an emergence of AI-assisted histological assessment of fibrosis that lends fascinating insights into the nuances of the liver as an organ. On the other hand, the field is still stuck with a very blunt tool inadequate in assessing the effectiveness of a drug. She states that it “hurts to see that this is what happens when we are not applying the right diagnostic markers and tools.” She goes on to say that “in a couple of years we'll be in a totally different data zone” in terms of having much more quantitative data to employ when assessing the safety and efficacy of these drugs. This leads Roger Green to read out his least favorite sentence from the document: “the exact prevalence of NASH is uncertain since diagnosis requires liver biopsy and many patients with NAFLD do not undergo biopsy.”

The group goes on to discuss some more of the challenges in the document and data sets and before shifting to a payoff question around the impact of the ICER report. The panel notes that ICER has produced what is fundamentally private draft report with no impact on how the drug is assessed by the FDA. However, Hannah points out  that while ICER sometimes issues updates, it's uncommon. She suggests that this trial provides no guidance on how we determine which patients are F2 or F3, which will provide a real challenge for payers trying to determine the economic impacts of the drugs. While ICER is a private organization, its recommendations carry weight with those assessing the value and pricing of new medications. As such, this report has the potential to leave a significant footprint in commercial space.

This episode was recorded in the presence of a live virtual audience. If you have interest in attending future recordings, please write to us at [email protected]. If you enjoy the episode, have questions or interest around its contents and Fatty Liver disease, we kindly ask that you submit reviews wherever you download our discussions.

Stay Safe and Surf On!

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Last week, Jeff McIntyre of the Global Liver Institute introduced a draft report from the Institute for Clinical and Economic Review (ICER) on resmetirom and obeticholic acid for NASH. Jeff, an expert reviewer of the report, returns with the Surfers to expand on the contents, its shortcomings and potential implications. Among the panelists are Veronica Miller of the Liver Forum and new guest, Hannah Mamuszka, who is founder and CEO of Alva10.

The session begins with questions from Roger Green around the report’s dated figures on disease prevalence. This leads Louise Campbell to note the intensity and speed in which the Fatty Liver field has developed over the previous decade. Provided this explosion in knowledge, she wonders whether we are able to effectively collect and implement the changes reflected by all this emerging data. Jeff and Roger add that socioeconomic shifts and the COVID-19 pandemic further amplify already swelling rates of incidence.

As this session winds down, Jörn Schattenberg poses a cogent line of questioning to consider in establishing a cost-effective intervention:

• Who was enrolled in the clinical trials? 
• Where's the evidence that there is a subgroup of patients benefiting from the therapy?
• How can we identify them moving forward and outside of clinical trials?

This episode was recorded in the presence of a live virtual audience. If you have interest in attending future recordings, please write to us at [email protected]. If you enjoy the episode, have questions or interest around its contents and Fatty Liver disease, we kindly ask that you submit reviews wherever you download our discussions.

Stay Safe and Surf On!

Send us Fan Mail

Last week, Jeff McIntyre of the Global Liver Institute introduced a draft report from the Institute for Clinical and Economic Review (ICER) on resmetirom and obeticholic acid for NASH. Jeff, an expert reviewer of the report, returns with the Surfers to expand on the contents, its shortcomings and potential implications. Among the panelists are Veronica Miller of the Liver Forum and new guest, Hannah Mamuszka, who is founder and CEO of Alva10.

Hannah begins this conversation by asserting that the report “understates the problem of the size of population we’re talking about.” She notes that it fails to consider the strength of data linking NAFLD and NASH to cardiovascular disease, liver cancers and even extrahepatic cancers. Hannah goes on to outline the relevant questions of commercial payers in the assessment of prospective pharmacotherapies: 

• What is the size of the patient population and what is going to be the effect of coverage in terms of how many patients are we going to prevent from progressing to liver transplant? 
• How many patients are we going to keep out of the hospital with chronic events?

Ultimately for Hannah, the analysis by ICER misses much of the potential cost savings of an effective drug. Louise echoes concerns surrounding the “difficulty in the communication and the language used throughout the report.”

This episode was recorded in the presence of a live virtual audience. If you have interest in attending future recordings, please write to us at [email protected]. If you enjoy the episode, have questions or interest around its contents and Fatty Liver disease, we kindly ask that you submit reviews wherever you download our discussions.

Stay Safe and Surf On!

Send us Fan Mail

Last week, Jeff McIntyre of the Global Liver Institute introduced a draft report from the Institute for Clinical and Economic Review (ICER) on resmetirom and obeticholic acid for NASH. Jeff, an expert reviewer of the report, returns with the Surfers to expand on the contents, its shortcomings and potential implications. Among the panelists are Veronica Miller of the Liver Forum and new guest, Hannah Mamuszka, who is founder and CEO of Alva10.

In this opening conversation, Roger Green introduces the ICER document and prompts panelists to share initial impressions around the assumptions and platforms that underlie it. Before diving in, Jörn Schattenberg briefly recaps the benefit behind obtaining relatively large datasets on safety and efficacy for resmetirom and obeticholic acid. Veronica asserts that she is “quite astounded” that this report would be generated before the emergence of a formal, peer-reviewed publication on the data. This leads Roger to note the competing interests of acquiring unassailable data (which can take endless time) versus serving the more immediate needs of patients desperate for solutions now.

Jeff discloses that while he is pleased with ICER’s inclusion of patient participation in the report, several critical shortcomings need addressing. The major concern: a statement claiming that NASH and NAFLD are not progressive diseases. Jörn responds to this statement with an anecdote from his specialty care clinic where patients do in fact arrive symptomatic as related to their troubled liver health. Surf on to the next conversation to hear what the others think.

This episode was recorded in the presence of a live virtual audience. If you have interest in attending future recordings, please write to us at [email protected]. If you enjoy the episode, have questions or interest around its contents and Fatty Liver disease, we kindly ask that you submit reviews wherever you download our discussions.

Stay Safe and Surf On!

Send us Fan Mail

Last week, Jeff McIntyre of the Global Liver Institute introduced a draft report from the Institute for Clinical and Economic Review (ICER) on resmetirom and obeticholic acid for NASH. Jeff, an expert reviewer of the report, returns with the Surfers to expand on the contents, its shortcomings and potential implications. Among the panelists are Veronica Miller of the Liver Forum and new guest, Hannah Mamuszka, who is founder and CEO of Alva10.

10:05 Introducing the Report
Jörn Schattenberg briefly revisits the relatively large datasets on these two drugs. Veronica is “quite astounded” that this report would be generated before the emergence of a formal peer-reviewed publication. While Jeff is pleased with ICER’s inclusion of patient participation in this report, he underscores critical concern around a statement claiming that NASH and NAFLD are not progressive diseases.

21:31 Assessment of Disease Prevalence
Hannah asserts that the report “understates the problem of the size of population" and fails to consider the strength of data linking NAFLD and NASH to cardiovascular outcomes, liver cancers and beyond. She suggests that commercial payers are looking to address the following questions in their assessment of the drug candidates: 

• What is the size of the patient population and what is going to be the effect of coverage in terms of how many patients are we going to prevent from progressing to liver transplant? 
• How many patients are we going to keep out of the hospital with chronic events? 

Ultimately for Hannah, the report's analysis misses many of the potential cost savings of an effective drug.

29:06 Keeping Pace with Field Advancements
Louise notes the intensity and speed in which the Fatty Liver field has developed over the previous decade. Provided this explosion in knowledge, she wonders whether we are able to effectively collect and implement the changes reflected by all this emerging data. Jeff and Roger add that socioeconomic shifts and the COVID-19 pandemic amplify already swelling rates of incidence. Jörn poses a cogent line of questioning to consider in establishing cost-effective interventions:

• Who was enrolled in the clinical trials? 
• Where's the evidence for a subgroup of patients benefiting from therapy?
• How can we identify them moving forward and outside of clinical trials?

38:55 Biopsy and Biomarkers
Veronica describes the dichotomy of biopsy. On one hand, AI-assisted histological assessment of fibrosis lends fascinating insights into the nuances of the liver as an organ. On the other, biopsy is still a very blunt tool inadequate in assessing the effectiveness of a drug. She states that it “hurts to see that this is what happens when we are not applying the right diagnostic markers and tools” and that “in a couple of years we'll be in a totally different data zone” in terms of having much more quantitative data to employ when assessing the safety and efficacy of these drugs.

48:36 Implications and Final Thoughts
As the session winds down, the group considers various other aspects for which this document can potentially have an impact. Comments range from notes on pricing to what FDA factors for approval.

This episode was recorded in the presence of a live virtual audience. If you have interest in attending future recordings, please write to us at [email protected]. If you enjoy the episode, have questions or interest around its contents and Fatty Liver disease, we kindly ask that you submit reviews wherever you download our discussions.

Stay Safe and Surf On!

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Last year on Thursday, June 9th we covered #NASHDay 2022, the 5th annual celebration of International NASH Day by the world’s largest liver patient advocacy organization, the Global Liver Institute. To celebrate the occasion, Stephen Harrison joined Jörn Schattenberg, Louise Campbell and Roger Green to comment on one crucial trend or event that most signified what the last year has meant in the Fatty Liver community.

This conversation includes three sections:

• First, Roger discusses the Law of Unintended Consequences in the context of the FDA Complete Response Letter to Intercept Pharmaceuticals over obeticholic acid. This was an event that many feared would bring all momentum around Fatty Liver disease to a standstill but, two years later, has driven real bursts of creative energy and innovative problem solving centered around the disease rather than a drug.
• Second, Stephen and Jörn offer impassioned statements that the providers will never give up on addressing the challenges of NASH, both because, as Stephen describes, it is not in their character and because, as Jörn describes, “this disease is not going away.” As long as people are dying too young from the effects of NASH and HCC, he contends, the fight will continue.
• Finally, Roger asked the panelists for bold predictions about what will have changed before we come together a year from now to celebrate the 6th International NASH Day.