Last Thursday, March 14, Rezdiffra (resmetirom) became the first drug approved in the US for MASH. Five leading North American MASLD patient advocates join the Surfers to discuss their feelings about this approval along with the opportunities and challenges that lie ahead.
00:00:00 - Surf's Up: Season 5 Episode 7
Opening introduction from an excited, enthusiastic panel, including brief quotes taken directly from the episode discussion.
00:05:55 - Groundbreakers
Each panelist shares one piece of good news from the previous week.
00:11:19 - Advocates recall March 14
As March 14 progressed, advocates' attitudes moved from excited anticipation to anxiety to deep happiness.
00:17:41 - Advocates describe their feelings as patients
None of these advocates are Rezdiffra candidates themselves, but each reflected on their personal experiences with MASLD and what the future holds for patients who are or will be candidates for Rezdiffra.
00:22:33 - Identifying target patients
This conversation starts with Roger Green asking the group to describe where the number "315,000 target patients" came from. After the group replies, Jeff McIntyre and Louise Campbell explain how this is different from a "warehoused" patient population, and Wayne Eskridge discusses the exciting, progressive Madrigal patient support program.
00:29:53 - The advocate's role today
Jeff begins this discussion by emphasizing the role GLI has shepherded and advocates have played in informing FDA about patients' key concerns for the label. He describes how these are reflected in the approval decision and label, with biopsy being the most obvious example. The other advocates agree, with Mike Betel emphasizing how closely the leading advocates co-ordinate with GLI and each other. Louise suggests it will be a "game changer" if FDA takes a similar view to labels for other metabolic diseases. Roger points to Madrigal's discussion of medical exception as proof of their commitment.
00:37:10 - The advocate's role tomorrow
Advocates agree that this approval creates new, broader opportunities for education and outreach. To Jeff, the approval will allow advocates to ask bigger questions on emerging needs. He offers treatment for cirrhosis and drug reimbursement as two such areas.
00:41:22 - Slowing the patient flow
Roger asks what steps advocates can take to slow the flow of patients through the progressive stages of MASLD. Tony Villiotti notes that this is the primary goal of NASH kNOWledge, starting with childhood education. Jenn Jones states that publicity about Rezdiffra may lead patients with MetALD or ALD to explore how they can protect their own livers and seek early detection.
00:46:15 - Overwhelming the system
Louise describes herself as "slightly fed up" at individuals who fear "overwhelming the system." Instead, she says, systems should build capacity to reflect the scale of the disease. Roger notes this may be harder to execute in the US than in countries where governments control their healthcare systems. Jeff points to the US Veterans Administration as a possible model for ways to build capacity.
00:52:21 - Emerging role of primary care
Louise states that much treatment will shift to primary care over the next 5-7 years. Roger agrees and seconds Jeff's comments about the role the VA can play.
00:54:55 - Closing question
Roger asks each panelist to identify a healthcare stakeholder group that needs to take a lesson from the issues discussed today. Answers vary widely.
01:02:06 - Question of the Week
The question asks what good ideas listeners have for other stakeholder groups in the aftermath of Rezdiffra's approval.
01:02:54 - Business report
This week's news on audience metrics, future episodes and why there will be no Vault conversation again this week
Last Thursday, March 14, Rezdiffra (resmetirom) became the first drug approved in the US for MASH. Five leading North American MASLD patient advocates join the Surfers to discuss their feelings about this approval along with the opportunities and challenges that lie ahead.
00:00:00 - Surf's Up: Season 5 Episode 7
Opening introduction from an excited, enthusiastic panel, including brief quotes taken directly from the episode discussion.
00:05:55 - Groundbreakers
Each panelist shares one piece of good news from the previous week.
00:11:19 - Advocates recall March 14
As March 14 progressed, advocates' attitudes moved from excited anticipation to anxiety to deep happiness.
00:17:41 - Advocates describe their feelings as patients
None of these advocates are Rezdiffra candidates themselves, but each reflected on their personal experiences with MASLD and what the future holds for patients who are or will be candidates for Rezdiffra.
00:22:33 - Identifying target patients
This conversation starts with Roger Green asking the group to describe where the number "315,000 target patients" came from. After the group replies, Jeff McIntyre and Louise Campbell explain how this is different from a "warehoused" patient population, and Wayne Eskridge discusses the exciting, progressive Madrigal patient support program.
00:29:53 - The advocate's role today
Jeff begins this discussion by emphasizing the role GLI has shepherded and advocates have played in informing FDA about patients' key concerns for the label. He describes how these are reflected in the approval decision and label, with biopsy being the most obvious example. The other advocates agree, with Mike Betel emphasizing how closely the leading advocates co-ordinate with GLI and each other. Louise suggests it will be a "game changer" if FDA takes a similar view to labels for other metabolic diseases. Roger points to Madrigal's discussion of medical exception as proof of their commitment.
00:37:10 - The advocate's role tomorrow
Advocates agree that this approval creates new, broader opportunities for education and outreach. To Jeff, the approval will allow advocates to ask bigger questions on emerging needs. He offers treatment for cirrhosis and drug reimbursement as two such areas.
00:41:22 - Slowing the patient flow
Roger asks what steps advocates can take to slow the flow of patients through the progressive stages of MASLD. Tony Villiotti notes that this is the primary goal of NASH kNOWledge, starting with childhood education. Jenn Jones states that publicity about Rezdiffra may lead patients with MetALD or ALD to explore how they can protect their own livers and seek early detection.
00:46:15 - Overwhelming the system
Louise describes herself as "slightly fed up" at individuals who fear "overwhelming the system." Instead, she says, systems should build capacity to reflect the scale of the disease. Roger notes this may be harder to execute in the US than in countries where governments control their healthcare systems. Jeff points to the US Veterans Administration as a possible model for ways to build capacity.
00:52:21 - Emerging role of primary care
Louise states that much treatment will shift to primary care over the next 5-7 years. Roger agrees and seconds Jeff's comments about the role the VA can play.
00:54:55 - Closing question
Roger asks each panelist to identify a healthcare stakeholder group that needs to take a lesson from the issues discussed today. Answers vary widely.
01:02:06 - Question of the Week
The question asks what good ideas listeners have for other stakeholder groups in the aftermath of Rezdiffra's approval.
01:02:54 - Business report
This week's news on audience metrics, future episodes and why there will be no Vault conversation again this week