6.12 - A Second US Drug Approval! What Semaglutide's Success Portends For MASLD Care in the US

00:00:00 - Surf's Up, Season 6, Episode 12
This week's episode is a special three-part roundtable on the implications of the FDA's recent approval of semaglutide. Naim Alkhouri, Manal Abdelmalek, Scott Isaacs and Zobair Younossi join Roger Green in a discussion that focuses less on specifics of pharmacotherapy and more on how having two drugs available will change MASH management in the US.

00:08:45 - Part I: How Will The Semaglutide Approval Affect Patient Treatment and Pharmacotherapy?
The group starts by describing the sense of "enthusiasm" and "fulfillment" hepatology drug developers feel to see two drugs approved in the US and many other major changes to come (more drug approvals, FDA acceptance of a path to approval that is not based on liver biopsy). One interesting takeaway is that while the approval of semaglutide will likely change the number of patients treated with MASH pharmacotherapy, the greater impact of this approval will be on public awareness of MASH and the accompanying demand for treatment. In terms of actual drug use, the first major change will come among patients living with obesity but not Type 2 diabetes. Most of these patients previously saw their semaglutide prescriptions rejected for payment by health insurers. However, many of these patients will be living with MASH, and they are likely to see their prescriptions approved.

Instead, the largest impact may involve increased education and awareness. Scott  pointed out that endocrinologists, who frequently prescribe incretin agonists, will have reason to learn how to diagnose and manage MASH in patients they already treat. Zobair noted that an array of companies, starting with pharmaceutical manufacturers and scanning companies, will dramatically increase investments in prescriber and patient education.

00:25:30 - Part II: How the Structure of Medical Practice Is Likely To Change
Naim states that many hepatologists are currently uncomfortable managing patients on GLP-1 agonists. This will need to change. Manal points out that providers must check for cirrhosis while testing for MASH and understand how to respond. An increase in the number of providers having access to in-office scanning devices will facilitate this process. Zobair states that even if all the related specialists integrate MASH into their practices, the actual patient care demand will require alternate  pathways in which the responsibility for patient care will rest with specialist APPs.

After Naim Alkhouri describes some of the differences between resmetirom and semaglutide in terms of practical treatment decisions, the discussion focuses on why MASLD and MASH will create unique challenges for hepatology practices. Manal views the issue as a matter of time; practices cannot absorb large numbers of new, non-urgent patients. Naim suggests that the real issue is the business question: specialists today do not profit simply from treating patients. Zobair agrees with Naim and notes that the challenge is not unique to hepatology. He expresses the hope that AI and efficient database management will make it easier to target patients, screen, diagnose and treat them.

00:44:17 - Part III: What Happens Next?
In this final section, panelists identify some of the changes they foresee if we are to manage the tsunami of undiagnosed MASLD patients. Many of the comments touch on themes discussed earlier in this episode, but a couple are unique. Zobair states we must remember that the vast majority of MASLD patients will never develop MASH. Manal foresees a more sophisticated approach to selecting pharmacotherapies as prescribers have a broader set of options, each with its own benefits and drawbacks. Scotts anticipates a "paradigm shift" in which endocrinologists view MASH similarly to how they view retinopathy, neuropathy and retinopathy.