S5 – E02.2 – After The First MASH Drug Approval, Focus Shifts To Patient Access

S5 - E02.2 - After The First MASH Drug Approval, Focus Shifts To Patient Access
Four leading MASLD patient advocates join Louise Campbell and Roger Green to discuss the challenges in patient access and education that will follow the first MASH drug approval. expectations for the resmetirom PDUFA data and, with it, the potential for the first MASH drug approval.

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.

To Jeff, a different kind of very hard work starts after the PDUFA rulings. First, he notes, the PDUFA ruling might not be a definitive decision, but simply a request for more information. Once approval has occurred, advocates need to analyze specific labeling, coding and price questions to identify the most important challenges in patient access and education. Roger raises the issue of Price/Volume tradeoffs and discusses in general terms how that might work. He goes on to ask the advocates what role these groups might play in access decisions.

The US advocates comment that for the most part, they have been “blocked out” of the process. As part of their “second half” activities, GLI anticipates driving conversations with health systems around policies and access. NASH kNOWledge, whicih focuses largely on patient and provider education, anticipates no role in this issue at all. Fatty Liver Foundation falls somewhere in the middle, working with drug company advisory groups but not so much with payers.

At this point, the conversation shifts to the impact of the US launch, pricing decisions and access issues on other countries. Milan anticipates identifying US challenges that will be relevant to EU markets as well. He identifies Global Liver Institute, with its strategic vision and global reach, as a valued partner in these analyses. Finally, he describes ways that ELPA will work with EMA, the European Parliament and other relevant groups. Louise suggests that private insurers will play a critical role in post-launch lobbying while noting that price approval from governmental health economic agencies like NICE will be the necessary first step.

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