The Role of Invasive Diagnostics in Prior Authorization for MASH
Author(s)
Rebecca Calvo-Cruz, MSc1, Jelena Sostar, MPharm MSc2, Maximilian Vargas, PhD, MBA1, Matias Junghahn, BS1, Maria Vutcovici Nicolae, .3.
1Certara Evidence and Access, Princeton, NJ, USA, 2Certara Evidence and Access, Milan, Italy, 3Certara Evidence and Access, Saint-Philippe, QC, Canada.
1Certara Evidence and Access, Princeton, NJ, USA, 2Certara Evidence and Access, Milan, Italy, 3Certara Evidence and Access, Saint-Philippe, QC, Canada.
OBJECTIVES: Prior authorization (PA) criteria in the US often include patient eligibility requirements. While PA criteria may align with clinical trial criteria, deviations may occur due to real-world applicability, cost, and clinical guidelines. For conditions involving invasive diagnostic tests PA requirements face challenges, balancing between clinical trial criteria to maintain clinical rigor or diverging from these to reduce barriers to access. This study evaluates the alignment between PA criteria and clinical trial inclusion/exclusion criteria for a recently approved noncirrhotic nonalcoholic steatohepatitis (NASH)/metabolic dysfunction-associated steatohepatitis (MASH) treatment.
METHODS: PA criteria for resmetirom, approved for NASH with moderate to advanced liver fibrosis, were reviewed focusing on requirements such as liver biopsy, stages of liver fibrosis, and metabolic risk factors. Major commercial formularies, including Cigna/Express Scripts, Aetna/CVS Caremark, Prime Therapeutics, Anthem/Elevance, and UnitedHealthcare/Optum were reviewed. Payer policies were compared to pivotal clinical trial criteria to assess alignment.
RESULTS: The clinical trial criteria for resmetirom included metabolic risk factors, a baseline or recent liver biopsy showing NASH with stage 2 or 3 fibrosis, and a NAFLD Activity Score (NAS) of at least 4, with a second liver biopsy performed at 36 weeks. While liver biopsy is considered the gold standard for confirming NASH, its invasiveness and risks limit feasibility, making noninvasive tests (NITs) safer, more accessible alternatives for diagnosis and monitoring. Among the five formularies reviewed, two required a diagnosis via liver biopsy for PA, while the others accepted NITs.
CONCLUSIONS: Our findings indicate that 3/5 reviewed plans do not mandate liver biopsy as a PA requirement, despite its use in clinical trials. This reflects a growing emphasis on balancing diagnostic accuracy with patient safety and accessibility. These findings highlight a divergence from clinical trial requirements, with payer criteria aligning more closely with real-world practices to reduce procedural risks and barriers to care.
METHODS: PA criteria for resmetirom, approved for NASH with moderate to advanced liver fibrosis, were reviewed focusing on requirements such as liver biopsy, stages of liver fibrosis, and metabolic risk factors. Major commercial formularies, including Cigna/Express Scripts, Aetna/CVS Caremark, Prime Therapeutics, Anthem/Elevance, and UnitedHealthcare/Optum were reviewed. Payer policies were compared to pivotal clinical trial criteria to assess alignment.
RESULTS: The clinical trial criteria for resmetirom included metabolic risk factors, a baseline or recent liver biopsy showing NASH with stage 2 or 3 fibrosis, and a NAFLD Activity Score (NAS) of at least 4, with a second liver biopsy performed at 36 weeks. While liver biopsy is considered the gold standard for confirming NASH, its invasiveness and risks limit feasibility, making noninvasive tests (NITs) safer, more accessible alternatives for diagnosis and monitoring. Among the five formularies reviewed, two required a diagnosis via liver biopsy for PA, while the others accepted NITs.
CONCLUSIONS: Our findings indicate that 3/5 reviewed plans do not mandate liver biopsy as a PA requirement, despite its use in clinical trials. This reflects a growing emphasis on balancing diagnostic accuracy with patient safety and accessibility. These findings highlight a divergence from clinical trial requirements, with payer criteria aligning more closely with real-world practices to reduce procedural risks and barriers to care.
Conference/Value in Health Info
2025-05, ISPOR 2025, Montréal, Quebec, CA
Value in Health, Volume 28, Issue S1
Code
HPR118
Topic
Health Policy & Regulatory
Topic Subcategory
Reimbursement & Access Policy
Disease
No Additional Disease & Conditions/Specialized Treatment Areas, SDC: Diabetes/Endocrine/Metabolic Disorders (including obesity)