Employer / Commercial Insurance
Covered with requirementsWhat you need to qualify
- Age 18 and older
- Confirmed MASH diagnosis by FIB-4, FibroScan_VCTE, liver_biopsy, MRE, and ELF_test, fibrosis stage F2 to F3
- Lab results confirming eligibility
Qualification pathways
You can qualify through any one of these.
MASH with moderate to advanced fibrosis (F2-F3)
All of:
- Adult patient (>= 18 years)
- Diagnosis of noncirrhotic metabolic dysfunction-associated steatohepatitis (MASH)
- Fibrosis stage F2 or F3 (moderate to advanced)
- NAFLD Activity Score (NAS) >= 4 with evidence of steatosis, lobular inflammation, and hepatocyte ballooning (per pivotal trial enrollment criteria)
Plus any one of:
- FIB-4 assessment as primary risk stratification (low risk <1.30, indeterminate 1.30-2.67, high risk >2.67)
- ELF test and/or elastography (VCTE) as secondary assessment
- Liver biopsy confirmation (reserved for indeterminate/discordant NITs or suspected alternate etiologies)
- MRE when uncertainty persists or cross-sectional imaging needed
Documentation to bring
- Diagnosis of noncirrhotic MASH (not cirrhotic)
- Fibrosis stage F2 or F3 confirmed by noninvasive testing or liver biopsy
- FIB-4 result as primary fibrosis risk assessment
- If FIB-4 is indeterminate or elevated: confirmatory ELF test and/or elastography (VCTE) result
- Liver biopsy results if NITs are discordant or alternate etiology suspected
- NAS score >= 4 with steatosis, lobular inflammation, and hepatocyte ballooning if biopsy-confirmed
Not covered when
- Cirrhotic MASH is excluded (noncirrhotic only)
- Concomitant use with other semaglutide-containing products or any other GLP-1 receptor agonist is not recommended
Policy note: FDA-approved for treatment of noncirrhotic MASH with moderate to advanced liver fibrosis (F2-F3) in adults. The clinical rationale describes a stepwise fibrosis assessment: Step 1 FIB-4 (primary), Step 2 ELF and/or elastography (VCTE) as secondary. MRE may be used when uncertainty persists. Liver biopsy is reserved for indeterminate/discordant NITs. Pivotal trial (Study 8/NCT04822181) required biopsy-confirmed MASH with F2-F3 fibrosis and NAS >= 4. No specific lookback periods for testing were stated in this document. Guidelines discourage alcohol consumption, with complete abstinence recommended in advanced fibrosis.
Policy effective May 18, 2026 · verified June 5, 2026 · source: Pa policy