Employer / Commercial Insurance
Covered with requirementsWhat you need to qualify
- Age 18 and older
- Confirmed MASH diagnosis by liver_biopsy, FIB-4, FibroScan_VCTE, MRE, and ELF_test, fibrosis stage F2 to F3
- Lab results confirming eligibility from the last 6 months
Qualification pathways
You can qualify through any one of these.
MASH with moderate-to-advanced fibrosis
All of:
- Adult patient (age >= 18)
- Noncirrhotic MASH diagnosis
- Fibrosis stage F2 to F3 confirmed by appropriate diagnostic method
Plus any one of:
- Liver biopsy confirming MASH with F2-F3 fibrosis
- FIB-4 elevated (> 1.30 low-risk threshold) with confirmatory ELF and/or elastography (VCTE or MRE) consistent with F2-F3
- ELF score >= 9.8 (intermediate risk) or >= 11.3 (high risk) with corroborating fibrosis staging
- VCTE >= 8 kPa (intermediate) or >= 12 kPa (high risk/advanced fibrosis)
Documentation to bring
- Diagnosis of noncirrhotic MASH
- Evidence of fibrosis stage F2 or F3 via liver biopsy, FIB-4 with confirmatory elastography (VCTE/MRE), or ELF test
- FIB-4 result (primary risk stratification): low-risk < 1.30, indeterminate 1.30–2.67, high-risk > 2.67 (for age > 65, high-risk threshold > 2.0)
- If FIB-4 indeterminate or elevated: confirmatory ELF and/or elastography results
- Confirmation patient does not have cirrhosis
Not covered when
- Cirrhotic MASH excluded (noncirrhotic only per FDA labeling)
- Fibrosis stage F4 (cirrhosis) excluded
- Concomitant use with other semaglutide-containing products not recommended
- Concomitant use with any other GLP-1 receptor agonist not recommended
Policy note: FDA indication is for noncirrhotic MASH with moderate-to-advanced fibrosis (F2-F3). The document outlines a stepwise diagnostic approach: Step 1 FIB-4 (primary risk stratification with cutoffs < 1.30 low, 1.30-2.67 indeterminate, > 2.67 high; age > 65 high threshold > 2.0), Step 2 ELF and/or elastography (VCTE/MRE) for confirmatory testing. ELF cutpoints: < 9.8 low risk, 9.8-11.3 intermediate, >= 11.3 high risk. VCTE cutpoints: < 8 kPa low, 8-12 kPa intermediate, >= 12 kPa high risk/advanced fibrosis. MRE may be used when uncertainty persists. Biopsy reserved for indeterminate/discordant NITs or suspected alternate etiologies. The NASH trial (NCT04822181) enrolled biopsy-confirmed MASH with F2-F3 and NAS >= 4. Imaging lookback set to 6 months for elastography; lab lookback set to 6 months for serum biomarkers (FIB-4, ELF) based on clinical guidance context, though specific lookback periods not explicitly stated in available document text.
Policy effective May 4, 2026 · verified June 2, 2026 · source: RI_Weight_Management_ProgSum.pdf