CurrentCignaPolicy IP0781

Metabolic Dysfunction-Associated Steatohepatitis - Wegovy

Defines coverage criteria, required documentation, prescriber specialty, duration of approval, and exclusions for Wegovy (semaglutide subcutaneous injection) when used to treat non-cirrhotic MASH/NASH (F2-F3 fibrosis) under Cigna Benefit Exclusion Overrides for Individual and Family Plans.

Policy Summary

PayerCigna

PolicyMetabolic Dysfunction-Associated Steatohepatitis - Wegovy

Policy CodePolicy IP0781

Change TypeNew policy

Effective DateMar 15, 2026

Next Review Date

Key ActionProvide documentation showing stage F2 or F3 fibrosis via biopsy within 3 years or VCTE/MRE/ELF within 6 months and ensure prescription is by or in consultation with an endocrinologist, gastroenterologist, or hepatologist.

POLICY UPDATE CHANGES

New policy establishing coverage criteria for Wegovy for MASH/NASH published.

F2-F3Covered Fibrosis Stages

≥18Minimum Age

1 yrInitial Approval Duration

Not coveredWeight loss indication

Coverage Summary

Coverage stance: Covered with criteria for Wegovy (semaglutide) when used to treat non-cirrhotic MASH/NASH with F2–F3 fibrosis. Approvals are provided for 1 year and require the medication to be prescribed by or in consultation with an endocrinologist, gastroenterologist, or hepatologist. Weight-loss use of Wegovy is not covered under this policy (coverage for weight loss is determined by the member's prescription benefit).

Initial Therapy Criteria (FDA-Approved Indication)

FDA-Approved Indication - Initial Therapy

Approve for 1 year if the patient meets ALL of the following:

ALL of the following

Patient is ≥ 18 years of age
Patient does not have cirrhosis (F4)
Patient has stage F2 or F3 fibrosis prior to initiating treatment with Rezdiffra or Wegovy
- identified by ONE of the following
  - Liver biopsy performed within the 3 years preceding treatmentwithin 3 years
    documentation required
  - Vibration-controlled transient elastography (VCTE) performed within the 6 months preceding treatmentwithin 6 months
    documentation required
  - Magnetic resonance elastography (MRE) performed within the 6 months preceding treatmentwithin 6 months
    documentation required
  - Enhanced Liver Fibrosis (ELF) test performed within the 6 months preceding treatment with a score of ≥ 9.2 to ≤ 10.5ELF ≥ 9.2 to ≤ 10.5; within 6 months
    documentation required
ALL of the following
- ANY of the following
  - Central obesity
  - Hypertriglyceridemia
  - Reduced high-density lipoprotein cholesterol
  - Hypertension
  - Elevated fasting plasma glucose indicative of diabetes or pre-diabetes
ALL of the following
- ANY of the following
  - Female* patient: Alcohol consumption is < 20 grams/day< 20 grams/day
    one standard drink ≈ 14 grams pure alcohol
  - Male* patient: Alcohol consumption is < 30 grams/day< 30 grams/day
    one standard drink ≈ 14 grams pure alcohol
The medication will be used in combination with appropriate diet and exercise therapy
The medication is prescribed by or in consultation with an endocrinologist, gastroenterologist, or hepatologist

Continuation Therapy Criteria

FDA-Approved Indication - Continued Therapy (Patient Currently Receiving Wegovy)

Approve for 1 year if the patient meets ALL of the following (applies to patients who have completed ≥ 1 year of therapy):

ALL of the following

Patient has completed ≥ 1 year of therapy with Wegovy and according to the prescriber, the patient has not had worsening of fibrosis or MASH/NASH≥ 1 year
According to the prescriber, patient does not have cirrhosis (F4)
According to the prescriber, metabolic risk factors are managed according to standard of care
ALL of the following
- ANY of the following
  - Female* patient: Alcohol consumption is < 20 grams/day< 20 grams/day
    one standard drink ≈ 14 grams pure alcohol
  - Male* patient: Alcohol consumption is < 30 grams/day< 30 grams/day
    one standard drink ≈ 14 grams pure alcohol
The medication will be used in combination with appropriate diet and exercise therapy
The medication is prescribed by or in consultation with an endocrinologist, gastroenterologist, or hepatologist

Provider Actions & Prior Authorization

Prior Authorization

Prior authorization and prescriber specialty

Wegovy for MASH/NASH requires prior authorization. Approvals are provided for 1 year, and the medication must be prescribed by or in consultation with an endocrinologist, gastroenterologist, or hepatologist.

Approval duration = 1 year

Documentation Required

Documentation of fibrosis staging and non-invasive tests

Provide documentation showing stage F2 or F3 fibrosis via one of the following: a liver biopsy within the prior 3 years, VCTE performed within the prior 6 months, MRE performed within the prior 6 months, or an ELF test performed within the prior 6 months with a score in the 9.2–10.5 range. Documentation may include chart notes, lab results, imaging, or biopsy reports.

Liver biopsy — within 3 years prior to treatment
VCTE — within 6 months prior to treatment
MRE — within 6 months prior to treatment
ELF test — within 6 months prior to treatment; ELF score ≥ 9.2 to ≤ 10.5

Documentation Required

Alcohol use documentation

Prescriber must document the patient’s alcohol consumption meets the policy’s gender-specific limits prior to approval.

Female: alcohol consumption < 20 grams/day
Male: alcohol consumption < 30 grams/day

Denial Risk

Exclusion for concomitant GLP-1/GIP agonists

Coadministration of Wegovy with other GLP-1 agonists or GLP-1/GIP agonists is not recommended and is considered not medically necessary; claims for concomitant use may be denied.

Examples: exenatide SC, Ozempic, Rybelsus, Saxenda, Trulicity, Victoza
Example GLP-1/GIP agonist: Mounjaro (tirzepatide)

Clinical Evidence

ESSENCE Part 1Phase 3 trial (n=800) in adults with F2-F3 MASH

Significant histologySignificant improvement in fibrosis and resolution of steatohepatitis vs placebo

BMI mean 34.6Baseline mean BMI 34.6 kg/m2; 56% had T2D; majority F3 (68.8%)

Background/evidence summary: Wegovy is FDA-approved for weight management, to reduce major adverse cardiovascular events in certain adults with established CV disease, and for treatment of non-cirrhotic MASH consistent with F2–F3 fibrosis. The Phase 3 ESSENCE trial (Part 1) randomized adults with biopsy-confirmed MASH and F2–F3 fibrosis and demonstrated significant histologic benefit: Wegovy produced both improvement in fibrosis with no worsening of steatohepatitis and resolution of steatohepatitis with no worsening of fibrosis versus placebo. AASLD practice guidance (updated to address Wegovy) supports selecting candidates using non-invasive testing or historical biopsy (e.g., liver biopsy within 3 years or VCTE/MRE within 6 months, or ELF score in the range 9.2 to 10.5) alongside assessment of metabolic risk factors and alcohol use limits.

Background & Definitions

Wegovy approvals and AASLD guidance: Wegovy is indicated in combination with diet and increased physical activity for weight reduction, CV risk reduction in certain adults, and for treatment of non-cirrhotic MASH with moderate to advanced fibrosis (F2–F3). AASLD guidance recommends comprehensive lifestyle modification and using non-invasive tests or a reasonably recent historical biopsy to identify appropriate candidates for MASH therapy; biopsy remains the gold standard when available.

Term	Definition
Female* / Male*
Defined by biological traits regardless of individual gender identity or gender expression.
One standard drink
Approximately 14 grams of pure alcohol (12 oz regular beer, 5 oz wine, 1.5 oz distilled spirits).

Key Thresholds

ELF score≥ 9.2 to ≤ 10.5

Liver biopsy recencyWithin 3 years prior to treatment

VCTE or MRE recencyWithin 6 months prior to treatment

Age≥ 18 years

Alcohol - female< 20 grams/day (one standard drink ≈ 14 g pure alcohol)

Alcohol - male< 30 grams/day (one standard drink ≈ 14 g pure alcohol)