CurrentCignaPolicy N/A

Non-Weight Loss Indications - Wegovy and Zepbound Benefit Exclusion Overrides Policy

Defines Cigna's Benefit Exclusion Overrides policy to authorize coverage of Wegovy and Zepbound for certain non-weight-loss FDA-approved and evidence-supported indications (MACE risk reduction, MASH/NASH, and OSA) with detailed clinical criteria, documentation requirements, approval durations, and exclusions.

Policy Summary

PayerCigna

PolicyNon-Weight Loss Indications - Wegovy and Zepbound Benefit Exclusion Overrides Policy

Policy CodePolicy N/A

Change TypeMaterial revisions and additions (drugs added, criteria revised, documentation added)

Effective DateN/A

Next Review DateN/A

Key ActionSubmit required documentation with patient-specific identifiers and specialist consultation when requesting Wegovy for MASH/NASH; approvals are for 1 year and must meet the specified initial or continuation criteria.

POLICY UPDATE CHANGES

Zepbound was added to the Policy and policy title changed to Non-Weight Loss Indications - Wegovy and Zepbound.

For Zepbound obstructive sleep apnea initial therapy, requirement that sleep study be within past 1 year was removed (patient still required to have a sleep study).

Wegovy: MASH/NASH added as a new condition of approval with requirement for specialist prescribing/consultation and documentation.

Conditions not covered: Concomitant use with GLP-1 agonists or GLP-1/GIP agonists clarified and examples updated; concomitant use with other medications FDA-approved for weight loss language was modified (removed as a condition not recommended for approval previously).

Policy statement added definition note: an asterisk next to specified gender denotes biological traits definition for males and females.

3Primary Non-Weight-Loss Indications Covered

1Approval Duration (years)

>=15AHI threshold (events/hour)

>=27/>=30BMI thresholds (kg/m2)

Coverage Summary

This Benefit Exclusion Overrides policy authorizes coverage of Wegovy (semaglutide) and Zepbound (tirzepatide) for specified non-weight-loss indications when a client’s benefit plan would otherwise exclude these products. Covered indications include: Wegovy for reduction of major adverse cardiovascular events (MACE), Wegovy for metabolic dysfunction-associated steatohepatitis (MASH)/non-alcoholic steatohepatitis (NASH), and Zepbound for moderate to severe obstructive sleep apnea (OSA) in adults with obesity. Approvals are provided for a duration of 1 year and require documentation per the clinical criteria. The policy excludes coverage for weight-loss indications (coverage determined by the member’s prescription benefit) and for concomitant use with GLP-1 or GLP-1/GIP agonists.

Key thresholds and approval duration

BMI thresholdsWegovy (MACE and MASH): ≥ 27 kg/m2; Zepbound (OSA): ≥ 30 kg/m2

Apnea-Hypopnea Index (AHI) thresholdAHI ≥ 15 events per hour for moderate to severe OSA

Weight-loss response threshold (Zepbound continuation)≥ 10% of baseline body weight lost after ≥ 1 year of therapy

AgePatient must be ≥ 18 years of age for all listed non-weight-loss indications

Ankle-Brachial Index (ABI) for PAD evidenceABI < 0.85 as evidence of symptomatic peripheral arterial disease

Liver biopsy NAFLD activity score (MASH)NAFLD activity score ≥ 4 with ≥1 in each: steatosis, ballooning, lobular inflammation (if biopsy used)

Baseline BMI (for continuation criteria)Baseline prior to therapy: ≥ 27 kg/m2 for Wegovy MACE; ≥ 30 kg/m2 for Zepbound OSA

Approval durationApprovals are provided for 1 year

Medical-Necessity Criteria

Wegovy - Major Adverse Cardiovascular Event(s) (MACE) Risk Reduction

Approve for 1 year if the patient meets ONE of the following (A or B):

A) Initial Therapy

Patient is ≥ 18 years of age
Patient has a current BMI ≥ 27 kg/m2≥ 27 kg/m2
ONE of
- Patient has had a prior myocardial infarction
- Patient has had a prior stroke

Not Covered / Experimental Uses

Exclusions: the policy states these agents are not covered for weight loss indications (coverage is determined by the member’s prescription benefit). Concomitant use of Wegovy or Zepbound with GLP-1 agonists or GLP-1/GIP agonists is considered not medically necessary; examples of GLP-1 and GLP-1/GIP products are provided. The policy also clarifies that any other uses not specifically listed as approved in this policy are considered not medically necessary.

Provider Actions & Authorization Requirements

Documentation Required

Documentation for MASH/NASH

Document patient-specific identifiers and supporting clinical evidence when requesting coverage for Wegovy for MASH/NASH. Acceptable documentation includes chart notes, laboratory reports, imaging reports, and liver biopsy pathology reports. For histologic confirmation, a liver biopsy report demonstrating MASH (NASH) with stage F2–F3 fibrosis must be provided and should be dated within the past 3 years. If imaging-based evidence is used instead of biopsy, provide imaging (e.g., transient elastography, MRI elastography) results that demonstrate fibrosis consistent with F2–F3 within the past 6 months. Ensure documentation clearly links the findings to the patient and the date of service.

Patient identifiers: name, DOB, member ID
Acceptable documents: chart notes, labs, imaging reports, biopsy pathology report
Biopsy timeline: liver biopsy within 3 years (if used for histologic confirmation)
Imaging timeline: transient elastography or MRI elastography within 6 months (if imaging used)

Coding

Drugs referencedmixed

Wegovy	semaglutide subcutaneous injection (Novo Nordisk) - referenced by product name in policy
Zepbound	tirzepatide subcutaneous injection (Eli Lilly) - referenced by product name in policy

Drugs explicitly named in policy textmixed

Wegovy	semaglutide subcutaneous injection (Novo Nordisk)
Zepbound	tirzepatide subcutaneous injection (Eli Lilly)

Background & Evidence

Background: the policy provides Benefit Exclusion Overrides to allow authorization of Wegovy and Zepbound for select non-weight-loss indications supported by clinical evidence. The SELECT trial demonstrated Wegovy reduced MACE (mean follow-up ~39.8 months) in adults with overweight or obesity and established cardiovascular disease. The ESSENCE (Part 1) trial showed significant histologic improvement and resolution of steatohepatitis with Wegovy in patients with MASH/NASH (F2–F3). The SURMOUNT-OSA program demonstrated Zepbound’s superiority versus placebo for reduction in apnea-hypopnea index (AHI) in adults with obesity and moderate to severe OSA. Guideline context for MASH and OSA emphasizes lifestyle modification and specialist involvement for MASH and the role of diagnostic sleep testing and weight management in OSA.

Study/Source	Key Finding
SELECT trial (Wegovy)	Demonstrated reduction in MACE (HR 0.80; 95% CI 0.72-0.90); mean follow-up 39.8 months
ESSENCE trial (Wegovy for MASH) Part 1	Significant improvement in fibrosis and resolution of steatohepatitis at Week 72; e.g., 62.9% vs 34.1% resolution (Wegovy vs placebo)
SURMOUNT-OSA (Zepbound)	Zepbound superior to placebo for reduction in AHI at Week 52 in two trials (treatment differences ~ -20 to -24 events/hour)
SURMOUNT-OSA	Tirzepatide for obstructive sleep apnea and obesity (N Engl J Med. 2024)
SELECT	Semaglutide and cardiovascular outcomes in obesity without diabetes (N Engl J Med. 2023)
Prescribing information dates	Wegovy Aug 2025; Zepbound Apr 2025 (as cited)

Definitions:

Specified gender*: males/females are defined by biological traits regardless of gender identity or expression and used where gender-specific thresholds apply (e.g., alcohol consumption limits).

Baseline: refers to the patient’s status prior to initiation of the specified therapy (e.g., prior to Wegovy or Zepbound).

Stability in obstructive sleep apnea signs or symptoms: per prescriber assessment; examples include but are not limited to snoring, excessive daytime sleepiness, and fatigue.

Revision History

10/23/2024 (selected revision entries indicate later dates through 08/27/2025)addition

Zepbound was added to the Policy and the policy title changed to 'Non-Weight Loss Indications - Wegovy and Zepbound.'

Selected revision noted in HISTORY (see entries through 01/08/2025 and HISTORY details updated 05/28/2025, 07/09/2025, 08/27/2025)revision

For Zepbound obstructive sleep apnea initial therapy, the requirement that the sleep study be within the past 1 year was removed; a sleep study is still required but the timeframe restriction was eliminated.

05/28/2025 (policy content reflects addition by 08/27/2025 review)addition

Policy Summary

PayerCigna

PolicyNon-Weight Loss Indications - Wegovy and Zepbound Benefit Exclusion Overrides Policy

Policy CodePolicy N/A

Change TypeMaterial revisions and additions (drugs added, criteria revised, documentation added)

Effective DateN/A

Next Review DateN/A

On This Page

This does not include a transient ischemic attack (TIA).

Patient has history of symptomatic peripheral arterial disease as evidenced by ONE of

Intermittent claudication with ankle-brachial index < 0.85< 0.85
Peripheral arterial revascularization procedure
Amputation due to atherosclerotic disease

According to the prescriber, the medication will be used in combination with optimized pharmacotherapy for established cardiovascular disease

The medication will be used concomitantly with behavioral modification and a reduced-calorie diet

B) Continuing Therapy with Wegovy

Patient is ≥ 18 years of age
At baseline, patient had a BMI ≥ 27 kg/m2≥ 27 kg/m2
Baseline refers to prior to Wegovy
ONE of
- Patient has had a prior myocardial infarction
- Patient has had a prior stroke
  This does not include a transient ischemic attack (TIA).
- Patient has history of symptomatic peripheral arterial disease as evidenced by ONE of
  - Intermittent claudication with ankle-brachial index < 0.85< 0.85
  - Peripheral arterial revascularization procedure
  - Amputation due to atherosclerotic disease
According to the prescriber, the medication will be used in combination with optimized pharmacotherapy for established cardiovascular disease
The medication will be used concomitantly with behavioral modification and a reduced-calorie diet

Wegovy - Metabolic Dysfunction-Associated Steatohepatitis (MASH)/NASH

Approve for 1 year if the patient meets ONE of the following (A or B):

A) Initial Therapy

Patient is ≥ 18 years of age
Patient does not have cirrhosis
Diagnosis of MASH/NASH confirmed by ONE of
- a) Liver biopsy
  - Liver biopsy has been performed within the 3 years preceding treatment with Wegovywithin 3 years
    [documentation required]
  - Liver biopsy shows non-alcoholic fatty liver disease activity score of ≥ 4 with a score of ≥ 1 in ALL of: steatosis; ballooning; lobular inflammationNAS ≥ 4 and ≥1 in components
    [documentation required]
- b) Imaging exam within 6 months
  - Patient has had elastography (e.g., FibroScan, transient elastography, MR elastography, ARFI, shear wave elastography) within 6 monthswithin 6 months
    [documentation required]
  - OR computed tomography within 6 monthswithin 6 months
    [documentation required]
  - OR magnetic resonance imaging within 6 monthswithin 6 months
    [documentation required]
Patient has stage
- Stage F2 fibrosisF2
- Stage F3 fibrosisF3
According to the prescriber, the patient has ONE or more metabolic risk factors managed according to standard of care (central obesity; hypertriglyceridemia; reduced HDL-C; hypertension; elevated fasting plasma glucose indicative of diabetes or pre-diabetes)
Alcohol consumption limits
- Female patient: Alcohol consumption is < 20 grams/day< 20 g/day
- Male patient: Alcohol consumption < 30 grams/day< 30 g/day
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
[documentation required]

B) Patient Currently Receiving Wegovy (continuation after ≥1 year)

Patient has completed ≥ 1 year of therapy with Wegovy≥ 1 year
According to the prescriber, the patient has not had worsening of fibrosis or MASH/NASH
According to the prescriber, patient has not progressed to stage F4 (cirrhosis)
According to the prescriber, metabolic risk factors are managed according to standard of care
Alcohol consumption limits
- Female patient: Alcohol consumption is < 20 grams/day< 20 g/day

Zepbound - Obstructive Sleep Apnea (OSA), Moderate to Severe, in a Patient with Obesity

Approve for 1 year if the patient meets ONE of the following (A or B):

A) Initial Therapy

Patient is ≥ 18 years of age
Patient has a current BMI ≥ 30 kg/m2≥ 30 kg/m2
Sleep study requirements
- Patient has been diagnosed with moderate to severe obstructive sleep apneaAHI criteria applies
- Patient has an apnea-hypopnea index (AHI) ≥ 15 events per hour≥ 15 events/hour
Exclusions (patient does NOT meet either of)
- Central sleep apnea with percent of central apneas/hypopneas ≥ 50%≥ 50% central apneas/hypopneas
- Cheyne Stokes respiration
The medication will be used concomitantly with behavioral modification and a reduced-calorie diet

B) Continuing Therapy with Zepbound

Patient is ≥ 18 years of age
At baseline, patient had a BMI ≥ 30 kg/m2≥ 30 kg/m2
Baseline refers to prior to Zepbound
Completed ≥1 year and response
- Patient has completed ≥ 1 year of therapy with Zepbound≥ 1 year
- Patient has lost ≥ 10% of baseline body weight≥ 10% of baseline

Zepbound - Continuation Therapy after 1 year of initial therapy

For a patient who has completed ≥ 1 year of initial therapy with Zepbound:

ALL of the following

Patient is ≥ 18 years of age
At baseline, patient had a BMI ≥ 30 kg/m2≥ 30 kg/m2
Baseline refers to status prior to starting Zepbound
AND
- Patient has completed ≥ 1 year of therapy with Zepbound≥ 1 year
- a and b
  - Patient has lost ≥ 10% of baseline body weight≥ 10% of baseline
  - According to the prescriber, patient has stability in obstructive sleep apnea signs or symptoms
    Examples of signs or symptoms include but are not limited to snoring, excessive daytime sleepiness, fatigue
Medication will be used concomitantly with behavioral modification and a reduced-calorie diet

Zepbound - Initial Therapy for Obstructive Sleep Apnea (context from HISTORY and criteria references)

Initial Therapy criteria (referenced; part 1 of policy not included here). Note: a sleep study is required for initial therapy but timeframe requirement was modified to remove the 'within 1 year' constraint (patient still required to have a sleep study).

ALL of the following

Patient has a sleep study confirming obstructive sleep apneaAHI criteria applies

Wegovy - MASH/NASH

New condition of approval added to FDA-Approved Indications (approval requires specialist involvement and documentation).

ALL of the following

Wegovy prescribed for metabolic dysfunction-associated steatohepatitis (MASH)/non-alcoholic steatohepatitis (NASH) is a condition of approval
Because of specialized skills required for evaluation, diagnosis, monitoring adverse events, and long-term efficacy
Approval requires Wegovy to be prescribed by or in consultation with a physician who specializes in the condition being treated
Documentation is required for use of Wegovy for MASH/NASH
Documentation may include chart notes, laboratory results, medical test results, claims records, prescription receipts, and/or other information and must include patient-specific identifying information

Prior Authorization

Prior authorization / Approval duration

Prior authorization approvals are granted for 1 year. Initial and continuation approvals require meeting the policy's specified criteria. Prescriber attestations are required where noted in the criteria (for example, attestations regarding baseline BMI, prior therapy, and concomitant medication use).

Approval duration: 1 year
Prescriber must attest to meeting all applicable initial or continuation criteria

Documentation Required

Specialist prescribing requirement for MASH/NASH

Wegovy prescribed for MASH/NASH must be prescribed by, or in consultation with, an endocrinologist, gastroenterologist, or hepatologist. Include name and specialty of consulting specialist in the request.

Prescriber requirement: endocrinologist, gastroenterologist, or hepatologist (or documented consultation)

Documentation Required

Baseline/previous BMI requirement for continuation

For continuation approval, the prescriber must document the baseline BMI prior to initiation of Wegovy and attest that baseline BMI met the policy-specified thresholds. The prescriber must attest that baseline BMI was obtained prior to starting therapy and include the value in the documentation.

Document baseline BMI prior to therapy
Prescriber attestation that baseline BMI met required threshold for continuation

Denial Risk

Excluded uses

Wegovy and Zepbound are not considered medically necessary for weight loss indications when coverage would be under the pharmacy prescription benefit rather than a medical benefit. Concomitant use of Wegovy or Zepbound with other GLP-1 or GLP-1/GIP agents is not medically necessary.

Not medically necessary for weight loss indications (coverage via prescription benefit)
Not medically necessary for concomitant use with GLP-1 or GLP-1/GIP agents

Prior Authorization

Continuation approval after 1 year of Zepbound

For requests to continue Zepbound beyond 1 year, document the patient's age, baseline BMI, completion of ≥1 year of Zepbound therapy, achievement of ≥10% weight loss from baseline, stability in signs/symptoms of obstructive sleep apnea (OSA), and ongoing participation in concomitant behavioral modification and diet interventions.

Document age and baseline BMI
Completion of ≥1 year of Zepbound therapy
Demonstrated ≥10% weight loss from baseline
Stability in OSA signs/symptoms
Document concomitant behavioral modification/diet participation

Denial Risk

Concomitant GLP-1/GLP-1-GIP agent use

Concomitant use of other GLP-1 or GLP-1/GIP agonists with Wegovy or Zepbound is not recommended and will be considered not covered. Provide medication history to demonstrate absence of concomitant GLP-1 or GLP-1/GIP agent use.

Examples of GLP-1 / GLP-1-GIP agents: exenatide, Ozempic (semaglutide), Rybelsus (semaglutide oral), Saxenda (liraglutide), Trulicity (dulaglutide), Victoza (liraglutide), Mounjaro (tirzepatide)
Concomitant use with these agents is not recommended / not covered

Wegovy: Metabolic Dysfunction-Associated Steatohepatitis (MASH)/NASH was added as a new condition of approval with requirements that diagnosis be confirmed by biopsy or recent imaging, stage F2–F3 fibrosis, metabolic risk factor management, alcohol limits, use with diet/exercise, and that Wegovy be prescribed by or in consultation with an endocrinologist, gastroenterologist, or hepatologist; documentation (chart notes, labs, tests, claims, prescription receipts) is required and must include patient-specific identifying information.

HISTORY entries across 01/08/2025 - 08/27/2025clarificationLatest

Conditions not covered: Concomitant use with GLP-1 agonists or GLP-1/GIP agonists clarified; examples of GLP-1 and GLP-1/GIP products were updated and guidance states these agents should not be combined with each other or with Zepbound. Language regarding concomitant use with other medications FDA-approved for weight loss was modified (the previous blanket 'Concomitant Use with Other Medications FDA-Approved for Weight Loss' condition was removed and clarified as 'not recommended').

07/09/2025 (policy statement update reflected by 08/27/2025 history)additionLatest

Policy statement added a definition note that an asterisk next to specified gender denotes biological traits for males and females (non-material per brief but recorded in HISTORY).

Male patient: Alcohol consumption < 30 grams/day< 30 g/day

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

According to the prescriber, patient has stability in obstructive sleep apnea signs or symptoms

Examples include snoring, excessive daytime sleepiness, fatigue

The medication will be used concomitantly with behavioral modification and a reduced-calorie diet