ModifiedCignaPolicy N/A

Weight Loss - Glucagon‑Like Peptide‑1 (GLP‑1) Agonists

This Cigna coverage policy governs prior authorization, medical necessity criteria, and documentation requirements for select GLP-1 and GLP-1/GIP agonists used for weight management and related indications (including MASH and OSA) for health plans administered by Cigna Companies.

Policy Summary

PayerCigna

PolicyWeight Loss - GLP-1 Agonists (coverage criteria)

Policy CodePolicy N/A

Change TypeMultiple material edits — additions and revisions

Effective DateN/A

Next Review DateN/A

Key ActionObtain prior authorization before prescribing Foundayo, liraglutide (Saxenda or generic), Wegovy (all formulations), or Zepbound.

SourceLink

POLICY UPDATE CHANGES

Wegovy and Zepbound added to the policy.

Examples of weight‑related comorbidities updated and metabolic dysfunction‑associated steatotic liver disease (new nomenclature for NAFLD) added.

Body weight decrease requirement changed by removing 'only required once' and requirement updated to tolerate a maintenance dose.

Conditions added for Wegovy: Major adverse cardiovascular event(s) risk reduction indication and clarifications about prior stroke excluding TIA.

Zepbound: Obstructive sleep apnea indication added and sleep study timeframe requirement modified (still required but timeframe removed).

Concomitant use with other FDA‑approved weight‑loss medications (including other GLP‑1 or GLP‑1/GIP agonists) is not recommended / considered not medically necessary.

Policy statement updated requiring Wegovy be prescribed by or in consultation with a physician specializing in the condition being treated.

Liraglutide (generic to Saxenda) was added to the policy and targeted by prior authorization.

Concomitant use language updated to specify 'FDA-approved' medications for weight loss and removed prior 'not recommended' condition for concomitant use in some sections.

Wegovy tablet, Wegovy HD injection, Wegovy injection, Foundayo, and Rezdiffra were added or explicitly included with new or updated criteria.

MASH/NASH criteria updated to require documentation of stage F2 or F3 fibrosis confirmed by specific tests (liver biopsy within 3 years; VCTE/MRE/ELF within 6 months with ELF score ≥9.2 to ≤10.5).

Approval durations for Wegovy (injection/tablet) initial therapy and pediatric initial approvals changed to 7–8 months and certain cardiovascular indication approvals standardized to 1 year.

Baseline BMI/reference baseline was clarified to refer to baseline prior to any GLP-1 or GLP-1/GIP receptor agonist (e.g., liraglutide, Wegovy, Zepbound, Foundayo).

Documentation requirement added for Wegovy use in MASH (examples listed) and general documentation statement updated to require patient-specific identifiers.

Trek Health ingests and normalizes Transparency in Coverage data and payer policy updates to give provider organizations a clear view of how commercial reimbursement behaves across markets, payers, and services. Our platform transforms raw payer disclosures into structured intelligence that supports contract evaluation, payer negotiations, and service line strategy. By combining market benchmarks with ongoing policy visibility, Trek helps teams identify variability, risk, and opportunity in commercial reimbursement. The result is faster insight, stronger negotiating positions, and more informed financial decisions.

6GLP-1 / GLP-1/GIP products listed

Prior AuthPrior auth required

4 moLiraglutide initial approval

8 moFoundayo/Wegovy initial approval

AHI ≥15OSA AHI threshold

9.2–10.5ELF acceptable range

Medical Necessity and Coverage Criteria

Medical necessity top-level

Glucagon-like peptide-1 (GLP-1) receptor agonists are considered medically necessary when ONE of the following major indication groups is met (I, II, III, IV, or V):

Top-level indication groups: Policy lists five top-level groups (I-V) where medical necessity can be met: I. Liraglutide (Saxenda, generic); II. Foundayo; III. Wegovy injection/Wegovy HD injection; IV. Wegovy tablet; V. Zepbound

See each agent-specific criteria set for detailed initial and continuation requirements

Liraglutide (Saxenda) — initial criteria

I. Liraglutide (Saxenda, generic) is considered medically necessary when ONE of the following is met (1 or 2):

Liraglutide (Saxenda) options

Initial Therapy (Adults): i. Patient ≥18 years of age; ii. Trial of behavioral modification and dietary restriction ≥3 months; iii. Baseline BMI meets ONE: (a) ≥30 kg/m2 OR (b) ≥27 kg/m2 with ≥1 weight‑related comorbidity; iv. Medication used concomitantly with behavioral modification and a reduced‑calorie diet; v. Preferred product criteria met
Baseline refers to measurement prior to any GLP‑1 or GLP‑1/GIP agonist
Patient Currently Receiving (Adults): i. Patient ≥18 years of age; ii. Baseline BMI as above; iii. Patient has lost ≥4% of baseline body weight; iv. Medication used concomitantly with behavioral modification and a reduced‑calorie diet>=4% weight loss
Approve for 1 year when ALL met; if patient has not completed 4 months, use Initial Therapy criteria
Initial Therapy (Pediatrics age ≥12 to <18): i. Patient ≥12 and <18 years of age; ii. Trial of behavioral modification and dietary restriction ≥3 months; iii. Baseline BMI ≥95th percentile for age and sex; iv. Medication used concomitantly with behavioral modification and a reduced‑calorie diet; v. Preferred product criteria met
Pediatric continuation: approve 1 year when criteria met and ≥1% BMI reduction

Operational note: Prior Authorization is required for liraglutide (Saxenda, generic). Documentation must include patient‑specific identifying information and supporting clinical records as noted in policy.

See Policy Statement for documentation and prescriber requirements

Liraglutide (Saxenda) — Covered Criteria

Liraglutide (Saxenda) is medically necessary when ONE of the following is met:

Liraglutide (Saxenda) Covered Criteria

Initial Therapy (Adults): i. Patient ≥18 years of age; ii. Trial of behavioral modification and dietary restriction for ≥3 months; iii. Baseline BMI meets ONE: (a) ≥30 kg/m2 OR (b) ≥27 kg/m2 AND at baseline had ≥1 weight‑related comorbidity (hypertension, type 2 diabetes, dyslipidemia, obstructive sleep apnea, cardiovascular disease, knee osteoarthritis, asthma, COPD, metabolic dysfunction‑associated steatotic liver disease/NAFLD, PCOS, or coronary artery disease); iv. Medication will be used concomitantly with behavioral modification and a reduced‑calorie diet; v. Preferred product criteria met
Baseline refers to measurement prior to any GLP‑1 or GLP‑1/GIP agonist
Currently Receiving (Adults): i. Patient ≥18 years of age; ii. Baseline BMI as described above; iii. Patient has lost ≥4% of baseline body weight; iv. Medication will be used concomitantly with behavioral modification and a reduced‑calorie diet>=4% weight loss
Approve for 1 year when ALL met; if <4 months completed, apply Initial Therapy criteria

Foundayo — Covered Criteria

Foundayo is medically necessary when ONE of the following is met:

Foundayo criteria

Initial Therapy (Adults): i. Patient ≥18 years of age; ii. Trial of behavioral modification and dietary restriction ≥3 months; iii. Baseline BMI meets ONE: (a) ≥30 kg/m2 OR (b) ≥27 kg/m2 AND at baseline had ≥1 weight‑related comorbidity (list as in policy); iv. Medication used concomitantly with behavioral modification and a reduced‑calorie diet
Approve for 8 months
Patient Currently Receiving (Adults): i. Patient ≥18 years of age; ii. Baseline BMI as above; iii. Patient has lost ≥5% of baseline body weight; iv. Medication used concomitantly with behavioral modification and a reduced‑calorie diet>=5% weight loss
Continuation approval 1 year

Operational note: Prior Authorization is required for Foundayo per Policy Statement; baseline refers to pre‑GLP‑1/GLP‑1‑GIP exposure

Wegovy (injection/HD/tablet) — Covered Criteria

Wegovy products (injection, HD injection, tablet) are medically necessary when ONE of the following is met:

Wegovy criteria overview: Options include Weight Loss (adult and pediatric), Major Adverse Cardiovascular Event(s) (MACE) risk reduction, and MASH/NASH; criteria include Initial Therapy and Currently Receiving variants where specified

Initial approvals typically 8 months for adult/pediatric weight‑loss; continuation approvals up to 1 year; baseline refers to pre‑GLP‑1/GLP‑1‑GIP exposure

Weight Loss - Adult Initial Therapy: i. Patient ≥18 years; ii. Trial of behavioral modification and dietary restriction ≥3 months; iii. Baseline BMI meets ONE: (a) ≥30 kg/m2 OR (b) ≥27 kg/m2 AND at baseline had ≥1 weight‑related comorbidity; iv. Medication used concomitantly with behavioral modification and a reduced‑calorie diet

Initial approval 8 months (see revisions for exceptions)

Weight Loss - Adult Currently Receiving: i. Patient ≥18 years; ii. Baseline BMI as above; iii. Patient has lost ≥5% of baseline body weight; iv. Medication used concomitantly with behavioral modification and a reduced‑calorie diet

FDA‑Approved Indications (Weight Loss, Cardiovascular Risk Reduction, Obstructive Sleep Apnea)

Covered when ALL of the following sets apply to the specified FDA‑approved indication and therapy status (Initial Therapy or Patient Currently Receiving):

General prerequisites: Medication will be used concomitantly with behavioral modification and a reduced‑calorie diet; patient age ≥18 years for adult indications

Baseline BMI references refer to measurements prior to any GLP‑1 or GLP‑1/GIP agonist therapy

Weight‑loss indication BMI criteria: Either (a) baseline BMI ≥30 kg/m2 OR (b) baseline BMI ≥27 kg/m2 plus at least one weight‑related comorbidity (hypertension, type 2 diabetes, dyslipidemia, obstructive sleep apnea, cardiovascular disease, knee osteoarthritis/dysfunction, asthma, COPD, metabolic dysfunction‑associated steatotic liver disease/NAFLD, PCOS, or coronary artery disease)

Baseline refers to measurement prior to any GLP‑1 or GLP‑1/GIP agonist

Continuation criteria for select agents: Where specified, patient has lost ≥5% of baseline body weight (or equivalent BMI reduction) and tolerates maintenance dose; approvals for continuing therapy typically 1 year

Metabolic Dysfunction-Associated Steatohepatitis (MASH)/NASH - Initial Therapy

MASH/NASH: Covered when ALL of the following are met

MASH/NASH initial therapy requirements: i. Patient ≥18 years of age; ii. Patient does not have cirrhosis (F4); iii. Documentation of stage F2 or F3 fibrosis prior to initiating Rezdiffra or Wegovy confirmed by ONE: (a) liver biopsy within 3 years; OR (b) VCTE within 6 months; OR (c) MRE within 6 months; OR (d) ELF test within 6 months with score ≥9.2 to ≤10.5; iv. Prescriber reports one or more managed metabolic risk factors (central obesity, hypertriglyceridemia, reduced HDL, hypertension, elevated fasting plasma glucose/diabetes or pre‑diabetes); v. Alcohol consumption limits met by sex (female <20 g/day; male <30 g/day); vi. Medication used with appropriate diet and exercise therapy; vii. Prescribed by or in consultation with an endocrinologist, gastroenterologist, or hepatologistF2-F3 or ELF 9.2-10.5

Documentation required; approvals for MASH/NASH initial therapy are for 1 year

Wegovy - Weight Loss and Cardiovascular Indications

Wegovy (injection/tablet/HD) weight‑loss and cardiovascular indications: criteria and approval durations

Initial approval durations for Wegovy weight‑loss indications are typically 7–8 months depending on formulation and indication (revisions updated initial approvals to 7 or 8 months in select contexts)7-8 months

For patients who have not completed the specified initial duration, apply Initial Therapy criteria

Cardiovascular risk reduction approval: For Major Adverse Cardiovascular Event(s) risk reduction indication, approve for 1 year when ALL cardiovascular criteria are met; baseline BMI refers to measurement prior to any GLP‑1 or GLP‑1/GIP agonist1 year

Baseline clarified to pre‑GLP‑1/GLP‑1‑GIP exposure

Zepbound - Obstructive Sleep Apnea

Zepbound - Obstructive Sleep Apnea initial therapy

Baseline BMI reference: Baseline BMI refers to measurement prior to any GLP‑1 or GLP‑1/GIP receptor agonist (e.g., liraglutide [Saxenda, generic], Wegovy); applies to initial therapy and patients currently receiving Zepboundpre-GLP-1/GIP baseline

For OSA indication, see sleep study and AHI requirements for initial and continuation approval

OSA Initial Therapy requirements: i. Patient ≥18 years; ii. At baseline patient had BMI ≥30 kg/m2; iii. Diagnostic sleep study documents diagnosis of moderate to severe OSA AND AHI ≥15 events/hour; iv. Exclusion of central sleep apnea or Cheyne‑Stokes respiration; v. Medication used concomitantly with behavioral modification and a reduced‑calorie dietAHI ≥15

Initial or continuation approvals per policy; continuation may require demonstrated clinical stability and weight‑loss thresholds

Benefit availability for weight-loss medications varies by purchaser and specific plan. Weight loss medications are specifically excluded under many benefit plans; always check the applicable benefit plan document (for example, Group Service Agreement, Evidence of Coverage, Certificate of Coverage, or Summary Plan Description) to determine whether the drug is a covered benefit. In the event of a conflict between this Coverage Policy and the member's benefit plan document, the benefit plan document controls.

Prior authorization is required for the listed products (Foundayo, liraglutide/Saxenda [including generic liraglutide], Wegovy injections/HD/tablet, and Zepbound) when benefit coverage is available; documentation supporting medical necessity must accompany requests as specified in the criteria. Claims submitted without covered diagnosis or procedure codes under the applicable Coverage Policy will be denied as not covered.

This policy specifically targets the GLP‑1 and GLP‑1/GIP agents that have FDA‑approved indications for weight management and related indications and does not target other GLP‑1 agents that lack an FDA weight‑loss indication. In other words, other GLP‑1 agonists which do not carry an FDA‑approved indication for weight loss are not targeted in this policy.

Examples of products not targeted by this policy include GLP‑1 agents that are FDA‑approved only for type 2 diabetes; providers should refer to product labeling and the member's benefit document to determine coverage consideration for non‑targeted agents.

Concomitant use of the listed agents with other GLP‑1 agonists, GLP‑1/GIP agonists, or other FDA‑approved medications for weight loss is not recommended and is addressed in the policy as a condition that may be considered not medically necessary. Specifically, combining these agents with each other or with any other GLP‑1 or GLP‑1/GIP agonist or other FDA‑approved weight‑loss medication is considered not medically necessary and may be subject to denial.

Providers should review the product‑ and indication‑specific criteria before requesting coverage for combination therapy; the policy lists examples and clarifies that some GLP‑1/GLP‑1‑GIP products approved for diabetes but not for chronic weight management are outside the targeted scope.

The scope of this Coverage Policy is limited to select GLP‑1 and GLP‑1/GIP agents with FDA‑approved weight‑loss or related indications. Covered products include Foundayo, liraglutide (Saxenda and generic liraglutide where indicated), Wegovy (injection, HD injection, and tablet formulations), and Zepbound for their respective FDA‑approved uses as enumerated in the clinical criteria.

Other GLP‑1 agonists that do not have an FDA‑approved indication for chronic weight management are intentionally not targeted by this policy; coverage determinations for non‑targeted products must rely on the applicable benefit plan document and clinical judgment.

Services billed for conditions or diagnoses that are not covered under this Coverage Policy will be denied as not covered. Claims submitted without covered diagnosis or procedure codes under the applicable Coverage Policy will be denied, so ensure coded diagnoses match the FDA‑approved indications and the criteria in this policy when submitting requests or claims.

Use of Foundayo, liraglutide (Saxenda, generic), Wegovy products, and Zepbound for uses outside the FDA‑approved indications described in this policy is considered not medically necessary and will be subject to denial under the policy's Conditions Not Covered.

Use of the policy‑targeted products for indications not listed among the FDA‑approved uses in this policy is not covered. The policy explicitly states that Foundayo, liraglutide (Saxenda, generic), Wegovy injection/HD/tablet, and Zepbound for any other use are considered not medically necessary.

Before submitting a request, confirm that the intended use aligns with an FDA‑approved indication included in this policy and provide the required documentation; off‑label uses or unlisted indications are not eligible under these criteria.

The policy's statements about concomitant use appear in multiple sections and use slightly different wording, but the operational stance is consistent: concomitant use of the listed agents with other GLP‑1 or GLP‑1/GIP agonists or with other FDA‑approved weight‑loss medications is not recommended and may be considered not medically necessary.

Where prior wording was revised, the policy now clarifies the limitation applies specifically to combinations with other medications that are FDA‑approved for weight loss and provides examples of products that fall outside the targeted scope (such as GLP‑1 agents approved only for diabetes). Providers should follow the current language in the policy when planning therapy and documentation.

Authorization, Documentation, and Prescriber Requirements

Prior Authorization

Prior Authorization Required

Prior Authorization is required for benefit coverage of Foundayo, liraglutide (Saxenda, generic), Wegovy injection, Wegovy HD injection, Wegovy tablet and Zepbound. Requests without required documentation or without covered diagnosis/procedure codes will be denied as not covered. All approvals are provided for the duration noted in the clinical criteria; when months are specified, 1 month = 30 days.

Prior authorization required for: Foundayo; liraglutide (Saxenda, generic); Wegovy injection; Wegovy HD injection; Wegovy tablet; Zepbound.
Claims submitted without covered diagnosis/procedure codes under this policy will be denied as not covered.
Approvals are time-limited per product as specified in the FDA-Approved Indications sections.

Documentation Required

Documentation and Prior Authorization Risk

Documentation is required for certain indications and may include chart notes, laboratory results, imaging, claims records, prescription receipts, and other medical records. All documentation must include patient-specific identifying information. Failure to provide required documentation (e.g., for Saxenda weight‑loss claims, Wegovy for MASH/NASH with required liver staging tests, or sleep study/OSA documentation) may result in denial.

Products, Codes, and Key Clinical Thresholds

Products referencedmixed

Foundayo	Foundayo™ (orforglipron tablets - Eli Lilly)
Saxenda	Saxenda® (liraglutide subcutaneous injection - Novo Nordisk, generic)
Wegovy_injection	Wegovy® (semaglutide subcutaneous injection - Novo Nordisk)
Wegovy_tablet	Wegovy® (semaglutide tablet - Novo Nordisk)
Wegovy_HD	Wegovy® HD (semaglutide subcutaneous injection - NovoNordisk)
Zepbound	Zepbound™ (tirzepatide subcutaneous injection - Eli Lilly)

No codes present in this document segmentmixed

No codes listed

BMI — thresholds

Adult BMI thresholdsBaseline BMI ≥30 kg/m2 OR baseline BMI ≥27 kg/m2 with at least one weight‑related comorbidity (hypertension, type 2 diabetes, dyslipidemia, OSA, cardiovascular disease, knee osteoarthritis, asthma, COPD, metabolic dysfunction‑associated steatotic liver disease/NAFLD, PCOS, or coronary artery disease)

Pediatric BMI thresholdAt baseline, BMI ≥95th percentile for age and sex (for patients ≥12 and <18 years)

Baseline definitionBaseline BMI refers to measurement prior to any GLP‑1 or GLP‑1/GIP receptor agonist therapy

Response evaluation — liraglutide

Adult response evaluation (liraglutide)Evaluate body weight at 16 weeks after initiating liraglutide; discontinue if patient has not lost ≥4% of baseline body weight.

Clinical Background and Scope

GLP‑1 receptor agonists (and GLP‑1/GIP agents in the case of Zepbound) are indicated as adjuncts to lifestyle intervention. The policy notes that these agents are intended to be used in combination with a reduced‑calorie diet and increased physical activity as part of weight‑loss therapy.

This context is reflected across the covered‑indication criteria: initiation and continuation of therapy require documentation that the medication is being used along with behavioral modification and a reduced‑calorie diet, and treatment response should be evaluated per the prescribing information and the policy's specified response thresholds.

Definitions and Terms Used in Criteria

Specified gender (policy context)

Specified gender definitionWhere an asterisk indicates specified gender in the clinical criteria, 'male' and 'female' refer to biological sex: males = individuals with biological traits of a male; females = individuals with biological traits of a female, regardless of gender identity or expression.

Context of useThis biological sex definition is applied only in clinical criteria where an asterisk denotes specified gender.

Documentation implicationSpecified gender notation informs criteria (e.g., alcohol consumption limits) that differ by biological sex.

Indications — summary

FoundayoFoundayo™ (orforglipron tablets) — indicated for weight reduction in adults with overweight/obesity in combination with diet and increased physical activity.

Liraglutide (Saxenda)

Policy Changes and Revision Notes

2024-05-02policy_revision

Wegovy and Zepbound were added to the policy; Saxenda (liraglutide) criteria updated including comorbidity examples, pediatric BMI options removed, weight‑loss requirement wording changed, and a maintenance‑dose tolerability requirement added.

2024-05-23policy_revision

Metabolic dysfunction‑associated steatotic liver disease (new nomenclature for NAFLD) added to the list of weight‑related comorbidities and comorbidity criterion modified to allow baseline or current comorbidity.

2024-07-15policy_effective_date

Policy Summary

PayerCigna

PolicyWeight Loss - GLP-1 Agonists (coverage criteria)

Policy CodePolicy N/A

Change TypeMultiple material edits — additions and revisions

Effective DateN/A

Next Review DateN/A

Key ActionObtain prior authorization before prescribing Foundayo, liraglutide (Saxenda or generic), Wegovy (all formulations), or Zepbound.

SourceLink

On This Page

Pediatric Initial Therapy and Continuation: Initial: Patient ≥12 and <18 years, ≥3 months trial of behavioral/diet therapy, baseline BMI ≥95th percentile for age/sex, use with behavioral modification/reduced‑calorie diet, preferred product criteria met. Continuation: Approve 1 year when patient achieves ≥1% BMI reduction from baseline>=1% BMI reduction for pediatric continuation

Baseline refers to measurement prior to any GLP‑1 or GLP‑1/GIP agonist

Documentation and Authorization: Prior Authorization required; documentation as described in Policy Statement must be provided when requested

See Policy Statement chunk for examples of acceptable documentation

If patient has not completed 8 months of initial therapy, apply Initial Therapy criteria

Approve for 1 year when ALL met; if <8 months completed, apply Initial Therapy criteria

Pediatric Weight Loss: Initial: Patient ≥12 and <18 years, trial of behavioral modification/diet ≥3 months, baseline BMI ≥95th percentile for age/sex, medication used with behavioral modification and reduced‑calorie diet; Continuation: ≥1% BMI reduction for ongoing therapy>=1% BMI reduction for pediatric continuation

Initial approval 8 months

MACE Risk Reduction (Wegovy): i. Patient ≥18 years; ii. Baseline BMI ≥27 kg/m2; iii. History of prior MI OR prior stroke (TIA excluded) OR symptomatic PAD (ABI <0.85, revascularization, or atherosclerotic amputation); iv. Medication used with optimized pharmacotherapy for CVD; v. Medication used concomitantly with behavioral modification and a reduced‑calorie diet

Approve for 1 year

MASH/NASH Initial Therapy: Initial: Patient ≥18 years; patient does not have cirrhosis (F4); stage F2–F3 fibrosis documented prior to initiating Wegovy by ONE of: liver biopsy within 3 years; VCTE within 6 months; MRE within 6 months; or ELF test within 6 months with score ≥9.2 to ≤10.5; metabolic risk factors managed; alcohol use limits met by sex; medication used with diet/exercise; prescribed by or in consultation with endocrinologist/gastroenterologist/hepatologistELF 9.2–10.5

Approve for 1 year; documentation required

MASH/NASH Currently Receiving: i. Completed ≥1 year of Wegovy therapy without worsening fibrosis/MASH; ii. Patient does not have cirrhosis (F4); iii. Metabolic risk factors managed; iv. Alcohol consumption limits met by sex; v. Medication used with diet/exercise; vi. Prescribed by or in consultation with appropriate specialist

Approve for 1 year

Applies to Foundayo, Wegovy, Zepbound where indicated

Cardiovascular risk reduction (Wegovy): Patient ≥18 years, baseline BMI ≥27 kg/m2, established cardiovascular disease defined by prior MI OR prior stroke (TIA excluded) OR symptomatic PAD (ABI <0.85, revascularization, or atherosclerotic amputation); medication used with optimized CVD pharmacotherapy and with behavioral modification/reduced‑calorie diet

Approve for 1 year

Obstructive sleep apnea (Zepbound): Patient ≥18 years, baseline BMI ≥30 kg/m2, diagnostic sleep study confirming moderate to severe OSA with apnea‑hypopnea index ≥15 events/hour, exclusion of central sleep apnea or Cheyne‑Stokes respiration, and medication used with behavioral modification/reduced‑calorie dietAHI ≥15

Initial therapy or continuation rules apply; continuation may require ≥10% weight loss and stability of OSA signs/symptoms after ≥1 year of therapy for renewal

Acceptable documentation examples: chart notes, labs, imaging, claims records, prescription receipts.
Wegovy for MASH/NASH requires documentation of fibrosis stage via one of: liver biopsy (within 3 years), VCTE (within 6 months), MRE (within 6 months), or ELF test (within 6 months) with ELF score ≥9.2 to ≤10.5.
Saxenda use for weight loss and Wegovy MASH/NASH: documentation required as noted in criteria.

Billing Rule

Coding and Billing Documentation

When submitting prior authorization requests, include supporting medical necessity and appropriate coding. Use the most appropriate diagnosis and procedure codes as of the date of submission. Requests lacking covered diagnosis/procedure codes or appropriate coding documentation will be denied.

Claims must be accompanied by covered codes under the applicable Coverage Policy.
Use current, appropriate ICD-10/CPT/HCPCS/NDC codes on submission to support medical necessity.

Documentation Required

Sleep Study Documentation Required for OSA Indication

For Obstructive Sleep Apnea (OSA) approvals, provide a diagnostic sleep study demonstrating moderate to severe OSA with apnea-hypopnea index (AHI) ≥ 15 events/hour (moderate) or ≥ 30 events/hour (severe). Ensure the sleep study report and interpretation are included in the documentation package.

Sleep study documenting diagnosis of moderate to severe OSA and AHI ≥ 15 events/hour (≥30 for severe).
Exclude patients with central sleep apnea or Cheyne-Stokes respiration per clinical criteria.

Documentation Required

Cardiovascular Disease Documentation

For cardiovascular disease (CV) indications (e.g., major adverse cardiovascular event risk reduction), provide evidence of established cardiovascular disease. Acceptable documentation includes records showing prior myocardial infarction, prior stroke (note: does not include transient ischemic attack), or symptomatic peripheral arterial disease (e.g., intermittent claudication with ABI < 0.85, prior peripheral arterial revascularization, or amputation due to atherosclerotic disease).

Prior myocardial infarction or prior stroke (TIA not included).
Evidence of symptomatic peripheral arterial disease: intermittent claudication with ABI < 0.85; peripheral arterial revascularization; or amputation due to atherosclerotic disease.

Step Therapy

Brand vs Generic Trial (Employer Plans)

Employer-plan-specific requirement: for Saxenda (liraglutide injection), a trial of the bioequivalent generic liraglutide subcutaneous injection is required prior to approving brand Saxenda, unless the prescriber documents that the patient cannot take the generic due to a formulation difference in inactive ingredients that would cause a significant allergy or serious adverse reaction. Documentation of this intolerance or allergy is required.

Prior trial of bioequivalent generic liraglutide required for Saxenda under Employer Plans.
If generic cannot be used, prescriber must document formulation-related allergy/serious adverse reaction and provide documentation.

Note

Product Targeting and Concomitant Use

This policy targets liraglutide (Saxenda, generic), Wegovy (all forms), Foundayo, and Zepbound. Other GLP‑1 agonists that do not carry an FDA‑approved indication for weight loss are not targeted by this policy. Concomitant use of GLP‑1 or GLP‑1/GIP agents with each other or with other FDA‑approved weight‑loss medications is not recommended and is considered not medically necessary.

Policy applies to: liraglutide (Saxenda, generic), Wegovy injection/HD/tablet, Foundayo, Zepbound.
Other GLP‑1 agents without FDA weight‑loss indications (e.g., exenatide, Ozempic, Rybelsus, Trulicity, Victoza, Mounjaro) are not targeted.
Concomitant use with other GLP‑1 or GLP‑1/GIP agonists or other FDA‑approved weight‑loss medications is not recommended / not medically necessary.

Pediatric response evaluation (liraglutide)

Evaluate BMI after 12 weeks on the maintenance dose; discontinue if BMI has not decreased by ≥1% from baseline.

Dose escalation noteFollow the 4‑week recommended dose escalation schedule in the prescribing information; delay escalation ~1 additional week if intolerance occurs.

ELF score cutoff for fibrosis ≥ F2

ELF cutoff for ≥F2 fibrosisAn ELF score cutoff of 9.2 provides optimal sensitivity and specificity for detecting ≥F2 fibrosis.

ELF guidance range for candidate selectionUse ELF score range 9.2 to 10.5 to guide selection of appropriate candidates for MASH therapy.

Further testing when ELF highFor values outside the upper range, consider VCTE or MRE to exclude cirrhosis/portal hypertension.

Apnea–Hypopnea Index (AHI) threshold

AHI threshold for moderate OSAApnea–Hypopnea Index (AHI) ≥ 15 events/hour defines moderate obstructive sleep apnea and is required for OSA indication documentation.

Severe OSA thresholdSevere OSA is defined as AHI ≥ 30 events/hour.

Diagnostic requirementAHI must be documented by a diagnostic sleep study (polysomnography or home sleep apnea test) meeting local guidelines.

ELF test score — acceptable range

Acceptable ELF score rangeELF test performed within 6 months with a score ≥9.2 to ≤10.5 is acceptable documentation for F2–F3 fibrosis.

Timing of ELF testingELF must be performed within 6 months preceding treatment for MASH/NASH documentation.

ELF use noteELF is one of three recommended noninvasive tests (with VCTE and MRE) for assessing fibrosis stage when biopsy not used.

BMI thresholds — summary

Adults (summary)Baseline BMI ≥30 kg/m2 OR baseline BMI ≥27 kg/m2 with ≥1 weight‑related comorbidity; baseline refers to pre‑GLP‑1/GLP‑1‑GIP therapy.

Pediatrics (summary)At baseline, BMI ≥95th percentile for age and sex (for patients ≥12 and <18 years).

Continuation contextThese baseline BMI thresholds are used to determine eligibility for initial therapy and to reference percent weight‑loss thresholds for continuation criteria.

Apnea‑Hypopnea Index (AHI) — clinical threshold

Key AHI thresholdAHI ≥15 events/hour is required to document moderate to severe OSA for the Zepbound indication.

AHI documentationAHI must be shown on a diagnostic sleep study; central sleep apnea and Cheyne‑Stokes respiration are exclusions.

Severity definitionsModerate OSA: AHI ≥15 events/hour; Severe OSA: AHI ≥30 events/hour.

Baseline BMI thresholds

Baseline BMI for adultsBaseline BMI ≥30 kg/m2 OR baseline BMI ≥27 kg/m2 with at least one weight‑related comorbidity (measured prior to any GLP‑1 or GLP‑1/GIP agonist).

Baseline definition reminder'Baseline' refers to measurement prior to any GLP‑1 or GLP‑1/GIP receptor agonist therapy (e.g., liraglutide, Wegovy, Zepbound).

Use across indicationsThis baseline reference applies to weight‑loss, cardiovascular risk reduction, and OSA indications where BMI criteria are required.

Weight loss response threshold

Common continuation thresholdPatient has lost ≥5% of baseline body weight (or equivalent BMI reduction) for continuation/renewal in many indications (e.g., Foundayo, Wegovy, cardiovascular indication).

Liraglutide distinctionSome agents (liraglutide) use a ≥4% weight‑loss threshold at 16 weeks for adults as an earlier discontinuation decision per prescribing information.

Pediatric continuationPediatric continuation for some agents requires ≥1% BMI reduction from baseline (e.g., liraglutide pediatric criteria).

ELF score — MASH/NASH documentation

ELF score range for MASH/NASHELF score ≥9.2 to ≤10.5 (performed within 6 months) is acceptable documentation of F2–F3 fibrosis for MASH/NASH treatment eligibility.

ELF roleELF is one of the recommended noninvasive tests; an ELF score of 9.2 is the cutoff for detecting ≥F2 fibrosis.

When to confirm with other testsIf ELF values are outside the upper range, consider VCTE or MRE to exclude cirrhosis/portal hypertension.

Baseline BMI — cardiovascular indication

Baseline BMI reference for cardiovascular indicationBaseline BMI is referenced to the measurement prior to any GLP‑1 or GLP‑1/GIP agonist therapy (pre‑exposure baseline) for cardiovascular risk‑reduction eligibility.

Cardiovascular BMI thresholdTypically requires baseline BMI ≥27 kg/m2 (plus established cardiovascular disease) or baseline BMI ≥30 kg/m2, per indication specifics.

Approval duration noteCardiovascular indication approvals are typically provided for 1 year when criteria are met.

Liraglutide (Saxenda, generic) — indicated for weight reduction in adults and pediatric patients ≥12 years (agent‑specific age/weight requirements apply).

Wegovy and ZepboundWegovy (injection/HD/tablet) — weight loss, MACE risk reduction, and MASH (Wegovy injection); Zepbound — indicated for moderate to severe OSA in adults with obesity.

Specified gender — repeat

Specified gender repeatAn asterisk next to gender in clinical criteria denotes biological sex: male/female defined by biological traits regardless of gender identity or expression.

Where appliedUsed where clinical thresholds or limits differ by biological sex (e.g., alcohol intake limits in MASH/NASH criteria).

Policy originDefinition included in the Policy Statement to standardize interpretation across criteria.

Cirrhosis F4 / Fibrosis stages F2–F3

Required fibrosis stagesFor MASH/NASH eligibility, patients must have stage F2 or F3 fibrosis documented prior to initiating therapy; patients with cirrhosis (F4) are excluded.

Documentation optionsF2–F3 must be documented by liver biopsy within 3 years OR VCTE/MRE within 6 months OR ELF within 6 months with score 9.2–10.5.

Prescription requirementWegovy for MASH must be prescribed by or in consultation with a specialist (endocrinologist, gastroenterologist, or hepatologist).

Apnea‑hypopnea index (AHI) — definitions

AHI definitionApnea‑Hypopnea Index (AHI) = number of apneas and hypopneas during 1 hour of sleep.

Moderate OSAModerate OSA: AHI ≥15 events/hour.

Severe OSASevere OSA: AHI ≥30 events/hour.

Baseline BMI — definition

Baseline BMI definitionBaseline BMI is measured prior to any GLP‑1 or GLP‑1/GIP agonist therapy and is used to determine eligibility thresholds (e.g., ≥30 kg/m2 or ≥27 kg/m2 with comorbidity).

ApplicationUsed across initial therapy and currently receiving criteria for weight‑loss, cardiovascular, and OSA indications.

Clarification in revisionsPolicy clarifies 'baseline' to refer to pre‑GLP‑1/GLP‑1‑GIP exposure to avoid counting prior treatment effects.

Specified gender — clinical note

Specified gender (clinical criteria asterisk)An asterisk next to specified gender denotes biological sex for criteria: males = individuals with biological traits of a male; females = individuals with biological traits of a female, regardless of gender identity or expression.

Reason for inclusionEnsures consistent application of sex‑specific thresholds (e.g., alcohol limits) in clinical eligibility criteria.

Policy placementDefinition is included in the Policy Statement and referenced where criteria use an asterisk.

Edits from May revisions listed with an effective date for changes including additions of Wegovy and Zepbound and Saxenda criteria updates.

2024-?documentation_update

Documentation requirements were added for Wegovy use in MASH, specifying acceptable documentation types and the need for patient identifiers.

2025-04-24policy_title_and_language_revision

Policy title and Conditions Not Covered language were revised; concomitant‑use language clarified to specify FDA‑approved weight‑loss medications and examples updated.

2026-02-12product_addition_and_criteria_update

Wegovy tablet was added and new criteria created; initial approval durations for certain Wegovy weight‑loss indications updated (examples: initial approval changed to 8 months for Wegovy injection).

2026-03-01product_addition

Foundayo was added to the policy and included among covered GLP‑1 products with new criteria.

2026-04-30cardiovascular_indication_update

Wegovy cardiovascular outcome indication criteria were combined for initial and continuing therapy with a standardized 1‑year approval and baseline BMI clarified to refer to pre‑GLP‑1/GLP‑1‑GIP exposure.

2026-?baseline_definition_clarificationLatest

Baseline BMI was clarified to refer to BMI prior to any GLP‑1 or GLP‑1/GIP receptor agonist (e.g., liraglutide, Wegovy, Zepbound); Wegovy HD injection and Wegovy tablet were added across criteria and documentation.