Weight Loss - GLP-1 and GLP-1/GIP Agonists (Foundayo, Liraglutide/Saxenda, Wegovy, Zepbound)
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Defines Cigna coverage and prior authorization requirements for Foundayo, liraglutide (Saxenda, generic), Wegovy (tablet and injection), and Zepbound for weight loss and specified related indications, and explains documentation and prescriber requirements for certain indications.
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 to comorbidity lists.
Requirement for reduction in body weight changed to reduction in BMI and removal of 'only required once'; added requirement to tolerate a maintenance dose.
New FDA‑approved indication: Wegovy for major adverse cardiovascular event risk reduction in patients with established cardiovascular disease who are overweight or obese.
Obstructive sleep apnea (moderate to severe) added as an FDA‑approved indication for Zepbound with specific sleep study and AHI criteria.
Concomitant use of GLP‑1 and GLP‑1/GIP agonists with each other is not recommended (not medically necessary).
Concomitant use with other medications FDA‑approved for weight loss is stated as not recommended (language clarified to specify 'FDA‑approved').
Wegovy tablet and Wegovy injection were added/recognized and corresponding criteria and notes created or updated.
Foundayo was added to the list of products the policy applies to and as an example GLP-1 receptor agonist.
Liraglutide (generic to Saxenda) was added to the policy and to documentation and baseline definitions.
Baseline BMI references were revised to indicate baseline prior to any GLP‑1 or GLP‑1/GIP agonist (not only prior to Wegovy).
Initial approval durations for Wegovy products changed (initial approval increased to 7 months or 8 months in certain indications) and many initial/continuation labels standardized.
Wegovy (Rezdiffra mention) MASH/NASH indication requires documentation of fibrosis stage F2 or F3 confirmed by specified tests with time windows and thresholds (ELF score 9.2–10.5).
A previously listed 'Conditions Not Recommended for Approval' item restricting concomitant use with other weight-loss medications was removed from the Conditions Not Recommended for Approval section in a later edit.
For MASH/NASH initial therapy, the absence of cirrhosis was clarified to mean no cirrhosis (F4).
Obstructive sleep apnea Zepbound criteria: the BMI requirement changed from current BMI to baseline BMI prior to any GLP‑1 or GLP‑1/GIP agonist.
Coverage and Medical Necessity Criteria
General medical necessity
Glucagon-like peptide-1 (GLP-1) receptor agonists are considered medically necessary when ONE of the following indication groups is met:
Liraglutide (Saxenda, generic) — Weight loss (adult and pediatric)
GLP-1 receptor agonists are considered medically necessary when ONE of the product-specific indications/criteria below are met.
Foundayo — Weight loss (adult)
Foundayo is considered medically necessary for weight loss when product-specific criteria are met.
Wegovy injection/tablet — Weight loss, pediatric, MACE risk reduction, MASH/NASH
Wegovy injection and Wegovy tablet are considered medically necessary when ONE of the FDA‑approved indication‑specific criteria below are met.
Weight Loss — Initial Therapy (Adult)
Covered when ALL of the following are met for indicated weight‑loss initial therapy in adults.
Adult weight‑loss initial therapy
- BMI eligibility: Either (a) baseline BMI ≥ 30 kg/m2 OR (b) baseline BMI ≥ 27 kg/m2 AND at baseline patient had or currently has at least one weight‑related comorbidity (eg, hypertension, type 2 diabetes, dyslipidemia, obstructive sleep apnea, cardiovascular disease, knee osteoarthritis, asthma, COPD, metabolic dysfunction‑associated steatotic liver disease/NAFLD, PCOS, coronary artery disease).BMI thresholds
Comorbidity may be baseline or current.
Weight Loss — Continuing Therapy
Covered when ALL of the following are met for patients currently receiving therapy.
Approval durations commonly 1 year.
Major Adverse Cardiovascular Event Risk Reduction
Covered when ALL of the following are met for MACE risk reduction with Wegovy.
Stroke does not include TIA.
Obstructive Sleep Apnea (Moderate to Severe)
Covered when ALL of the following are met for Zepbound in moderate‑to‑severe obstructive sleep apnea.
Baseline BMI refers to BMI prior to any GLP‑1 or GLP‑1/GIP therapy; exclusion for central sleep apnea remains but percent‑central‑apnea threshold was removed.
MASH/NASH Initial Therapy
Covered when ALL of the following are met for MASH/NASH initial therapy with Wegovy or Rezdiffra:
Documentation required; time windows specified for each test.
Weight Loss Initial Therapy
Covered when ALL of the following are met for Wegovy injection/tablet initial weight‑loss therapy:
Baseline refers to pre‑GLP‑1 therapy BMI; initial approval durations updated (eg, 7–8 months depending on indication).
Cardiovascular Risk Reduction
Covered when ALL of the following are met for Wegovy major adverse cardiovascular event (MACE) risk‑reduction indication:
Initial and continuation criteria combined in revisions; approval duration commonly 1 year.
Zepbound - Obstructive Sleep Apnea
Covered when ALL of the following are met for Zepbound initial therapy for obstructive sleep apnea (moderate to severe).
Baseline definition updated to pre‑GLP‑1 baseline; percent‑central‑apnea requirement was removed in revisions.
Weight‑loss medications may be excluded by a member’s benefit plan. Refer to the applicable benefit plan document to determine whether coverage for Foundayo, liraglutide (Saxenda, generic), Wegovy (injection or tablet), or Zepbound is available under the member’s specific plan because many employer and individual/family plans specifically exclude weight‑loss medications.
This policy specifically targets Foundayo, liraglutide (Saxenda, generic), Wegovy (injection and tablet), and Zepbound. Other GLP‑1 agonists that do not carry an FDA‑approved indication for weight loss are not targeted by this policy and are not addressed in the coverage criteria.
Use of Foundayo, liraglutide (Saxenda or generic liraglutide), Wegovy (injection or tablet), or Zepbound is limited to the FDA‑approved indications described in the policy. Use for indications not explicitly listed in FDA‑approved labeling is considered not medically necessary and is not covered under the policy criteria.
For clarity, GLP‑1 receptor agonists and GLP‑1/GIP receptor agonists that do not have an FDA‑approved indication for chronic weight management are outside the scope of this policy. The policy applies only to the named products (Foundayo, liraglutide/Saxenda, Wegovy, Zepbound) and their FDA‑approved weight‑related indications; other products are not targeted here.
Concomitant use of a GLP‑1 agent with another GLP‑1 or GLP‑1/GIP agent (for example, combining semaglutide, tirzepatide, or other GLP‑1 class products) is addressed in the policy as not medically necessary. Combining GLP‑1 and GLP‑1/GIP agents is considered not medically necessary and is not supported by the coverage criteria.
The policy clarifies that concomitant use of a targeted agent with other medications that are FDA‑approved for weight loss is not recommended. While some earlier wording was revised, the current guidance states that concomitant use with other FDA‑approved weight‑loss medications is not recommended and may lead to denial under the policy.
Codes, Thresholds, and Key Clinical Metrics
Prior Authorization, Documentation, and Operational Requirements
Prior Authorization Required
Prior Authorization is required for benefit coverage of Foundayo, liraglutide (Saxenda, generic), Wegovy injection, Wegovy tablet, and Zepbound. Lack of prior authorization may result in denial of coverage. Wegovy injection for MASH/NASH must be prescribed by or in consultation with a physician who specializes in the condition being treated.
- Affected products: Foundayo; Liraglutide (Saxenda and bioequivalent generic); Wegovy (injection and tablet); Zepbound.
Prior Authorization Details and Approval Durations
Approvals are provided for product- and indication-specific initial durations and for 1 year for patients currently receiving therapy, as specified in the clinical criteria. Examples: initial approvals for Saxenda/Wegovy/Zepbound vary by product (4 or 8 months as noted); continuation/‘currently receiving’ approvals are generally for 1 year where indicated.
- Initial therapy durations are product-dependent (e.g., Saxenda initial approval period, Wegovy/Zepbound initial approval periods).
- Patients currently receiving an approved product are typically authorized for 1 year if continuation criteria are met.
Prior Authorization Requirements — Clinical Criteria
Prior authorization requests must include documentation of baseline BMI (baseline defined as prior to any GLP-1 or GLP-1/GIP agonist use where specified), the presence of required weight-related comorbidities, and evidence of behavioral modification/diet trials when required. For Wegovy MASH/NASH, approval requires documentation supporting fibrosis staging and absence of cirrhosis (F4).
- Baseline BMI = BMI prior to any GLP-1 or GLP-1/GIP agonist (e.g., Foundayo, liraglutide, Wegovy, Zepbound).
- Behavioral modification and reduced-calorie diet trial of at least 3 months required for initial therapy for most adult weight-loss indications.
- For continuation approvals, evidence of treatment response (e.g., % weight loss thresholds) and use with behavioral modification is required.
Documentation Requirements
Documentation is required for use of Saxenda for weight loss and for Wegovy injection for MASH/NASH. Acceptable documentation may include chart notes, laboratory results, medical test results, claims records, prescription receipts, and other records; all documentation must include patient-specific identifying information.
- Documentation required examples: chart notes, labs, test results, claims records, prescriptions.
- All documentation must include patient identifying information.
- Claims or requests missing required documentation or covered diagnosis/procedure codes will be denied.
Behavioral Modification Trial for Zepbound
For Zepbound initial therapy, a trial of behavioral modification and dietary restriction for at least 3 months is required prior to initiation; document this in the prior authorization submission.
- Behavioral modification/diet trial duration: ≥ 3 months prior to initiation (Initial Therapy criteria).
- Documentation of the trial should be included with the authorization request.
OSA Sleep Study Documentation
OSA-specific documentation: For Zepbound use in patients with obstructive sleep apnea, include a sleep study showing diagnosis of moderate to severe OSA with an apnea–hypopnea index (AHI) ≥ 15 events/hour, and documentation regarding CPAP use/intolerance and stability of OSA signs/symptoms for continuation requests.
- Required sleep study showing: diagnosis of moderate–severe OSA and AHI ≥ 15 events/hour.
- For continuation: evidence of ≥ 10% baseline weight loss and prescriber statement of stability in OSA signs/symptoms; document CPAP usage/intolerance if relevant.
Brand vs Generic Trial Requirement for Saxenda
Brand vs generic trial for Saxenda: For employer plans, prior authorization requires the patient to have tried the bioequivalent generic liraglutide subcutaneous injection (generic for Saxenda) and be unable to take it due to a formulation difference in inactive ingredients that, per the prescriber, would cause significant allergy or a serious adverse reaction. Documentation of the intolerance/allergy is required.
- Requirement applies to Saxenda (liraglutide SC injection) on Employer Plans.
- Documentation required to support inability to take the generic due to inactive ingredient differences.
MASH/NASH Diagnostic Confirmation and Accepted Tests
MASH/NASH diagnostic confirmation: To support Wegovy (and Rezdiffra where applicable) for MASH/NASH, provide evidence of stage F2–F3 fibrosis and absence of cirrhosis (F4) prior to initiating therapy. Acceptable methods and time windows: liver biopsy within 3 years, VCTE within 6 months, MRE within 6 months, or ELF test within 6 months with a score ≥ 9.2 to ≤ 10.5. Include supporting documentation (test reports, labs, chart notes) with the authorization.
- Acceptable fibrosis documentation: biopsy within 3 years; VCTE, MRE, or ELF within 6 months prior to treatment.
- ELF score guidance: 9.2–10.5 recommended range; report actual score.
- Wegovy not indicated for cirrhotic (F4) MASH — document absence of F4.
Clinical Background and Policy Scope
GLP‑1 receptor agonists (e.g., liraglutide, Foundayo, Wegovy) and the GLP‑1/GIP agonist Zepbound are FDA‑indicated as adjuncts to a reduced‑calorie diet and increased physical activity for adults with overweight or obesity and, for some products, for pediatric patients and other specific indications (cardiovascular risk reduction, MASH/NASH, obstructive sleep apnea). Clinical trials cited in the policy support benefits beyond weight loss — for example, Wegovy demonstrated reduction in major adverse cardiovascular events in a secondary prevention trial, and Zepbound trials (SURMOUNT‑OSA) showed clinically meaningful reductions in apnea‑hypopnea index when used with lifestyle intervention. The policy therefore frames coverage around the FDA‑approved indications and requires that medication be used in combination with behavioral modification and a reduced‑calorie diet.
Definitions and Key Terms
Policy Changes and Revision Notes
Foundayo was added to the policy and new criteria were created; Wegovy tablet added and initial/continuing criteria updated (MACE criteria combined).
Wegovy tablet was added to the policy and new criteria created; initial approval durations for Wegovy adjusted (initial approval changed to 8 months for certain indications).
Wegovy tablet added and MACE risk reduction criteria updated to clarify baseline BMI notes include Wegovy tablet; other Wegovy criteria refined.
Wegovy and Zepbound were added to the policy; Saxenda comorbidity examples updated; body weight decrease requirement changed to BMI reduction and requirement to tolerate a maintenance dose added.
Metabolic dysfunction-associated steatotic liver disease (new terminology for NAFLD) added to weight-related comorbidity lists and comorbidity criterion clarified as baseline or current.
Updated body weight decrease requirement to BMI reduction, removed 'only required once', and added requirement to tolerate a maintenance dose; pediatric BMI percentile options narrowed.
Concomitant use guidance clarified to state concomitant use with other medications FDA-approved for weight loss is not recommended and examples updated; separate concomitant-use note for GLP-1/GLP-1-GIP products clarified.
Wegovy and Rezdiffra MASH/NASH indication added with documentation requirements for fibrosis staging (F2–F3) and ELF score thresholds of ≥9.2 to ≤10.5 within defined time windows.
Obstructive sleep apnea (Zepbound) baseline BMI requirement revised to baseline prior to any GLP‑1 or GLP‑1/GIP agonist; sleep study and AHI criteria retained (AHI ≥15) for initial therapy and continuation requirements specified.
OSA criteria specified: initial therapy requires a sleep study documenting moderate-to-severe OSA with AHI ≥15; continuing therapy requires ≥10% baseline weight loss after ≥1 year and prescriber documentation of stability.
Zepbound OSA initial and continuing therapy criteria detailed to require baseline BMI ≥30 kg/m2 (baseline defined as pre‑GLP‑1) and sleep study confirmation of OSA with AHI ≥15.
Zepbound continuation criteria require completion of ≥1 year of therapy with ≥10% baseline body weight loss and prescriber documentation of stability in OSA symptoms.
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