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    v1.0.31
    OpenPayerPolicy UpdatesPharmacy & Specialty DrugsRegence GLP-1 Coverage Prior Auth | OpenPayer
    Ask Trek AI about this page
    ModifiedRegencePolicy dru787

    GLP-1 Agonist-Containing Medications for Non-Diabetic Indications

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    This policy governs pharmacy-benefit coverage and prior authorization for GLP-1 agonist-containing medications used for non-diabetic indications, including obesity or overweight, cardiovascular event prevention, obstructive sleep apnea with obesity, and noncirrhotic MASH/NASH. It applies to members whose benefit contracts permit coverage for the relevant indication and excludes GLP-1 products specifically approved for type 2 diabetes.

    Policy Summary
    PayerRegence
    PolicyGLP-1 Agonist-Containing Medications for Non-Diabetic Indications
    Policy CodePolicy dru787
    Change TypeModified
    Effective DateAugust 15, 2026
    Next Review DateJanuary 1, 2027
    Key ActionSubmit clinical documentation supporting both new-start and continuation-of-therapy requests.
    SourceLink
    POLICY UPDATE CHANGES

    Added Foundayo (orforglipron) to the policy for overweight and obesity.

    Added Wegovy HD (semaglutide) injection at parity with Wegovy semaglutide injections and tablets.

    Removed the MASH/NASH criterion requiring prior failure to achieve weight-loss goals with diet and exercise.

    Updated MASH testing requirements used to determine disease stage.

    Added Wegovy semaglutide criteria for metabolic dysfunction-associated steatohepatitis and added Wegovy tablets at parity with Wegovy.

    Added criteria for use of Zepbound in obstructive sleep apnea.

    Added liraglutide, including generic Saxenda, at parity with brand Saxenda.

    Updated new-start and continuation-of-therapy criteria to require clinical documentation.

    OpenPayer is powered by Trek Health's payer performance platform. Trek continuously ingests, validates, and normalizes Transparency in Coverage data alongside payer policies and other commercial payer data to create a structured payer intelligence foundation. OpenPayer uses this foundation to deliver personalized search results, dynamically generated policy pages, and tailored policy monitoring based on each user's payers, specialties, billing codes, and areas of interest. The same intelligence powers broader payer performance workflows, including reimbursement benchmarking, contract evaluation, payer negotiations, and financial decision-making.

    5GLP-1 products in the quantity-limit table
    BMI ≥30Adult obesity threshold
    BMI ≥27 + comorbidityAdult overweight threshold
    AHI ≥15/hourModerate-to-severe OSA threshold
    ≥5% weight reductionAdult continuation response criterion

    Coverage Criteria

    Continuation Therapy

    GLP-1 agonist-containing medications for non-diabetic indications may be considered medically necessary for continuation of therapy when <strong>ONE</strong> of the following pathways is met:

    ONE of the following

    • For diagnoses not listed in the coverage criteria below, the full policy criteria must be met for coverage.

    • All of the following

      • The patient was established on therapy prior to current health plan membership, and documentation shows that the medication was covered by another health plan.
      • There is clinical benefit, such as disease stability, as detailed in the reauthorization criteria.
      • For treatment of obesity or overweight, including obstructive sleep apnea with obesity, the member benefit contract allows coverage of medications for weight loss in obesity or overweight. Coverage cannot be approved when the member benefit contract excludes coverage of obesity/overweight treatments, regardless of clinical criteria met.

    Initial Therapy

    GLP-1 agonist-containing medications for non-diabetic indications may be considered medically necessary for new starts when <strong>ALL</strong> of the following are met:

    ALL of the following

    • At least ONE diagnostic criterion

      • Obesity/overweight

        • The member benefit contract allows coverage of medications for weight loss in obesity/overweight.

        • ONE of the following clinical criteria

          • Adults, obesity (18 years of age or older): BMI is at least 30 kg/m².
          • Adults, overweight (18 years of age or older): BMI is at least 27 kg/m² and the patient has at least one weight-related comorbid condition, such as hypertension, dyslipidemia, type 2 diabetes mellitus, prediabetes, insulin resistance, obstructive sleep apnea, cardiovascular disease, or symptomatic arthritis of the lower extremities.

    Continuation and Reauthorization Criteria

    Authorization is reviewed at least annually to confirm ongoing coverage under the member benefit contract. For reauthorization, the requested medication must be used with lifestyle modification and <strong>ONE</strong> of the following clinical-response pathways must be met:

    ALL of the following

    • The requested medication will be used with lifestyle modification, such as dietary/caloric restriction, exercise, a weight management program, nutritional counseling, or behavioral therapy.

    • ONE of the following

      • Obesity or overweight

        • The member benefit contract allows coverage of medications for weight loss in obesity/overweight.

        • ONE of the following

          • Adults (18 years of age or older): The patient has at least a 5% body-weight reduction from pretreatment baseline.

    This policy applies to GLP-1 formulations not specifically approved for diabetes. It does not apply to GLP-1 formulations specifically approved for type 2 diabetes mellitus, including Mounjaro (tirzepatide), Ozempic (semaglutide), and Victoza (liraglutide), which may be addressed in different policies. Coverage of medications for weight loss in obesity or overweight, including obstructive sleep apnea in adults with obesity, is defined by benefit contract language.

    Coadministration of any two medications for obesity or overweight, including medications in this policy, is investigational and not covered.

    Use for type 1 diabetes or diabetic ketoacidosis, central or mixed sleep apnea, Cheyne-Stokes respiration, obstructive sleep apnea with major craniofacial abnormalities, and other specified populations is investigational and not covered.

    Concurrent use of Contrave (naltrexone/bupropion), Qsymia (phentermine/topiramate), or other weight-loss medications with a medication covered under this policy is investigational and not covered.

    Use of these medications for type 1 diabetes or diabetic ketoacidosis is investigational and not covered.

    Zepbound (tirzepatide) for obstructive sleep apnea is not covered for patients with central or mixed sleep apnea, Cheyne-Stokes respiration, or significant craniofacial abnormalities.

    Use of GLP-1 agonist-containing medications for type 2 diabetes without obesity or overweight is not medically necessary under this policy. Coverage for obesity or overweight, including obstructive sleep apnea with obesity, is defined by benefit contract language.

    Combination use with other weight-loss products is investigational because the safety and effectiveness of these medications in combination with other products intended for weight loss have not been established.

    GLP-1 agonist-containing medications for obesity or overweight are not medically necessary under this policy for type 1 diabetes or diabetic ketoacidosis; the FDA-approved prescribing information for GLP-1 agonists approved for type 2 diabetes states that they should not be used in patients with type 1 diabetes or for treatment of diabetic ketoacidosis.

    Indication Thresholds and Clinical Definitions

    Adult obesity
    PopulationAdults
    DefinitionObesity
    BMI thresholdBMI ≥30 kg/m²
    Adult overweight
    PopulationAdults
    BMI thresholdBMI ≥27 kg/m²
    Additional requirementAt least one weight-related comorbid condition

    Authorization, Documentation, and Coverage Risks

    Prior Authorization

    Prior Authorization Required

    Most contracts require prior authorization before coverage of GLP-1 agonist-containing medications for non-diabetic indications listed in the policy. Submit the request before dispensing under the pharmacy benefit.

    • Applies to covered non-diabetic indications in Table 1.
    • Medications are coverable only under the pharmacy benefit as self-administered medications.
    Prior Authorization

    Continuation Authorization

    Continuation of therapy may be covered when the patient meets either the full policy criteria for an unlisted diagnosis or the established-therapy criteria for a diagnosis listed in the policy.

    • For a listed diagnosis, document that therapy was established before current health plan membership, the medication was covered by another health plan, and there is clinical benefit.
    • Samples, coupons, cash purchases, promotions, and other out-of-pocket access do not necessarily establish prior covered therapy or medical necessity.

    Policy Background

    This policy addresses GLP-1 agonist-containing medications used with lifestyle modification for obesity or overweight and selected non-diabetic indications. Covered pathways include qualifying obesity or overweight, secondary prevention of major adverse cardiovascular events, moderate-to-severe obstructive sleep apnea with obesity, and noncirrhotic metabolic dysfunction-associated steatohepatitis (MASH/NASH) with F2 or F3 fibrosis. Coverage for weight-loss treatment, including OSA with obesity, depends on the member's benefit contract.

    Definitions

    Definition of obesity
    ConditionObesity
    NatureA chronic disease of body-weight regulation
    DefinitionBMI of 30 kg/m² or more
    Definition of overweight
    ConditionOverweight
    MeasureBody mass index
    DefinitionBMI of 27 kg/m² or more

    Initial Therapy

    New-Start Therapy

    Treatment-naive patients may be considered medically necessary when one covered diagnostic indication and lifestyle-modification requirements are met.

    New-start requirements

    • Covered diagnostic indication

      • Obesity or overweight: The member benefit contract allows coverage of medications for weight loss in obesity or overweight, and the patient meets adult obesity, adult overweight with a weight-related comorbidity, or qualifying pediatric obesity criteria.Adults: BMI ≥30 kg/m² for obesity; BMI ≥27 kg/m² plus at least one weight-related comorbid condition for overweight.

        For pediatric obesity, the patient must be 12 through 17 years of age. Wegovy/Wegovy HD requires BMI ≥95th percentile standardized for age and sex; liraglutide (generic or Saxenda) requires baseline BMI corresponding to ≥30 kg/m² for adults based on the Cole Criteria and baseline body weight >60 kg. Only liraglutide (generic or Saxenda) and Wegovy/Wegovy HD are coverable for pediatric obesity.

    Continuation and Reauthorization

    Continuation and Annual Reauthorization

    Continuation therapy and annual reauthorization may be considered medically necessary when the applicable establishment or clinical-benefit requirements, benefit eligibility, and response requirements are met.

    Continuation and reauthorization requirements

    • Establishment or clinical benefit

      • Established therapy before current membership: For a listed diagnosis, the patient was established on therapy before current health plan membership, the medication was covered by another health plan, and there is clinical benefit such as disease stability.
      • Full criteria for unlisted diagnosis: For a diagnosis not listed in the coverage criteria, the full policy criteria must be met for coverage.
    • Benefit eligibility when applicable:

    Product Quantity Limits

    Liraglutide (generic), Saxenda
    ProductLiraglutide (generic), Saxenda
    Quantity limitFive pens
    PeriodPer 30 days
    Foundayo (orforglipron)
    ProductFoundayo (orforglipron)
    Quantity limit30 tablets
    PeriodPer 30 days

    Site of Care and Benefit Channel

    Billing Rule

    Use the pharmacy benefit site of care

    These medications are coverable only under the pharmacy benefit as self-administered medications. Submit them through the pharmacy benefit rather than a medical-benefit site of care.

    Policy Summary
    PayerRegence
    PolicyGLP-1 Agonist-Containing Medications for Non-Diabetic Indications
    Policy CodePolicy dru787
    Change TypeModified
    Effective DateAugust 15, 2026
    Next Review DateJanuary 1, 2027
    Key ActionSubmit clinical documentation supporting both new-start and continuation-of-therapy requests.
    SourceLink
    On This Page
    Coverage CriteriaIndication Thresholds and Clinical DefinitionsAuthorization, Documentation, and Coverage RisksPolicy BackgroundDefinitionsInitial TherapyContinuation and ReauthorizationProduct Quantity LimitsSite of Care and Benefit Channel

  1. Pediatrics, obesity (12 through 17 years of age): ONE of the following

    • Wegovy/Wegovy HD (semaglutide) only: BMI is at least the 95th percentile standardized for age and sex.
    • Liraglutide (generic, Saxenda): Baseline BMI corresponds to at least 30 kg/m² for adults based on the Cole Criteria, and baseline body weight is greater than 60 kg.

  2. Wegovy/Wegovy HD (semaglutide) only: Major adverse cardiovascular event (MACE) secondary prevention

    • At least ONE cardiovascular disease criterion

      • Myocardial infarction.
      • Stroke.
      • Symptomatic peripheral artery disease evidenced by intermittent claudication with ankle-brachial index less than 0.85 at rest, peripheral arterial revascularization procedure, or amputation due to atherosclerotic disease.
    • BMI is at least 27 kg/m².
    • The patient will use optimized pharmacotherapy, such as blood pressure- and cholesterol-lowering agents, for established cardiovascular disease in combination with the requested agent.

  3. Wegovy/Wegovy HD (semaglutide) only: Noncirrhotic MASH/NASH

    • A diagnosis of metabolic dysfunction-associated steatohepatitis (MASH), also known as non-alcoholic steatohepatitis (NASH), is established by or in consultation with a gastroenterologist or hepatologist.
    • The patient has Stage F2 or F3 fibrosis confirmed by liver biopsy, vibration-controlled transient elastography (VCTE), enhanced liver fibrosis (ELF) score, or magnetic resonance elastography (MRE).

  4. Zepbound (tirzepatide) only: Obstructive sleep apnea

    • The member benefit contract allows coverage of medications for weight loss in obesity/overweight.
    • Clinical documentation shows moderate to severe obstructive sleep apnea, defined as an apnea-hypopnea index (AHI) of at least 15 events/hour.
    • The patient has concurrent obesity, with baseline BMI corresponding to at least 30 kg/m².
  5. The requested medication will be used concomitantly with lifestyle modification, such as dietary/caloric restriction, exercise, a weight management program, nutritional counseling, or behavioral therapy.
    6. >= 5% body-weight reduction
  6. Adults (18 years of age or older): The dose is currently being titrated upward.
  7. Pediatrics (12 through 17 years of age): The patient has a reduction from pretreatment baseline BMI.
  8. Pediatrics (12 through 17 years of age): The dose is currently being titrated upward.
  9. Major adverse cardiovascular event prevention: The patient will continue optimized pharmacotherapy, such as blood pressure- and cholesterol-lowering agents, for established cardiovascular disease in combination with the requested agent.

  10. Obstructive sleep apnea

    • The member benefit contract allows coverage of medications for weight loss in obesity/overweight.
    • There is improvement in signs and symptoms of obstructive sleep apnea, such as improvement in sleep quality, daytime functioning, or apnea-hypopnea index (AHI) from baseline.
  11. MASH/NASH: The medication is providing clinical benefit, such as stability or improvement of liver fibrosis stage relative to baseline.
    12. Pediatric obesity
    Age range12 through 17 years
    Wegovy/Wegovy HDBMI ≥95th percentile standardized for age and sex
    Liraglutide or SaxendaBaseline BMI corresponding to ≥30 kg/m² for adults by the Cole Criteria and baseline body weight >60 kg
    MACE secondary prevention
    IndicationMACE secondary prevention
    ProductWegovy or Wegovy HD
    BMI thresholdBMI ≥27 kg/m²
    Moderate-to-severe OSA
    ConditionModerate-to-severe obstructive sleep apnea
    MeasureApnea-hypopnea index (AHI)
    ThresholdAHI ≥15 events/hour
    MASH/NASH fibrosis
    ConditionNoncirrhotic MASH/NASH
    Qualifying stagesF2 or F3 fibrosis
    Confirmation methodsLiver biopsy, VCTE, ELF score, or MRE
    Adult continuation response
    PopulationAdults receiving continuation therapy for obesity or overweight
    Weight-response criterionAt least 5% body-weight reduction from pretreatment baseline
    Alternative criterionDose is currently being titrated upward
    SELECT cardiovascular disease population
    Age≥45 years
    BMI≥27 kg/m²
    Other requirementsEstablished cardiovascular disease and no history of diabetes
    Peripheral arterial disease indicator
    IndicatorAnkle-brachial index
    Threshold<0.85 at rest
    Clinical significanceMay indicate peripheral arterial disease
    MASH fibrosis stage
    ConditionMASH
    Fibrosis stageF2 or F3
    Disease typeNoncirrhotic metabolic dysfunction-associated steatohepatitis
    OSA apnea-hypopnea index
    MeasureApnea-hypopnea index (AHI)
    Threshold≥15 events per hour
    Associated conditionModerate-to-severe obstructive sleep apnea
    OSA obesity threshold
    ConditionObstructive sleep apnea treated with Zepbound
    Obesity thresholdBaseline BMI ≥30 kg/m²
    Coverage contextThe member benefit contract must allow coverage of medications for weight loss in obesity or overweight
    Pediatric obesity pharmacotherapy
    Minimum age≥12 years
    BMI criterionBMI ≥95th percentile
    UseWeight-loss pharmacotherapy as an adjunct to lifestyle treatment
    Prior Authorization

    Annual Reauthorization and Quantity Limits

    Authorization is reviewed at least annually. Each reauthorization request must address quantity limits, ongoing benefit eligibility, lifestyle modification, and clinical response.

    • Quantity limits include: liraglutide/generic Saxenda—five pens per 30 days; Foundayo—30 tablets per 30 days; Wegovy—four pens per 28 days or 30 tablets per 30 days; Wegovy HD—four pens per 28 days; Zepbound—four pens per 28 days.
    • Provide attestation of concurrent lifestyle modification.
    • For obesity or overweight, document at least 5% adult weight reduction from pretreatment baseline or upward titration; for pediatrics, document BMI reduction or upward titration.
    • For MACE prevention, document continued optimized cardiovascular pharmacotherapy; for OSA, improvement in signs or symptoms; for MASH/NASH, stability or improvement in liver fibrosis stage.
    Prior Authorization

    Prior Authorization for Addressed GLP-1 Medications

    Prior authorization applies to the addressed GLP-1 medications when requested for obesity, overweight, obstructive sleep apnea with obesity, MACE secondary prevention, MASH, or another covered non-diabetic indication.

    • Clinical documentation is required for both new-start and continuation requests.
    Documentation Required

    Clinical Documentation Required

    Include clinical documentation supporting the diagnosis, product-specific indication, and applicable eligibility criteria. Requests should clearly identify age, BMI, comorbidities, cardiovascular disease, OSA, MASH, and treatment response as applicable.

    • Obesity: document adult BMI ≥30 kg/m², or adult BMI ≥27 kg/m² with a qualifying weight-related comorbidity; pediatric criteria apply only to eligible products.
    • MACE secondary prevention with Wegovy/Wegovy HD: document qualifying CVD, BMI ≥27 kg/m², and optimized cardiovascular pharmacotherapy.
    • OSA with Zepbound: document moderate-to-severe OSA with AHI ≥15 events/hour and obesity with BMI ≥30 kg/m².
    • MASH with Wegovy/Wegovy HD: document diagnosis by or in consultation with a gastroenterologist or hepatologist and qualifying fibrosis stage.
    • Document lifestyle modification and, for continuation, clinical response or disease stability.
    Documentation Required

    Document Prior Coverage

    For continuation requests, establish that treatment began before the member joined the current health plan and that the medication was covered by another health plan when relying on the prior-therapy pathway.

    • Coverage through samples, coupons, promotions, cash payment, or other sources outside an established insurance benefit does not necessarily satisfy this requirement.
    • Document ongoing clinical benefit, such as disease stability, in accordance with reauthorization criteria.
    Documentation Required

    Indication-Specific Records

    Match the submitted records to the requested indication and product. Indication-specific documentation must support the qualifying disease, severity, and treatment response.

    • For cardiovascular disease, document myocardial infarction, stroke, or symptomatic peripheral artery disease meeting the policy definition; for MACE prevention, document secondary-prevention status and optimized pharmacotherapy.
    • For MASH/NASH, document specialist-established diagnosis and Stage F2 or F3 fibrosis using liver biopsy, VCTE, ELF score, or MRE.
    • For OSA, document moderate-to-severe disease by AHI and concurrent obesity; overweight with comorbidities follows the obesity/overweight criteria.
    • For obesity or overweight, document the applicable BMI, age, qualifying comorbidity, benefit eligibility, lifestyle modification, and response.
    Documentation Required

    Documentation for New Starts and Continuation

    Clinical documentation is required for both new-start and continuation requests, including requests for the GLP-1 medications addressed by this policy.

    • New starts must document the qualifying diagnosis and all applicable clinical criteria.
    • Continuation requests must document prior coverage when applicable, ongoing clinical benefit, lifestyle modification, and annual reauthorization criteria.
    Documentation Required

    MASH Disease-Stage Documentation

    For Wegovy/Wegovy HD requests for noncirrhotic MASH, document a diagnosis established by or in consultation with a gastroenterologist or hepatologist and fibrosis at Stage F2 or F3.

    • Acceptable fibrosis-stage documentation includes liver biopsy, vibration-controlled transient elastography (VCTE), enhanced liver fibrosis (ELF) score, or magnetic resonance elastography (MRE).
    • Non-invasive testing such as VCTE, ELF, or MRE is identified as appropriate for staging; lifestyle modification remains part of management.

    Unsupported block type: billing_rule

    Unsupported block type: denial_risk

    Unsupported block type: denial_risk

    Unsupported block type: billing_rule

    Unsupported block type: denial_risk

    Unsupported block type: denial_risk

    Unsupported block type: denial_risk

    Unsupported block type: denial_risk

    Definition of moderate-to-severe OSA
    ConditionModerate-to-severe obstructive sleep apnea
    MeasureApnea-hypopnea index
    DefinitionAHI of at least 15 events per hour
    Definition of MASH/NASH
    TermMASH/NASH
    Full nameMetabolic dysfunction-associated steatohepatitis
    Alternative nameNon-alcoholic steatohepatitis
    Definition of MACE
    TermMajor adverse cardiovascular event (MACE)
    Included eventsCardiovascular death, nonfatal myocardial infarction, or nonfatal stroke
    Endpoint typeComposite cardiovascular endpoint
    Definition of symptomatic peripheral arterial disease
    ConditionSymptomatic peripheral arterial disease
    ManifestationsIntermittent claudication or peripheral arterial revascularization
    Additional manifestationAmputation due to atherosclerotic disease
    Definition of obstructive sleep apnea
    TermObstructive sleep apnea (OSA)
    TypeSleep disorder characterized by moderate-to-severe obstruction
    Clinical measureAHI of at least 15 events per hour in the cited trials
    Definition of apnea-hypopnea index
    TermApnea-hypopnea index (AHI)
    MeasureNumber of apnea or hypopnea breathing disruptions
    UnitPer hour of sleep
    Definition of MASH and evidence population
    Full nameMetabolic dysfunction-associated steatohepatitis
    Evidence populationPatients with histologically confirmed steatohepatitis
    Fibrosis stagesF2 or F3
    MACE secondary prevention:
    Wegovy or Wegovy HD only: the patient has cardiovascular disease demonstrated by myocardial infarction, stroke, or qualifying symptomatic peripheral artery disease, has BMI ≥27 kg/m², and will use optimized pharmacotherapy for established cardiovascular disease in combination with the requested agent.
    BMI ≥27 kg/m²
  12. MASH/NASH: Wegovy or Wegovy HD only: noncirrhotic MASH/NASH is established by or in consultation with a gastroenterologist or hepatologist, and the patient has stage F2 or F3 fibrosis confirmed by liver biopsy, VCTE, ELF score, or MRE.F2 or F3 fibrosis
  13. Obstructive sleep apnea: Zepbound only: the member benefit contract allows coverage of medications for weight loss in obesity or overweight, and the patient has moderate-to-severe OSA with concurrent obesity.AHI ≥15 events/hour; baseline BMI ≥30 kg/m²

    For overweight with OSA, use the obesity/overweight criteria.

  14. Lifestyle modification: The requested medication will be used concomitantly with lifestyle modification, such as dietary or caloric restriction, exercise, a weight-management program, nutritional counseling, or behavioral therapy.
    15. For obesity or overweight, including obstructive sleep apnea with obesity, the member benefit contract allows coverage of medications for weight loss.
  15. Lifestyle modification: The requested medication continues to be used with lifestyle modification, and this use is attested at annual review.

  16. Applicable response or clinical-benefit requirement

    • Obesity or overweight

      • Adults: The patient has at least a 5% body-weight reduction from pretreatment baseline or the dose is currently being titrated upward.≥5% body-weight reduction
      • Pediatrics: The patient has a reduction from pretreatment baseline BMI or the dose is currently being titrated upward.
    • MACE prevention: The patient continues optimized pharmacotherapy for established cardiovascular disease in combination with the requested agent.
    • Obstructive sleep apnea: There is improvement in OSA signs or symptoms, such as sleep quality, daytime functioning, or apnea-hypopnea index from baseline.
    • MASH/NASH: The medication provides clinical benefit, such as stability or improvement of liver fibrosis stage relative to baseline.
    17. Wegovy (semaglutide)
    ProductWegovy (semaglutide)
    Pen limitFour pens per 28 days
    Tablet limit30 tablets per 30 days
    Wegovy HD (semaglutide)
    ProductWegovy HD (semaglutide)
    Quantity limitFour pens
    PeriodPer 28 days
    Zepbound (tirzepatide)
    ProductZepbound (tirzepatide)
    Quantity limitFour pens
    PeriodPer 28 days