ModifiedCignaPolicy IP0206

Weight Loss - Glucagon-Like Peptide-1 Agonists - Foundayo

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This policy governs prior authorization and medical-necessity coverage for Foundayo (orforglipron tablets) used with behavioral modification, a reduced-calorie diet, and increased physical activity for adults with obesity or overweight plus a weight-related comorbidity. Coverage is subject to the applicable benefit plan, laws, and the criteria in this policy.

Policy Summary

PayerCigna

PolicyWeight Loss - Glucagon-Like Peptide-1 Agonists - Foundayo

Policy CodePolicy IP0206

Change TypeModified

Effective DateSep 1, 2026

Last ReviewJul 9, 2026

Next Review DateNot specified

Key ActionSubmit prior authorization for Foundayo benefit coverage and document the applicable eligibility criteria.

SourceLink

POLICY UPDATE CHANGES

Saxenda, liraglutide, Wegovy tablet, Wegovy injection, and Zepbound were removed from this policy and moved to new individual policies.

Wegovy HD injection was added with approval criteria stated to be the same as Wegovy injection.

MASH/NASH criteria were revised to require documented stage F2 or F3 fibrosis before treatment with Rezdiffra or Wegovy and to permit confirmation by liver biopsy, VCTE, MRE, or an ELF test meeting the specified score range.

Initial approval for adult and pediatric Wegovy weight-loss therapy was changed to 8 months, and Wegovy tablet initial-therapy approval was changed to 7 months.

The cardiovascular-risk-reduction criteria for Wegovy were combined for initial and current therapy with a 1-year approval duration and a baseline BMI requirement of ≥27 kg/m².

Zepbound obstructive sleep apnea criteria were revised to use baseline BMI ≥30 kg/m² before any GLP-1 or GLP-1/GIP agonist and to exclude central sleep apnea without the former requirement that central apneas or hypopneas comprise at least 50%.

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ModifiedCignaPolicy IP0206

Weight Loss - Glucagon-Like Peptide-1 Agonists - Foundayo

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Get alerted when Policy IP0206 changes without checking for updates manually.

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Policy Summary

PayerCigna

PolicyWeight Loss - Glucagon-Like Peptide-1 Agonists - Foundayo

Policy CodePolicy IP0206

Change TypeModified

Effective DateSep 1, 2026

Last ReviewJul 9, 2026

Next Review DateNot specified

Key ActionSubmit prior authorization for Foundayo benefit coverage and document the applicable eligibility criteria.

SourceLink

POLICY UPDATE CHANGES

Saxenda, liraglutide, Wegovy tablet, Wegovy injection, and Zepbound were removed from this policy and moved to new individual policies.

Wegovy HD injection was added with approval criteria stated to be the same as Wegovy injection.

Initial approval for adult and pediatric Wegovy weight-loss therapy was changed to 8 months, and Wegovy tablet initial-therapy approval was changed to 7 months.

The cardiovascular-risk-reduction criteria for Wegovy were combined for initial and current therapy with a 1-year approval duration and a baseline BMI requirement of ≥27 kg/m².

18 yearsMinimum age

BMI ≥30Baseline obesity threshold

BMI ≥27Baseline overweight threshold

8 monthsInitial Foundayo approval

≥5%Continuation weight loss

5Products moved to individual policies

Medical Necessity and Coverage Criteria

FDA-approved indication: adult weight loss

Covered for the FDA-approved adult weight-loss indication when ONE of the following pathways is met.

Initial or continuation therapy

Initial therapy
- Age: Patient is ≥18 years of age.≥18 years
- Lifestyle trial: Patient has engaged in a trial of behavioral modification and dietary restriction for at least 3 months.≥3 months
- Baseline BMI pathway
  - Obesity: At baseline, patient had a BMI ≥30 kg/m².BMI ≥30 kg/m²
  - Overweight with comorbidity
    Weight-related comorbidity: Hypertension; type 2 diabetes; dyslipidemia; obstructive sleep apnea; cardiovascular disease; knee osteoarthritis; asthma; chronic obstructive pulmonary disease; metabolic dysfunction-associated steatotic liver disease/non-alcoholic fatty liver disease; polycystic ovarian syndrome; or coronary artery disease.≥1 listed comorbidity
- Concomitant lifestyle treatment: Medication will be used concomitantly with behavioral modification and a reduced-calorie diet.
Continuation therapy
- Age: Patient is ≥18 years of age.≥18 years
- Baseline BMI pathway
  - Obesity: At baseline, patient had a BMI ≥30 kg/m².BMI ≥30 kg/m²
  - Overweight with comorbidity
    Weight-related comorbidity: Hypertension; type 2 diabetes; dyslipidemia; obstructive sleep apnea; cardiovascular disease; knee osteoarthritis; asthma; chronic obstructive pulmonary disease; metabolic dysfunction-associated steatotic liver disease/non-alcoholic fatty liver disease; polycystic ovarian syndrome; or coronary artery disease.≥1 listed comorbidity

MASH/NASH initial therapy

MASH/NASH initial therapy requires all of the following, with fibrosis confirmed by one qualifying method.

Qualifying fibrosis confirmation: Stage F2 or F3 fibrosis is confirmed by liver biopsy, vibration-controlled elastography (VCTE), magnetic resonance elastography (MRE), or Enhanced Liver Fibrosis (ELF) testing.ELF score ≥9.2 to ≤10.5 when ELF is used
Liver biopsy must be performed within 3 years before treatment; VCTE, MRE, and ELF must be performed within 6 months before treatment.

Zepbound obstructive sleep apnea

Zepbound obstructive sleep apnea criteria require the stated baseline BMI and sleep-study conditions.

Moderate-to-severe obstructive sleep apnea: Patient has obesity with baseline BMI ≥30 kg/m², has completed a sleep study, and does not have central sleep apnea.Baseline BMI ≥30 kg/m²

Baseline is measured before any GLP-1 agonist or GLP-1/GIP agonist; the former sleep-study one-year timeframe was removed.

Wegovy approval durations and cardiovascular indication

Approval durations and continuation rules vary by indication and Wegovy formulation.

Wegovy weight-loss approval duration: Adult and pediatric weight-loss therapy has an 8-month initial approval; Wegovy tablet initial therapy has a 7-month approval duration.8 months or 7 months depending on formulation and phase of therapy

Patients who have not completed 7 months of initial Wegovy therapy are directed to the initial-therapy criteria.

Wegovy cardiovascular-risk reduction: Initial and currently receiving therapy criteria were combined with a 1-year approval duration and require baseline BMI ≥27 kg/m² in a patient with established cardiovascular disease who is overweight or obese.Baseline BMI ≥27 kg/m²; approval 1 year

Baseline refers to BMI before applicable GLP-1 or GLP-1/GIP agonist therapy.

Coverage excludes concomitant use of Foundayo with another GLP-1 receptor agonist or with a GLP-1/GIP receptor agonist, including other medications approved for weight loss in these classes.

For Zepbound treatment of obstructive sleep apnea, coverage criteria exclude patients with central sleep apnea. The former requirement concerning central apneas or hypopneas comprising at least 50% was removed.

MASH/NASH treatment criteria require documentation of stage F2 or F3 fibrosis and require that the patient does not have cirrhosis, designated F4.

Foundayo is considered not medically necessary for any use other than the covered FDA-approved adult weight-loss indication. This includes concomitant use with another GLP-1 or GLP-1/GIP receptor agonist.

Thresholds and Coding Reference

Wegovy Cardiovascular-Risk Reduction

Baseline BMI threshold≥ 27 kg/m²

Applicable indicationWegovy cardiovascular-risk-reduction therapy in a patient with established cardiovascular disease who is overweight or obese

Baseline timingMeasured before treatment with any applicable GLP-1 or GLP-1/GIP receptor agonist

Zepbound Obstructive Sleep Apnea

Baseline BMI threshold≥ 30 kg/m²

Applicable indicationZepbound treatment of moderate-to-severe obstructive sleep apnea in a patient with obesity

Baseline timing

Authorization, Documentation, and Denial Risks

Prior Authorization

Prior Authorization Required

Prior authorization is required for benefit coverage of Foundayo. Approvals are issued for the applicable duration: 8 months for initial therapy and 1 year for patients continuing therapy.

One month equals 30 days when approval is authorized in months.

Prior Authorization

Prescription Benefit Prior Authorization

Prior authorization is recommended for prescription benefit coverage of liraglutide (Saxenda, generic), Wegovy, and Zepbound. This policy targets those products; other GLP-1 agonists without an FDA-approved indication for weight loss are not targeted.

Apply the current prescription-benefit authorization process to the listed products.

Therapy Background

Foundayo is an oral GLP-1 receptor agonist indicated for use with a reduced-calorie diet and increased physical activity to reduce excess body weight and maintain long-term weight reduction in adults with obesity or adults with overweight and at least one weight-related comorbidity. Treatment is used as an adjunct to behavioral modification.

Policy Definitions

BMI Categories

OverweightBMI ≥25.0 to ≤29.9 kg/m²

Class I obesityBMI ≥30.0 to ≤34.9 kg/m²

Class II obesityBMI ≥35.0 to ≤39.9 kg/m²

Class III obesityBMI ≥40 kg/m²

Baseline

Baseline BMIBMI measured before use of any GLP-1 agonist or GLP-1/GIP receptor agonist

Baseline body weightBody weight measured before use of any GLP-1 agonist or GLP-1/GIP receptor agonist

Policy Summary

PayerCigna

PolicyWeight Loss - Glucagon-Like Peptide-1 Agonists - Foundayo

Policy CodePolicy IP0206

Change TypeModified

Effective DateSep 1, 2026

Last ReviewJul 9, 2026

Next Review DateNot specified

Key ActionSubmit prior authorization for Foundayo benefit coverage and document the applicable eligibility criteria.

SourceLink

On This Page

Treatment response: Patient has lost at least 5% of baseline body weight.≥5% baseline body-weight loss

Baseline weight is measured before any GLP-1 or GLP-1/GIP receptor agonist.

Concomitant lifestyle treatment: Medication will be used concomitantly with behavioral modification and a reduced-calorie diet.

Measured before treatment with any applicable GLP-1 or GLP-1/GIP receptor agonist

MASH/NASH ELF Fibrosis Test

Qualifying ELF score≥ 9.2 to ≤ 10.5

Test timingELF test performed within 6 months preceding treatment with Rezdiffra or Wegovy

DocumentationThe qualifying score must be documented when ELF testing is used to confirm fibrosis

MASH/NASH Fibrosis Stage

Required fibrosis stageF2 or F3

TimingDocumented before initiating treatment

Applicable treatmentTreatment with Rezdiffra or Wegovy

Documentation Required

Clinical Eligibility Documentation

Submit documentation supporting the applicable clinical eligibility pathway for initial or continuation therapy. Initial therapy requires an adult patient who has completed at least 3 months of behavioral modification and dietary restriction, meets the baseline BMI and comorbidity criteria, and will use the medication with behavioral modification and a reduced-calorie diet; continuation additionally requires at least 5% loss of baseline body weight.

Patient must be ≥18 years of age.
At baseline, BMI must be ≥30 kg/m², or BMI must be ≥27 kg/m² with at least one qualifying weight-related comorbidity.
Qualifying comorbidities include hypertension, type 2 diabetes, dyslipidemia, obstructive sleep apnea, cardiovascular disease, knee osteoarthritis, asthma, chronic obstructive pulmonary disease, metabolic dysfunction-associated steatotic liver disease/non-alcoholic fatty liver disease, polycystic ovarian syndrome, or coronary artery disease.
Document baseline values before any GLP-1 or GLP-1/GIP receptor agonist when applicable.

Documentation Required

MASH/NASH Supporting Documentation

For Wegovy use for MASH/NASH, submit patient-specific records supporting the diagnosis and treatment eligibility. Documentation must identify the patient and may include chart notes, laboratory results, medical test results, claims records, prescription receipts, and other relevant information.

Ensure every submitted record contains patient-specific identifying information.
Include the relevant clinical, laboratory, imaging, and treatment records supporting MASH/NASH.

Documentation Required

Fibrosis Confirmation

Before initiating treatment with Rezdiffra or Wegovy, document stage F2 or F3 fibrosis using one accepted qualifying test. The test report and required documentation must support the fibrosis stage.

Liver biopsy performed within 3 years before treatment.
Vibration-controlled elastography (VCTE) performed within 6 months before treatment.
Magnetic resonance elastography (MRE) performed within 6 months before treatment.
Enhanced Liver Fibrosis (ELF) test performed within 6 months before treatment, with a score ≥9.2 to ≤10.5.
Do not use documentation showing cirrhosis (F4) to satisfy the F2/F3 requirement.

Documentation Required

Obstructive Sleep Apnea Sleep Study

For Zepbound coverage for moderate-to-severe obstructive sleep apnea in a patient with obesity, document that the patient has completed a sleep study. The current requirement does not limit the study to the past 1 year; a sleep study is still required.

Retain the sleep-study report or other patient-specific evidence of completion.
Central sleep apnea is excluded from this Zepbound obstructive sleep apnea coverage.

Denial Risk

Noncovered Use or Concomitant Incretin Therapy

Foundayo for uses outside the covered indications is considered not medically necessary. Concomitant use with another GLP-1 receptor agonist or a GLP-1/GIP receptor agonist is not recommended and may result in denial.

Do not submit Foundayo for noncovered uses.
Flag concurrent therapy with another GLP-1 agonist or GLP-1/GIP agonist before requesting coverage.

Denial Risk

Unsupported Diagnosis or Coding

Claims may be denied when submitted for conditions or diagnoses that are not covered under the policy or when the required supporting documentation is absent. Use the most appropriate codes in effect on the submission date.

Reimbursement is not allowed for services billed for unsupported conditions or diagnoses.
Claims submitted without covered code(s) under the applicable policy may be denied as not covered.

Denial Risk

MASH/NASH Fibrosis or Cirrhosis Failure

MASH/NASH-related coverage may be denied when the record does not establish F2 or F3 fibrosis with an accepted qualifying test, when the test is outside the required time window, or when documentation is inadequate. Coverage is also not supported when the patient has cirrhosis (F4).

Required confirmation: biopsy within 3 years, or VCTE, MRE, or ELF within 6 months before treatment.
ELF must score ≥9.2 to ≤10.5.
The prescriber must document that the patient does not have cirrhosis (F4) for applicable continuation criteria.

Denial Risk

Central Sleep Apnea Exclusion

Zepbound coverage for moderate-to-severe obstructive sleep apnea in a patient with obesity excludes patients with central sleep apnea. Do not treat central sleep apnea as qualifying obstructive sleep apnea for this benefit.

The exclusion applies to central sleep apnea regardless of the percentage of central apneas or hypopneas.

Examples of applicable therapiesLiraglutide, Wegovy, or Zepbound

Cirrhosis (F4)

DefinitionCirrhosis is designated as stage F4

MASH/NASH relevanceCirrhosis (F4) is excluded from the stated MASH/NASH treatment criteria

Required status for treatmentThe patient must not have cirrhosis (F4)

Stage F2 or F3 Fibrosis

Required stagesStage F2 or F3 fibrosis

TimingDocumentation is required before initiating MASH/NASH treatment

Confirmation methodsLiver biopsy, VCTE, MRE, or an ELF test meeting the qualifying score range

Baseline BMI

DefinitionBaseline BMI is the BMI measured before treatment with the applicable GLP-1 agonist or GLP-1/GIP receptor agonist

Applicable GLP-1 therapyAny applicable GLP-1 agonist, such as liraglutide or Wegovy

Applicable GLP-1/GIP therapyAny applicable GLP-1/GIP receptor agonist, such as Zepbound