CurrentCignaPolicy CNF950

Weight Loss – Glucagon-Like Peptide-1 Agonists Benefit Exclusion Overrides Policy for EncircleRx BMI 35 - (CNF950)

Defines authorization (override of benefit exclusion) criteria for coverage of specified GLP-1 and GLP-1/GIP agents (Foundayo, liraglutide/Saxenda, Wegovy injection/tablet/HD, Zepbound) for weight loss and certain FDA-approved non-weight-loss indications (CV risk reduction, MASH/NASH, OSA) in adults and pediatric patients, including required documentation and prescriber specialty for select indications.

Policy Summary

PayerCigna

PolicyWeight Loss – Glucagon-Like Peptide-1 Agonists Benefit Exclusion Overrides Policy for EncircleRx BMI 35 - (CNF950)

Policy CodePolicy CNF950

Change TypeMultiple additions and revisions (products, criteria, documentation, durations)

Effective Date

Next Review Date

Key ActionSubmit documentation of baseline BMI (prior to any GLP-1/GLP-1-GIP therapy) and required supporting documentation (comorbidities, weight-loss response, liver fibrosis staging, or sleep study) as applicable.

SourceLink

POLICY UPDATE CHANGES

Liraglutide, generic to Saxenda, was added to the policy and baseline definition notes.

Wegovy MASH/NASH criteria updated to require stage F2 or F3 fibrosis confirmed by specified tests and numerical ELF range when used.

Zepbound OSA initial therapy baseline BMI requirement clarified to baseline prior to any GLP-1/GLP-1/GIP agonist and notes updated accordingly.

Foundayo and Wegovy HD injection were added to the policy; Foundayo added to not-covered list; Wegovy HD added with same criteria as Wegovy injection.

Initial approval duration for Wegovy (injection and tablet), Wegovy HD injection, and Wegovy tablet was changed to 8 months for weight-loss indications.

Wegovy tablet was added to the policy and related criteria; prior note that Wegovy tablet was not targeted was removed.

Policy Statement: added gender-definition note regarding specified gender where an asterisk is used in clinical criteria.

Condition not covered: Concomitant use with other GLP-1 or GLP-1/GIP agonists was removed in a prior revision but Concomitant Use with GLP-1 or GLP-1/GIP agonists is listed in this document as not medically necessary.

6Targeted products

8Adult initial approval (months)

3Specialty-required indications (MASH/NASH)

5Named not-covered medications

1OSA approval duration (years)

Coverage Summary

This policy defines authorization criteria to override benefit exclusions for specified GLP-1 and GLP-1/GIP agents (Foundayo, liraglutide/Saxenda, Wegovy injection/tablet/HD, and Zepbound) for weight loss and certain FDA-approved non-weight-loss indications; approvals require documentation of baseline BMI (defined as prior to any GLP-1 or GLP-1/GIP agonist), adherence to behavioral modification and reduced-calorie diet, and, for select indications, specialist prescribing or consultation. The scope covers adults and pediatric patients with obesity/overweight and lists product-specific approval durations and continuation thresholds.

Adult authorization BMI thresholds (policy)Baseline BMI ≥ 35 kg/m2 OR baseline BMI ≥ 27 kg/m2 with ≥ 2 weight‑related comorbidities

Pediatric thresholdBMI ≥ 95th percentile for age and sex

Liraglutide continuation weight‑loss threshold (adult)≥ 4% of baseline body weight

Foundayo/Wegovy/Zepbound continuation weight‑loss threshold (adult)≥ 5% of baseline body weight for Foundayo and Wegovy continuation; Zepbound continuation requires ≥ 10% of baseline body weight

Pediatric continuation (liraglutide/Wegovy)≥ 1% reduction in BMI from baseline

OSA AHI thresholdsApnea–hypopnea index ≥ 15 events/hour (moderate); ≥ 30 events/hour (severe). Zepbound OSA baseline BMI: ≥ 30 kg/m2

ELF test range for F2–F3 fibrosisELF score ≥ 9.2 to ≤ 10.5 when used to document F2–F3 fibrosis (within 6 months)

Alcohol consumption limits (MASH/NASH)Female < 20 grams/day; Male < 30 grams/day

General Policy Statement & Documentation Requirements

Covered when ALL of the following documentation requirements are met:

{

"operator":"all",

"children":[

{"text":"Documentation demonstrates patient meets BMI threshold (see policy for applicable adult or pediatric thresholds).","threshold":""},

{"text":"Baseline weight and BMI must be documented within 90 days prior to the request (include date, weight in kg or lb, height, and calculated BMI).","threshold":""},

I. Liraglutide (Saxenda, generic) — FDA-Approved Indications

Documentation Required

Weight‑loss response documentation for liraglutide continuation

For continuation approvals, provide documentation showing the percent weight (or BMI) reduction from baseline. For liraglutide (adult), the required continuation threshold is ≥ 4% weight loss from baseline. For pediatric patients receiving liraglutide, the required continuation threshold is ≥ 1% reduction in BMI from baseline. Baseline refers to measurements prior to any GLP‑1 or GLP‑1/GIP agonist.

Document baseline weight/BMI prior to any GLP-1/GLP-1‑GIP agonist
Provide weight at continuation timepoint demonstrating ≥4% (adult liraglutide) or ≥1% BMI reduction (pediatric liraglutide)

II. Foundayo — FDA-Approved Indications

Documentation Required

Weight‑loss response documentation for Foundayo continuation (≥5%)

For continuation approvals with Foundayo, provide documentation showing the patient has lost ≥ 5% of baseline body weight. Baseline refers to weight prior to any GLP‑1 or GLP‑1/GIP agonist.

Document baseline weight prior to any GLP-1/GLP-1‑GIP agonist
Provide weight at continuation timepoint demonstrating ≥5% weight loss

III. Wegovy injection & Wegovy HD injection — FDA-Approved Indications

III. Wegovy injection and Wegovy HD injection - FDA-Approved Indications

Covered when criteria below are met for weight loss, pediatric obesity, CV risk reduction, and MASH/NASH.

2. Pediatric Weight Loss - ONE of A or B

A) Initial Therapy - Approve for 8 months
- i: Patient is ≥ 12 years and < 18 years of age
- ii: Patient has engaged in a trial of behavioral modification and dietary restriction for at least 3 months
- iii: At baseline, patient had a BMI ≥ 95th percentile for age and sex

IV. Wegovy tablet — FDA-Approved Indications

Documentation Required

Weight‑loss response documentation for Wegovy continuation (≥5%)

For continuation approvals with Wegovy (injection/tablet/HD), provide documentation showing the patient has lost ≥ 5% of baseline body weight. Baseline refers to weight prior to any GLP‑1 or GLP‑1/GIP agonist.

Document baseline weight prior to any GLP-1/GLP-1‑GIP agonist
Provide weight at continuation timepoint demonstrating ≥5% weight loss

V. Zepbound — Obstructive Sleep Apnea (moderate to severe) & Weight-Loss Indications

Obstructive Sleep Apnea, Moderate to Severe, in a Patient with Obesity — Approve for 1 year

Covered as medically necessary when criteria below are met, including weight loss and obstructive sleep apnea indications.

2. Obstructive Sleep Apnea (moderate to severe) in a Patient with Obesity - ONE of A or B

A) Initial Therapy
- i: Patient is ≥ 18 years of age
- ii: At baseline, patient had a BMI ≥ 30 kg/m2BMI ≥30 kg/m2
  [documentation required]

Not Covered / Exclusions

The policy lists multiple not-covered statements: Foundayo, Saxenda (liraglutide), Wegovy (tablet and injection), Wegovy HD, and Zepbound are identified in the not-covered section for uses outside the specified FDA‑approved indications, and the policy explicitly states that Concomitant Use with GLP-1 Agonists or GLP-1/GIP Agonists is considered not medically necessary. History/changes note that Foundayo and other products were added to policy content and to not-covered lists during updates, and that the concomitant-use exclusion was removed in a prior revision then reappeared in the current document, consistent with the policy’s mixed coverage stance.

Denial Risk

Denial risk: Concomitant use with other GLP‑1 or GLP‑1/GIP agonists

Concomitant use of a GLP‑1 agonist with another GLP‑1 agonist or a GLP‑1/GIP agonist (coadministration of products in this class) is considered not medically necessary and is listed as a condition not covered.

Do not combine GLP‑1 agonists with other GLP‑1 or GLP‑1/GIP agonists
Prescribing information and policy explicitly state coadministration is not recommended/covered

Relevant Products Mentioned

Targeted drugs listed in policy textmixedCovered

Foundayo	orforglipron tablets - Eli Lilly (product name listed)
Saxenda	liraglutide subcutaneous injection - Novo Nordisk, generic
Wegovy_injection	semaglutide subcutaneous injection - Novo Nordisk
Wegovy_tablet	semaglutide tablets - Novo Nordisk
Wegovy_HD	Wegovy HD semaglutide subcutaneous injection - NovoNordisk
Zepbound	tirzepatide subcutaneous injection (pens and vials) - Eli Lilly

Products mentioned / referencedmixed

Foundayo	orforglipron tablets - Eli Lilly (listed as not covered)
Saxenda	liraglutide subcutaneous injection - Novo Nordisk, generic (listed as not covered)
Wegovy	semaglutide tablets and subcutaneous injection - Novo Nordisk (listed as not covered)
Wegovy HD	semaglutide subcutaneous injection - Novo Nordisk (listed as not covered)
Zepbound	tirzepatide subcutaneous injection [pens and vials] - Eli Lilly (listed as not covered)

Provider Actions & Documentation Requirements

Immediate authorization & documentation callouts

Specialty & diagnostic requirements

Background & Evidence

GLP-1 receptor agonists and the GLP-1/GIP agonist are indicated for weight reduction in combination with a reduced-calorie diet and increased physical activity for adults with overweight/obesity and for selected pediatric populations (liraglutide and Wegovy pediatric indications). Additional FDA indications in the policy include major adverse cardiovascular event (CV) risk reduction for Wegovy products, MASH/NASH (Wegovy injection/tablet/HD for non‑cirrhotic adults with stage F2–F3 fibrosis meeting specified diagnostic tests and ELF score criteria), and moderate to severe obstructive sleep apnea (OSA) for Zepbound. BMI category context is provided using standard ranges (overweight BMI ≥ 25.0–29.9; Class I BMI ≥ 30.0–34.9; Class II BMI ≥ 35.0–39.9; Class III BMI ≥ 40 kg/m2) and policy thresholds reference baseline BMI prior to any GLP-1 or GLP-1/GIP agonist.

Reference	Note
Wegovy prescribing information (semaglutide) — March 2026	Key clinical prescribing info cited in policy references list
MASH/NASH ELF threshold — Enhanced Liver Fibrosis (ELF) test	ELF score ≥ 9.2 to ≤ 10.5 (ELF performed within 6 months) — required to document stage F2–F3 fibrosis per updated criteria

Definitions

Baseline (term)Refers to status prior to any GLP‑1 agonist or GLP‑1/GIP receptor agonist therapy

Female* / Male* (specified gender)Specified gender refers to biological traits regardless of gender identity or expression

Moderate obstructive sleep apnea (definition)Apnea–hypopnea index (AHI) ≥ 15 events per hour

Severe obstructive sleep apnea (definition)Apnea–hypopnea index (AHI) ≥ 30 events per hour

MASH/NASH fibrosis staging documentationStage F2 or F3 fibrosis must be documented by ONE of: liver biopsy within 3 years, VCTE within 6 months, MRE within 6 months, or ELF within 6 months (ELF score ≥ 9.2 to ≤ 10.5)

Baseline BMI for Zepbound OSA indicationBaseline refers to BMI prior to any GLP‑1 or GLP‑1/GIP agonist; required baseline BMI ≥ 30 kg/m2 for initial and continuation OSA criteria

Revision History

11/01/2025Material

Liraglutide (generic) (Saxenda) was added to the policy and notes defining baseline were updated to include liraglutide (Saxenda, generic). Liraglutide added to pediatric and adult baseline definitions.

09/10/2025Non-material

Policy Statement: specified-gender definition (biological traits) was added and specialist prescribing requirement for Wegovy MASH/NASH was clarified.

10/22/2025Material

Wegovy MASH/NASH criteria updated: clarified absence of cirrhosis as 'F4' and diagnosis must be confirmed by liver biopsy within 3 years or VCTE/MRE within 6 months or ELF within 6 months with score ≥ 9.2 to ≤ 10.5.

Policy Summary

PayerCigna

PolicyWeight Loss – Glucagon-Like Peptide-1 Agonists Benefit Exclusion Overrides Policy for EncircleRx BMI 35 - (CNF950)

Policy CodePolicy CNF950

Change TypeMultiple additions and revisions (products, criteria, documentation, durations)

Effective Date

Next Review Date

SourceLink

On This Page

{"text":"Documentation of at least two weight-related comorbidities for adults with BMI ≥27 kg/m2 when applicable, or documentation supporting BMI ≥35 kg/m2 when that threshold is used. Examples of weight-related comorbidities include: type 2 diabetes mellitus, hypertension, dyslipidemia, obstructive sleep apnea, osteoarthritis of weight-bearing joints, and nonalcoholic steatohepatitis (MASH/NASH).","threshold":""},

{"text":"For requests related to MASH/NASH, submission must include diagnostic documentation (e.g., liver biopsy results, transient elastography/FibroScan, MR elastography, or other specialist documentation) that supports the diagnosis and fibrosis staging consistent with the indication (eg, F2–F3 where applicable). Wegovy injection and Wegovy HD for MASH/NASH must be prescribed by or in consultation with a physician who specializes in the condition being treated.","threshold":""},

{"text":"For requests related to obstructive sleep apnea (OSA), provide objective diagnostic documentation such as a sleep study (polysomnography) report or home sleep apnea test report supporting moderate to severe OSA in the context of obesity.","threshold":""},

All documentation must include patient identifiers (name, date of birth) and dates of measurements or test results. Chart notes, prescription records, and test reports are acceptable.

Documentation Required

Documentation

Provide baseline BMI and comorbidity documentation. Acceptable documentation includes:

Recent (within 90 days) height, weight, and calculated BMI with date of measurement
Chart notes documenting weight-related comorbidities (e.g., T2DM, HTN, dyslipidemia, OSA, osteoarthritis, MASH/NASH)
Sleep study (polysomnography or home sleep apnea test) report for OSA-related requests
Specialist reports or objective testing for MASH/NASH (liver biopsy, FibroScan, MR elastography) when applicable
Prescription claims records or receipts when relevant

BMI ≥ 95th percentile

[documentation required]

iv: Medication will be used concomitantly with behavioral modification and a reduced-calorie diet

B) Patient is Currently Receiving Wegovy (injection/HD/tablet) - Approve for 1 year

i: Patient is ≥ 12 years and < 18 years of age
ii: At baseline, patient had a BMI ≥ 95th percentile for age and sexBMI ≥ 95th percentile
[documentation required]
iii: Patient has had a reduction in BMI of ≥ 1% from baseline≥1%
[documentation required]
iv: Medication will be used concomitantly with behavioral modification and a reduced-calorie diet

3. Major Adverse Cardiovascular Event(s) Risk Reduction - Approve for 1 year

i: Patient is ≥ 18 years of age
[documentation required]
ii: At baseline, patient had a BMI ≥ 27 kg/m2BMI ≥27 kg/m2
[documentation required]
iii: Patient has ONE of: prior myocardial infarction, prior stroke (not TIA), or symptomatic peripheral arterial disease evidenced by ONE of (intermittent claudication with ABI < 0.85; peripheral arterial revascularization; amputation due to atherosclerotic disease)
[documentation required]
iv: Medication will be used in combination with optimized pharmacotherapy for established CV disease (per prescriber)
v: Medication will be used concomitantly with behavioral modification and a reduced-calorie diet

4. MASH/NASH - ONE of A or B - Approve for 1 year

A) Initial Therapy
- i: Patient is ≥ 18 years of age
- ii: Patient does not have cirrhosis (F4)F4 negative
- iii
  - a: Liver biopsy performed within 3 years prior to treatment3 years
    [documentation required]
  - b: Vibration-controlled transient elastography (VCTE) within 6 months prior6 months
    [documentation required]
  - c: Magnetic resonance elastography (MRE) within 6 months prior6 months
    [documentation required]
  - d: Enhanced Liver Fibrosis (ELF) test within 6 months prior with score ≥ 9.2 to ≤ 10.5ELF 9.2-10.5
    [documentation required]
- iv: ONE or more metabolic risk factors managed per standard of care (central obesity; hypertriglyceridemia; reduced HDL; hypertension; elevated fasting plasma glucose)
  per prescriber
- v: Alcohol consumption threshold by sexFemale <20 g/day; Male <30 g/day
  per prescriber
- vi: Medication used with appropriate diet and exercise therapy
- vii: Medication prescribed by or in consultation with an endocrinologist, gastroenterologist, or hepatologist
B) Patient is Currently Receiving Wegovy (injection/HD/tablet)
- i: Patient has completed ≥ 1 year of therapy with Wegovy (injection/HD/tablet) and per prescriber has not had worsening of fibrosis or MASH/NASH≥1 year
  [documentation required]
- ii: Patient does not have cirrhosis (F4) (per prescriber)F4 negative
- iii: Metabolic risk factors are managed according to standard of care (per prescriber)
- iv: Alcohol consumption threshold by sex

Documentation Required

MASH/NASH diagnostic and specialist prescribing documentation

Provide documentation confirming stage F2 or F3 liver fibrosis by ONE of the following: liver biopsy within the prior 3 years, VCTE within the prior 6 months, MRE within the prior 6 months, or ELF test within the prior 6 months with a score ≥ 9.2 to ≤ 10.5. Also provide prescriber attestation that the patient does not have cirrhosis (F4) and that metabolic risk factors are managed per standard of care. Wegovy injection and Wegovy HD injection for MASH/NASH must be prescribed by or in consultation with an endocrinologist, gastroenterologist, or hepatologist.

Liver biopsy performed within 3 years
VCTE within 6 months
MRE within 6 months
ELF within 6 months with score ≥ 9.2 to ≤ 10.5
Prescriber attestation: no cirrhosis (F4) and metabolic risk factors managed
Prescriber specialty: endocrinologist, gastroenterologist, or hepatologist (prescribe or consult)

Patient has a sleep study that shows BOTH: diagnosed moderate to severe obstructive sleep apnea AND apnea-hypopnea index ≥ 15 events per hour

AHI ≥15 events/hour

[documentation required]

iv: The patient does NOT have either central sleep apnea or Cheyne-Stokes respiration

v: Medication will be used concomitantly with behavioral modification and a reduced-calorie diet

B) Patient is Currently Receiving Zepbound

i: Patient is ≥ 18 years of age
ii: At baseline, patient had a BMI ≥ 30 kg/m2BMI ≥30 kg/m2
[documentation required]
iii: Patient has completed ≥ 1 year of therapy with Zepbound AND the patient has BOTH: lost ≥ 10% of baseline body weight AND per prescriber has stability in obstructive sleep apnea signs or symptoms≥10%
[documentation required]
iv: Medication will be used concomitantly with behavioral modification and a reduced-calorie diet

Documentation Required

OSA diagnostic documentation and prescriber attestation (Zepbound continuation ≥10%)

Provide sleep study documentation diagnosing moderate to severe obstructive sleep apnea with an apnea–hypopnea index (AHI) ≥ 15 events/hour and documentation that the patient does NOT have central sleep apnea or Cheyne‑Stokes respiration. For patients currently receiving Zepbound, provide documentation that the patient has completed ≥ 1 year of therapy and, per the prescriber, has lost ≥ 10% of baseline body weight and has stability in OSA signs/symptoms.

Sleep study showing diagnosis of moderate–severe OSA and AHI ≥ 15 events/hour
Document absence of central sleep apnea and absence of Cheyne‑Stokes respiration
For continuation on Zepbound: documentation of ≥10% weight loss from baseline and prescriber attestation of symptom stability

12/03/2025Material

Zepbound OSA baseline BMI requirement clarified to reference baseline prior to any GLP-1 or GLP-1/GIP agonist; exclusion for central sleep apneas modified (removed percent central apneas/hypopneas requirement).

03/11/2026Material

Wegovy tablet was added to the policy; Wegovy tablet criteria created and added to documentation and continuity rules; note that Wegovy tablet is not currently targeted was removed; Zepbound baseline notes updated to reference baseline prior to any GLP-1/GLP-1/GIP agonist.

04/01/2026Material

Wegovy HD injection and Foundayo were added to the policy; Foundayo added with new criteria; Wegovy HD added with same criteria as Wegovy injection.

04/15/2026MaterialLatest

Initial approval durations for Wegovy (injection and tablet), Wegovy HD injection, and Wegovy tablet for weight-loss indications changed to 8 months; related notes and criteria updated to reflect 8-month initial approvals and inclusion of Wegovy HD/Foundayo in documentation.

11/01/2025Material

Condition not covered: Concomitant use with other GLP-1 or GLP-1/GIP agonists was previously removed in a prior revision but is listed here as not medically necessary (policy lists Concomitant Use as not covered).

Female <20 g/day; Male <30 g/day

v: Medication used with appropriate diet and exercise therapy

vi: Medication prescribed by or in consultation with an endocrinologist, gastroenterologist, or hepatologist