Pharmacy Prior Authorization Criteria

Wegovy (semaglutide) and Zepbound (tirzepatide) Label Based PA

Indications for Prior Authorization

Wegovy (semaglutide)

• For diagnosis of Chronic Weight Management
  Indicated as an adjunct to a reduced-calorie diet and increased physical activity for chronic weight management in adults with an initial BMI of 30 kg/m(2) or greater (obesity), or 27 kg/m(2) or greater (overweight) in the presence of at least one weight-related comorbid condition (eg, hypertension, type 2 diabetes mellitus, or dyslipidemia).

• For diagnosis of Chronic Weight Management
  Indicated as an adjunct to a reduced calorie diet and increased physical activity for chronic weight management in pediatric patients aged 12 years and older with an initial BMI at the 95th percentile or greater for age and sex (obesity).

• For diagnosis of Reduce the risk of major adverse cardiovascular events
  Indicated in combination with a reduced calorie diet and increased physical activity to reduce the risk of major adverse cardiovascular events (cardiovascular death, non-fatal myocardial infarction, or non-fatal stroke) in adults with established cardiovascular disease and either obesity or overweight.

• For diagnosis of Limitations of Use:
  Wegovy contains semaglutide and should not be coadministered with other semaglutide-containing products or with any other GLP-1 receptor agonist. The safety and effectiveness of Wegovy in combination with other products intended for weight loss, including prescription drugs, over-the-counter drugs, and herbal preparations, have not been established. Wegovy has not been studied in patients with a history of pancreatitis.

Zepbound (tirzepatide) Injection

• For diagnosis of Chronic Weight Management
  Indicated as an adjunct to a reduced-calorie diet and increased physical activity for chronic weight management in adults with an initial BMI of 30 kg/m(2) or greater (obesity), or 27 kg/m(2) or greater (overweight) in the presence of at least one weight-related comorbid condition (e.g., hypertension, dyslipidemia, type 2 diabetes mellitus, obstructive sleep apnea, or cardiovascular disease).

• For diagnosis of Limitations of Use:
  Zepbound contains tirzepatide. Coadministration with other tirzepatide-containing products or with any glucagon-like peptide-1 (GLP-1) receptor agonist is not recommended. The safety and efficacy of Zepbound in combination with other products intended for weight management, including prescription drugs, over-the-counter drugs, and herbal preparations, have not been established. Zepbound has not been studied in patients with a history of pancreatitis.

• For diagnosis of Obstructive sleep apnea
  indicated in combination with a reduced calorie diet and increased physical activity for the treatment of moderate to severe obstructive sleep apnea in adults with obesity.

Criteria

Wegovy*,**

*Please consult client-specific resources to confirm whether benefit exclusions should be reviewed for medical necessity. **If being used for any indication other than appetite suppression/weight loss or to reduce the risk of major adverse cardiovascular events, deny the case for medical necessity and do not review for off-label use.

Prior Authorization (Initial Authorization)

Length of Approval: 6 Month(s) [D]
For diagnosis of Weight Management

• Treatment is being requested for appetite suppression or weight loss
AND
• One of the following:
• Both of the following:
• Patient is 18 years of age or older
• Baseline BMI greater than or equal to 30 kg/m2 prior to initiating any GLP-1 therapy
OR
• All of the following:
• Patient is 18 years of age or older
• Baseline BMI is greater than or equal to 27 kg/m2 prior to initiating any GLP-1 therapy
• Patient has a weight-related comorbidity (e.g., hypercholesterolemia, hypertension, diabetes, sleep apnea)
OR
• Both of the following:
• Patient is between 12 and 17 years of age
• Baseline BMI is in the 95th percentile or greater standardized for age and sex prior to initiating any GLP-1 therapy
AND
• One of the following:
• Patient is new to Wegovy therapy or has been on Wegovy therapy for less than 6 months
• Patient has been on therapy for at least 6 months and has had a weight loss of greater than or equal to 5% of baseline body weight
AND
• Used as an adjunct to lifestyle modification (e.g., dietary or caloric restriction, exercise, behavioral support, community based program)
AND
• Medication is not being co-administered with any of the following:
• Tirzepatide-containing products (e.g., Mounjaro)
• GLP-1 receptor agonists (e.g., Saxenda, Trulicity, Victoza)

Wegovy

*Baseline BMI refers to patient’s BMI prior to initiating any GLP-1 therapy.

Prior Authorization (Reauthorization)

Length of Approval: 6 Month(s)
For diagnosis of Weight Management

• One of the following:
• Patient has been receiving Wegovy therapy for up to 6 months and has had a weight loss of greater than or equal to 5% of baseline body weight* [B]
• Patient has been receiving Wegovy therapy for greater than 6 months and is continuing to experience or maintain weight loss
AND
• Medication is not being co-administered with any of the following:
• Tirzepatide-containing products (e.g., Mounjaro)
• GLP-1 receptor agonists (e.g., Saxenda, Trulicity, Victoza)
AND
• Used as an adjunct to lifestyle modification (e.g., dietary or caloric restriction, exercise, behavioral support, community based program)
AND
• Both of the following:
• Patient has been adherent to 4 consecutive months of treatment
AND
• One of the following:
• Patient is currently on a maintenance dose of 1.7mg or 2.4mg once weekly
• Patient has received less than 6 months of treatment with Wegovy and is continuing to titrate to a target dose of 1.7mg or 2.4mg once weekly

Wegovy*

*If being used for any indication other than appetite suppression/weight loss or to reduce the risk of major adverse cardiovascular events, deny the case for medical necessity and do not review for off-label use.

Prior Authorization (Initial Authorization)

Length of Approval: 12 Month(s)
For diagnosis of Reduce the risk of major adverse cardiovascular events

• Treatment is being requested to reduce the risk of major adverse cardiovascular events (cardiovascular death, non-fatal myocardial infarction, or non-fatal stroke)
AND
• Patient is 18 years of age or older
AND
• Patient has established cardiovascular disease as evidenced by one of the following [7]:
• Prior myocardial infarction (MI)
• Prior stroke (i.e., transient ischemic attack, ischemic or hemorrhagic stroke)
• Peripheral arterial disease (i.e., intermittent claudication with ankle-brachial index < 0.85, peripheral arterial revascularization procedure, or amputation due to atherosclerotic disease)
AND
• Used in as an adjunct to lifestyle modification (e.g., dietary or caloric restriction, exercise, behavioral support, community-based program)
AND
• BMI greater than or equal to 27 kg/m2
AND
• Medication is not being co-administered with any of the following:
• GLP-1 receptor agonists (e.g., Victoza, Ozempic, Rybelsus, Trulicity)
• Tirzepatide-containing products (e.g., Mounjaro)

Wegovy

Prior Authorization (Reauthorization)

Length of Approval: 12 Month(s)
For diagnosis of Reduce the risk of major adverse cardiovascular events

• Patient is currently on a maintenance dose of 1.7mg or 2.4mg once weekly
AND
• Used in as an adjunct to lifestyle modification (e.g., dietary or caloric restriction, exercise, behavioral support, community-based program)
AND
• Medication is not being co-administered with any of the following:
• GLP-1 receptor agonists (e.g., Victoza, Ozempic, Rybelsus, Trulicity)
• Tirzepatide-containing products (e.g., Mounjaro)

Zepbound Pen*,**

*Please consult client-specific resources to confirm whether benefit exclusions should be reviewed for medical necessity. **If being used for any indication other than appetite suppression/weight loss or obstructive sleep apnea, deny the case for medical necessity and do not review for off-label use. ^Baseline BMI refers to patient's BMI prior to initiating any GLP-1 therapy.

Prior Authorization (Initial Authorization)

Length of Approval: 6 Month(s)
For diagnosis of Weight Management

• Treatment is being requested for appetite suppression or weight loss
AND
• One of the following:
• Both of the following:
• Patient is 18 years of age or older
• Baseline BMI greater than or equal to 30 kg/m2 prior to initiating any GLP-1 therapy^
OR
• All of the following:
• Patient is 18 years of age or older
• Baseline BMI is greater than or equal to 27 kg/m2 prior to initiating any GLP-1 therapy
• Patient has a weight-related comorbidity (e.g., hypercholesterolemia, hypertension, diabetes, sleep apnea)
AND
• One of the following:
• Patient is new to Zepbound therapy or has been on Zepbound therapy for less than 6 months
• Patient has been on therapy for at least 6 months and has had a weight loss of greater than or equal to 5% of baseline body weight
AND
• Used as an adjunct to lifestyle modification (e.g., dietary or caloric restriction, exercise, behavioral support, community based program)
AND
• Medication is not being co-administered with any of the following:
• Tirzepatide-containing product (e.g., Mounjaro)
• GLP-1 receptor agonists (e.g., Saxenda, Trulicity, Victoza)

Zepbound Pen

Prior Authorization (Reauthorization)

Length of Approval: 6 Month(s)
For diagnosis of Weight Management

• One of the following:
• Patient has been receiving Zepbound therapy for up to 6 months and has had a weight loss of greater than or equal to 5% of baseline body weight [B]
• Patient has been receiving Zepbound therapy for greater than 6 months and is continuing to experience or maintain weight loss
AND
• Medication is not being co-administered with any of the following:
• Tirzepatide-containing products (e.g., Mounjaro)
• GLP-1 receptor agonists (e.g., Saxenda, Trulicity, Victoza)
AND
• Used as an adjunct to lifestyle modification (e.g., dietary or caloric restriction, exercise, behavioral support, community based program)
AND
• Both of the following:
• Patient has been adherent to 1 month of treatment
• Patient is currently on a maintenance dose of 5mg, 7.5mg, 10mg, 12.5mg or 15mg once weekly

Zepbound Pen*

*If being used for any indication other than appetite suppression/weight loss or obstructive sleep apnea, deny the case for medical necessity and do not review for off-label use.

Prior Authorization (Initial Authorization)

Length of Approval: 6 Month(s)
For diagnosis of Obstructive Sleep Apnea

• Diagnosis of obstructive sleep apnea
AND
• Disease is moderate to severe as defined by 15 or more obstructive respiratory events (e.g., apnea-hypopnea index [AHI]) per hour of sleep confirmed by a sleep study
AND
• Patient is 18 years of age or older
AND
• Body Mass Index (BMI) of greater than or equal to 30 kg/m2
AND
• One of the following:
• Prescriber attests that the patient has been evaluated and counseled on continuous positive airway pressure CPAP therapy as the preferred treatment of choice
OR
• Patient is not a candidate for CPAP therapy (e.g., upper airway anatomic abnormalities, etc.)
AND
• Used as an adjunct to lifestyle modification (e.g., dietary or caloric restriction, exercise, behavioral support, community based program)
AND
• Medication is not being co-administered with any of the following:
• Tirzepatide-containing product (e.g., Mounjaro)
• GLP-1 receptor agonists (e.g., Saxenda, Trulicity, Victoza)

Zepbound Pen

Prior Authorization (Reauthorization)

Length of Approval: 6 Month(s)
For diagnosis of Obstructive Sleep Apnea

• Patient is currently on a maintenance dose of 10 mg, 12.5mg, or 15 mg once weekly
AND
• One of the following:
• Patient has been receiving Zepbound therapy for up to 6 months and has had a weight loss of greater than or equal to 5% of baseline body weight
OR
• Patient has been receiving Zepbound therapy for greater than 6 months and is continuing to experience or maintain weight loss
AND
• Used as an adjunct to lifestyle modification (e.g., dietary or caloric restriction, exercise, behavioral support, community based program)
AND
• Medication is not being co-administered with any of the following:
• Tirzepatide-containing product (e.g., Mounjaro)
• GLP-1 receptor agonists (e.g., Saxenda, Trulicity, Victoza)

Zepbound Vial

Prior Authorization

• Requests for Zepbound vials will not be approved as they are not authorized for coverage through pharmacy benefits

P & T Revisions

2025-06-04, 2025-04-29, 2025-03-05, 2025-01-15, 2024-12-23, 2024-10-18, 2024-10-03, 2024-09-05, 2024-08-02, 2024-06-27, 2024-06-24, 2024-06-03, 2024-05-02, 2024-04-17, 2024-03-22, 2024-03-20, 2024-03-20, 2024-02-19, 2024-02-14, 2024-01-16, 2024-01-12, 2023-12-20, 2023-11-16, 2023-08-01, 2023-06-16, 2023-02-27, 2023-01-31, 2022-11-02, 2022-09-06, 2022-07-21, 2022-06-27, 2022-06-03, 2022-05-06, 2022-02-28, 2021-11-01, 2021-09-01, 2021-08-04, 2021-05-21, 2021-03-03, 2021-02-04, 2020-07-15, 2020-02-19, 2019-10-29, 2019-07-01

References

1. Apovian CM, Aronne LJ, Bessesen DH, et al. Pharmacological Management of Obesity: An Endocrine Society Clinical Practice Guideline. J Clin Endocrinol Metab. 2015;100(2): 342-62.
2. Wegovy Prescribing Information. Novo Nordisk Inc. Plainsboro, NJ. March 2024.
3. Zepbound Prescribing Information. Lilly USA, LLC Indianapolis, IN. December 2024.
4. Pharmacological Management of Obesity: An Endocrine Society Clinical Practice Guideline. The Journal of Clinical Endocrinology & Metabolism, Volume 100, Issue 2, 1 February 2015, Pages 342–362. https://academic.oup.com/jcem/article/100/2/342/2813109. Accessed May 17, 2022.
5. Eisenberg D, Shikora SA, Aarts E, et al. 2022 American Society for Metabolic and Bariatric Surgery (ASMBS) and International Federation for the Surgery of Obesity and Metabolic Disorders (IFSO): Indications for Metabolic and Bariatric Surgery. Surg Obes Relat Dis. 2022;18(12):1345-1356.
6. A. Michael Lincoff, Kirstine Brown‐Frandsen, Colhoun HM, et al. Semaglutide and Cardiovascular Outcomes in Obesity without Diabetes. The New England Journal of Medicine. 2023;389(24). doi:https://doi.org/10.1056/nejmoa2307563
7. Messineo L, Bakker JP, Cronin J, Yee J, White DP. Obstructive sleep apnea and obesity: a review of epidemiology, pathophysiology and the effect of weight-loss treatments. Sleep Medicine Reviews. Published online August 1, 2024:101996-101996.
8. Patil SP, Ayappa IA, Caples SM, Kimoff RJ, Patel SR, Harrod CG. Treatment of Adult Obstructive Sleep Apnea with Positive Airway Pressure: An American Academy of Sleep Medicine Clinical Practice Guideline. Journal of Clinical Sleep Medicine. 2019;15(02):335-343.
9. Kapur VK, Auckley DH, Chowdhuri S, et al. Clinical Practice Guideline for Diagnostic Testing for Adult Obstructive Sleep Apnea: An American Academy of Sleep Medicine Clinical Practice Guideline. Journal of Clinical Sleep Medicine. 2017;13(03):479-504.
10. Clinical Guideline for the Evaluation, Management and Long-term Care of Obstructive Sleep Apnea in Adults. Journal of Clinical Sleep Medicine. 2009;05(03):263-276.

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End Notes

1. If a patient's response to a weight loss medication is deemed effective (weight loss greater than or equal to 5% of body weight or BMI) and safe, it is recommended that the medication be continued. [2]
2. Wegovy has a 7 month approval duration for initial auth, this allows for 16 weeks of dose escalation to reach maintenance dosage and 12 additional weeks of maintenance therapy. The Endocrine Society Clinical Practice Guideline states that 3 months is a reasonable trial period for weight loss medications. [5]
3. This list includes the most prevalent comorbidities in obesity based on clinical trials and current literature. [1, 2, 3]

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Revision History

• 2025-06-04: Updated guideline
• 2025-04-29: For Zepbound OSA indication, include apnea hypopnea index [AHI] > or equal to 15 as an example of obstructive respiratory event
• 2025-03-05: Formatting update to NF criteria Added Zepbound 7.5mg and 10mg vials to criteria
• 2025-01-15: Update to Zepbound OSA NF criteria; Saxenda, wegovy, and zepbound weight loss criteria updated to clarify that baseline BMI requirement is prior to any GLP-1 therapy.
• 2024-12-23: Addition of new Zepbound indication of Obstructive Sleep Apnea
• 2024-10-18: Removal of trial requirement for two non-GLP1s from reauth criteria for Saxenda, Wegovy and Zepbound NF criteria
• 2024-10-03: Removal of Contrave as example of non-glp1 weight loss agent
• 2024-09-05: Zepbound vial criteria added to guideline and update to Wegovy initial auth duration to 6 months and updates to any criteria requiring being on Wegovy for 7 months to 6 months
• 2024-08-02: Added in TIA as an example for stroke for Wegovy CVD indication. Updated Zepbound criteria to remove trial of Saxenda and Wegovy from both initial and reauth.
• 2024-06-27: Background update
• 2024-06-24: Obesity GLP1 separate criteria created
• 2024-06-03: Update to Wegovy NF criteria
• 2024-05-02: Updated operational note for Wegovy. No changes to criteria.
• 2024-04-17: Updated Zepbound PA criteria.
• 2024-03-22: Updated effective date to 3/22/24
• 2024-03-20: 1) Update Zepbound NF language based on PA ops feedback. No changes to clinical intent, wording updates. 2) Modify Saxenda, Wegovy NF criteria to align with Zepbound NF criteria except for the trial of Saxenda and Wegovy.
• 2024-03-20: Add in new criteria for Wegovy reduction in MACE indication
• 2024-02-19: Addition of operational note to Zepbound “Shortage of drug is not a reason for bypass of trial requirement."
• 2024-02-14: Updates to Zepbound NF criteria and Saxenda/Wegovy PA Criteria
• 2024-01-16: Updated Zepbound criteria.
• 2024-01-12: Zepbound PA criteria updated to mirror existing Non Formulary criteria.
• 2023-12-20: Updated Zepbound Non-Formulary criteria.
• 2023-11-16: New program for Zepbound
• 2023-08-01: Added in Wegovy 1.7mg as maintenance therapy option in the NF Reauth criteria
• 2023-06-16: Updated NF criteria for Wegovy and Saxenda to mirror risk-stratified PA. Separated pediatric and adult indications.
• 2023-02-27: Annual review - no criteria changes
• 2023-01-31: Removed generic products including phentermine, phendimetrazine, diethylpropion, diethylpropion ER & benzphetamine as target drugs. Added new criteria for pediatric indication for Wegovy. Consolidated adults/peds criteria for Saxenda to streamline guideline. Updated background and references.
• 2022-11-02: Added Orlistat to mirror Xenical. Updated references.
• 2022-09-06: Updated criteria with new indication for Qsymia. Updated background and references.
• 2022-07-21: Add NF criteria for Saxenda. Also added 90-day lookback duration for absence of paid claims language in NF criteria.
• 2022-06-27: Updated NF verbiage for Wegovy per PA feedback.
• 2022-06-03: Added submission of MR/paid claims verbiage to NF sections. Decreased initial auth approval duration to 7 months for Wegovy.
• 2022-05-06: Added NF criteria for Wegovy.
• 2022-02-28: Annual Review - no criteria changes
• 2021-11-01: Updated Saxenda criteria: not to be used in combination with other GLP-1 agonists.
• 2021-09-01: Removed Brand Regimex as target, now obsolete
• 2021-08-04: Added Wegovy as new target to guideline.
• 2021-05-21: Updated guideline name.
• 2021-03-03: 2021 Annual Review, no changes to criteria.
• 2021-02-04: Updated Saxenda criteria with expanded indication
• 2020-07-15: Removed step through Contrave for Qsymia and Saxenda. Contrave now steps through Qsymia.
• 2020-02-19: 2020 Annual Review: removed Belviq/Belviq XR as targets due to withdrawal from market, updated references. No changes to criteria.
• 2019-10-29: Added Brand Adipex-P
• 2019-07-01: Removal of "continuation of lifestyle modification" criteria within the reauth section was approved at May P&T for Saxenda; proceed with updating this for Saxenda only, eff 7/1/19. Evaluate if we should remove this from all drugs in this program for consistency, and if so we can bring these to July P&T. Decision was to remove criteria from guideline…as onust should be on presciber to recommend continuous lifestyle modifications. Also, will remove from Contrave as this is preferred agent, and 7/1 guideline has the non preferred agent, Saxenda, less restrictive until the next update of 8/1 or 9/1

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