WHA

Zepbound (tirzepatide) – NF

Indications for Prior Authorization

Zepbound (tirzepatide) Injection
  • 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

Zepbound Pen

Non Formulary (Initial Authorization)

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

  • Diagnosis of obstructive sleep apnea
    • AND
  • Submission of medical records (e.g., chart notes) confirming disease is moderate to severe as defined by 15 or more obstructive respiratory events per hour of sleep confirmed by a sleep study [3, 5-6]
    • AND
  • Patient is 18 years of age or older
    • AND
  • Submission of medical records (e.g., chart notes) confirming Body Mass Index (BMI) of greater than or equal to 30 kg/m2
    • AND
  • Submission of medical records (e.g., chart notes) confirming one of the following: [9]
    • 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
  • Submission of medical records (e.g., chart notes) confirming medication will be used in combination with a program supporting a reduced calorie diet of at least 500 kcal/day and patient can be active for at least 150 minutes per week
    • AND
  • Submission of medical records (e.g., chart notes) confirming HbA1c less than 6.5% in the past 12 months
    • AND
  • One of the following:
    • Paid claims or submission of medical records (e.g., chart notes) confirming at least a 3 month trial and inadequate response, contraindication, or intolerance to one non-GLP-1 receptor agonist weight loss medication
      • OR
    • No formulary alternative is available to treat the patient's condition
    AND
  • Submission of medical records (e.g., chart notes) or absence of paid claims confirming medication is not being co-administered with any of the following:
    • Tirzepatide-containing product (e.g., Mounjaro)
    • GLP-1 receptor agonists (e.g., Trulicity, Victoza)
    • Other weight loss agents indicated for short-term weight reduction or chronic weight management
Zepbound Pen

Non Formulary (Reauthorization)

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

  • Paid claims or submission of medical records (e.g., chart notes) confirming patient is currently on a maintenance dose of 10 mg, 12.5mg, or 15 mg once weekly
    • AND
  • One of the following:
    • Both of the following:
      • Paid claims or submission of medical records (e.g., chart notes) confirming patient has been receiving Zepbound therapy for up to 6 months
      • Submission of medical records (e.g., chart notes) confirming weight loss of greater than or equal to 5% of baseline body weight
      OR
    • Both of the following:
      • Paid claims or submission of medical records (e.g., chart notes) confirming patient has been receiving Zepbound therapy for greater than 6 months
      • Submission of medical records (e.g., chart notes) confirming patient is continuing to experience or maintain weight loss
    AND
  • Submission of medical records (e.g., chart notes) confirming medication will be used in combination with a program supporting a reduced calorie diet of at least 500 kcal/day and patient can be active for at least 150 minutes per week
    • AND
  • Submission of medical records (e.g., chart notes) confirming HbA1c less than 6.5% in the past 12 months
    • AND
  • Submission of medical records (e.g., chart notes) or absence of paid claims confirming medication is not being co-administered with any of the following:
    • Tirzepatide-containing product (e.g., Mounjaro)
    • GLP-1 receptor agonists (e.g., Trulicity, Victoza)
    • Other weight loss agents indicated for short-term weight reduction or chronic weight management
Zepbound Vial

Non Formulary

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

  • Guideline ID
    GL-314233

  • Formulary
    ehb

  • Effective date
    Aug 17, 2025

  • P&T approval date

P & T Revisions

2025-07-09, 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

  1. Zepbound Prescribing Information. Lilly USA, LLC Indianapolis, IN. December 2024.
  2. 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
  3. 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.
  4. 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.
  5. 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.
  6. 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.
  • 2025-07-09: New custom program NF criteria for OSA.
  • 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