WHA
 

Foundayo - PA, NF

Indications for Prior Authorization

Foundayo (orforglipron)
  • For diagnosis of Chronic Weight Management
    Indicated in combination with a reduced-calorie diet and increased physical activity to reduce excess body weight and maintain weight reduction long term in adults with obesity or adults with overweight in the presence of at least one weight-related comorbid condition. Limitations of Use: Concomitant use with another GLP-1 receptor agonist is not recommended.

Criteria

Foundayo*,**

Prior Authorization, Non Formulary (Initial Authorization)

Length of Approval: 6 Months [A]
For diagnosis of Weight Management

  • Treatment is for weight loss
    • AND
  • Patient is 18 years of age or older
    • AND
  • Patient's baseline weight and Body Mass Index (BMI) prior to initiating any GLP-1 therapy are provided
    • AND
  • Submission of medical records (e.g., chart notes) documenting baseline BMI is greater than or equal to 35 kg/m2 prior to initiating any GLP-1 therapy
    • AND
  • One of the following:
    • Patient is new to Foundayo therapy or has been on orforglipron therapy for less than 6 months
    • Patient has been on Foundayo therapy for at least 6 months and has had a weight loss of greater than or equal to 5% of baseline body weight [A, C]
    AND
  • Drug is not being used for Type 2 diabetes mellitus (T2DM) (Note: use a GLP-1 receptor agonist that is indicated for the treatment of T2DM [e.g., Ozempic, Rybelsus, Victoza])
    • AND
  • Patient has one or more of the following cardiovascular-related comorbidities:
    • Hypercholesterolemia
    • Hypertension
    • Type 2 diabetes mellitus
    • Obstructive sleep apnea
    • Cardiovascular disease
    AND
  • Submission of medical records (e.g., chart notes) documenting both of the following:
    • Trial of lifestyle modification that promotes a reduced calorie diet of 500 kcal/day and exercise of at least 150 minutes per week for at least 6 months and patient has failed to achieve adequate weight loss
      • AND
    • Patient will be using Foundayo with continued lifestyle modification that promotes a reduced calorie diet (e.g., reduction of 500 kcal per day) and exercise of at least 150 minutes per week
    AND
  • Medication is not being co-administered with another GLP-1 receptor agonist (e.g., Victoza, Trulicity, Mounjaro, Ozempic, Wegovy, Rybelsus, Zepbound)
    • AND
  • Medication is not being co-administered with other weight loss agents indicated for short-term weight reduction or chronic weight management (e.g., phentermine)
    • AND
  • One of the following:
    • Paid claims or submission of medical records (e.g., chart notes) documenting at least a 3 month trial and inadequate response, contraindication, or intolerance to one non-GLP-1 receptor agonist weight loss medication (e.g., phentermine, Qsymia)
      • OR
    • No formulary alternative is available to treat the patient's condition
    AND
  • Prescribed by a Healthcare Professional knowledgeable about the use of GLP-1s for chronic weight management who will be overseeing the treatment and monitoring of the patient
    • AND
  • Medication is not prescribed by the following practitioners:
    • Chiropractor
    • Physical therapist
    • Ophthalmologist
    • Social Worker
    • Nurse Midwife
    • Dentist
    • Acupuncturist
    • Audiologist
    • Fitness Trainer
    • Anesthesiologist
    • Counselor
    • Dermatologist
    • Registered Dietician
    • Therapist
    • Pathologist
    • Podiatrist
    • Urologist
Foundayo

Prior Authorization, Non Formulary (Reauthorization)

Length of Approval: 6 Months [A]
For diagnosis of Weight Management

  • Treatment is for weight loss
    • AND
  • One of the following:
    • Both of the following:
      • Patient has been receiving Foundayo therapy for up to 6 months
      • Patient has had a weight loss of greater than or equal to 5% of baseline body weight* [A, C]
      OR
    • Both of the following:
      • Patient has been receiving Foundayo therapy for greater than 6 months
      • Patient is continuing to experience or maintain weight loss
    AND
  • Patient will be using orforglipron with continued lifestyle modification that promotes a reduced calorie diet (e.g., reduction of 500 kcal per day) and exercise of at least 150 minutes per week [D]
    • AND
  • Medication is not being co-administered with another GLP-1 receptor agonist (e.g., Victoza, Trulicity, Mounjaro, Ozempic, Wegovy, Rybelsus, Zepbound)
    • AND
  • Medication is not being co-administered with other weight loss agents indicated for short-term weight reduction or chronic weight management (e.g., phentermine)
    • AND
  • Prescribed by a Healthcare Professional knowledgeable about the use of GLP-1s for chronic weight management who will be overseeing the treatment and monitoring of the patient
    • AND
  • Medication is not prescribed by the following practitioners:
    • Chiropractor
    • Physical therapist
    • Ophthalmologist
    • Social Worker
    • Nurse Midwife
    • Dentist
    • Acupuncturist
    • Audiologist
    • Fitness Trainer
    • Anesthesiologist
    • Counselor
    • Dermatologist
    • Registered Dietician
    • Therapist
    • Pathologist
    • Podiatrist
    • Urologist

  • Guideline ID
    GL-490236

  • Formulary
    Premium

  • Effective date
    Apr 2, 2026

  • P&T approval date
    Jan 21, 2026

P & T Revisions

2026-04-06, 2026-01-23, 2025-12-18, 2025-11-05, 2025-10-08, 2025-09-18, 2025-08-18, 2025-08-18, 2025-06-18, 2025-03-21, 2025-03-05, 2025-01-15, 2024-12-23, 2024-10-03, 2024-09-05, 2024-08-02, 2024-07-09, 2024-06-05, 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. Foundayo Prescribing Information. Lilly USA, LLC. Indianapolis, IN. April 2026.
  2. Orforglipron for weight management in adults with obesity or overweight. Unpublished [AMCP dossier]. Eli Lilly; 2025. Updated October 17, 2025. Accessed January 7, 2026.
  3. Wharton S, Aronne LJ, Stefanski A, et al.; ATTAIN-1 Trial Investigators. Orforglipron, an oral small-molecule GLP-1 receptor agonist for obesity treatment. N Engl J Med. 2025; 393(18):1796-1806.
  4. 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.
  5. Jensen MD, Ryan DH, Apovian CM, et al. 2013 AHA/ACC/TOS guideline for the management of overweight and obesity in adults: a report of the American College of Cardiology/American Heart Association Task Force on Practice Guidelines and The Obesity Society. Circulation. 2014; 129(25 S2):S102-138.
  6. American Diabetes Association Professional Practice Committee; 8. Obesity and weight management for the prevention and treatment of type 2 diabetes: Standards of care in diabetes – 2025. Diabetes Care. 2025; 48(S1):S167-S180.
  7. A study of orforglipron in adult participants with obesity or overweight and Type 2 diabetes (ATTAIN-2). ClinicalTrials.gov identifier: NCT05872620. Updated September 18, 2025. Accessed January 3, 2026. https://clinicaltrials.gov/study/NCT05872620
  8. A study of orforglipron for the maintenance of body weight reduction in participants who have obesity or overweight with weight-related comorbidities (ATTAIN-MAINTAIN). ClinicalTrials.gov identifier: NCT06584916. Updated December 22, 2025. Accessed January 3, 2026. https://clinicaltrials.gov/study/NCT06584916
  9. Aronne LJ, Horn DB, le Roux CW, et al.; SURMOUNT-5 Trial Investigators. Tirzepatide as compared with semaglutide for the treatment of obesity. N Engl J Med. 2025; 393(1):26-36.
  1. 6 month approval duration accounts for maximum 20-week dose escalation period to maintenance dosing, followed by at least 4 weeks continued treatment on maintenance dose. This aligns with clinical practice guideline recommendations to assess effectiveness of weight loss medications (often defined as weight loss of at least 5% from baseline at month 3) and to monitor patients every 3 months during active weight management treatment. By week 24 (month 6) of the pivotal study ATTAIN-1, there was at least a 5% mean weight reduction from baseline across each of the 36 mg, 12 mg, and 6 mg orforglipron-treated groups. [3-6]
  2. In ATTAIN-1 and ATTAIN-MAINTAIN (which included only participants who had previously completed the SURMOUNT-5 study on investigational treatment), participants with BMI of at least 27 kg/m2 to less than 30 kg/m2 had at least one of the following weight-related comorbidities: hypertension, dyslipidemia, obstructive sleep apnea, or cardiovascular disease (e.g., ischemic cardiovascular disease, New York Heart Association Functional Class I-III heart failure). In ATTAIN-2, participants had BMI of 27 kg/m2 or greater and diagnosed Type 2 diabetes, while patients with type 1 diabetes were excluded. [3, 7-9]
  3. 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. [4-6]
  4. To achieve weight loss, an energy deficit is required. Guidelines recommend an energy deficit of 500 or 750 kcal/day or 30% energy deficit. Increased physical activity is also recommended, defined as increased aerobic physical activity for at least 150 min/week (i.e., at least 30 min per day, most days of the week). Higher levels of physical activity, about 200 to 300 minutes per week, are recommended to maintain lost weight or minimize weight regain long-term. [5]
  • 2026-04-06: New program
  • 2026-01-23: New program for Wegovy tablets
  • 2025-12-18: no criteria changes, added IL statute operational note
  • 2025-11-05: Update to add endocrinolgist as an additional prescriber option for MASH indication
  • 2025-10-08: Addition of generic liraglutide as a target drug, Update to Wegovy CV Risk & MASH Reauth Criterias and operational notes
  • 2025-09-18: Update to MASH indication
  • 2025-08-18: Addition of new Zepbound SC vials
  • 2025-08-18: Addition of new Wegovy MASH criteria
  • 2025-06-18: Guideline updated
  • 2025-03-21: Minor formatting update to Zepbound OSA criteria
  • 2025-03-05: Formatting update to PA criteria Added Zepbound 7.5mg and 10mg vials to criteria
  • 2025-01-15: Update to Zepbound OSA 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
  • 2024-10-03: Removal of Contrave as example of non-glp1 weight loss agent. Removal of trial requirement for two non-GLP1s from reauth criteria for Saxenda, Wegovy and Zepbound
  • 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.
  • 2024-07-09: New Risk-Stratified Program
  • 2024-06-05: Client adopts Risk-Stratified criteria (as per SN request TSK005887421).
  • 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