Pharmacy Prior Authorization Criteria

Obesity GLP-1 Agonists – PA, NF

Indications for Prior Authorization

Saxenda (liraglutide)

• 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 12 years or older with body weight above 60 kg and an initial BMI corresponding to 30 kg/m(2) or greater for adults (obese) by international cut-offs using Cole Criteria. [14]

  Limitations of Use: The safety and effectiveness of Saxenda in pediatric patients with type 2 diabetes have not been established

• For diagnosis of Chronic Weight Management
  Indicated as an adjunct to a reduced-calorie diet and increased physical activity for chronic weight management in adult patients with an initial BMI of greater than or equal to 30 kg/m2 (obese) or greater than or equal to 27 kg/m2 (overweight) in the presence of at least one weight-related comorbidity (e.g., hypertension, type 2 diabetes mellitus, dyslipidemia).

• For diagnosis of Limitations of Use:
  Saxenda contains liraglutide and should not be coadministered with other liraglutide-containing products or with any other GLP-1 receptor agonist. The safety and effectiveness of Saxenda in pediatric patients with type 2 diabetes have not been established. The safety and effectiveness of Saxenda in combination with other products intended for weight loss, including prescription drugs, over-the-counter drugs, and herbal preparations, have not been established.

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.

Criteria

Zepbound Pen*,**

*Please consult client-specific resources to confirm whether benefit exclusions should be reviewed for medical necessity. **If being used for any other indication, deny the case for medical necessity and do not review for off-label use.

Prior Authorization (Initial Authorization)

Length of Approval: 6 Month(s)

• 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 40 kg/m2 prior to initiating Zepbound therapy
OR
• All of the following:
• Patient is 18 years of age or older
AND
• One of the following:
• Baseline BMI greater than or equal to 30 kg/m2 prior to initiating Zepbound therapy
OR
• Both of the following:
• Baseline BMI greater than or equal to 27 kg/m2 prior to initiating Zepbound 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)

• 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

Saxenda*,**, Wegovy*,**, Zepbound Pen*,**

*Please consult client-specific resources to confirm whether benefit exclusions should be reviewed for medical necessity. **If being used for any other indication, deny the case for medical necessity and do not review for off-label use. ***Shortage of drug is not a reason for bypass of trial requirement.

Non Formulary (Initial Authorization)

Length of Approval: 6 Month(s) [D]

• 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 40 kg/m2 prior to initiating therapy
OR
• All of the following:
• Patient is 18 years of age or older
AND
• Patient must have one or more of the following cardiovascular-related comorbidities [E]:
• Hypercholesterolemia
• Hypertension
• Type 2 diabetes mellitus
• Obstructive sleep apnea
• Cardiovascular disease
AND
• Drug is not being used for Type 2 diabetes mellitus [Note: if patient has T2DM, please consider choosing a GLP-1 receptor agonist that is indicated for the treatment of T2DM (e.g., Ozempic, Rybelsus, Victoza)
AND
• Patient’s baseline weight and BMI prior to initiating therapy is provided
AND
• Submission of medical records (e.g., chart notes) documenting baseline BMI greater than or equal to 35 kg/m2 prior to initiating therapy
AND
• Submission of medical records (e.g., chart notes) documenting both of the following:
• Trial of lifestyle modification that promotes a reduced calorie diet and exercise of at least 150 minutes per week for at least 6 months and patient has failed to achieve adequate weight loss
• Patient will be using therapy with continued lifestyle modification that promotes a reduced calorie diet and exercise of at least 150 minutes per week
AND
• Submission of medical records (e.g., chart notes) or absence of paid claims within the past 90 days confirming medication is not being co-administered with any of the following:
• GLP-1 receptor agonists (e.g., Victoza, Ozempic, Rybelsus, Trulicity)
• Tirzepatide-containing product (e.g., Mounjaro)
• Other weight loss agents indicated for short-term weight reduction or chronic weight management (e.g., Phentermine)
AND
• Provider attests to discontinuing or lowering the dose of drugs that may contribute to weight gain when clinically appropriate (e.g., neuropathic pain medications [gabapentin], antipsychotic medications [olanzapine], corticosteroids, hormonal therapy [estrogen replacement therapy])
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 two non-GLP1 receptor agonist weight loss medications (e.g., Phentermine, Qsymia)
• 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

Saxenda, Wegovy, Zepbound Pen

^PA clinician to confirm weight loss using the patient's baseline and current weight.

Non Formulary (Reauthorization)

Length of Approval: 6 Month(s)

• Patient's baseline and current weight and BMI is provided
AND
• One of the following:
• Both of the following:
• Patient has received up to 6 months of treatment
• Weight loss of greater than or equal to 5% of baseline body weight as confirmed by patient’s current weight and baseline weight^ [B]
OR
• Both of the following:
• Patient has received greater than 6 months of treatment
• Patient is continuing to experience or maintain weight loss as confirmed by patient’s current weight and baseline weight^
AND
• Submission of medical records (e.g., chart notes) documenting that patient will be using therapy with continued lifestyle modification that promotes a reduced calorie diet and exercise of at least 150 minutes per week
AND
• Submission of medical records (e.g., chart notes) or absence of paid claims within the past 90 days confirming medication is not being co-administered with any of the following:
• GLP-1 receptor agonists (e.g., Victoza, Ozempic, Rybelsus, Trulicity)
• Tirzepatide-containing product (e.g., Mounjaro)
• Other weight loss agents indicated for short-term weight reduction or chronic weight management (e.g., Phentermine)
AND
• Provider attests to discontinuing or lowering the dose of drugs that may contribute to weight gain when clinically appropriate (e.g., neuropathic pain medications [gabapentin], antipsychotic medications [olanzapine], corticosteroids, hormonal therapy [estrogen replacement therapy])
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

Saxenda, Wegovy*,**

*Please consult client-specific resources to confirm whether benefit exclusions should be reviewed for medical necessity. **If being used for any other indication, deny the case for medical necessity and do not review for off-label use.

Non Formulary (Initial Authorization)

Length of Approval: 6 Month
For diagnosis of Weight Management in Pediatric Patients between 12 and 17 years of age

• Treatment is being requested for appetite suppression or weight loss
AND
• One of the following:
• Both of the following:
• Patient is between 12 and 17 years of age
• Baseline BMI greater than or equal to 40 kg/m2 prior to initiating therapy
OR
• All of the following:
• Patient is between 12 and 17 years of age
AND
• Submission of medical records (e.g., chart notes) confirming initial BMI is in the 95th percentile or greater standardized for age and sex prior to initiating therapy
AND
• Used as an adjunct to lifestyle modification (e.g., dietary or caloric restriction, exercise, behavioral support, community based program)
AND
• Submission of medical records (e.g., chart notes) or absence of paid claims within the past 90 days confirming medication is not being co-administered with any of the following:
• Tirzepatide-containing product (e.g., Mounjaro)
• GLP-1 receptor agonists (e.g., Victoza, Ozempic, Rybelsus, Trulicity)
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
• Anesthesiologist
• Fitness Trainer
• Counselor
• Dermatologist
• Registered Dietician
• Therapist
• Pathologist
• Podiatrist
• Urologist

Saxenda, Wegovy

Non Formulary (Reauthorization)

Length of Approval: 6 Month(s)
For diagnosis of Weight Management in Pediatric Patients between 12 and 17 years of age

• Patient is between 12 and 17 years of age
AND
• Submission of medical records (e.g., chart notes) confirming weight loss of greater than or equal to 5% of baseline body weight [B]
AND
• Submission of medical records (e.g., chart notes) or absence of paid claims within the past 90 days confirming medication is not being co-administered with any of the following:
• Tirzepatide-containing products (e.g., Mounjaro)
• GLP-1 receptor agonists (e.g., Ozempic, Rybelsus, Trulicity, Wegovy)
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

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 45 years of age or older
AND
• Submission of medical records (e.g., chart notes) documenting patient has established cardiovascular disease as evidenced by one of the following:
• 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
• Submission of medical records (e.g., chart notes) documenting that medication is being 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) documenting BMI greater than or equal to 27 kg/m2
AND
• Submission of medical records (e.g., chart notes) documenting HbA1c less than 6.5% in the past 12 months
AND
• Submission of medical records (e.g., chart notes) documenting patient does not have any of the following [7]:
• Diagnosis of type 1 or type 2 diabetes (excluding gestational diabetes)
• NY Heart Association functional class IV heart failure
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:
• 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

• Submission of medical records (e.g., chart notes) documenting that patient demonstrated medication adherence (e.g., 80% adherence to treatment) over prior 6 months
AND
• Submission of medical records (e.g., chart notes) documenting that medication is being 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
• Paid claims or submission of medical records (e.g., chart notes) documenting patient is receiving a dose of 1.7mg or 2.4mg per week
AND
• Submission of medical records (e.g., chart notes) documenting HbA1c less than 6.5% in the past 12 months
AND
• Submission of medical records (e.g., chart notes) documenting patient does not have any of the following:
• Diagnosis of type 1 or type 2 diabetes (excluding gestational diabetes)
• NY Heart Association functional class IV heart failure
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:
• GLP-1 receptor agonists (e.g., Victoza, Ozempic, Rybelsus, Trulicity)
• Tirzepatide-containing products (e.g., Mounjaro)

Zepbound Vial

Prior Authorization and Non Formulary

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

P & T Revisions

1970-01-01, 2024-12-17, 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. Saxenda Prescribing Information. Novo Nordisk Inc. Plainsboro, NJ. December 2020.
2. 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.
3. Wegovy Prescribing Information. Novo Nordisk Inc. Plainsboro, NJ. March 2024.
4. Zepbound Prescribing Information. Lilly USA, LLC Indianapolis, IN. November 2023.
5. 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.
6. 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.
7. 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

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End Notes

1. An adult patient receiving Saxenda should have his/her body weight evaluated at week 16 after initiating therapy. [1]
2. 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]
3. A pediatric patient receiving Saxenda should have his/her BMI evaluated after maintenance dose has been achieved and patient has received 12 weeks of therapy at maintenance dose. [1]
4. 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]
5. 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

• 2024-12-17: New Program
• 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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